Exhibit
|
|
|
Number
|
|
Exhibit Description
|
EX-101.INS
|
XBRL Taxonomy Instance Document
|
|
EX-101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
EX-101.CAL
|
XBRL Taxonomy Calculation Linkbase Document
|
|
EX-101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
EX-101.LAB
|
XBRL Taxonomy Label Linkbase Document
|
|
EX-101.PRE
|
XBRL Taxonomy Presentation Linkbase Document
|
MEDIWOUND LTD. | |||
Date: August 14, 2024 |
By:
|
/s/ Hani Luxenburg | |
Name: | Hani Luxenburg | ||
Title: | Chief Financial Officer |
● |
Construction of our new, state-of-the-art GMP-compliant manufacturing facility is complete. Commissioning will begin soon, aiming for full operational capacity in 2025. This expansion will increase manufacturing capacity sixfold.
|
● |
U.S. launch by Vericel continues to build momentum. Approximately 70 burn centers have completed submissions to Pharmacy and Therapeutics (P&T) committees, with 40+ centers already obtaining approval, and nearly all of those placing
initial product orders. Vericel reported a notable increase in hospital orders and the number of patients treated, driving a revenue growth of 76% over prior quarter.
|
● |
Results from the U.S. NexoBrid Expanded Access Protocol (NEXT) were positive and aligned with the findings from Phase III studies. Conducted at 29 burn centers across the U.S. with 239 patients enrolled, and designed to ensure continuous
availability until commercialization, NEXT reaffirmed NexoBrid's proven safety and efficacy in eschar removal, significantly reducing the need for surgical procedures in burn patients.
|
● |
U.S. Food and Drug Administration (FDA) approval of the pediatric indication is expected in the third quarter of 2024.
|
● |
Phase III study of EscharEx for treating venous leg ulcers (VLUs) is scheduled to start in the second half of 2024, as planned.
|
● |
€16.25 million in funding from the EIC will accelerate the clinical development of EscharEx for treating diabetic foot ulcers (DFUs). This will expedite MediWound's DFU program, and its associated revenue projections by four years. DFUs
are more prevalent than VLUs, with a higher percentage of them requiring debridement. Preparations for the DFU Phase II/III study are currently underway.
|
● |
Results of EscharEx Phase II ChronEx study were published in THE LANCET’s eClinicalMedicine journal. EscharEx outperformed non-surgical SOC in debridement and promotion of healthy granulation tissue.
|
● |
Secured $25 million in a strategic private investment in public equity with several new and existing investors. Mölnlycke Health Care, a global leader in innovative wound care solutions, led the PIPE and has entered into a collaboration
agreement with MediWound.
|
● |
Company included in the Russell 3000® Index, as part of the 2024 Russell indexes annual reconstitution.
|
● |
Revenue: Revenue for the second quarter of 2024 was $5.1 million, up from $4.8 million in the same period of 2023. The increase is primarily attributed to revenue from Vericel.
|
● |
Gross Profit: Gross profit for the second quarter of 2024 was $0.4 million, representing 9% of total revenue, compared to $1.1 million, representing 24% of total revenue in the second quarter of
2023. The decrease in gross margin is mainly due to changes in the revenue mix and nonrecurring production costs.
|
● |
Expenditures:
|
o |
Research and Development: R&D expenses for the second quarter of 2024 were $1.9 million, compared to $2.0 million in the same period of 2023.
|
o |
Selling, General, and Administrative: SG&A expenses for the second quarter of 2024 were $3.0 million, compared to $3.1 million in the second quarter of 2023.
|
● |
Operating Results: Operating loss for the second quarter of 2024 was $4.5 million, compared to an operating loss of $4.0 million in the second quarter of 2023.
|
● |
Net Profit (Loss): Net loss for the second quarter of 2024 was $6.3 million, or $0.68 per share, compared to a net profit of $0.9 million, or $0.10 per share, in the second quarter of 2023. This
change is primarily due to financial expenses driven by the revaluation of warrants.
|
● |
Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the second quarter of 2024 was a loss of $3.4 million, compared to a loss of $3.0 million in the same period of 2023.
|
● |
Revenue: Total revenues for the first half of 2024 were $10.0 million, up from $8.6 million in the first half of 2023. The increase is mainly attributed to revenue from Vericel and new contracts
with the U.S. Department of Defense (DoD).
|
● |
Gross Profit: Gross profit for the first half of 2024 was $1.1 million, or 11% of total revenue, compared to $2.0 million, or 23% of total revenue, in the first half of 2023.
|
● |
Expenditures:
|
o |
Research and Development: R&D expenses for the first half of 2024 were $3.4 million, compared to $4.1 million in the first half of 2023. This decrease is primarily due to the completion of the
EscharEx Phase II study.
|
o |
Selling, General, and Administrative: SG&A expenses for the first half of 2024 were $5.9 million, down from $6.2 million in the first half of 2023.
|
● |
Operating Results: Operating loss for the first half of 2024 was $8.2 million, compared to an operating loss of $8.4 million in the same period of 2023.
|
● |
Net Loss: Net loss for the first half of 2024 was $16.0 million, or $1.73 per share, compared to a net loss of $2.8 million, or $0.32 per share, in the first half of 2023. The increase in net loss
is primarily attributable to financial expenses from the revaluation of warrants, which amounted to $8 million, driven by a 53% increase in the Company’s share price.
|
● |
Adjusted EBITDA: Adjusted EBITDA for the first half of 2024 was a loss of $6.2 million, compared to a loss of $6.4 million in the first half of 2023.
|
Contacts:
|
|
Hani Luxenburg
Chief Financial Officer MediWound Ltd. ir@mediwound.com
|
Daniel Ferry
Managing Director, LifeSci Advisors 617-430-7576 daniel@lifesciadvisors.com
|
MediWound, Ltd.
|
Unaudited Condensed Consolidated Statements of Financial Position
|
June 30,
|
December 31,
|
|||||||||||
2024
|
2023
|
2023
|
||||||||||
CURRENT ASSTS:
|
||||||||||||
Cash and cash equivalents and short-term deposits
|
29,215
|
51,122
|
41,708
|
|||||||||
Trade and other receivable
|
4,888
|
3,818
|
5,141
|
|||||||||
Inventories
|
3,210
|
3,113
|
2,846
|
|||||||||
Total current assets
|
37,313
|
58,053
|
49,695
|
|||||||||
Non-current assets
|
||||||||||||
Trade and other receivables
|
238
|
277
|
233
|
|||||||||
Long-term restricted bank deposits
|
453
|
-
|
440
|
|||||||||
Property, plant and equipment, net
|
12,308
|
4,705
|
9,228
|
|||||||||
Right of use assets, net
|
6,852
|
1,133
|
6,698
|
|||||||||
Intangible assets, net
|
132
|
198
|
165
|
|||||||||
Total non-current assets
|
19,983
|
6,313
|
16,764
|
|||||||||
Total assets
|
57,296
|
64,366
|
66,459
|
|||||||||
CURRENT LIABILITIES:
|
||||||||||||
Current maturities of long-term liabilities
|
1,496
|
1,961
|
1,410
|
|||||||||
Warrants, net
|
14,902
|
9,683
|
7,296
|
|||||||||
Trade payables and accrued expenses
|
2,745
|
3,531
|
5,528
|
|||||||||
Other payables
|
3,468
|
2,817
|
3,891
|
|||||||||
Total current liabilities
|
22,611
|
17,992
|
18,125
|
|||||||||
NON- CURRENT LIABILITIES:
|
||||||||||||
Liabilities in respect of IIA grants
|
8,009
|
7,806
|
7,677
|
|||||||||
Liabilities in respect of TEVA
|
1,962
|
2,529
|
2,256
|
|||||||||
Lease liability
|
6,355
|
677
|
6,350
|
|||||||||
Severance pay liability, net
|
490
|
433
|
456
|
|||||||||
Total non-current liabilities
|
16,816
|
11,445
|
16,739
|
|||||||||
Shareholders' equity
|
17,869
|
34,929
|
31,595
|
|||||||||
Total liabilities & shareholder equity
|
57,296
|
64,366
|
66,459
|
MediWound, Ltd.
|
Unaudited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss
|
U.S. dollars in thousands (except of share and per share data)
|
Six months ended
|
Three months ended
|
Year ended
|
||||||||||||||||||
June 30,
|
June 30,
|
December 31,
|
||||||||||||||||||
2024
|
2023
|
2024
|
2023
|
2023
|
||||||||||||||||
Total Revenues
|
10,027
|
8,572
|
5,063
|
4,773
|
18,686
|
|||||||||||||||
Cost of revenues
|
8,973
|
6,609
|
4,616
|
3,636
|
15,108
|
|||||||||||||||
Gross profit
|
1,054
|
1,963
|
447
|
1,137
|
3,578
|
|||||||||||||||
Research and development
|
3,368
|
4,126
|
1,898
|
2,024
|
7,467
|
|||||||||||||||
Selling and Marketing
|
2,403
|
2,438
|
1,224
|
1,332
|
4,844
|
|||||||||||||||
General and administrative
|
3,501
|
3,770
|
1,809
|
1,788
|
6,768
|
|||||||||||||||
Other Income
|
-
|
-
|
-
|
-
|
(211
|
)
|
||||||||||||||
Total operating expenses
|
9,272
|
10,334
|
4,931
|
5,144
|
18,868
|
|||||||||||||||
Operating loss
|
(8,218
|
)
|
(8,371
|
)
|
(4,484
|
)
|
(4,007
|
)
|
(15,290
|
)
|
||||||||||
Financial income (expenses), net
|
(7,794
|
)
|
5,611
|
(1,823
|
)
|
4,935
|
8,759
|
|||||||||||||
Taxes on income
|
(22
|
)
|
(17
|
)
|
2
|
(12
|
)
|
(185
|
)
|
|||||||||||
Net profit (loss)
|
(16,034
|
)
|
(2,777
|
)
|
(6,305
|
)
|
916
|
(6,716
|
)
|
|||||||||||
Foreign currency translation adjustments
|
10
|
(9
|
)
|
2
|
-
|
(13
|
)
|
|||||||||||||
Total comprehensive profit (loss)
|
(16,024
|
)
|
(2,786
|
)
|
(6,303
|
)
|
916
|
(6,729
|
)
|
|||||||||||
Basic and diluted loss per share:
|
||||||||||||||||||||
Net profit (loss) per share
|
(1.73
|
)
|
(0.32
|
)
|
(0.68
|
)
|
0.1
|
(0.75
|
)
|
|||||||||||
Weighted average number of ordinary shares
|
9,256,862
|
8,803,065
|
9,279,370
|
9,208,902
|
9,013,144
|
MediWound, Ltd.
|
Unaudited Condensed Consolidated Statements of Cash Flows
|
U.S. dollars in thousands
|
Six months ended
|
Three months ended
|
Year Ended
|
||||||||||||||||||
June 30,
|
June 30,
|
December 31,
|
||||||||||||||||||
2024
|
2023
|
2024
|
2023
|
2023
|
||||||||||||||||
Cash Flows from Operating Activities:
|
||||||||||||||||||||
Net profit (loss)
|
(16,034
|
)
|
(2,777
|
)
|
(6,305
|
)
|
916
|
(6,716
|
)
|
|||||||||||
Adjustments to reconcile net profit (loss) to net cash used in operating activities:
|
||||||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||||||
Depreciation and amortization
|
725
|
618
|
357
|
315
|
1,303
|
|||||||||||||||
Share-based compensation
|
1,270
|
1,331
|
758
|
712
|
1,940
|
|||||||||||||||
Revaluation of warrants accounted at fair value
|
8,007
|
(5,923
|
)
|
1,927
|
(4,990
|
)
|
(8,310
|
)
|
||||||||||||
Revaluation of liabilities in respect of IIA grants
|
470
|
492
|
237
|
233
|
427
|
|||||||||||||||
Revaluation of liabilities in respect of TEVA
|
206
|
241
|
99
|
119
|
468
|
|||||||||||||||
Financing income and exchange differences of lease liability
|
17
|
(22
|
)
|
(11
|
)
|
(9
|
)
|
257
|
||||||||||||
Increase in severance liability, net
|
48
|
67
|
13
|
(10
|
)
|
83
|
||||||||||||||
Other income
|
-
|
-
|
-
|
-
|
(211
|
)
|
||||||||||||||
Financial income, net
|
(918
|
)
|
(1,005
|
)
|
(405
|
)
|
(759
|
)
|
(2,231
|
)
|
||||||||||
Un-realized foreign currency loss
|
78
|
466
|
11
|
120
|
189
|
|||||||||||||||
9,903
|
(3,735
|
)
|
2,986
|
(4,269
|
)
|
(6,085
|
)
|
|||||||||||||
Changes in asset and liability items:
|
||||||||||||||||||||
Decrease (increase) in trade receivables
|
753
|
6,115
|
876
|
(707
|
)
|
5,658
|
||||||||||||||
Decrease (increase) in inventories
|
(345
|
)
|
(1,162
|
)
|
103
|
(579
|
)
|
(906
|
)
|
|||||||||||
Decrease (increase) in other receivables
|
(574
|
)
|
122
|
(459
|
)
|
435
|
(894
|
)
|
||||||||||||
Increase (decrease) in trade payables and accrued expenses
|
(1,900
|
)
|
(1,636
|
)
|
(530
|
)
|
312
|
(594
|
)
|
|||||||||||
Decrease in other payables
|
(34
|
)
|
(1,526
|
)
|
(294
|
)
|
(1,359
|
)
|
(928
|
)
|
||||||||||
(2,100
|
)
|
1,913
|
(304
|
)
|
(1,898
|
)
|
2,336
|
|||||||||||||
Net cash used in operating activities
|
(8,231
|
)
|
(4,599
|
)
|
(3,623
|
)
|
(5,251
|
)
|
(10,465
|
)
|
Unaudited Condensed Consolidated Statements of Cash Flows
|
U.S. dollars in thousands
|
Six months ended
|
Three months ended
|
Year Ended
|
||||||||||||||||||
June 30,
|
June 30,
|
December 31,
|
||||||||||||||||||
2024
|
2023
|
2024
|
2023
|
2023
|
||||||||||||||||
Cash Flows from Investment Activities:
|
||||||||||||||||||||
Purchase of property and equipment
|
(4,275
|
)
|
(2,570
|
)
|
(3,016
|
)
|
(1,065
|
)
|
(6,464
|
)
|
||||||||||
Interest received
|
1,127
|
879
|
522
|
577
|
1,947
|
|||||||||||||||
Proceeds from (investment in) short term bank deposits, net
|
4,209
|
(31,830
|
)
|
5,339
|
(25,590
|
)
|
(29,804
|
)
|
||||||||||||
Net cash provided by (used in) investing activities
|
1,061
|
(33,521
|
)
|
2,845
|
(26,078
|
)
|
(34,321
|
)
|
||||||||||||
Cash Flows from Financing Activities:
|
||||||||||||||||||||
Repayment of lease liabilities
|
(458
|
)
|
(334
|
)
|
(214
|
)
|
(157
|
)
|
(778
|
)
|
||||||||||
Proceeds from exercise of warrants
|
610
|
(
|
*)
|
111
|
(
|
*)
|
-
|
|||||||||||||
Proceeds from issuance of shares and warrants, net
|
-
|
24,909
|
-
|
(248
|
)
|
24,909
|
||||||||||||||
Repayments of IIA grants, net
|
(120
|
)
|
(310
|
)
|
-
|
-
|
(380
|
)
|
||||||||||||
Repayment of liabilities in respect of TEVA
|
(834
|
)
|
(417
|
)
|
-
|
-
|
(834
|
)
|
||||||||||||
Net cash provided by (used in) financing activities
|
(802
|
)
|
23,848
|
(103
|
)
|
(405
|
)
|
22,917
|
||||||||||||
Exchange rate differences on cash and cash equivalent balances
|
(104
|
)
|
(457
|
)
|
(15
|
)
|
(120
|
)
|
(160
|
)
|
||||||||||
Decrease in cash and cash equivalents
|
(8,076
|
)
|
(14,729
|
)
|
(896
|
)
|
(31,854
|
)
|
(22,029
|
)
|
||||||||||
Balance of cash and cash equivalents at the beginning of the period
|
11,866
|
33,895
|
4,686
|
51,020
|
33,895
|
|||||||||||||||
Balance of cash and cash equivalents at the end of the period
|
3,790
|
19,166
|
3,790
|
19,166
|
11,866
|
MediWound Ltd.
|
Adjusted EBITDA
|
Six months ended
|
Three months ended
|
Year Ended
|
||||||||||||||||||
June 30,
|
June 30,
|
December 31,
|
||||||||||||||||||
2024
|
2023
|
2024
|
2023
|
2023
|
||||||||||||||||
Net profit (loss)
|
(16,034
|
)
|
(2,777
|
)
|
(6,305
|
)
|
916
|
(6,716
|
)
|
|||||||||||
Adjustments:
|
||||||||||||||||||||
Financial income (expenses), net
|
(7,794
|
)
|
5,611
|
(1,823
|
)
|
4,935
|
8,759
|
|||||||||||||
Other Income, net
|
-
|
-
|
-
|
-
|
211
|
|||||||||||||||
Taxes on income
|
(22
|
)
|
(17
|
)
|
2
|
(12
|
)
|
(185
|
)
|
|||||||||||
Depreciation and amortization
|
(725
|
)
|
(618
|
)
|
(357
|
)
|
(315
|
)
|
(1,303
|
)
|
||||||||||
Share-based compensation expenses
|
(1,270
|
)
|
(1,331
|
)
|
(758
|
)
|
(712
|
)
|
(1,940
|
)
|
||||||||||
Total adjustments
|
(9,811
|
)
|
3,645
|
(2,936
|
)
|
3,896
|
5,542
|
|||||||||||||
Adjusted EBITDA
|
(6,223
|
)
|
(6,422
|
)
|
(3,369
|
)
|
(2,980
|
)
|
(12,258
|
)
|
Page | |
F-2 | |
F-3 | |
F-4 – F-5 | |
F-6 – F-7 | |
F-8 – F-11 |
June 30,
|
December 31,
|
|||||||||||
2024
|
2023
|
2023
|
||||||||||
Cash and cash equivalents
|
|
|
|
|||||||||
Short-term and restricted bank deposits
|
|
|
|
|||||||||
Trade receivables
|
|
|
|
|||||||||
Inventories
|
|
|
|
|||||||||
Other receivables
|
|
|
|
|||||||||
Total current assets
|
|
|
|
|||||||||
Other receivables
|
|
|
|
|||||||||
Long-term restricted bank deposits
|
|
|
|
|||||||||
Property, plant and equipment, net
|
|
|
|
|||||||||
Right-of-use assets, net
|
|
|
|
|||||||||
Intangible assets, net
|
|
|
|
|||||||||
Total non-current assets
|
|
|
|
|||||||||
Total assets
|
|
|
|
|||||||||
Current maturities of long-term liabilities
|
|
|
|
|||||||||
Warrants, net
|
|
*
|
*
|
|||||||||
Trade payables and accrued expenses
|
|
|
|
|||||||||
Other payables
|
|
|
|
|||||||||
Total current liabilities
|
|
|
|
|||||||||
Liabilities in respect of IIA grants
|
|
|
|
|||||||||
Liabilities in respect of TEVA
|
|
|
|
|||||||||
Lease liabilities
|
|
|
|
|||||||||
Severance pay liability, net
|
|
|
|
|||||||||
Total non-current liabilities
|
|
|
|
|||||||||
Total liabilities
|
|
|
|
|||||||||
Shareholders' equity:
|
||||||||||||
Ordinary shares of NIS
|
||||||||||||
Authorized:
|
|
|
|
|||||||||
Share premium
|
|
|
|
|||||||||
Foreign currency translation adjustments
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Total equity
|
|
|
|
|||||||||
Total liabilities and equity
|
|
|
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
2024
|
2023
|
2024
|
2023
|
2023
|
||||||||||||||||
Revenues from sale of products
|
|
|
|
|
|
|||||||||||||||
Revenues from development services
|
|
|
|
|
|
|||||||||||||||
Revenues from license agreements and royalties
|
|
|
|
|
|
|||||||||||||||
Total revenues
|
|
|
|
|
|
|||||||||||||||
Cost of revenues from sale of products
|
|
|
|
|
|
|||||||||||||||
Cost of revenues from development services
|
|
|
|
|
|
|||||||||||||||
Cost of revenues from license agreements and royalties
|
|
|
|
|
|
|||||||||||||||
Total cost of revenues
|
|
|
|
|
|
|||||||||||||||
Gross profit
|
|
|
|
|
|
|||||||||||||||
Research and development
|
|
|
|
|
|
|||||||||||||||
Selling and marketing
|
|
|
|
|
|
|||||||||||||||
General and administrative
|
|
|
|
|
|
|||||||||||||||
Other income
|
|
|
|
|
(
|
)
|
||||||||||||||
Total operating expenses
|
|
|
|
|
|
|||||||||||||||
Operating loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Financial income
|
|
|
|
|
|
|||||||||||||||
Financial expenses
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Financing income (expenses), net
|
(
|
)
|
|
(
|
)
|
|
|
|||||||||||||
Profit (loss) before taxes on income
|
(
|
)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||||
Taxes on income
|
(
|
)
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|||||||||||
Net profit (loss)
|
(
|
)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||||
Other comprehensive income (loss):
|
||||||||||||||||||||
Foreign currency translation adjustments
|
|
(
|
)
|
|
|
(
|
)
|
|||||||||||||
Total comprehensive profit (loss)
|
(
|
)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||||
Profit (loss) per share data:
|
||||||||||||||||||||
Basic and diluted net profit (loss) per share - USD
|
(
|
)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||||
Number of shares used in calculating basic and diluted profit (loss) per share
|
|
|
|
|
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity (deficit)
|
||||||||||||||||
Balance as of April 1, 2024
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Other comprehensive income
|
|
|
|
|
|
|||||||||||||||
Total comprehensive income
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Exercise of warrants
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
Balance as of June 30, 2024 (unaudited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Balance as of April 1, 2023
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Profit for the period
|
|
|
|
|
|
|||||||||||||||
Other comprehensive income
|
|
|
|
|
|
|||||||||||||||
Total comprehensive income
|
|
|
|
|
|
|||||||||||||||
Issuance expenses
|
|
|
|
|
|
|||||||||||||||
Exercise of options
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
Balance as of June 30, 2023 (unaudited)
|
|
|
(
|
)
|
(
|
)
|
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity (deficit)
|
||||||||||||||||
Balance as of December 31, 2023 (audited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Other comprehensive (loss)
|
|
|
|
|
|
|||||||||||||||
Total comprehensive (loss)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Exercise of warrants
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
Balance as of June 30, 2024 (unaudited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Balance as of December 31, 2022 (audited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Other comprehensive (loss)
|
|
|
(
|
)
|
|
(
|
)
|
|||||||||||||
Total comprehensive (loss)
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||
Issuance of ordinary shares, net of issuance expenses
|
|
|
|
|
|
|||||||||||||||
Exercise of options
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
Balance as of June 30, 2023 (unaudited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Balance as of December 31, 2022 (audited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Net loss
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Other comprehensive loss
|
|
|
(
|
)
|
|
(
|
)
|
|||||||||||||
Total comprehensive loss
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||
Exercise of RSU
|
|
|
|
|
|
|||||||||||||||
Issuance of ordinary shares, net of issuance expenses
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
Balance as of December 31, 2023 (audited)
|
|
|
(
|
)
|
(
|
)
|
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
2024
|
2023
|
2024
|
2023
|
2023
|
||||||||||||||||
Cash flows from operating activities:
|
||||||||||||||||||||
Net profit (loss)
|
(
|
)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||||
Adjustments to reconcile net profit (loss) to net cash used in operating activities:
|
||||||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||||||
Depreciation and amortization
|
|
|
|
|
|
|||||||||||||||
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
Revaluation of warrants accounted at fair value
|
|
(
|
)
|
|
(
|
)
|
(
|
)
|
||||||||||||
Revaluation of liabilities in respect of IIA grants
|
|
|
|
|
|
|||||||||||||||
Revaluation of liabilities in respect of TEVA
|
|
|
|
|
|
|||||||||||||||
Financing income and exchange differences of lease liability
|
|
(
|
)
|
(
|
)
|
(
|
)
|
|
||||||||||||
Increase in severance pay liability, net
|
|
|
|
(
|
)
|
|
||||||||||||||
Other income
|
|
|
|
|
(
|
)
|
||||||||||||||
Financial income, net
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Un-realized foreign currency loss
|
|
|
|
|
|
|||||||||||||||
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|||||||||||||
Changes in asset and liability items:
|
||||||||||||||||||||
Decrease (increase) in trade receivables
|
|
|
|
(
|
)
|
|
||||||||||||||
Decrease (increase) in inventories
|
(
|
)
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|||||||||||
Decrease (increase) in other receivables
|
(
|
)
|
|
(
|
)
|
|
(
|
)
|
||||||||||||
Increase (decrease) in trade payables and accrued expenses
|
(
|
)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||||
Decrease in other payables
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
(
|
)
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
2024
|
2023
|
2024
|
2023
|
2023
|
||||||||||||||||
Cash Flows from Investing Activities:
|
||||||||||||||||||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Interest received
|
|
|
|
|
|
|||||||||||||||
Proceeds from (investment in) short term bank deposits, net
|
|
(
|
)
|
|
(
|
)
|
(
|
)
|
||||||||||||
Net cash provided by (used in) investing activities
|
|
(
|
)
|
|
(
|
)
|
(
|
)
|
||||||||||||
Cash Flows from Financing Activities:
|
||||||||||||||||||||
Repayment of leases liabilities
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Proceeds from exercise of warrants
|
|
(
|
)
|
|
(
|
)
|
|
|||||||||||||
Proceeds from issuance of shares and warrants, net
|
|
|
|
(
|
)
|
|
||||||||||||||
Repayment of IIA grants, net
|
(
|
)
|
(
|
)
|
|
|
(
|
)
|
||||||||||||
Repayment of liabilities in respect of TEVA
|
(
|
)
|
(
|
)
|
|
|
(
|
)
|
||||||||||||
Net cash provided by (used in) financing activities
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|
||||||||||||
Exchange rate differences on cash and cash equivalent balances
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Decrease in cash and cash equivalents
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Balance of cash and cash equivalents at the beginning of the period
|
|
|
|
|
|
|||||||||||||||
Balance of cash and cash equivalents at the end of the period
|
|
|
|
|
|
|||||||||||||||
Supplement disclosure of Non-cash transactions:
|
||||||||||||||||||||
ROU asset, net recognized with corresponding lease liability
|
|
|
|
|
|
|||||||||||||||
Purchase of property and equipment
|
(
|
)
|
|
(
|
)
|
|
(
|
)
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Note 1: |
General
|
a. |
Description of the Company and its operations:
|
MediWound Ltd. Was incorporated in Israel in January 2000. The Company which is located in Yavne, Israel (The "Company" or "MediWound"), is biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic, non-surgical solutions for tissue repair and regeneration. The Company’s strategy leverages its breakthrough enzymatic technology platform into diversified portfolio of biotherapeutics across multiple indications to pioneer solutions for unmet medical needs. The Company’s current portfolio is focused on next-generation protein-based therapies for burn care, wound care and tissue repair.
The Company's first innovative biopharmaceutical product, Nexobrid, has received in December 2022, an approval from the U.S. Food and Drug Administration (“FDA”) and marketing approval in each of India, Switzerland and Japan. In addition, it has a marketing authorization from the European Medicines Agency (“EMA”) and regulatory agencies in other international markets for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full thickness thermal burns.
The Company commercialize Nexobrid globally through multiple sales channels.
The Company sells Nexobrid to burn centers in the European Union, United Kingdom and Israel, primarily through its commercial organizations.
The Company has established local distribution channels in multiple international markets, focusing on Asia Pacific, EMEA, CEE and LATAM, which local distributors are also responsible for obtaining local marketing authorization within the relevant territories.
In the United States, the Company entered into an exclusive license and supply agreements with Vericel Corporation (“Vericel”) to commercialize Nexobrid in North America upon FDA approval. On September 21, 2023, the Company announced the U.S. commercial availability of Nexobrid® for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns.
On September 20, 2022, The Company announced that EMA has validated for review the Type II Variation to expand the currently approved indication for Nexobrid (removal of eschar in adults with deep partial-and full-thickness thermal burn wounds) into the pediatric population.
The Company’s second investigational next-generation enzymatic therapy product, EscharEx, a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds.
The Company expected to initiate the Phase III study in the second half of 2024.
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Unaudited Condensed Interim Consolidated Financial Statements
Note 1: |
General (Cont.)
|
b. |
The Company's securities are listed for trading on NASDAQ since March 2014.
|
c. |
The Company has three wholly owned subsidiaries: MediWound Germany GmbH, acting as Europe (“EU”) marketing authorization holder and EU sales and marketing arm, and MediWound UK Limited and MediWound US, Inc. which are currently inactive companies.
|
d. |
In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these consolidated financial statements, the war in Israel is ongoing and continues to evolve. The company’s head quarter, manufacturing and R&D facilities are located in Israel. Currently, such activities in Israel remain largely unaffected. During the first half of 2024, the impact of this war on the company’s results of operations and financial condition was immaterial.
|
e. |
BARDA Contracts
|
In September 2015, the Company was awarded BARDA Contract for treatment of thermal burn injuries. This contract was amended multiple times to extend its term until September 2024 and its total value, up to a total amount of $
As of June 30, 2024, the Company has received approximately $
|
f. |
DOD and MTEC contracts:
|
On February 17, 2022, the Company was entered into a contract with the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), to develop Nexobrid as a non-surgical solution for field-care burn treatment for the U.S. Army. The contract provides funding up to $
During 2023, the DoD through MTEC awarded the Company additional funding of $
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Unaudited Condensed Interim Consolidated Financial Statements
Note 1: |
General (Cont.)
|
g. |
In June 2024, the Company signed new agreements with suppliers to precure services totaling $
|
h. |
The accompanying consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern. From inception to June 30, 2024, the Company has incurred cash outflows from operations, losses from operations, and has an accumulated deficit of $
The Company believes that its existing cash and cash equivalents, short-term and restricted bank deposits of $
|
Note 2: |
Material 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 consolidated financial statements for the six and three months ended June 30, 2024, have been prepared in accordance with IAS 34 "Interim Financial Reporting".
These condensed consolidated interim financial statements have been prepared in accordance with IAS 34 Interim Financial Reporting and do not include all of the information required for full annual financial statements. They should be read in conjunction with the financial statements as at and for the year ended December 31, 2023 (hereinafter – “the annual financial statements”). These condensed consolidated interim financial statements were authorized for issue by the Group’s Board of Directors on August 14, 2024.
|
c. |
Presentation of Financial Statements: Classification of Liabilities as Current or Non-Current (amendment to IAS 1).
As a result of applying the Amendment the warrants presented in these financial statements were classified as a current liability pursuant to the conversion option. |
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Unaudited Condensed Interim Consolidated Financial Statements
Note 3: |
Equity
|
1. |
On February 26, 2024, the Company granted
|
2. |
During the first half of 2024,
|
Note 4: |
Subsequent events
|
1. |
On July 15, 2024, the Company entered into a definitive share purchase agreement. The agreement includes the sale and purchase of
|
2. |
Concurrently with the PIPE offering, on July 15, 2024, the Company and Teva Pharmaceutical Industries Ltd. (“Teva”) entered into Amendment No. 2 (the “Amendment”) to the settlement agreement and mutual general release, dated March 24, 2019, as previously amended by Amendment No. 1, dated December 13, 2020, by and between the Company and Teva (the “Agreement”). Under the terms of the Amendment, the Company will pay Teva $ |
3. |
On July 16, 2024,
|
4. |
Following the PIPE offering, exercise of Series A warrants, and exercise of options, the Company’s updated number of Issued and Outstanding shares are
|
5. |
On July 16, 2024, the company was selected to receive €
|
6. |
In July 2024, the Company signed new agreements with suppliers to procure services totaling $
|
F - 11
A.
|
Operating Results
|
Six Months Ended June 30,
|
||||||||
|
2024 |
2023
|
||||||
|
(in thousands)
|
|||||||
Condensed statements of operations data:
|
||||||||
Revenues
|
$
|
10,027
|
$
|
8,572
|
||||
Cost of revenues
|
8,973
|
6,609
|
||||||
Gross profit
|
1,054
|
1,963
|
||||||
Operating expenses:
|
||||||||
Research and development
|
3,368
|
4,126
|
||||||
Selling and marketing
|
2,403
|
2,438
|
||||||
General and administrative
|
3,501
|
3,770
|
||||||
Other (income) expenses
|
-
|
-
|
||||||
Operating loss
|
(8,218
|
)
|
(8,371
|
)
|
||||
Financial income (expenses), net
|
(7,794
|
)
|
5,611
|
|||||
Loss before taxes on income
|
(16,012
|
)
|
(2,760
|
)
|
||||
Taxes on income
|
(22
|
)
|
(17
|
)
|
||||
Net loss
|
$
|
(16,034
|
)
|
$
|
(2,777
|
)
|
|
Six Months Ended June 30,
|
|||||||
|
2024
|
2023
|
||||||
|
(in thousands)
|
|||||||
Revenues from sale of products
|
$
|
3,202
|
$
|
2,358
|
||||
|
||||||||
Revenues from development services
|
6,727
|
6,149
|
||||||
|
||||||||
Revenues from license agreements and royalties
|
98
|
65
|
|
Six Months Ended June 30,
|
|||||||
|
2024
|
2023
|
||||||
|
(in thousands)
|
|||||||
International (excluding U.S.)
|
$
|
2,286
|
$
|
2,322
|
||||
U.S.
|
7,741
|
6,250
|
|
Six Months Ended
June 30,
|
|||||||
|
2024
|
2023
|
||||||
|
(in thousands)
|
|||||||
Cost of revenues from sales of products
|
$
|
3,144
|
$
|
1,436
|
||||
Cost of revenues from development services
|
5,821
|
5,170
|
||||||
Cost of revenues from license agreements and royalties
|
8
|
3
|
Financial income, net
|
|
Six Months Ended June 30,
|
|
|||||
|
|
2024
|
|
|
2023
|
|
||
|
|
(in thousands)
|
|
|||||
Financial income
|
|
$
|
1,171
|
|
|
$
|
7,480
|
|
Financial expenses
|
|
|
(8,965)
|
|
|
(1,869)
|
B.
|
Liquidity and Capital Resources
|
|
Six Months Ended
June 30,
|
|||||||
|
2024
|
2023
|
||||||
|
||||||||
Net cash provided by (used in):
|
||||||||
Operating activities
|
$
|
(8,231
|
)
|
$
|
(4,599
|
)
|
||
Investing activities
|
1,061
|
(33,521
|
)
|
|||||
Financing activities
|
(802
|
)
|
23,848
|
C.
|
Research and Development, Patents and Licenses, Etc.
|
D.
|
Trend Information
|
E.
|
Critical Accounting Estimates
|