● |
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
|
)
|