PROSENSA HOLDING N.V.
|
||||
By:
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/s/Hans G.C.P. Schikan
|
|||
Name:
|
Hans G.C.P. Schikan
|
|||
Title:
|
Chief Executive Officer
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By:
|
/s/Berndt A.E. Modig
|
|||
Name:
|
Berndt A.E. Modig
|
|||
Title:
|
Chief Financial Officer
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Exhibit
|
Description of Exhibit
|
1
|
Prosensa Holding N.V. Unaudited Condensed Consolidated Interim Financial Statements as of March 31, 2014
|
2
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Prosensa Holding N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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Page
|
|
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 | ) |
€ (‘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 |
€ (‘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 |
€ (‘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 |
1.
|
Prosensa Therapeutics B.V. (100%);
|
2.
|
Prosensa Technologies B.V. (100%);
|
3.
|
Polybiotics B.V. (100%); and
|
4.
|
Prosensa Inc. (100%)
|
·
|
Amendment to IAS 36 Impairment of Assets
|
·
|
Amendment to IAS 39 Financial Instruments
|
·
|
IFRIC 21 Levies
|
€ (‘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 |
€ (‘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 |
€ (‘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 |
€ (‘000)
|
March 31,
|
December 31,
|
||||||
2014
|
2013
|
|||||||
Deposit for rental obligations
|
89 | 89 | ||||||
Restricted cash
|
200 | 200 | ||||||
Total
|
289 | 289 |
€ (‘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 |
€ (‘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 |
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 |
€ (‘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 |
€ (‘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 |
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 |
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 | (*) |
·
|
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.
|
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 | ) |
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 |
·
|
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.
|
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 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.
|
Three months ended March 31
|
||||||||
2014
|
2013
|
|||||||
Investments in tangible fixed assets
|
45 | 167 | ||||||
Investments in intangible assets
|
12 | 28 | ||||||
Total
|
57 | 195 |
·
|
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).
|