
| • |
The U.S. Food and Drug Administration (FDA) approved AMZEEQ™ (minocycline) topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in adults and pediatric patients nine years of age
and older. AMZEEQ™ is the first topical formulation of minocycline to be approved by the FDA for any condition. Foamix commercially launched AMZEEQ™ in the U.S. in January 2020.
|
| • |
A New Drug Application (NDA) was submitted to the FDA for FMX103 (minocycline) topical foam, 1.5%, for the treatment of papulopustular rosacea in adults. The FDA set a Prescription Drug User Fee Act (PDUFA) action date of June 2,
2020. If approved, FMX103 would be the first minocycline product available for rosacea patients.
|
| • |
Enrollment has been completed in the ongoing Phase 2 trial for FCD105, a topical combination foam of minocycline and adapalene, currently being evaluated for the treatment of moderate-to-severe acne vulgaris. Topline data from this
trial are expected in the second quarter of 2020.
|
| • |
Serlopitant is being evaluated in two Phase 3 clinical trials for the treatment of pruritus associated with prurigo nodularis (PN). The studies are fully enrolled, with results expected in March or April 2020. Assuming successful
completion of the Phase 3 clinical trials, an NDA submission for serlopitant for the treatment of pruritus in PN is planned in the second half of 2020.
|
|
Toll Free:
|
877-407-0784
|
|
International:
|
201-689-8560
|
|
Conference ID:
|
13700089
|
|
Webcast:
|
http://public.viavid.com/index.php?id=138439
|
|
December 31
|
||||||||
|
2019
|
2018 | |||||||
|
A s s e t s
|
||||||||
|
CURRENT ASSETS:
|
||||||||
|
Cash and cash equivalents
|
$
|
43,759
|
$
|
27,868
|
||||
|
Restricted cash
|
825
|
250
|
||||||
|
Short term bank deposits
|
12,102
|
24,047
|
||||||
|
Investment in marketable securities
|
16,246
|
46,669
|
||||||
|
Restricted investment in marketable securities
|
434
|
268
|
||||||
|
Trade receivable
|
135
|
1,066
|
||||||
|
Other
|
1,557
|
999
|
||||||
|
Inventory
|
1,356
|
-
|
||||||
|
TOTAL CURRENT ASSETS
|
76,414
|
101,167
|
||||||
|
NON-CURRENT ASSETS:
|
||||||||
|
Investment in marketable securities
|
-
|
150
|
||||||
|
Restricted investment in marketable securities
|
-
|
133
|
||||||
|
Property and equipment, net
|
2,885
|
2,235
|
||||||
|
Operating lease right of use assets
|
1,694
|
-
|
||||||
|
Other
|
166
|
46
|
||||||
|
TOTAL NON-CURRENT ASSETS
|
4,745
|
2,564
|
||||||
|
TOTAL ASSETS
|
$
|
81,159
|
$
|
103,731
|
||||
|
December 31
|
||||||||
|
2019
|
2018
|
|||||||
|
Liabilities and shareholders’ equity
|
||||||||
|
CURRENT LIABILITIES:
|
||||||||
|
Trade payables
|
$
|
19,352
|
$
|
6,327
|
||||
|
Accrued expenses
|
3,381
|
351
|
||||||
|
Employee related obligations
|
5,231
|
3,498
|
||||||
|
Operating lease liabilities
|
1,092
|
-
|
||||||
|
Other
|
270
|
292
|
||||||
|
TOTAL CURRENT LIABILITIES
|
29,326
|
10,468
|
||||||
|
LONG-TERM LIABILITIES:
|
||||||||
|
Liability for employee severance benefits
|
424
|
367
|
||||||
|
Operating lease liabilities
|
653
|
-
|
||||||
|
Long-term debt
|
32,725
|
-
|
||||||
|
Other liabilities
|
456
|
714
|
||||||
|
TOTAL LONG-TERM LIABILITIES
|
34,258
|
1,081
|
||||||
|
TOTAL LIABILITIES
|
63,584
|
11,549
|
||||||
|
COMMITMENTS AND CONTINGENCIES
|
||||||||
|
SHAREHOLDERS' EQUITY:
|
||||||||
|
Ordinary Shares, NIS 0.16 par value - authorized: 135,000,000 and 90,000,000 Ordinary Shares as of December 31, 2019 and December 31, 2018; issued and outstanding:
61,580,544 and 54,351,140 Ordinary Shares as of December 31, 2019 and December 31, 2018, respectively
|
2,659
|
2,331
|
||||||
|
Additional paid-in capital
|
325,498
|
305,303
|
||||||
|
Accumulated deficit
|
(310,587
|
)
|
(215,409
|
)
|
||||
|
Accumulated other comprehensive income (loss)
|
5
|
(43
|
)
|
|||||
|
TOTAL SHAREHOLDERS' EQUITY
|
17,575
|
92,182
|
||||||
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
|
$
|
81,159
|
$
|
103,731
|
||||
|
Year ended December 31
|
||||||||||||
|
2019
|
2018 |
2017
|
||||||||||
|
REVENUES
|
$
|
443
|
$
|
3,595
|
$
|
3,669
|
||||||
|
COST OF REVENUES
|
-
|
-
|
13
|
|||||||||
|
GROSS PROFIT
|
443
|
3,595
|
3,656
|
|||||||||
|
OPERATING EXPENSES:
|
||||||||||||
|
Research and development
|
51,202
|
64,474
|
57,779
|
|||||||||
|
Selling, general and administrative
|
45,114
|
14,013
|
11,491
|
|||||||||
|
TOTAL OPERATING EXPENSES
|
96,316
|
78,487
|
69,270
|
|||||||||
|
OPERATING LOSS
|
95,873
|
74,892
|
65,614
|
|||||||||
|
FINANCE INCOME
|
(1,672
|
)
|
(985
|
)
|
(1,134
|
)
|
||||||
|
FINANCE EXPENSES
|
1,153
|
44
|
71
|
|||||||||
|
LOSS BEFORE INCOME TAX
|
95,354
|
73,951
|
64,551
|
|||||||||
|
INCOME TAX
|
(176
|
)
|
212
|
1,164
|
||||||||
|
NET LOSS FOR THE YEAR
|
$
|
95,178
|
$
|
74,163
|
$
|
65,715
|
||||||
|
LOSS PER SHARE BASIC AND DILUTED
|
$
|
1.66
|
$
|
1.70
|
$
|
1.76
|
||||||
|
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS
|
57,292
|
43,660
|
37,376
|
|||||||||