0001171843-14-002434.txt : 20140520 0001171843-14-002434.hdr.sgml : 20140520 20140520072208 ACCESSION NUMBER: 0001171843-14-002434 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140520 FILED AS OF DATE: 20140520 DATE AS OF CHANGE: 20140520 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Prosensa Holding N.V. CENTRAL INDEX KEY: 0001574111 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: P7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35990 FILM NUMBER: 14856369 BUSINESS ADDRESS: STREET 1: J.H. OORTWEG 21 CITY: 2133 CH LEIDEN STATE: P7 ZIP: 00000 BUSINESS PHONE: 31 0 713320100 MAIL ADDRESS: STREET 1: J.H. OORTWEG 21 CITY: 2133 CH LEIDEN STATE: P7 ZIP: 00000 FORMER COMPANY: FORMER CONFORMED NAME: Prosensa Holding B.V. DATE OF NAME CHANGE: 20130410 6-K 1 f6k_052014.htm FORM 6-K f6k_052014.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
     
 
FORM 6-K
     

Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934

May 20, 2014

Commission File Number: 001-35990
     
 
Prosensa Holding N.V.
     

J.H. Oortweg 21
2333 CH Leiden
The Netherlands
(Address of principal executive offices)
     
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F ☒                          Form 40-F ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
 
 
 

 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in Leiden, The Netherlands on May 20, 2014.
 
 
PROSENSA HOLDING N.V.
 
     
     
 
By:
/s/Hans G.C.P. Schikan
 
   
Name:
Hans G.C.P. Schikan
 
   
Title:
Chief Executive Officer
 

 
 
By:
/s/Berndt A.E. Modig
 
   
Name:
Berndt A.E. Modig
 
   
Title:
Chief Financial Officer
 

 
 
 

 
EXHIBIT INDEX
 

Exhibit
Description of Exhibit
1
Prosensa Holding N.V. Unaudited Condensed Consolidated Interim Financial Statements as of March 31, 2014
2
Prosensa Holding N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
EX-1 2 exh_1.htm EXHIBIT 1 exh_1.htm
Exhibit 1
 
INDEX TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
     
 

 


 
 

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
 
 
         
Three months ended March 31,
 
   
Note
   
2014
   
2013
 
    € (‘000 except per share data)  
License revenue
  16       14,695       1,407  
Collaboration revenue
          60       993  
Total revenue
          14,755       2,400  
Other income
  17       237       1  
Research and development expense
  18       (5,257 )     (4,060 )
General and administrative expense
  19       (2,455 )     (1,795 )
Other gains - net
          24       1  
Operating gain/(loss)
          7,304       (3,453 )
Finance income
          227       192  
Finance costs
          (241 )     (188 )
Finance income/(cost) – net
          (14 )     4  
Net income/(loss)
          7,290       (3,449 )
Other comprehensive income
          -       -  
Total comprehensive income/(loss)*
          7,290       (3,449 )
Income/(loss) per share from operations attributable to the equity holders of the company during the year (in € per share)
                     
Basic earnings/(loss) per share
  21       0.20       (0.12 )
Diluted earnings/(loss) per share
  21       0.19       (0.12 )

*Total comprehensive income/(loss) is fully attributable to equity holders of the group
 
 
 
The notes are an integral part of these condensed consolidated financial statements.
 
2

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 

 
€ (‘000)
       
As of March 31,
   
As of December 31
 
   
Note
   
2014
   
2013
 
                   
Assets
                 
Non-current assets
                 
Leasehold improvements and equipment
  7       1,995       2,177  
Intangible assets
  8       708       758  
Other financial assets
  9       289       289  
Total non-current assets
          2,992       3,224  
Current assets
                     
Trade and other receivables
  10       3,455       4,403  
Prepayments
  11       904       931  
Cash and cash equivalents
  12       77,423       82,232  
Total current assets
          81,782       87,566  
Total assets
          84,774       90,790  
                       
Equity and liabilities
                     
Equity attributable to owners of the parent
                     
Share capital
          359       359  
Share premium
          119,268       119,222  
Other reserves
          2,545       2,123  
Accumulated deficit
          (58,494 )     (41,890 )
Unappropriated earnings
          7,290       (16,604 )
Total equity
  13       70,968       63,210  
                       
Liabilities
                     
Non-current liabilities
                     
Borrowings – non-current portion
  15       7,869       7,630  
Derivative financial instruments
          20       22  
Deferred revenue
  16       90       10,852  
Total non-current liabilities
          7,979       18,504  
Current liabilities
                     
Borrowings – current portion
  15       191       191  
Derivative financial instruments
          7       8  
Trade and other payables
  14       5,618       5,150  
Deferred revenue
  16       11       3,727  
Total current liabilities
          5,827       9,076  
Total liabilities
          13,806       27,580  
Total equity and liabilities
          84,774       90,790  
 
 
The notes are an integral part of these condensed consolidated financial statements.
 
3

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 
 
€ (‘000)
 
Common
Share
capital
   
Class O
Share
capital
   
Class A
Share
capital
   
Class B
Share
capital
   
Total Share
capital
   
Share
premium
   
Other
reserves
   
Retained
earnings
   
Unappropriated
earnings
   
Total equity
 
Balance at January 1, 2014
    359       -       -       -       359       119,222       2,123       (41,890 )     (16,604 )     63,210  
Net income/(loss)
    -       -       -       -       -       -       -       -       7,290       7,290  
Appropriation of result
    -       -       -       -       -       -       -       (16,604 )     16,604       -  
Share-based payments
    -       -       -       -       -       -       422       -       -       422  
Proceeds from shares issued
    -       -       -       -       -       46       -       -       -       46  
Share issuance cost
    -       -       -       -       -       -       -       -       -       -  
Balance at March 31, 2014
    359       -       -       -       359       119,268       2,545       (58,494 )     7,290       70,968  
                                                                                 
Balance at January 1, 2013
    35       7       74       174       290       56,118       1,056       (31,998 )     (9,892 )     15,574  
Net income/(loss)
    -       -       -       -       -       -       -       -       (3,449 )     (3,449 )
Appropriation of result
    -       -       -       -       -       -       -       (9,892 )     9,892       -  
Share-based payments
    -       -       -       -       -       -       58       -       -       58  
Proceeds from shares issued
    -       -       -       -       -       -       -       -       -       -  
Share issuance cost
    -       -       -       -       -       -       -       -       -       -  
Balance at March 31, 2013
    35       7       74       174       290       56,118       1,114       (41,890 )     (3,449 )     12,183  
 
 
The notes are an integral part of these condensed consolidated financial statements.
 
4

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
 
 
€ (‘000)
       
Three months ended March 31,
 
   
Note
   
2014
   
2013
 
Cash flows from operating activities
                 
Net income/(loss)
          7,290       (3,449 )
Adjustments for:
                     
- Amortization/depreciation
  7,8       317       304  
- Costs employee share option plan
  20       422       58  
- Reversal finance income, net
          (14 )     (4 )
- Changes in the fair value of derivatives
          (3 )     (3 )
- Changes in trade and other receivables
  10       829       (928 )
- Changes in prepayments
  11       27       (30 )
- Changes in trade and other payables
  14       440       693  
- Currency effect (outstanding) receivables and payables
          31       (6 )
- Changes in deferred revenue
  16       (14,478 )     (1,407 )
            (5,139 )     (4,772 )
Interest received
          315       453  
Interest paid
          (10 )     (10 )
Cash (used in)/generated from operating activities
          (4,834 )     (4,329 )
Cash flows from investing activities
                     
Purchases of tangible fixed assets
  7       (45 )     (167 )
Purchases of intangible assets
  8       (12 )     (28 )
Net cash (used in)/generated from investing activities
          (57 )     (195 )
Cash flows from financing activities
                     
Proceeds from issuance of share capital
  13       46       -  
Proceeds from borrowings
  15       50       -  
Redemption financial lease
  15       -       (62 )
Repayments of borrowings
  15       (25 )     (25 )
Net cash (used in)/generated from financing activities
          71       (87 )
Net increase/(decrease) in cash and cash equivalents
          (4,820 )     (4,611 )
Currency effect cash and cash equivalents
          11       (12 )
Cash and cash equivalents at beginning of the period
          82,232       40,738  
Cash and cash equivalents at end of the period
  12       77,423       36,115  
Restricted cash
  9       200       500  

 
The notes are an integral part of these condensed consolidated financial statements.
 
5

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
 
 
1. General information
 
The activities of Prosensa Holding N.V. and its subsidiaries (together “the Company”) primarily consist of developing innovative, RNA-based therapeutics for the treatment of genetic disorders.
 
Since July 3, 2013, the company completed its initial public offering ("IPO"). The IPO process resulted in the listing of  the Company’s ordinary shares under the ticker symbol “RNA” in the United States on the NASDAQ Global Select Market.
 
Effective January 12, 2014, GlaxoSmithKline (“GSK”) and the Company mutually agreed to terminate the Research and Development Collaboration and License agreement (the “research and collaboration agreement”) entered into on October 6, 2009. As of the effective date, the Company regained all rights for the development and commercialization of drisapersen, PRO044 and other applicable compounds in the DMD portfolio.
 
The Company is incorporated and domiciled in the Netherlands. The address of its registered office is J.H. Oortweg 21, Leiden. Prosensa Holding N.V. is the ultimate parent of the following group of entities:
 
1.
Prosensa Therapeutics B.V. (100%);
2.
Prosensa Technologies B.V. (100%);
3.
Polybiotics B.V. (100%); and
4.
Prosensa Inc. (100%)
 
The shares of Prosensa Holding N.V. are held by multiple shareholders, none of them having a share in the Company in excess of 25%.
 
The Management Board approved these condensed consolidated financial statements for issuance on May 20, 2014.
 
2. Summary of significant accounting policies
 
2.1 Basis of preparation
 
The condensed consolidated financial statements of the Company were prepared in accordance with IFRS for interim financial information (“IAS 34”). Certain information and disclosures normally included in consolidated financial statements prepared in accordance with IFRS have been condensed or omitted. Accordingly, these condensed consolidated financial statements should be read in conjunction with the Company’s annual consolidated financial statements for the year ended December 31, 2013 and accompanying notes included in the Form 20-F filed with the Securities & Exchange Commission (’Company’s annual consolidated financial statements’ or ‘financial statements’), which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board (IASB).
 
The principal accounting policies applied in the preparation of these condensed consolidated financial statements have been consistently applied to all the periods presented, unless otherwise stated and are consistent with those of the Company annual consolidated financial statement.
 
The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to these condensed consolidated financials are disclosed in note 4.
 
2.2 Changes in accounting policy and disclosures
 
The accounting policies adopted are consistent with those of the previous year, except as described below:
 
(a) New and amended standards adopted by the Company
 
The following standards and amendments to standards became effective for annual periods on January 1, 2014, and have been adopted by the Company in the preparation of the consolidated financial statements:
 
·
Amendment to IAS 36 Impairment of Assets
·
Amendment to IAS 39 Financial Instruments
·
IFRIC 21 Levies
 
 
6

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
The adoption of these new standards and amendments to standards had an immaterial effect to the Company’s financial position or results of operations in the periods presented.
 
(b) New standards and interpretations not yet adopted by the Company
 
There are no standards which are currently available for early adoption which are expected to have a significant effect on the condensed consolidated financial statements of the Company.
 
3. Financial risk management
 
3.1 Financial risk factors
 
The Company’s activities expose it to a variety of financial risks: market risk (including currency risk, fair value interest rate risk, cash flow interest rate risk and price risk), credit risk and liquidity risk.
 
The condensed consolidated financial statements do not include all financial risk management information and disclosures required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the period ended December 31, 2013.
 
There have been no changes in the financial management team that is responsible for financial risk management or in the Company’s financial risk management policies since December 31, 2013.
 
Liquidity risk
 
The table below sets forth the Company’s financial liabilities based on the remaining period at the balance sheet date to the contractual maturity date. Derivative financial liabilities are included in the analysis if their contractual maturities are essential for an understanding of the timing of the cash flows. The amounts disclosed in the table are the contractual undiscounted cash flows.
 
€ (‘000)
 
Less than
1 year
   
Between
1 and 2 years
   
Between
2 and 5 years
   
Over 5 years
   
Undefined
 
At March 31, 2014
                             
Borrowings (excl. finance lease liabilities)
    100       100       175       -       7,851  
Finance lease liabilities
    91       -       -       -       -  
Derivative financial instruments
(interest rate swap)
    7       7       13       -       -  
Trade and other payables
    5,618       -       -       -       -  
Total
    5,816       107       188       -       7,851  
                                         
At December 31, 2013
                                       
Borrowings (excl. finance lease liabilities)
    100       100       200       -       7,792  
Finance lease liabilities
    91       -       -       -       -  
Derivative financial instruments
(interest rate swap)
    8       8       14       -       -  
Trade and other payables
    5,150       -       -       -       -  
Total
    5,349       108       214       -       7,792  
 
3.2 Fair value estimation
 
The Company has entered into a floating-to-fixed interest rate swap to reduce the impact of volatility in changes to interest rates. The determined fair value of the interest rate swap is the impact between a fixed interest rate of 4.15% and the estimated interest rate at measurement date for the remaining period of the instrument discounted over time. The estimated interest rate and discount rates are level two fair value hierarchy inputs. As of March 31, 2014 and 2013, the change in fair value of the interest rate swap which was recorded through the condensed consolidated statement of comprehensive income amounted to €3 thousand gain and €3 thousand gain, respectively. The interest rate swap is recorded as both a non-current and current liability in the condensed consolidated balance sheet.
 
The carrying amount of the Company’s financial assets and financial liabilities is a reasonable approximation of their fair value.
 
 
7

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
4. Critical accounting estimates and judgments
 
Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances.
 
The preparation of financial statements in conformity with IFRS requires the Company to make estimates and assumptions that affect the reported amounts and classifications of assets and liabilities, revenues and expenses in the condensed consolidated financial statements. Actual results could differ materially from those estimates and assumptions.
 
The preparation of financial statements in conformity with IFRS also requires the Company to exercise judgment in applying accounting policies. Critical judgments in the application of the Company’s accounting policies and the key sources of estimation of uncertainty were the same as those applied to the consolidated financial statements for the year ended December 31, 2013.
 
The condensed consolidated financial statements do not include all disclosures for critical accounting estimates and judgments that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the period ended December 31, 2013.
 
On September 20, 2013 GlaxoSmithKline (“GSK”) and the Company announced that the drisapersen Phase III study (DEMAND III, or DMD114044) did not meet its primary endpoint. Effective January 12, 2014, the Company and GSK terminated the research and collaboration agreement for the development of drisapersen and the Company’s other DMD product candidates. On January 16, 2014, the Company reported preliminary data on the overall clinical program for drisapersen. On March 17, 2014, the Company reported preliminary results on the DEMAND V study (DMD114876), a Phase II placebo controlled exploratory study, and is currently working to complete the full evaluation of the benefit-to-risk profile of drisapersen treatment across all studies (“the evaluation”). The outcome of the evaluation may have a material impact on the further development of drisapersen and other DMD compounds by the Company. A negative outcome of the evaluation could alter the Company’s development plans and costs, and potentially impact the following accounts in the Company’s consolidated financial statements.

Borrowings
 
Certain loans from patient organizations have no fixed redemption schemes, and repayment is due when certain pre-determined milestones are met. As of March 31, 2014, the Company recorded €6.6 million of such loans with no fixed redemption schemes. The outcome of the evaluation may result in deferral of the redemption dates of our loans, which would lower the recorded amount of our outstanding loans, potentially to nil if the DMD program is discontinued. As of March 31, 2014, no deferral of the redemption dates of the loans or adjustment to the borrowings was necessary.
 
Intangible assets
 
As of March 31, 2014, we recorded patents and licenses with a net book value of €499 thousand. As of March 31, 2014, there were no changes to management’s assumptions used to determine the patent and licenses’ recoverable amount, which would exceed the carrying value of €499 thousand even if the outcome of the evaluation is negative, and therefore no impairment is required.
 
Deferred revenue & License revenue
 
Upfront license fee payments received were initially deferred and recognized based on the percentage of completion method, which required the Company to estimate the work performed to date as a proportion of the total work expected to be performed.
 
As a result of the termination of the research and collaboration agreement the Company was released from any performance obligations and recorded €14.7 million license revenue in the first quarter of 2014. As of March 31, 2014, the Company’s deferred revenue balance totals €0.1 million of grants deferred (reference is made to footnote 17).

 
8

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
5. Seasonality of Operations
 
The Company’s financial results have varied substantially and are expected to continue to vary from quarter to quarter. The Company therefore believes that period to period comparisons should not be relied upon as indicative of future financial results.
 
6. Segment information
 
The Company operates in one reportable segment, which comprises the discovery and development of innovative, RNA-based therapeutics. The Management Board is identified as the chief operating decision maker. The Management Board reviews the consolidated operating results regularly to make decisions about resources and to assess overall performance.
 
As of March 31, 2014, the Company derived its revenues from a single party, GSK, under the research and collaboration agreement, an exclusive worldwide collaboration for the development and commercialization of RNA-based therapeutics for DMD. The agreement was terminated effective January 12, 2014.
 
7. Leasehold improvements and equipment
 
€ (‘000)
 
Leasehold
improvements
   
Laboratory
equipment*
   
Office
equipment*
   
Construction
in progress
   
Total
 
Three months ended March 31, 2014
                             
Opening net book amount
    262       1,486       224       205       2,177  
Additions
    -       241       13       (181 )     73  
Depreciation charge (note 18, 19)
    (9 )     (209 )     (37 )     -       (255 )
Closing net book amount
    253       1,518       200       24       1,995  
                                         
At March 31, 2014
                                       
Cost
    354       4,713       802       24       5,893  
Accumulated depreciation
    (101 )     (3,195 )     (602 )     -       (3,898 )
Net book amount
    253       1,518       200       24       1,995  
 
* The Company made a reclassification between Laboratory equipment and Office equipment in the opening balance.
 
Depreciation expense of €215 thousand for the three months ended March 31, 2014 (three months ended March 31, 2013: €199 thousand) has been charged to research and development expense. Depreciation expense of €40 thousand for the three months ended March 31, 2014 (three months ended March 31, 2013: €48 thousand) has been charged to general and administrative expense.
 
Construction in progress mainly comprises laboratory equipment not ready for use as of March 31, 2014.
 
As of March 31, 2014, acquired equipment for an amount of €28 thousand was not yet paid and accordingly not reflected in the consolidated statement of cash flows.

 
9

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
8. Intangible assets
 
€ (‘000)
 
Patents and
licenses
   
Software
   
Total
 
Three months ended March 31, 2014
                 
Opening net book amount
    522       236       758  
Additions
    -       12       12  
Amortization charge
    (23 )     (39 )     (62 )
Closing net book amount
    499       209       708  
                         
At March 31, 2014
                       
Cost
    939       745       1,684  
Accumulated amortization and impairment
    (440 )     (536 )     (976 )
Net book amount
    499       209       708  
 
Amortization expense of €43 thousand for the three months ended March 31, 2014 (three months ended March 31, 2013: €40 thousand) has been charged to research and development expense. Amortization expense of €19 thousand for the three months ended March 31, 2014 (three months ended March 31, 2013: €18 thousand) has been charged to general and administrative expense.
 
9. Other financial assets
 
€ (‘000)
 
March 31,
   
December 31,
 
   
2014
   
2013
 
Deposit for rental obligations
    89       89  
Restricted cash
    200       200  
Total
    289       289  
 
The restricted cash balance secures a bank loan. Refer to note 12 of the condensed consolidated financial statements for further detail.
 
10. Trade and other receivables
 
€ (‘000)
 
March 31,
   
December 31,
 
   
2014
   
2013
 
Trade accounts receivable
    2,396       1,298  
Amounts to be invoiced to partners
    369       2,380  
Trade receivables
    2,765       3,678  
Value-added tax
    375       351  
Government and other grants to be received
    45       30  
Advances to personnel
    45       -  
Interest receivables on bank accounts
    225       344  
Total
    3,455       4,403  
 
As of March 31, 2014, trade receivables include an allowance related to the final settlement of the termination agreement. No other receivables were impaired or not performing. The carrying amount of the Company’s trade receivables are fully denominated in British pounds, while other receivables are fully denominated in Euros.
 
The maximum exposure to credit risk at the reporting date is the carrying value of each class of receivable mentioned above. The Company does not hold any collateral as security.
 
 
10

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
11. Prepayments
 
As of March 31, 2014, the Company made prepayments to suppliers for (pre)clinical studies and drug substance of €448 thousand and prepayments of €213 thousand on insurance fees (including D&O insurance).
 
12. Cash and cash equivalents
 
€ (‘000)
 
March 31,
   
December 31,
 
   
2014
   
2013
 
Cash at bank and on hand
    9,454       9,119  
Short-term bank deposits
    67,969       73,113  
Total
    77,423       82,232  
 
In 2006 the Company received a bank loan of €900 thousand from ABN Amro N.V. An amount of €200 thousand secures the bank loan and is therefore considered restricted cash and recorded as a component of other financial assets. The remaining balance is at the free disposal of the Company.
 
13. Equity
 
   
Number of shares
 
Class of shares and stated value
 
March 31, 2014
   
December 31, 2013
 
Total Common shares of EUR 0.01
    35,975,261       35,932,792  
 
The par value as of March 31, 2014, is €0.01 per share (as of December 31, 2013: €0.01 per share). All issued shares are fully paid. Besides the minimum amount of share capital to be held under Dutch law, there are no distribution restrictions applicable to equity of the Company.
 
In the three month period ended March 31, 2014, 42,469 shares were issued as a result of the exercise of vested options granted under the Company’s share-based compensation plans (refer to the Company’s annual consolidated financial statements for the period ended December 31, 2013 for details of the plans). The related weighted average price at the time of exercise was $5.78 per share.
 
14. Trade and other payables
 
€ (‘000)
 
March 31,
   
December 31,
 
   
2014
   
2013
 
Trade payables
    2,197       1,910  
Holiday payments and holiday rights
    646       457  
Social security and wage tax
    154       246  
Other liabilities
    2,621       2,537  
Total
    5,618       5,150  
 
Other liabilities
 
Other liabilities mainly consist of accruals for services provided by vendors but not yet billed and miscellaneous liabilities.
 
 
11

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
15. Borrowings
 
€ (‘000)
 
March 31,
   
December 31,
 
   
2014
   
2013
 
Non-current
           
Bank borrowings
    275       300  
Other loans
    7,594       7,330  
Finance lease liabilities
    -       -  
Total non-current
    7,869       7,630  
Current
               
Bank borrowings
    100       100  
Finance lease liabilities
    91       91  
Total current
    191       191  
Total
    8,060       7,821  
 
The payment of the finance lease obligation corresponding to the three month period ended March 31, 2014, was made in April 2014.
 
Borrowings
 
In 2006, the Company received a bank loan of €900 thousand from ABN Amro N.V. which matures in 2017. The loan bears interest equal to Euribor plus 1.75% per year. The Company redeems an amount of €25 thousand per quarter. The current portion of €100 thousand is included in borrowings-current portion. There is no portion of the loan exceeding five years.
 
In the three months ended March 31, 2014, the Company received a loan installment of €50 thousand from Agentschap NL as part of the innovation credit facility (Innovatiekrediet) of the Dutch Ministry of Economic Affairs. During 2013 the Company received a loan installment of €99 thousand from Agentschap NL, €500 thousand from the Duchenne Children’s Trust as installment of a €1.5 million funding agreement for research and development at an interest rate that approximates the market interest rate, €250 thousand from Association Française contre les Myopathies as installment of a €3.0 million funding agreement and €202 thousand from Everest International Pte Ltd as installment of a €1.0 million funding agreement for research and development at below market interest rates.
 
The condensed consolidated financial statements do not include all disclosures for borrowings that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the period ended December 31, 2013.
 
16. Revenue and deferred revenue
 
From October 2009 to January 2014, the Company operated under an exclusive worldwide collaboration with GSK for the development and commercialization of RNA-based therapeutics for DMD, with GSK exclusively licensing worldwide rights to develop and commercialize drisapersen and obtaining an option to exclusively license PRO044 and other specified assets in the Company’s DMD portfolio. Under the research and collaboration agreement, GSK paid the Company a total of £41.5 million (€47.4 million) in upfront and milestone payments. Under the research and collaboration agreement, GSK was responsible for all costs of clinical development of drisapersen.
 
In January 2014, the research and collaboration agreement was mutually terminated pursuant to a termination agreement, which terminates all intellectual property license grants as well as any rights arising under the research and collaboration agreement (other than rights to payments that accrued prior to termination of the collaboration). In addition, the termination agreement required GSK to transfer to the Company certain data and know-how, inventory, regulatory filings, clinical trial sponsorships, clinical study reports and material agreements relating to the development of the Company’s products.
 
Going forward, the Company will be solely responsible for the cost of developing and commercializing drisapersen and its other product candidates, which may have significant financial and operational implications.
 
The agreement to terminate the research and collaboration agreement released the Company from any performance obligations under the upfront payments already received from GSK. As a result, in the three months period ended March 31, 2014, the Company recognized €14.5 million deferred license income. The release from any performance obligations also resulted in recognition of €0.2 million revenue related to other services delivered under the research and collaboration agreement with GSK. In the three months ended March 31, 2014, collaboration revenue was minimal due to the termination of the research and collaboration agreement.
 
 
12

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
In the three months ended March 31, 2013, €859 thousand of the initial upfront payment under the research and collaboration agreement with GSK was recognized as license revenue in the consolidated condensed income statement and €548 thousand related to other upfront payments under the research and collaboration agreement.
 
The condensed consolidated financial statements do not include all disclosures for revenue and deferred revenue that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the period ended December 31, 2013.
 
17. Other income
 
The Company is part of two pan-European consortia, each of which has been awarded a Framework Programme 7 (“FP7”) research grant of €6 million from the European Commission to support the ongoing clinical study of PRO045 and the development of imaging biomarkers for Duchenne muscular dystrophy (DMD), respectively. The Company also received governmental research subsidies. Grant proceeds are deferred and recognized in other income based on the percentage of completion method in the amount of €231 thousand in the three month period ended March 31, 2014 (for the three months ended March 31, 2013: nil).

The Company obtained certain loans made to support research and development that generally bear interest at a rate below the market interest rate, considered by the Company to be 12% over the last four years. The difference between fair value and the notional amount at inception is treated as a grant received for certain research performed by the Company and recognized in other income over the periods during which expenses are incurred.
 
18. Research and development expense
 
Research and development expenses mainly increased due to the ongoing clinical phase I/II studies of PRO045 and PRO053, higher intellectual property expenses and the expansion of our development and regulatory capabilities directly impacted by the termination of the research and collaboration agreement with GSK.
 
19. General and administrative expense
 
General and administrative expense increased from €1.8 million to €2.5 million in the three months ended March 31, 2013 and 2014, respectively. The increase is primarily due to share-based compensation expense and costs associated with operating as a public company.
 
20. Share-based Payments
 
Share-based compensation expenses of €422 thousand were recognized during the three month period ended March 31, 2014 (for the three months ended March 31, 2013: €58 thousand). A total of 422,500 options were granted in the three month period ended March 31, 2014. The exercise price of the options is the quoted share price at the time, which ranged between $6.0 and $6.21. The Company used similar valuation assumptions, such as volatility, as used for previously granted options during the second half of 2013.
 
The condensed consolidated financial statements do not include all disclosures for share-based payments that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the period ended December 31, 2013.
 
21. Earnings/(Loss) per share
 
Basic
 
Basic earnings/(loss) per share is calculated by dividing the profit/(loss) attributable to equity holders of the Company by the weighted average number of ordinary and preferred shares in issue during the year.
 
 
13

 
PROSENSA HOLDING N.V.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 
   
Three months ended March 31,
 
   
2014
   
2013
 
Income/(Loss) attributable to equity holders of the company in EUR (‘000) 
    7,290       (3,449 )
Weighted average number of Common and Preference shares in issue
    35,933,264       29,002,298  
 
Diluted
 
Diluted earnings/(loss) per share is calculated by adjusting the weighted average number of ordinary shares outstanding to assume conversion of all dilutive potential ordinary shares.
 
   
Three months ended March 31,
 
   
2014
   
2013
 
Income/(Loss) attributable to equity holders of the company in EUR (‘000) 
    7,290       (3,449 )
Dilutive potential Common and Preference shares                                                                                                
    2,485,165         (*)
Weighted average number of Common and Preference shares in issue - diluted
    37,859,678       29,002,298 (*)
 
(*) In the three months ended March 31, 2013 the Company was loss making, and all potential ordinary shares had an antidilutive effect, if converted, and thus were excluded from the computation of loss per share.
 
22. Income tax expense
 
No tax charge or income has been recognized in the three month period ended March 31, 2014, or the corresponding period in 2013. The Company has a history of tax losses and expects to record a loss for the year ended December 31, 2014. Management’s judgment is that sufficient evidence is currently not available that future taxable profit will be available against which the unused tax losses or unused tax credits can be utilized by the fiscal unity, therefore a deferred tax asset is not recognized.
 
23. Related-party transactions
 
In the period ended March 31, 2014 and 2013, the Management Board was paid regular salaries and contributions to post-employment schemes. Additionally, selected members of the Supervisory Board received compensation for their services in the form of cash compensation. No loans, advances or guarantees were made to the Management Board or Supervisory Board members as of March 31, 2014 and 2013.
 
The condensed consolidated financial statements do not include all disclosures for related-party transactions that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s annual consolidated financial statements for the period ended December 31, 2013.
 
24. Events after the balance sheet date
 
On April 7, 2014, we informed ABN that the Company intended to repay the full outstanding loan amount in the second quarter of 2014. Per March 31, 2014, the amount of the loan is €375 thousand plus interest. At the time of issue of this report the loan has not been repaid. The floating-to-fixed interest rate swap outstanding as of March 31, 2014 will be dissolved in the three month period ended June 30, 2014.
 
 
 
14
 

EX-2 3 exh_2.htm EXHIBIT 2 exh_2.htm
Exhibit 2
 
Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
This section should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in Exhibit 1 of this Quarterly Report and the section contained in our Annual Report on Form 20-F (our “Annual Report”) — Operating And Financial Review And Prospects”. This discussion contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Many of the forward-looking statements contained in this Quarterly Report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “will,” “estimate” and “potential,” among others. Forward-looking statements appear in a number of places in this 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 our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the section “Item 3. Key Information—D. Risk factors” of our Annual Report.

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.
 
These risks and uncertainties include factors relating to:

·
the timing or likelihood of regulatory filings and approvals;
 
·
our expectations regarding regulators’ acceptance of accelerated approval pathways for drisapersen and our follow-on product candidates by the FDA and the EMA;
 
·
the currently ongoing evaluation of the benefit-to-risk profile of drisapersen treatment across all studies and potential impact on the development and commercial pathway of all our product candidates;
 
·
the timing and conduct of our trials of drisapersen and our other product candidates, including statements regarding the timing of initiation and completion of the trials and when results of the trials will be made public;
 
·
our plans to pursue research and development of our product candidates for DMD and product candidates for other indications;
 
·
the potential advantages of our RNA modulation therapies, in particular drisapersen and our other product candidates for DMD;
 
·
the clinical utility of drisapersen and our other product candidates;
 
·
our estimates regarding the market opportunity for drisapersen and our other product candidates;
 
·
our ability to establish sales, marketing and distribution capabilities;
 
·
our ability to establish and maintain manufacturing arrangements for our product candidates;
 
·
our intellectual property position;
 
·
our estimates regarding expenses, future revenues, capital requirements and the need for additional financing;
 
·
the impact of government laws and regulations;
 
·
our competitive position; and
 
·
other risk factors discussed under “Risk Factors” included in our Annual Report on Form 20-F.
 
On September 20, 2013, we announced that the drisapersen Phase III study did not meet its primary endpoint. We are currently working to complete a full evaluation of the benefit-to-risk profile of drisapersen treatment across all studies (“the evaluation”) which will include analyses of pooled results from various drisapersen studies.
 
 
15

 
Exhibit 2
 
 
The outcome of the evaluation may have a material impact on the further development of drisapersen and other DMD compounds. A negative outcome of the evaluation could alter our development plans and financial results in the upcoming period.

On January 16, 2014, the Company reported preliminary data on the overall clinical program for drisapersen. On March 17, 2014 we reported 48-week data from our U.S.-based, Phase II placebo-controlled study (DMD114876 or DEMAND V) of our lead compound, drisapersen. The results of this study suggest that, compared to placebo, boys in the higher-dose drisapersen group (6 mg/kg once weekly) experienced stabilization and even improvements in their muscle function and physical activity as measured by the six-minute walk test (6MWT) for the 24-week treatment phase and maintained this improvement during the 24-week follow-up period. Additionally, when evaluating the percent-predicted six-minute walk distance (6MWD), a clinically meaningful treatment difference was observed at week 24 and at week 48.
 
 
Results of Operations - Comparison of the Three Months Ended March 31, 2014 and 2013
 
   
Three months ended March 31,
 
   
2014
   
2013
   
Change
 
      (€ in thousands)       %  
License revenue
    14,695       1,407       944.4  
Collaboration revenue
    60       993       (94.0 )
Total revenue
    14,755       2,400       514.8  
Other income
    237       1       23,600.0  
Research and development expense
    (5,257 )     (4,060 )     29.5  
General and administrative expense
    (2,455 )     (1,795 )     36.8  
Other gains - net
    24       1       2,300.0  
Operating gain/(loss)
    7,304       (3,453 )     (311.5 )
Finance income
    227       192       18.2  
Finance costs
    (241 )     (188 )     28.2  
Finance income/(cost) – net
    (14 )     4       (450.0 )
Net income/(loss)
    7,290       (3,449 )     (311.4 )
 
 
License Revenue
 
From October 2009 to January 2014, we operated under an exclusive worldwide collaboration with GSK for the development and commercialization of RNA-based therapeutics for DMD, with GSK exclusively licensing worldwide rights to develop and commercialize drisapersen and obtaining an option to exclusively license PRO044 and other specified assets in our DMD portfolio. Under the collaboration agreement, GSK paid us a total of £41.5 million (€47.4 million) in upfront and milestone payments and GSK was responsible for all costs of clinical development of drisapersen.
 
In January 2014, we and GSK mutually terminated the collaboration pursuant to a termination agreement, which terminated all intellectual property license grants as well as any rights arising under the collaboration agreement (other than rights to payments that accrued prior to termination of the collaboration). In addition, the termination agreement required GSK to transfer to us certain data and know-how, inventory, regulatory filings, clinical trial sponsorships, clinical study reports and material agreements relating to the development of our products.
 
License revenue increased €13.3 million in the three months ended March 31, 2014, compared to the corresponding period in 2013 due to the termination of the collaboration agreement and the release of deferred revenue balances.
 
Collaboration Revenue
 
Collaboration revenue is revenue from contracts, typically for research and development activities related to the services provided under the GSK Agreement. The decrease in collaboration revenue to €0.1 million in the three months period ended March 31, 2014 from €1.0 million in the three months period ended March 31, 2013 is due to the termination of the agreement with GSK effective January 12, 2014.
 
The timing of our operating cash flows may vary significantly from the recognition of the related cash flows, as the revenue from some upfront or initiation payments is deferred and recognized as revenue when earned, while other revenue is earned when received, such as milestone payments or service fees. Our revenue has varied, and varies substantially from quarter to quarter and year to year, depending upon, among other things, the number of milestones achieved and the level of revenues earned for ongoing development efforts. Pursuant to the termination of our collaboration with GSK, we do not expect any future license or collaboration revenue under the collaboration. Any new collaboration arrangements we may enter into and the terms we are able to negotiate with our partners will impact our revenue for future periods. We therefore believe that period to period comparisons should not be relied upon as indicative of our future revenues.
 
 
16

 
Exhibit 2
 
 
Other income
 
Other income for the three months ended March 31, 2014, amounts to €0.2 million (three months ended March 31, 2013: nil). We are part of two pan-European consortia, each of which has been awarded Framework Programme 7 (“FP7”) research grants from the European Commission, and we have also received governmental research subsidies. Grant proceeds are deferred, and other income is recognized based on the percentage of completion method.
 
We obtained certain loans made to support research and development that generally bear interest at a rate below the market interest rate, considered by us to be 12% over the last four years. The difference between fair value and the notional amount at inception is treated as a grant received for certain research performed by us and is deferred and will be recognized in other income over the periods when expenses are incurred.
 
 
Research and Development Expense for the three months ended March 31, 2014 and 2013
 
Project expenses by project
 
Three months ended March 31,
 
   
2014
   
2013
   
Change
 
   
(€ in thousands)
   
%
 
DMD Projects
    3,223       2,520       27.9  
PRO044
    115       364       (68.4 )
PRO045 and PRO053
    1,383       970       42.6  
Other DMD projects
    1,725       1,186       45.4  
Non-DMD projects
    323       286       12.9  
Infrastructure costs
    1,711       1,254       36.4  
Total
    5,257       4,060       29.5  
 
Research and development expense increased from €4.1 million in the three months ended March 31, 2013 to €5.3 million in the three months ended March 31, 2014. Our research and development expense is highly dependent on the development phases of our projects and therefore fluctuates highly from period to period.
 
The variance in our research and development expense during the three months ended March 31, 2014, and the corresponding period in 2013 is primarily related to the following projects:
 
 
·
DMD projects. PRO044 has completed a Phase I/II study in Europe, and results were presented in October 2013; an extension study for PRO044 is planned for the 2nd half of this year, which resulted in lower expenses in the three month period ended March 31, 2014 compared to corresponding period in 2013. During the three month period ended March 31, 2014, we incurred expenses for the Phase I/II studies of both PRO045 and PRO053. Our research and development expenses increased substantially in connection with these clinical trials. In the three month period ended March 31, 2014 we also incurred research and development expenses for drisapersen as a result of the termination of the research and collaboration agreement with GSK, in addition to expenses for our other DMD projects, such as Natural History, PROSPECT, PRO052 and PRO055.The DMD project expenses mainly consist of salaries, costs for production of the compounds and costs paid to contract research organizations.
 
 
·
Non-DMD projects. The expenses for our non-DMD projects DM1 and HD mainly consist of outsourced in vivo proof-of-concept studies.
 
 
·
Infrastructure cost: we incur a significant amount of costs associated with our research and development that are less dependent on individual ongoing programs so they are not allocated to specific projects. These costs were higher in the three month period ended March 31, 2014, compared to the corresponding period in 2013, due higher intellectual property cost and the expansion of our development and regulatory capabilities directly impacted by the termination of the research and collaboration agreement with GSK.
 
 
17

 
Exhibit 2
 
 
General and Administrative Expense
 
General and administrative expense increased from €1.8 million to €2.5 million in the three months ended March 31, 2013 and 2014, respectively. The increase is primarily due to share-based compensation expense and costs associated with operating as a public company.
 
Other Gains-net
 
Other gains mainly related to currency effects on outstanding receivables in the three months ended March 31, 2014, and were insignificant in the three months ended March 31, 2013.
 
Finance Income
 
Finance income increased € 40 thousand in the three months ended March 31, 2014, compared to the three months ended March 31, 2013 due to higher cash balances offset by lower interest rates.
 
Finance Cost
 
Finance cost increased €0.1 million in the three months ended March 31, 2014, compared to the three months ended March 31, 2013. Higher finance costs were mainly due to higher outstanding borrowing balances in the three month period ended March 31, 2014.
 
 
Liquidity and Capital Resources
 
To date, we have financed our operations through private placements and our initial public offering of our equity securities, upfront, milestone and expense reimbursement payments received from GSK, as well as funding from patient organizations, governmental bodies and bank loans.
 
Cash Flows
 
Our cash and cash equivalents as of March 31, 2014, were €77.4 million. The table below summarizes our consolidated unaudited statement of cash flows for each of the three month periods ended March 31, 2014 and 2013:
 
   
Three months ended March 31,
 
   
2014
   
2013
 
   
(€ in thousands)
 
Net cash (used in)/generated from operating activities
    (4,834 )     (4,329 )
Net cash (used in)/generated from investing activities
    (57 )     (195 )
Net cash (used in)/generated from financing activities
    71       (87 )
Net increase (decrease) in cash and cash equivalents
    (4,820 )     (4,611 )
Currency effect cash and cash equivalents
    11       (12 )
Cash, cash equivalents and bank overdrafts at the beginning of the period
    82,232       40,738  
Cash, cash equivalents and bank overdrafts at the end of the period
    77,423       36,115  
 
The net cash used in operating activities of €4.8 million in the three months ended March 31, 2014, increased from net cash used in operating activities of €4.3 million in 2013 mainly due to a higher operating loss excluding license income and share based compensation expenses (both non-cash items) for an amount of €2.0 million, less interest received in the amount of €0.1 million and increased cash generated from changes in working capital for an amount of €1.6 million. For an explanation of the operating loss, please see “Results of Operations”.
 
The net cash used in investing activities decreased to €0.1 million in the three months ended March 31, 2014 from €0.2 million in the three months ended March 31, 2013 due to lower investments in fixed assets.
 
The increase in net cash generated from financing activities to €0.1 million in the three months ended March 31, 2014 from a net cash used of €0.1 million in the three months ended March 31, 2013 is due to proceeds received from issuance of share capital of €0.1 million for options exercised under our share-based compensation plans and proceeds received from a loan installment of €0.1 million in the three month period ended March 31, 2014 compared to minimal financing activities in the three month period ended March 31, 2013.
 
 
18

 
Exhibit 2
 
 
Funding Requirements
 
Our funding requirements may vary substantially from the periods presented in this report. Under our historical collaboration with GSK, GSK reimbursed us for the cost of the clinical trials of drisapersen as well as a substantial portion of the costs of the clinical trials of PRO044 and our natural history study of DMD, and paid us milestone payments upon successful development. Following the mutual termination of the collaboration in January 2014, we will bear the full cost of any additional clinical trials of drisapersen and our other DMD product candidates and will receive no future payments under the collaboration other than those accrued on the date of the termination. Furthermore we continued to work to fully complete an evaluation of all data and patient groups across all DMD studies with drisapersen and to engage collaboratively with patient groups, clinical experts and regulators to understand the benefit-to-risk ratio of drisapersen therapy. Following positive feedback from patients and investigators regarding the willingness and desire of patients to go back on drisapersen and encouraging analyses of clinical trial data, we intend to re-dose an initial cohort of boys in the third quarter of 2014. We have made significant progress in the transition of the program from our former partner, GSK, and we expect to communicate on a possible regulatory path forward for drisapersen before the end of June, 2014. If the FDA or EMA were to require us to conduct additional studies of drisapersen in order to support an application for marketing approval, or require us to conduct additional preclinical and clinical studies beyond those that we currently anticipate will be required to complete clinical development of our other DMD product candidates, we could be required to expend significant additional financial resources and time on the completion of the clinical development of drisapersen and the rest of our DMD portfolio. Depending on the outcome of our evaluation of drisapersen, our research and development expense may change substantially. In addition, we expect that our research and development expense in relation to our non-DMD product candidates will increase as we further advance that portfolio.
 
We believe that our existing cash and cash equivalents and research funding that we expect to receive will be sufficient to fund our operating expenses, debt service obligations and capital expenditure requirements for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect.
 
Our present and future funding requirements will depend on many factors, including, among other things:
 
 
the time and costs involved in obtaining regulatory approval for drisapersen as well our other compounds and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these compounds;
 
 
the progress, timing and completion of preclinical testing and clinical trials for any current or future compounds, including our DMD compounds;
 
 
the number of potential new compounds we identify and decide to develop;
 
 
the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims or infringements raised by third parties;
 
 
selling and marketing activities undertaken in connection with the anticipated commercialization of our DMD compounds and any other current or future compounds, and costs involved in the creation of an effective sales and marketing organization; and
 
 
the amount of revenues, if any, we may derive either directly or in the form of royalty payments from future sales of our products.
 
Capital Expenditures
 
The following table sets forth our capital expenditures for the three months ended March 31, 2014 and 2013.
 
 
19

 
Exhibit 2
 
 
   
Three months ended March 31
 
   
2014
   
2013
 
Investments in tangible fixed assets
    45       167  
Investments in intangible assets
    12       28  
Total
    57       195  
 
We plan to make investments during the remainder of 2014 to enhance our research and development capacity. The total investments will depend on a possible path forward of drisapersen. For the three months period ended March 31, 2014, we invested €0.1 million in tangible and intangible fixed assets.
 
 
 
 
 
 
20

 
Exhibit 2
 
 
JOBS Act exemptions
 
On April 5, 2012, the JOBS Act was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an “emerging growth company.” As an emerging growth company, we are electing to take advantage of the following exemptions:
 
 
·
not providing an auditor attestation report on our system of internal controls over financial reporting;
 
 
·
not providing all of the compensation disclosure that may be required of non-emerging growth public companies under the U.S. Dodd-Frank Wall Street Reform and Consumer Protection Act;
 
 
·
not disclosing certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the Chief Executive Officer’s compensation to median employee compensation; and
 
 
·
not complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis).
 
The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are choosing to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards as required when they are adopted. This decision to opt out of the extended transition period under the JOBS Act is irrevocable.
 
These exemptions will apply for a period of five years following the completion of our IPO or until we no longer meet the requirements of being an “emerging growth company,” whichever is earlier. We would cease to be an emerging growth company if we have more than $1.0 billion in annual revenue, have more than $700 million in market value of our ordinary shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.
 
 
 
 
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