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
|
Description of Exhibit
|
1
|
Prosensa Holding N.V. Unaudited Condensed Consolidated Interim Financial Statements as of June 30, 2014
|
2
|
Prosensa Holding N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
3†
|
Convertible Note Purchase Agreement dated on August 11, 2014, by and between Prosensa Holding N.V. and Pro200, LLC
|
†
|
Confidential treatment requested as to portions of the exhibit. Confidential material omitted and filed separately with the Securities and Exchange Commission. |
Page
|
|
Note
|
2014
|
Three months
2013ended June 30, |
2014
|
Six months
2013ended June 30, |
||||||||||||||||
€ (‘000 except per share data)
|
||||||||||||||||||||
License revenue
|
16 | - | 1,286 | 14,695 | 2,693 | |||||||||||||||
Collaboration revenue
|
- | 698 | 60 | 1,691 | ||||||||||||||||
Total revenue
|
- | 1,984 | 14,755 | 4,384 | ||||||||||||||||
Other income
|
17 | 214 | 33 | 452 | 34 | |||||||||||||||
Research and development expense
|
18 | (5,539 | ) | (4,549 | ) | (10,796 | ) | (8,609 | ) | |||||||||||
General and administrative expense
|
19 | (2,696 | ) | (2,074 | ) | (5,151 | ) | (3,869 | ) | |||||||||||
Other gains - net
|
72 | 7 | 96 | 8 | ||||||||||||||||
Operating loss
|
(7,949 | ) | (4,599 | ) | (644 | ) | (8,052 | ) | ||||||||||||
Finance income
|
229 | 100 | 456 | 292 | ||||||||||||||||
Finance costs
|
(242 | ) | (211 | ) | (483 | ) | (399 | ) | ||||||||||||
Finance cost – net
|
(13 | ) | (111 | ) | (27 | ) | (107 | ) | ||||||||||||
Net loss
|
(7,962 | ) | (4,710 | ) | (671 | ) | (8,159 | ) | ||||||||||||
Other comprehensive income
|
- | - | - | - | ||||||||||||||||
Total comprehensive loss*
|
(7,962 | ) | (4,710 | ) | (671 | ) | (8,159 | ) | ||||||||||||
Loss per share from operations attributable to the equity holders of the company during the period (in € per share)
|
||||||||||||||||||||
Basic and diluted loss per share
|
21 | (0.22 | ) | (0.16 | ) | (0.02 | ) | (0.28 | ) |
€ (‘000) |
Note
|
As of June 30,
2014 |
As of December 31
2013 |
|||||||||
Assets
|
||||||||||||
Non-current assets
|
||||||||||||
Leasehold improvements and equipment
|
7 | 2,027 | 2,177 | |||||||||
Intangible assets
|
8 | 1,036 | 758 | |||||||||
Other financial assets
|
9 | 89 | 289 | |||||||||
Total non-current assets
|
3,152 | 3,224 | ||||||||||
Current assets
|
||||||||||||
Trade and other receivables
|
10 | 3,453 | 4,403 | |||||||||
Prepayments
|
11 | 998 | 931 | |||||||||
Cash and cash equivalents
|
12 | 69,467 | 82,232 | |||||||||
Total current assets
|
73,918 | 87,566 | ||||||||||
Total assets
|
77,070 | 90,790 | ||||||||||
Equity and liabilities
|
||||||||||||
Equity attributable to owners of the parent
|
||||||||||||
Share capital
|
361 | 359 | ||||||||||
Share premium
|
119,442 | 119,222 | ||||||||||
Other reserves
|
3,050 | 2,123 | ||||||||||
Accumulated deficit
|
(58,494 | ) | (41,890 | ) | ||||||||
Unappropriated earnings
|
(671 | ) | (16,604 | ) | ||||||||
Total equity
|
13 | 63,688 | 63,210 | |||||||||
Liabilities
|
||||||||||||
Non-current liabilities
|
||||||||||||
Borrowings – non-current portion
|
15 | 7,874 | 7,630 | |||||||||
Derivative financial instruments
|
- | 22 | ||||||||||
Deferred revenue / income
|
16 | 87 | 10,852 | |||||||||
Total non-current liabilities
|
7,961 | 18,504 | ||||||||||
Current liabilities
|
||||||||||||
Borrowings – current portion
|
15 | 30 | 191 | |||||||||
Derivative financial instruments
|
- | 8 | ||||||||||
Trade and other payables
|
14 | 5,233 | 5,150 | |||||||||
Deferred revenue / income
|
16 | 158 | 3,727 | |||||||||
Total current liabilities
|
5,421 | 9,076 | ||||||||||
Total liabilities
|
13,382 | 27,580 | ||||||||||
Total equity and liabilities
|
77,070 | 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 loss
|
- | - | - | - | - | - | - | - | (671 | ) | (671 | ) | ||||||||||||||||||||||||||||
Appropriation of result
|
- | - | - | - | - | - | - | (16,604 | ) | 16,604 | - | |||||||||||||||||||||||||||||
Share-based payments
|
- | - | - | - | - | - | 927 | - | - | 927 | ||||||||||||||||||||||||||||||
Proceeds from shares issued
|
2 | - | - | - | 2 | 220 | - | - | - | 222 | ||||||||||||||||||||||||||||||
Balance at June 30, 2014
|
361 | - | - | - | 361 | 119,442 | 3,050 | (58,494 | ) | (671 | ) | 63,688 | ||||||||||||||||||||||||||||
Balance at January 1, 2013
|
35 | 7 | 74 | 174 | 290 | 56,118 | 1,056 | (31,998 | ) | (9,892 | ) | 15,574 | ||||||||||||||||||||||||||||
Net loss
|
- | - | - | - | - | - | - | - | (8,159 | ) | (8,159 | ) | ||||||||||||||||||||||||||||
Appropriation of result
|
- | - | - | - | - | - | - | (9,892 | ) | 9,892 | - | |||||||||||||||||||||||||||||
Share-based payments
|
- | - | - | - | - | - | 289 | - | - | 289 | ||||||||||||||||||||||||||||||
Proceeds from shares issued
|
- | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||
Balance at June 30, 2013
|
35 | 7 | 74 | 174 | 290 | 56,118 | 1,345 | (41,890 | ) | (8,159 | ) | 7,704 |
€ (‘000)
|
Six months ended June 30,
|
|||||||||||
Note
|
2014
|
2013
|
||||||||||
Cash flows from operating activities
|
||||||||||||
Net loss
|
(671 | ) | (8,159 | ) | ||||||||
Adjustments for:
|
||||||||||||
- Amortization/depreciation
|
7,8 | 617 | 608 | |||||||||
- Costs employee share option plan
|
20 | 927 | 289 | |||||||||
- Reversal finance income, net
|
(71 | ) | 107 | |||||||||
- Changes in the fair value of derivatives
|
(30 | ) | (11 | ) | ||||||||
- Changes in trade and other receivables
|
10 | 884 | (2,301 | ) | ||||||||
- Changes in prepayments
|
11 | (67 | ) | (1,331 | ) | |||||||
- Changes in trade and other payables
|
14 | (42 | ) | 2,793 | ||||||||
- Currency effect (outstanding) receivables and payables
|
98 | (1 | ) | |||||||||
- Changes in deferred revenue
|
16 | (14,334 | ) | (2,693 | ) | |||||||
(12,689 | ) | (10,699 | ) | |||||||||
Interest received
|
453 | 613 | ||||||||||
Interest paid
|
(14 | ) | (30 | ) | ||||||||
Cash used in operating activities
|
(12,250 | ) | (10,116 | ) | ||||||||
Cash flows from investing activities
|
||||||||||||
Purchases of tangible fixed assets
|
7 | (338 | ) | (283 | ) | |||||||
Purchases of intangible assets
|
8 | (282 | ) | (34 | ) | |||||||
Decrease of other financial assets
|
200 | - | ||||||||||
Net cash used in investing activities
|
(420 | ) | (317 | ) | ||||||||
Cash flows from financing activities
|
||||||||||||
Proceeds from issuance of share capital
|
13 | 222 | - | |||||||||
Proceeds from borrowings
|
15 | 100 | 650 | |||||||||
Redemption financial lease
|
15 | (61 | ) | (125 | ) | |||||||
Repayments of borrowings
|
15 | (400 | ) | (50 | ) | |||||||
Net cash (used in)/generated from financing activities
|
(139 | ) | 475 | |||||||||
Net decrease in cash and cash equivalents
|
(12,809 | ) | (9,958 | ) | ||||||||
Currency effect cash and cash equivalents
|
44 | (23 | ) | |||||||||
Cash and cash equivalents at beginning of the period
|
82,232 | 40,738 | ||||||||||
Cash and cash equivalents at end of the period
|
12 | 69,467 | 30,757 | |||||||||
Restricted cash
|
9 | - | 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 June 30, 2014
|
||||||||||||||||||||
Borrowings (excl. finance lease liabilities)
|
- | - | - | - | 7,906 | |||||||||||||||
Finance lease liabilities
|
30 | - | - | - | - | |||||||||||||||
Derivative financial instruments
(interest rate swap)
|
- | - | - | - | - | |||||||||||||||
Trade and other payables
|
5,233 | - | - | - | - | |||||||||||||||
Total
|
5,263 | - | - | - | 7,906 | |||||||||||||||
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
|
|||||||||||||||
Period ended June 30, 2014
|
||||||||||||||||||||
Opening net book amount
|
262 | 1,486 | 224 | 205 | 2,177 | |||||||||||||||
Additions
|
- | 370 | 167 | (199 | ) | 338 | ||||||||||||||
Depreciation charge (note 18, 19)
|
(18 | ) | (396 | ) | (74 | ) | - | (488 | ) | |||||||||||
Closing net book amount
|
244 | 1,460 | 317 | 6 | 2,027 | |||||||||||||||
At June 30, 2014
|
||||||||||||||||||||
Cost
|
353 | 4,842 | 957 | 6 | 6,158 | |||||||||||||||
Accumulated depreciation
|
(109 | ) | (3,382 | ) | (640 | ) | - | (4,131 | ) | |||||||||||
Net book amount
|
244 | 1,460 | 317 | 6 | 2,027 |
€ (‘000)
|
Patents
and licenses |
Software
|
Total
|
|||||||||
Period ended June 30, 2014
|
||||||||||||
Opening net book amount
|
522 | 236 | 758 | |||||||||
Additions
|
- | 407 | 407 | |||||||||
Amortization charge
|
(47 | ) | (82 | ) | (129 | ) | ||||||
Closing net book amount
|
475 | 561 | 1,036 | |||||||||
At June 30, 2014
|
||||||||||||
Cost
|
939 | 1,140 | 2,079 | |||||||||
Accumulated amortization and impairment
|
(464 | ) | (579 | ) | (1,043 | ) | ||||||
Net book amount
|
475 | 561 | 1,036 |
€ (‘000) |
June 30,
2014 |
December 31,
2013 |
||||||
Deposit for rental obligations
|
89 | 89 | ||||||
Restricted cash
|
- | 200 | ||||||
Total
|
89 | 289 |
€ (‘000) |
June 30,
2014 |
December 31,
2013 |
||||||
Trade accounts receivable
|
2,422 | 1,298 | ||||||
Amounts to be invoiced to partners
|
- | 2,380 | ||||||
Trade receivables
|
2,422 | 3,678 | ||||||
Value-added tax
|
421 | 351 | ||||||
Government and other grants to be received
|
171 | 30 | ||||||
Advances to personnel
|
92 | - | ||||||
Interest receivables on bank accounts
|
279 | 344 | ||||||
Other receivables
|
68 | - | ||||||
Total
|
3,453 | 4,403 |
€ (‘000) |
June 30,
2014 |
December 31,
2013 |
||||||
Cash at bank and on hand
|
9,242 | 9,119 | ||||||
Short-term bank deposits
|
60,225 | 73,113 | ||||||
Total
|
69,467 | 82,232 |
Class of shares and stated value
|
June 30,
2014 |
December 31, 2013
|
||||||
Common shares of EUR 0.01
|
36,095,972 | 35,932,792 |
€ (‘000) |
June 30,
2014 |
December 31,
2013 |
||||||
Trade payables
|
1,493 | 1,910 | ||||||
Holiday payments and holiday rights
|
410 | 457 | ||||||
Social security and wage tax
|
672 | 246 | ||||||
Other liabilities
|
2,658 | 2,537 | ||||||
Total
|
5,233 | 5,150 |
€ (‘000)
|
June 30,
2014 |
December 31,
2013 |
||||||
Non-current
|
||||||||
Bank borrowings
|
- | 300 | ||||||
Other loans
|
7,874 | 7,330 | ||||||
Total non-current
|
7,874 | 7,630 | ||||||
Current
|
||||||||
Bank borrowings
|
- | 100 | ||||||
Finance lease liabilities
|
30 | 91 | ||||||
Total current
|
30 | 191 | ||||||
Total
|
7,904 | 7,821 |
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
2014
|
2013
|
2014
|
2013
|
|||||||||||||
Loss attributable to equity holders of the company in EUR (‘000)
|
(7,962 | ) | (4,710 | ) | (671 | ) | (8,159 | ) | ||||||||
Weighted average number of Common and Preference shares in issue
|
35,985,467 | 29,002,298 | 35,959,275 | 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;
|
|
·
|
our expectation on the timing and success of confirmatory studies for drisapersen;
|
|
·
|
the 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, including the outcome of interference proceedings relating to our product candidates, including both drisapersen (PRO051) and PRO053;
|
|
·
|
our estimates regarding expenses, future revenues, capital requirements and the need for additional financing;
|
|
·
|
the impact of government laws and regulations;
|
|
·
|
our competitive position;
|
|
·
|
the outcome of litigation in which we are involved; and
|
|
·
|
other risk factors discussed under “Risk Factors” included in our Annual Report on Form 20-F.
|
Three months ended June 30,
|
||||||||||||
2014
|
2013
|
Change
|
||||||||||
(€ in '000)
|
%
|
|||||||||||
License revenue
|
– | 1,286 | (100.0 | ) | ||||||||
Collaboration revenue
|
– | 698 | (100.0 | ) | ||||||||
Total revenue
|
– | 1,984 | (100.0 | ) | ||||||||
Other income
|
214 | 33 | 548.5 | |||||||||
Research and development expense
|
(5,539 | ) | (4,549 | ) | 21.8 | |||||||
General and administrative expense
|
(2,696 | ) | (2,074 | ) | 30.0 | |||||||
Other gains - net
|
72 | 7 | 928.6 | |||||||||
Operating loss
|
(7,949 | ) | (4,599 | ) | 72.8 | |||||||
Finance income
|
229 | 100 | 129.0 | |||||||||
Finance costs
|
(242 | ) | (211 | ) | 14.7 | |||||||
Finance cost – net
|
(13 | ) | (111 | ) | (88.3 | ) | ||||||
Net loss
|
(7,962 | ) | (4,710 | ) | 69.0 |
Project expenses by project
|
Three months ended June 30,
|
|||||||||||
2014
|
2013
|
Change
|
||||||||||
(€ in '000)
|
%
|
|||||||||||
DMD Projects
|
3,617 | 2,367 | 52.8 | |||||||||
PRO044
|
103 | 316 | (67.4 | ) | ||||||||
PRO045 and PRO053
|
1,399 | 860 | 62.7 | |||||||||
Other DMD projects
|
2,115 | 1,191 | 77.6 | |||||||||
Non-DMD projects
|
207 | 272 | (23.9 | ) | ||||||||
Infrastructure costs
|
1,715 | 1,910 | (10.2 | ) | ||||||||
Total
|
5,539 | 4,549 | 21.8 |
|
·
|
DMD projects. The DMD project expenses mainly consist of salaries, costs for production of the compounds, costs paid to contract research organizations and costs relating to preparing our regulatory filings for drisapersen. During the three month period ended June 30, 2014, we mostly incurred expenses related to the expansion of our development and regulatory capabilities (directly impacted by the termination of the research and collaboration agreement with GSK) and costs for progressing clinical Phase I/II studies of both PRO045 and PRO053 (€1.4 million). An extension study for PRO044 is planned to start the second half of this year, resulting in lower expenses in the three month period ended June 30, 2014 compared to the corresponding period in 2013. In the three month period ended June 30, 2014, we also incurred expenses for drisapersen (€1.4 million) and for our other DMD projects, such as the Natural History study, PROSPECT and PRO052.
|
|
·
|
Non-DMD projects. The expenses for our non-DMD projects DM1 and HD mainly consist of outsourced 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.
|
Six months ended June 30,
|
||||||||||||
2014
|
2013
|
Change
|
||||||||||
(€ in '000)
|
%
|
|||||||||||
License revenue
|
14,695 | 2,693 | 445.7 | |||||||||
Collaboration revenue
|
60 | 1,691 | (96.5 | ) | ||||||||
Total revenue
|
14,755 | 4,384 | 236.6 | |||||||||
Other income
|
452 | 34 | 1,229.4 | |||||||||
Research and development expense
|
(10,796 | ) | (8,609 | ) | 25.4 | |||||||
General and administrative expense
|
(5,151 | ) | (3,869 | ) | 33.1 | |||||||
Other gains - net
|
96 | 8 | 1,100.0 | |||||||||
Operating loss
|
(644 | ) | (8,052 | ) | (92.0 | ) | ||||||
Finance income
|
456 | 292 | 56.2 | |||||||||
Finance costs
|
(483 | ) | (399 | ) | 21.1 | |||||||
Finance cost – net
|
(27 | ) | (107 | ) | (74.8 | ) | ||||||
Net loss
|
(671 | ) | (8,159 | ) | (91.8 | ) |
Project expenses by project
|
Six months ended June 30,
|
|||||||||||
2014
|
2013
|
Change
|
||||||||||
(€ in '000)
|
%
|
|||||||||||
DMD Projects
|
6,941 | 4,874 | 42.4 | |||||||||
PRO044
|
223 | 671 | (66.8 | ) | ||||||||
PRO045 and PRO053
|
2,810 | 1,830 | 53.6 | |||||||||
Other DMD projects
|
3,908 | 2,373 | 64.7 | |||||||||
Non-DMD projects
|
478 | 527 | (9.3 | ) | ||||||||
Infrastructure costs
|
3,377 | 3,208 | 5.3 | |||||||||
Total
|
10,796 | 8,609 | 25.4 |
|
·
|
DMD projects. The DMD project expenses mainly consist of salaries, costs for production of the compounds, costs paid to contract research organizations and costs relating to preparing our regulatory filings for drisapersen. During the six month period ended June 30, 2014, we mostly incurred expenses related to the expansion of our development and regulatory capabilities (directly impacted by the termination of the research and collaboration agreement with GSK) and costs for progressing clinical Phase I/II studies of both PRO045 and PRO053 (€2.8 million). An extension study for PRO044 is planned to start the second half of this year, resulting in lower expenses in the six month period ended June 30, 2014 compared to the corresponding period in 2013. In the six month period ended June 30, 2014, we also incurred research and development expenses for drisapersen (€1.9 million) and for our other DMD projects, such as the Natural History study, PROSPECT and PRO052.
|
|
·
|
Non-DMD projects. The expenses for our non-DMD projects DM1 and HD mainly consist of outsourced 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.
|
Six months ended June 30,
|
||||||||
(€ in '000)
|
2014
|
2013
|
||||||
Net cash used in operating activities
|
(12,250 | ) | (10,116 | ) | ||||
Net cash used in investing activities
|
(420 | ) | (317 | ) | ||||
Net cash (used in)/generated from financing activities
|
(139 | ) | 475 | |||||
Net decrease in cash and cash equivalents
|
(12,809 | ) | (9,958 | ) | ||||
Currency effect cash and cash equivalents
|
44 | (23 | ) | |||||
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
|
69,467 | 30,757 |
|
•
|
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;
|
|
•
|
the 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;
|
|
•
|
the amount of revenues, if any, we may derive either directly or in the form of royalty payments from future sales of our products; and
|
|
•
|
the outcome of litigation and other proceedings in which we are involved.
|
Six months ended June 30,
|
||||||||
2014
|
2013
|
|||||||
Investments in tangible fixed assets
|
338 | 283 | ||||||
Investments in intangible assets
|
282 | 34 | ||||||
Total
|
620 | 317 |
|
·
|
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; and
|
|
·
|
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.
|
Page
|
||
Section 1. DEFINITIONS
|
3 | |
Section 2. ISSUANCE AND SALE OF THE SECURITIES
|
4 | |
2.1
|
The Initial Note
|
4
|
2.2
|
The Second Tranche Note, the Third Tranche Note, the Fourth Tranche Note and the Fifth Tranche Note
|
4
|
Section 3. THE CLOSINGS
|
4 | |
3.1
|
Initial Closing
|
4
|
3.2
|
Second Closing
|
4
|
3.3
|
Third Closing
|
4
|
3.4
|
Fourth Closing
|
4
|
3.5
|
Fifth Closing
|
4
|
3.6
|
Order of Closings
|
5
|
3.7
|
Deliveries by the Company
|
5
|
3.8
|
Deliveries by the Investor
|
5
|
Section 4. REPRESENTATIONS, WARRANTIES AND COVENANTS
|
6 | |
4.1
|
Representations and Warranties of the Company
|
6
|
4.2
|
Representations and Warranties of the Investor
|
7
|
4.3
|
Covenant of the Company
|
8
|
Section 5. CONDITIONS TO CLOSING
|
8 | |
5.1
|
Conditions to Closing by the Investor
|
8
|
5.2
|
Conditions to Closing by the Company
|
8
|
Section 6. MISCELLANEOUS
|
9 | |
6.1
|
Waivers and Amendments
|
9
|
6.2
|
Costs and Expenses
|
9
|
6.3
|
Remedies Cumulative
|
9
|
6.4
|
Remedies Not Waived
|
9
|
6.5
|
Entire Agreement
|
9
|
6.6
|
Specific Performance
|
9
|
6.7
|
Governing Law
|
10
|
6.8
|
Notices
|
10
|
6.9
|
Counterparts
|
10
|
6.1
|
Successors and Assigns
|
11
|
6.11
|
Third Parties
|
11
|
6.12
|
Schedules and Exhibits
|
11
|
6.13
|
Headings
|
11
|
6.14
|
Publicity
|
11
|
PROSENSA HOLDING N.V.
|
|||
By: | /s/ Hans Schikan | ||
Name: Hans Schikan | |||
Title: Chief Executive Officer | |||
|
|||
By: | /s/ Berndt Modig | ||
Name: Bernt Modig | |||
Title: Chief Financial Officer | |||
€[________]1 | [_____], 2014 |
COMPANY:
PROSENSA HOLDING N.V.
|
|||
By:
|
|||
Name:
|
|||
Title:
|
|||
By:
|
|||
Name:
|
|||
Title:
|
|||
Address for notices:
|
|||
Berndt Modig
|
|||
Tel: + 31 61 47 90 201
|
|||
J.H. Oortweg 21
|
|||
2333 CH Leiden, the Netherlands
|
AGREED TO AND ACCEPTED:
PRO200, LLC
|
|||
By:
|
|||
Name:
|
|||
Title:
|
|||
Address for notices: | |||
PRO200, LLC
|
|||
1400 Quail Street, Suite 110 | |||
Newport Beach, CA 92660 | |||
Attention: Debra Miller |
PRO200, LLC
|
|||
By:
|
|||
Name:
|
|||
Title:
|
|||
Date:
|
|||
|
·
|
Progressing the second exon skipping candidate for the treatment of DMD, PRO044, by initiating a Phase II clinical extension study in Europe by the end of 2014 and a placebo-controlled trial in the US in the first half of 2015, which may serve as one of two confirmatory studies to support a potential accelerated approval for drisapersen.
|
|
·
|
Supporting re-dosing efforts for drisapersen clinical trial participants in North America and Europe and facilitate the drug’s New Drug Application (NDA) filing in the US in 2014.
|
|
·
|
Supporting the development of other Prosensa’s other exon skipping compounds, PRO045 and PRO053.
|