MEDIWOUND LTD.
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|||
Date: May 4, 2015
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By:
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/s/ Sharon Malka | |
Name: Sharon Malka | |||
Title: Chief Financial Officer | |||
Exhibit
99.1
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Description
Press release dated May 4, 2015 titled “MediWound Reports First Quarter 2015 Financial Results”.
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99.2
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Un-Audited Interim Financial Statements as of March 31, 2015.
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·
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Initiated U.S. Phase 3 clinical trial of NexoBrid® to treat severe burns
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·
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NexoBrid highlighted in award-winning poster presentation at the American Burn Association (ABA) Annual Meeting
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·
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NexoBrid featured at the International Conference on Minimally Invasive Medicine
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·
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Expanded global distribution of NexoBrid through agreement in Mexico
|
Contacts:
Sharon Malka
Chief Financial & Operation Officer
MediWound Ltd.
ir@mediwound.co.il
|
Anne Marie Fields
Senior Vice President
LHA
212-838-3777
afields@lhai.com
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March 31,
|
December 31,
|
|||||||
2015
|
2014
|
|||||||
CURRENT ASSETS:
|
||||||||
Cash, cash equivalents and short term deposits
|
59,427 | 64,853 | ||||||
Accounts and other receivable
|
2,081 | 2,223 | ||||||
Inventories
|
1,997 | 1,421 | ||||||
63,505 | 68,497 | |||||||
LONG-TERM ASSETS:
|
||||||||
Long term deposits and deferred costs
|
151 | 168 | ||||||
Property, plant and equipment, net
|
1,050 | 1,088 | ||||||
Intangible assets, net
|
930 | 951 | ||||||
Other assets
|
- | 417 | ||||||
65,636 | 71,121 | |||||||
CURRENT LIABILITIES:
|
||||||||
Trade payables
|
1,096 | 1,214 | ||||||
Accrued expenses and other payables
|
2,859 | 2,683 | ||||||
3,955 | 3,897 | |||||||
LONG-TERM LIABILITIES:
|
||||||||
Liabilities in respect of Chief Scientist government grants net of current maturities
|
7,140 | 6,985 | ||||||
Contingent consideration for the purchase of treasury shares net of current maturities
|
17,385 | 17,361 | ||||||
Severance pay liability, net
|
7 | 7 | ||||||
24,532 | 24,353 | |||||||
SHAREHOLDERS' EQUITY (DEFICIENCY)
|
37,149 | 42,871 | ||||||
65,636 | 71,121 |
Three months ended
|
||||||||
March 31,
|
||||||||
2015
|
2014
|
|||||||
Revenues
|
67 | 50 | ||||||
Cost of revenues
|
175 | 170 | ||||||
Gross loss
|
(108 | ) | (120 | ) | ||||
Operating expenses:
|
||||||||
Research and development, net
|
1,397 | 1,465 | ||||||
Selling, general & administrative
|
2,963 | 2,882 | ||||||
Total operating expenses
|
4,360 | 4,347 | ||||||
Operating loss
|
(4,468 | ) | (4,467 | ) | ||||
Financial income (expenses), net
|
(1,525 | ) | 3,732 | |||||
Loss from continuing operations
|
(5,993 | ) | (735 | ) | ||||
Loss from discontinued operation
|
(417 | ) | (14 | ) | ||||
Loss for the period
|
(6,410 | ) | (749 | ) | ||||
Foreign currency translation adjustments
|
1 | (10 | ) | |||||
Total comprehensive loss
|
(6,409 | ) | (759 | ) | ||||
Basic and diluted loss per share:
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||||||||
Loss from continuing operations
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(0.28 | ) | (0.05 | ) | ||||
Loss from discontinued operation
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(0.02 | ) | 0.00 | |||||
Net loss per share
|
(0.30 | ) | (0.05 | ) | ||||
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
|
21,550 | 15,749 |
Three months ended
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||||||||
March 31,
|
||||||||
2015
|
2014
|
|||||||
Cash Flows from Operating Activities:
|
||||||||
Net loss
|
(6,410 | ) | (749 | ) | ||||
Adjustments to reconcile net income (loss) to net cash used in continuing operating activities:
|
||||||||
Adjustments to profit and loss items:
|
||||||||
Loss from discontinued operation
|
417 | 14 | ||||||
Depreciation and amortization
|
115 | 117 | ||||||
Revaluation of warrants to shareholders
|
0 | (4,491 | ) | |||||
Share-based compensation
|
687 | 1,261 | ||||||
Revaluation of liabilities in respect of Chief Scientist government grants
|
202 | 141 | ||||||
Revaluation of contingent consideration for the purchase of treasury shares
|
641 | 586 | ||||||
Net financing expenses (income)
|
504 | (14 | ) | |||||
2,566 | (2,386 | ) | ||||||
Changes in asset and liability items:
|
||||||||
Increase in trade receivables
|
30 | (16 | ) | |||||
Decrease in other receivables
|
90 | 8 | ||||||
Increase in inventories
|
(783 | ) | (809 | ) | ||||
Increase in trade payables
|
(105 | ) | (359 | ) | ||||
(Decrease) increase in other payables
|
(157 | ) | 1,092 | |||||
(925 | ) | (84 | ) | |||||
Net cash used in continuing operating activities
|
(4,769 | ) | (3,219 | ) | ||||
Net cash used in discontinued operating activities
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0 | (14 | ) | |||||
Net cash flows used in operating activities
|
(4,769 | ) | (3,233 | ) | ||||
Cash Flows from Investing Activities:
|
||||||||
Purchase of property and equipment
|
(61 | ) | (74 | ) | ||||
Interest received
|
7 | 3 | ||||||
Proceeds from (investment in) short term bank deposits, net of investments
|
(2,897 | ) | 2,500 | |||||
Net cash provided by (used in) investing activities
|
(2,951 | ) | 2,429 | |||||
Cash Flows from Financing Activities:
|
||||||||
Proceeds from exercise of options
|
- | 208 | ||||||
Proceeds from issuance of shares and warrants, net
|
- | 74,082 | ||||||
Proceeds from the Chief Scientist government grants
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- | 12 | ||||||
Net cash provided by financing activities
|
0 | 74,302 | ||||||
Exchange rate differences on cash and cash equivalent balances
|
(603 | ) | 19 | |||||
Increase in cash and cash equivalents from continuing activities
|
(7,720 | ) | 73,512 | |||||
Decrease in cash and cash equivalents from discontinued activities
|
- | (14 | ) | |||||
Balance of cash and cash equivalents at the beginning of the period
|
25,422 | 7,053 | ||||||
Balance of cash and cash equivalents at the end of the period
|
17,099 | 80,570 |
Three months ended
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||||||||
March 31,
|
||||||||
2015
|
2014
|
|||||||
Loss for the period
|
(6,410 | ) | (749 | ) | ||||
Adjustments:
|
||||||||
Financial (expenses) income, net
|
(1,525 | ) | 3,732 | |||||
Other expenses*
|
(417 | ) | (14 | ) | ||||
Depreciation and amortization
|
(115 | ) | (117 | ) | ||||
Share-based compensation expenses
|
(687 | ) | (1,261 | ) | ||||
Total adjustments
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(2,744 | ) | 2,340 | |||||
Adjusted EBITDA from continuing operation
|
(3,666 | ) | (3,089 | ) | ||||
* Loss from discontinued operation
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||||||||
Share-based compensation and options expenses:
|
||||||||
Cost of revenues
|
101 | 132 | ||||||
Research and development
|
122 | 346 | ||||||
Selling, general & administrative
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464 | 783 | ||||||
Equity-based compensation continuing operations
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687 | 1,261 |
Page
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2
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3
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4 - 5
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6 – 7
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8 - 10
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March 31,
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December 31,
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|||||||||||
2015
|
2014
|
2014
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
CURRENT ASSETS:
|
||||||||||||
Cash and cash equivalents
|
17,099 | 80,570 | 25,422 | |||||||||
Short-term bank deposits
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42,328 | - | 39,431 | |||||||||
Trade receivables
|
29 | 16 | 64 | |||||||||
Inventories
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1,997 | 809 | 1,421 | |||||||||
Other receivables
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2,052 | 2,439 | 2,159 | |||||||||
63,505 | 83,834 | 68,497 | ||||||||||
LONG-TERM ASSETS:
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||||||||||||
Long term deposits and deferred costs
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151 | 140 | 168 | |||||||||
Property, plant and equipment, net
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1,050 | 1,110 | 1,088 | |||||||||
Intangible assets, net
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930 | 987 | 951 | |||||||||
Other assets
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- | 417 | 417 | |||||||||
2,131 | 2,654 | 2,624 | ||||||||||
65,636 | 86,488 | 71,121 | ||||||||||
CURRENT LIABILITIES:
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||||||||||||
Trade payables
|
1,096 | 823 | 1,214 | |||||||||
Other payables
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2,859 | 4,523 | 2,683 | |||||||||
3,955 | 5,346 | 3,897 | ||||||||||
LONG-TERM LIABILITIES:
|
||||||||||||
Liabilities in respect of Chief Scientist government grants
|
7,140 | 6,714 | 6,985 | |||||||||
Contingent consideration for the purchase of treasury shares
|
17,385 | 17,115 | 17,361 | |||||||||
Severance pay liability, net
|
7 | 3 | 7 | |||||||||
24,532 | 23,832 | 24,353 | ||||||||||
SHAREHOLDERS' EQUITY:
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||||||||||||
Ordinary shares of NIS 0.01 par value:
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||||||||||||
Authorized: 33,000,000 shares as of March 31, 2014 and 32,244,508 shares as of December 31, 2014
and March 31, 2015; Issued: 22,053,336 and 21,550,300 shares respectively;
Outstanding: 21,297,844 and 21,550,300 shares respectively
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59 | 61 | 59 | |||||||||
Share premium
|
109,804 | 140,052 | 109,117 | |||||||||
Treasury shares
|
- | (34,600 | ) | - | ||||||||
Foreign currency translation adjustments
|
(17 | ) | (42 | ) | (18 | ) | ||||||
Accumulated deficit
|
(72,697 | ) | (48,161 | ) | (66,287 | ) | ||||||
37,149 | 57,310 | 42,871 | ||||||||||
65,636 | 86,488 | 71,121 |
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
2015
|
2014
|
2014
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
Revenues
|
67 | 50 | 259 | |||||||||
Cost of revenues
|
175 | 170 | 2,785 | |||||||||
Gross loss
|
(108 | ) | (120 | ) | (2,526 | ) | ||||||
Operating expenses:
|
||||||||||||
Research and development, net of participations
|
1,397 | 1,465 | 5,349 | |||||||||
Selling and marketing
|
2,084 | 1,615 | 8,829 | |||||||||
General and administrative
|
879 | 1,267 | 4,723 | |||||||||
Total operating expenses
|
(4,360 | ) | (4,347 | ) | (18,901 | ) | ||||||
Operating loss
|
(4,468 | ) | (4,467 | ) | (21,427 | ) | ||||||
Financial income
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74 | 4,523 | 4,665 | |||||||||
Financial expense
|
(1,599 | ) | (791 | ) | (2,113 | ) | ||||||
Loss from continuing operations
|
(5,993 | ) | (735 | ) | (18,875 | ) | ||||||
Loss from discontinued operation
|
(417 | ) | (14 | ) | - | |||||||
Net loss
|
(6,410 | ) | (749 | ) | (18,875 | ) | ||||||
Other comprehensive income (loss):
|
||||||||||||
Items to be reclassified to profit or loss in subsequent periods:
|
||||||||||||
Foreign currency translation adjustments
|
1 | (10 | ) | 14 | ||||||||
Total other comprehensive income (loss)
|
1 | (10 | ) | 14 | ||||||||
Total comprehensive loss
|
(6,409 | ) | (759 | ) | (18,861 | ) | ||||||
Basic and diluted loss per share:
|
||||||||||||
Loss from continuing operations
|
(0.28 | ) | (0.05 | ) | (0.95 | ) | ||||||
Loss from discontinued operation
|
(0.02 | ) | (* | ) | - | |||||||
Net loss per share
|
(0.30 | ) | (0.05 | ) | (0.95 | ) | ||||||
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
|
21,550 | 15,749 | 19,940 |
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
||||||||||||||||
Balance as of January 1, 2015
|
59 | 109,117 | (18 | ) | (66,287 | ) | 42,871 | |||||||||||||
Loss for the period
|
- | - | - | (6,410 | ) | (6,410 | ) | |||||||||||||
Other comprehensive income
|
- | - | 1 | - | 1 | |||||||||||||||
Total comprehensive income (loss)
|
- | - | 1 | (6,410 | ) | (6,409 | ) | |||||||||||||
Share-based compensation
|
- | 687 | - | - | 687 | |||||||||||||||
Balance as of March 31, 2015 (unaudited)
|
59 | 109,804 | (17 | ) | (72,697 | ) | 37,149 |
Share capital
|
Share premium
|
Treasury
shares
|
Foreign currency translation reserve
|
Accumulated deficit
|
Total equity
|
|||||||||||||||||||
Balance as of January 1, 2014
|
11 | 62,229 | (34,600 | ) | (32 | ) | (47,412 | ) | (19,804 | ) | ||||||||||||||
Loss for the period
|
- | - | - | - | (749 | ) | (749 | ) | ||||||||||||||||
Other comprehensive loss
|
- | - | - | (10 | ) | - | (10 | ) | ||||||||||||||||
Total comprehensive loss
|
- | - | - | (10 | ) | (749 | ) | (759 | ) | |||||||||||||||
Exercise of options
|
(* | ) | 208 | - | - | - | 208 | |||||||||||||||||
Exercise of warrants
|
1 | 4,711 | - | - | - | 4,712 | ||||||||||||||||||
Issuance of shares, net
|
17 | 71,675 | - | - | - | 71,692 | ||||||||||||||||||
Share-based compensation
|
- | 1,261 | - | - | - | 1,261 | ||||||||||||||||||
Effect of share split
|
32 | (32 | ) | - | - | - | - | |||||||||||||||||
Balance as of March 31, 2014 (unaudited)
|
61 | 140,052 | (34,600 | ) | (42 | ) | (48,161 | ) | 57,310 |
Share capital
|
Share premium
|
Treasury
shares
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
|||||||||||||||||||
Balance as of January 1, 2014
|
11 | 62,229 | (34,600 | ) | (32 | ) | (47,412 | ) | (19,804 | ) | ||||||||||||||
Loss for the period
|
- | - | - | - | (18,875 | ) | (18,875 | ) | ||||||||||||||||
Other comprehensive income
|
- | - | - | 14 | - | 14 | ||||||||||||||||||
Total comprehensive income (loss)
|
- | - | - | 14 | (18,875 | ) | (18,861 | ) | ||||||||||||||||
Exercise of warrants
|
1 | 4,711 | - | - | - | 4,712 | ||||||||||||||||||
Exercise of options
|
1 | 305 | - | - | - | 306 | ||||||||||||||||||
Cancellation of treasury shares
|
(2 | ) | (34,598 | ) | 34,600 | - | - | - | ||||||||||||||||
Effect of share split
|
32 | (32 | ) | - | - | - | - | |||||||||||||||||
Share-based compensation
|
- | 4,827 | - | - | - | 4,827 | ||||||||||||||||||
Issuance of shares, net
|
16 | 71,675 | - | - | - | 71,691 | ||||||||||||||||||
Balance as of December 31, 2014
|
59 | 109,117 | - | (18 | ) | (66,287 | ) | 42,871 |
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
2015
|
2014
|
2014
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
Cash Flows from Operating Activities:
|
||||||||||||
Net loss
|
(6,410 | ) | (749 | ) | (18,875 | ) | ||||||
Adjustments to reconcile net loss to net cash used in continuing operating activities:
|
||||||||||||
Adjustments to profit and loss items:
|
||||||||||||
Loss from discontinued operation
|
417 | 14 | - | |||||||||
Depreciation and amortization
|
115 | 117 | 492 | |||||||||
Revaluation of warrants to shareholders
|
- | (4,491 | ) | (4,491 | ) | |||||||
Share-based compensation
|
687 | 1,261 | 4,827 | |||||||||
Revaluation of liabilities in respect of Chief Scientist government grants
|
202 | 141 | 87 | |||||||||
Revaluation of contingent consideration for the purchase of treasury shares
|
641 | 586 | 612 | |||||||||
Other financing expenses, net
|
504 | (14 | ) | 226 | ||||||||
2,566 | (2,386 | ) | 1,753 | |||||||||
Changes in asset and liability items:
|
||||||||||||
Decrease (increase) in trade receivables
|
30 | (16 | ) | (67 | ) | |||||||
Decrease in other receivables
|
90 | 8 | 186 | |||||||||
Increase in inventories
|
(783 | ) | (809 | ) | (1,421 | ) | ||||||
Increase (decrease) in trade payables
|
(105 | ) | (359 | ) | 22 | |||||||
Increase (decrease) in other payables
|
(157 | ) | 1,092 | 1,909 | ||||||||
(925 | ) | (84 | ) | 629 | ||||||||
Net cash used in continuing operating activities
|
(4,769 | ) | (3,219 | ) | (16,493 | ) | ||||||
Net cash used in discontinued operating activities
|
- | (14 | ) | - | ||||||||
Net cash flows used in operating activities
|
(4,769 | ) | (3,233 | ) | (16,493 | ) |
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
2015
|
2014
|
2014
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
Cash Flows from Investing Activities:
|
||||||||||||
Purchase of property and equipment
|
(61 | ) | (74 | ) | (366 | ) | ||||||
Purchase of intangible assets
|
- | - | (30 | ) | ||||||||
Interest received
|
7 | 3 | 173 | |||||||||
Proceeds from (investment in) short term bank deposits, net of investments
|
(2,897 | ) | 2,500 | (36,931 | ) | |||||||
Net cash provided by (used in) investing activities
|
(2,951 | ) | 2,429 | (37,154 | ) | |||||||
Cash Flows from Financing Activities:
|
||||||||||||
Proceeds from exercise of options
|
- | 208 | 306 | |||||||||
Proceeds from issuance of shares and warrants, net
|
- | 74,082 | 71,824 | |||||||||
Proceeds from the Chief Scientist government grants
|
- | 12 | 345 | |||||||||
Net cash provided by financing activities
|
- | 74,302 | 72,475 | |||||||||
Exchange rate differences on cash and cash equivalent balances
|
(603 | ) | 19 | (459 | ) | |||||||
Increase (decrease) in cash and cash equivalents from continuing activities
|
(8,323 | ) | 73,531 | 18,828 | ||||||||
Decrease in cash and cash equivalents from discontinued activities
|
- | (14 | ) | - | ||||||||
Balance of cash and cash equivalents at the beginning of the period
|
25,422 | 7,053 | 7,053 | |||||||||
Balance of cash and cash equivalents at the end of the period
|
17,099 | 80,570 | 25,422 | |||||||||
Non-cash activities:
|
||||||||||||
Treasury shares cancellation against share premium
|
- | - | 34,600 | |||||||||
Exercise of cashless warrants into shares
|
- | 4,709 | 4,709 | |||||||||
Unpaid issuance expenses
|
- | 2,258 | - |
NOTE 1:
|
GENERAL
|
|
a.
|
General description of the Company and its operations:
MediWound Ltd. (the "Company" or "MediWound"), is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel products to address unmet needs in the fields of severe burns, chronic and other hard to heal wounds and connective tissue disorders and others.
The Company's innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency, or the EMA, in December 2012 for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full thickness thermal burns. The Company launched NexoBrid in the European Union and in Israel through its own commercial organization and first generated initial sales in 2014.
|
|
b.
|
The Company has two wholly-owned subsidiaries: MediWound Germany GmbH, acting as EU marketing authorization holder and EU sales and marketing arm and MediWound UK Limited, an inactive company. In addition, the Company owns about 7% of Polyheal Ltd., a private life sciences company ("Polyheal").
|
|
c.
|
On March 25, 2014, the Company closed its initial public offering in the United States and listing on the NASDAQ Global Select Market ("the IPO") of 5,750,000 ordinary shares in the offering, including 750,000 additional shares to cover underwriters over-allotments, which was exercised on March 25, 2014 by the underwriters. As a result, the Company issued and sold a total of 5,750,000 ordinary shares at a price per share of $14.00 with aggregate gross proceeds of approximately $80,500. Under the terms of the offering, the Company incurred aggregate underwriting discounts of approximately $5,635 and expenses of approximately $3,173 in connection with the offering, resulting in net proceeds to us of approximately $71,692. Following the IPO the Company's securities are listed for trading on NASDAQ.
|
NOTE 2:
|
SIGNIFICANT ACCOUNTING POLICIES
|
|
a.
|
Basis of presentation of financial statements:
These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB").
|
|
b.
|
Basis of preparation of the interim consolidated financial statements
The interim condensed financial statements for the three months ended March 31, 2015 have been prepared in accordance with IAS 34 "Interim Financial Reporting".
The interim condensed financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Company's annual financial statements as of December 31, 2014 that were included in the Annual Report on Form 20-F filed on February 12, 2015.
|
NOTE 3:
|
CONTINGENT LIABILITIES
|
NOTE 4:
|
EQUITY
|
NOTE 5:
|
OTHER ASSETS
|