MEDIWOUND LTD.
|
|||
Date: November 21, 2023
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By:
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/s/ Hani Luxenburg
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Name:
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Hani Luxenburg
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||
Title:
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Chief Financial Officer
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Exhibit
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Description
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• |
Announced U.S. commercial availability of NexoBrid for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns, with the Company’s U.S. strategic partner, Vericel Corporation.
|
• |
Announced commercial availability of NexoBrid in Japan for the treatment of deep partial thickness and full thickness burns in adults and pediatric patients with the Company’s strategic partner, Kaken Pharmaceutical Co., a top ranked
Japanese pharmaceutical company.
|
• |
Deployed all available non-U.S. NexoBrid inventory to support the emergency demand from hospitals and military to treat mass burn casualties resulting from the war in Israel.
|
• |
Responded to surging U.S. and global demand for NexoBrid by strategically reallocating resources to prioritize production and the scale-up of manufacturing capabilities. The new GMP-compliant state-of-the-art manufacturing facility is
projected to be completed by mid-2024, with full-scale manufacturing currently expected to commence in 2025.
|
• |
Announced positive Committee for Medicinal Products for Human Use (CHMP) opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for the removal of eschar in patients
with deep partial- and full-thickness thermal burns.
|
• |
Expanded European market presence by establishing a collaboration with PolyMedics Innovations (PMI) for the promotion of NexoBrid in Germany, Austria, Belgium, the Netherlands and Luxemburg.
|
• |
Secured $6.5 million R&D budget from the U.S. Department of Defense to advance the development of a new, temperature stable formulation of NexoBrid to be used by the U.S. Army as a first line, non-surgical solution for field-care
burn treatment.
|
• |
Positive results from the NexoBrid U.S. Phase III (DETECT) study were published in the Journal of Burn Care & Research, demonstrating that treatment with NexoBrid resulted in early complete eschar removal in more than 90% of
treated burn patients and reduced the need for surgical excision compared to gel vehicle and standard of care.
|
• |
An updated Phase III protocol will be submitted in the first quarter of 2024 in accordance with recent discussions with the U.S. FDA and EMA. Simultaneously, plans are underway for other exploratory studies aimed at supporting the
Biologics License Application (BLA) for EscharEx and enhancing future commercialization and market access strategies.
|
• |
The global Phase III clinical trial intends to enroll approximately 216 patients, randomly assigned in a 1:1 ratio to receive either EscharEx or the placebo gel vehicle. The study's co-primary endpoints are the incidence of complete
debridement at the end of the daily visit period and the incidence of wound closure by the end of weekly follow-ups. An interim assessment is planned after 67% of the participants have completed the trial. Patient enrollment is currently
expected to commence in the second half of 2024.
|
• |
Established research and development partnership with 3M Healthcare, adding to previously announced partnerships with MIMEDX, and Mölnlycke, to provide product and support for the EscharEx Phase III clinical study.
|
• |
Appointed Shmulik Hess, Ph.D. as the Chief Operating Officer and Chief Commercial Officer effective as of December 1, 2023. Dr. Hess brings extensive global expertise in operations and commercial activities, along with a proven track
record of success during pivotal phases in a company's development. His capabilities will significantly contribute to fortifying the Company as a world-class operation.
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• |
Cash, restricted cash, and investments totaled $46 million as of September 30, 2023, ensuring an operating cash runway that extends through profitability.
|
• |
Revenues: Revenues for the third quarter of 2023 were $4.8 million, compared to $5.8 million in the same quarter of the previous year. The decrease is primarily attributed to the absence of
nonrecurring income from BARDA.
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• |
Gross Profit: Gross profit in the third quarter 2023 was $0.9 million, representing 19% of total revenues, compared to $2.4 million, representing 41.9% of total revenue in the third quarter of
2022. The decrease is primarily attributed to the absence of nonrecurring income from BARDA.
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• |
Expenditures:
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o |
Research and development expenses in the third quarter of 2023 were $1.5 million compared to $2.9 million in the third quarter of 2022. This change is primarily attributed to the completion of EscharEx phase II study in 2022.
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o |
Selling, general, and administrative expenses in the third quarter of 2023 were $2.6 million, compared to $3.1 million in the third quarter of 2022.
|
• |
Operating Results: Operating loss in the third quarter of 2023 was $3.0 million, compared to $3.5 million loss in the third quarter of 2022.
|
• |
Net Loss: Net loss in the third quarter of 2023 was $2.2 million or $0.24 per share, compared to the net loss of $4.2 million, or $0.88 per share in the third quarter of 2022. The decrease is
primarily attributed to a favorable adjustment from the revaluation of warrants.
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• |
Non-GAAP Adjusted EBITDA: Adjusted EBITDA in the third quarter of 2023 was a loss of $2.6 million, compared to a loss of $2.5 million in the third quarter of 2022.
|
• |
Revenues: Total revenues for the first nine months of 2023 were $13.3 million, compared to $14.9 million in the first nine months of 2022. The decrease is primarily attributed to the absence of
nonrecurring income from BARDA.
|
• |
Operating results: Operating loss for the first nine months of 2023 was $11.4 million, compared to the operating loss of $10.5 million recorded in the first nine months of 2022.
|
• |
Net loss: Net loss for the first nine months of 2023 was $5 million, or $0.56 per share compared to a net loss of $12.1 million or $2.67 per share for the first nine months of 2022.
|
• |
Non-GAAP Adjusted EBITDA: Adjusted EBITDA, for the first nine months of 2023, showed a loss of $9 million, compared to a loss of $7.9 million reported in the first nine months of 2022.
|
Hani Luxenburg
Chief Financial Officer MediWound Ltd. ir@mediwound.com
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Daniel Ferry
Managing Director, LifeSci Advisors 617-430-7576 daniel@lifesciadvisors.com
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September 30,
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Dec 31,
|
||||||||||
|
2023
|
2022
|
2022
|
|||||||||
Cash and cash equivalents
|
9,279
|
14,905
|
33,895
|
|||||||||
Short-term bank deposits
|
36,244
|
2,687
|
-
|
|||||||||
Trade and other receivable
|
4,071
|
4,976
|
9,982
|
|||||||||
Inventories
|
3,656
|
1,880
|
1,963
|
|||||||||
Total current assets
|
53,250
|
24,448
|
45,840
|
|||||||||
|
||||||||||||
Other receivables
|
483
|
230
|
364
|
|||||||||
Property, plant and equipment, net
|
6,437
|
2,354
|
2,366
|
|||||||||
Right of use assets, net
|
6,665
|
1,305
|
1,215
|
|||||||||
Intangible assets, net
|
182
|
248
|
231
|
|||||||||
Total non-current assets
|
13,767
|
4,137
|
4,176
|
|||||||||
|
||||||||||||
Total assets
|
67,017
|
28,585
|
50,016
|
|||||||||
|
||||||||||||
Current maturities of non-current liabilities
|
1,692
|
2,461
|
2,242
|
|||||||||
Trade payables and accrued expenses
|
3,680
|
3,565
|
5,656
|
|||||||||
Other payables
|
3,069
|
2,986
|
4,159
|
|||||||||
Total current liabilities
|
8,441
|
9,012
|
12,057
|
|||||||||
|
||||||||||||
Deferred revenues
|
-
|
31
|
-
|
|||||||||
Warrants
|
8,901
|
5,092
|
15,606
|
|||||||||
Liabilities in respect of IIA grants
|
7,860
|
8,451
|
7,445
|
|||||||||
Liability in respect of TEVA
|
2,394
|
3,076
|
2,788
|
|||||||||
Lease liabilities
|
5,935
|
952
|
846
|
|||||||||
Severance pay liability, net
|
436
|
315
|
360
|
|||||||||
Total non-current liabilities
|
25,526
|
17,917
|
27,045
|
|||||||||
|
||||||||||||
Shareholders' equity:
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||||||||||||
Ordinary shares of NIS 0.07 par value: Issued and Outstanding: 9,219,261 as of September 30, 2023; 7,240,020 as of December 31, 2022, and 5,819,314 as of September 30, 2022
|
33,050
|
1,656
|
10,914
|
|||||||||
Total liabilities & equity
|
67,017
|
28,585
|
50,016
|
|
Nine months ended
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Three months ended
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||||||||||||||
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September 30,
|
September 30,
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||||||||||||||
|
2023
|
2022
|
2023
|
2022
|
||||||||||||
Revenues
|
13,348
|
14,878
|
4,776
|
5,803
|
||||||||||||
Cost of revenues
|
10,489
|
9,871
|
3,880
|
3,369
|
||||||||||||
Gross profit
|
2,859
|
5,007
|
896
|
2,434
|
||||||||||||
|
||||||||||||||||
Operating (Income) expenses:
|
||||||||||||||||
Research and development
|
5,659
|
7,482
|
1,533
|
2,883
|
||||||||||||
Selling, general and administrative
|
8,820
|
7,684
|
2,612
|
3,061
|
||||||||||||
Other (income) expenses
|
(224
|
)
|
309
|
(224
|
)
|
-
|
||||||||||
Operating loss
|
(11,396
|
)
|
(10,468
|
)
|
(3,025
|
)
|
(3,510
|
)
|
||||||||
|
||||||||||||||||
Financial income (expenses), net
|
6,488
|
(1,661
|
)
|
877
|
(684
|
)
|
||||||||||
Loss before taxes on income
|
(4,908
|
)
|
(12,129
|
)
|
(2,148
|
)
|
(4,194
|
)
|
||||||||
|
||||||||||||||||
Taxes on income
|
(65
|
)
|
(13
|
)
|
(48
|
)
|
(5
|
)
|
||||||||
Net loss
|
(4,973
|
)
|
(12,142
|
)
|
(2,196
|
)
|
(4,199
|
)
|
||||||||
|
||||||||||||||||
Foreign currency translation adjustments
|
(2
|
)
|
34
|
7
|
12
|
|||||||||||
Total comprehensive loss
|
(4,975
|
)
|
(12,108
|
)
|
(2,189
|
)
|
(4,187
|
)
|
||||||||
|
||||||||||||||||
Basic and diluted net loss per share - USD
|
(0.56
|
)
|
(2.67
|
)
|
(0.24
|
)
|
(0.88
|
)
|
||||||||
|
||||||||||||||||
Weighted average Number of shares used in calculating basic and diluted net loss per share
|
8,943
|
4,546
|
9,217
|
4,784
|
Nine months ended
|
Three months ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2023
|
2022
|
2023
|
2022
|
|||||||||||||
Cash Flows from Operating Activities:
|
||||||||||||||||
Net loss
|
(4,973
|
)
|
(12,142
|
)
|
(2,196
|
)
|
(4,199
|
)
|
||||||||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||
Depreciation and amortization
|
957
|
988
|
339
|
338
|
||||||||||||
Share-based compensation
|
1,642
|
1,304
|
311
|
707
|
||||||||||||
Revaluation of warrants accounted at fair value
|
(6,705
|
)
|
-
|
(782
|
)
|
-
|
||||||||||
Revaluation of liabilities in respect of IIA grants
|
709
|
812
|
217
|
330
|
||||||||||||
Revaluation of contingent in respect of TEVA
|
357
|
404
|
116
|
132
|
||||||||||||
Revaluation of lease liabilities
|
(206
|
)
|
(146
|
) |
(184
|
)
|
6
|
|||||||||
Increase in severance liability, net
|
80
|
64
|
13
|
9
|
||||||||||||
Other income
|
(224
|
)
|
-
|
(224
|
)
|
-
|
||||||||||
Net financing income
|
(1,395
|
)
|
334
|
(390
|
)
|
345
|
||||||||||
Un-realized foreign currency (gain) loss
|
534
|
465
|
68
|
(63
|
)
|
|||||||||||
(4,251
|
)
|
4,225
|
(516
|
)
|
1,804
|
|||||||||||
Changes in asset and liability items:
|
||||||||||||||||
Decrease (increase) in trade receivables
|
6,186
|
(2,445
|
)
|
71
|
(421
|
)
|
||||||||||
Decrease (increase) in inventories
|
(1,688
|
)
|
(608
|
)
|
(526
|
)
|
139
|
|||||||||
Decrease (increase) in other receivables
|
(198
|
)
|
143
|
(320
|
)
|
(187
|
)
|
|||||||||
Decrease in trade payables and accrued expenses
|
(1,687
|
)
|
(1,232
|
)
|
(51
|
)
|
(1,243
|
)
|
||||||||
Increase (decrease) in other payables and deferred revenues
|
(1,239
|
)
|
(1,826
|
)
|
287
|
(459
|
)
|
1,374
|
(5,968
|
)
|
(539
|
)
|
(2,171
|
)
|
||||||||||
Net cash used in operating activities
|
(7,850
|
)
|
(13,885
|
)
|
(3,251
|
)
|
(4,566
|
)
|
Cash Flows from Investing Activities:
|
||||||||||||||||
Purchase of property and equipment
|
(4,255
|
)
|
(381
|
)
|
(1,685
|
)
|
(83
|
)
|
||||||||
Interest received
|
1,225
|
3
|
346
|
3
|
||||||||||||
Investment in short term bank deposits, net
|
(36,319
|
)
|
(2,499
|
)
|
(4,489
|
)
|
-
|
|||||||||
Net cash used in investing activities
|
(39,349
|
)
|
(2,877
|
)
|
(5,828
|
)
|
(80
|
)
|
||||||||
Cash Flows from Financing Activities:
|
||||||||||||||||
Repayment of lease liabilities
|
(574
|
)
|
(531
|
)
|
(240
|
)
|
(181
|
)
|
||||||||
Proceeds from issuance of shares and warrants, net
|
24,909
|
21,915
|
-
|
12,054
|
||||||||||||
Repayments of IIA grants, net
|
(380
|
)
|
(258
|
)
|
(70
|
)
|
(96
|
)
|
||||||||
Repayment of liabilities in respect of TEVA
|
(834
|
)
|
-
|
(417
|
)
|
-
|
||||||||||
Net cash provided by (used in) financing activities
|
23,121
|
21,126
|
(727
|
)
|
11,777
|
|||||||||||
Exchange rate differences on cash and cash equivalent balances
|
(538
|
)
|
(505
|
)
|
(81
|
)
|
45
|
|||||||||
Increase (decrease) in cash and cash equivalents
|
(24,616
|
)
|
3,859
|
(9,887
|
)
|
7,176
|
||||||||||
Balance of cash and cash equivalents at the beginning of the period
|
33,895
|
11,046
|
19,166
|
7,729
|
||||||||||||
Balance of cash and cash equivalents at the end of the period
|
9,279
|
14,905
|
9,279
|
14,905
|
Nine months ended
|
Three months ended
|
|||||||||||||||
|
September 30,
|
September 30,
|
||||||||||||||
|
2023
|
2022
|
2023
|
2022
|
||||||||||||
|
||||||||||||||||
Net loss
|
(4,973
|
)
|
(12,142
|
)
|
(2,196
|
)
|
(4,199
|
)
|
||||||||
Adjustments:
|
||||||||||||||||
Financial income (expenses), net
|
6,488
|
(1,661
|
)
|
877
|
(684
|
)
|
||||||||||
Other income (expenses)
|
224
|
(309
|
)
|
224
|
-
|
|||||||||||
Taxes on income
|
(65
|
)
|
(13
|
)
|
(48
|
)
|
(5
|
)
|
||||||||
Depreciation and amortization
|
(957
|
)
|
(988
|
)
|
(339
|
)
|
(338
|
)
|
||||||||
Share-based compensation
|
(1,642
|
)
|
(1,304
|
)
|
(311
|
)
|
(707
|
)
|
||||||||
Total adjustments
|
4,048
|
(4,275
|
)
|
403
|
(1,734
|
)
|
||||||||||
Adjusted EBITDA
|
(9,021
|
)
|
(7,867
|
)
|
(2,599
|
)
|
(2,465
|
)
|