Israel
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001-36621
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N/A
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(State or other jurisdiction
of incorporation) |
(Commission File Number)
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(IRS Employer
Identification No.) |
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2 Holzman Street,
Weizmann Science Park
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Rehovot, Israel
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7670402
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(Address of principal executive offices)
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(Zip Code)
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+972-8-9316233
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(Registrant’s telephone number, including
area code)
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(Former name or former address, if changed since last report)
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Ticker symbol(s)
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Name of each exchange on which registered
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Ordinary Shares, par value NIS 0.16 per share
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FOMX
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Nasdaq Global Stock Market
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Item 7.01 Regulation FD Disclosure
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Exhibit No.
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Description
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FOAMIX PHARMACEUTICALS LTD.
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By:
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/s/ Mutya Harsch
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Mutya Harsch
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Chief Legal Officer
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• |
Submitted a New Drug Application (“NDA”) to U.S. FDA for FMX103 for the treatment of moderate-to-severe papulopustular rosacea
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o |
Submission is supported by the results from two Phase 3 clinical trials, FX2016-11 and FX2016-12. In these trials, FMX103 achieved both co-primary endpoints,
demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment scores. It also incorporates information on chemistry manufacturing and controls, and data from non-clinical
toxicology studies.
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• |
Publication of Phase 3 study FX2017-22 (“Study 22) of FMX101 in acne in the Journal
of the American Academy of Dermatology.
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o |
Study 22 was conducted by Foamix to support the NDA submission of FMX101, which is currently under review by the FDA for the treatment of inflammatory lesions of
non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older.
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• |
Two posters featuring FMX101 and the FMX101 vehicle were presented at the Annual Meeting of the Society for Investigative Dermatology, held May 8-11, 2019, in
Chicago.
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• |
Completed Clinical Investigator Training Meeting for Phase 2 study of FCD105 (3% minocycline + 0.3% adapalene foam) for the treatment of moderate-to-severe acne
vulgaris
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• |
Secured up to $64 million in financing in transactions with Perceptive Advisors and OrbiMed.
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Toll Free:
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855-327-6838
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International:
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604-235-2082
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Conference ID:
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10007347
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Webcast: | http://public.viavid.com/index.php?id=135538 |
Contact:
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U.S. Investor Relations
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Ilan Hadar
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Michael Rice
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Foamix Pharmaceuticals Ltd.
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LifeSci Advisors, LLC
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+972-8-9316233 | 646-597-6979 |
IR@foamixpharma.com | mrice@lifesciadvisors.com |
FOAMIX PHARMACEUTICALS LTD.
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CONSOLIDATED BALANCE SHEETS
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||||||||
(U.S. dollars in thousands)
|
||||||||
Jun-30
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Dec-31
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|||||||
2019
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2018
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|||||||
A s s e t s
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||||||||
CURRENT ASSETS:
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||||||||
Cash and cash equivalents
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$
|
39,085
|
$
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27,868
|
||||
Restricted cash
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250
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250
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||||||
Short term bank deposits
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16,187
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24,047
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||||||
Investment in marketable securities
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14,091
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46,669
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||||||
Restricted investment in marketable securities
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282
|
268
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||||||
Accounts receivable:
|
||||||||
Trade
|
308
|
1,066
|
||||||
Other
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1,511
|
999
|
||||||
TOTAL CURRENT ASSETS
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71,714
|
101,167
|
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NON-CURRENT ASSETS:
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||||||||
Investment in marketable securities
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-
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150
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||||||
Restricted investment in marketable securities
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139
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133
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||||||
Property and equipment, net
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2,497
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2,235
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Operating lease right of use assets
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1,858
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-
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Other
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18
|
46
|
||||||
TOTAL NON-CURRENT ASSETS
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4,512
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2,564
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TOTAL ASSETS
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$
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76,226
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$
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103,731
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Jun-30
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Dec-31
|
|||||||
2019
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2018
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|||||||
Liabilities and shareholders’ equity
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||||||||
CURRENT LIABILITIES:
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||||||||
Accounts payable and accruals:
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||||||||
Trade
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$
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9,434
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$
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6,327
|
||||
Operating lease liabilities
|
999
|
-
|
||||||
Other
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3,664
|
4,141
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||||||
TOTAL CURRENT LIABILITIES
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14,097
|
10,468
|
||||||
LONG-TERM LIABILITIES:
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||||||||
Liability for employee severance benefits
|
409
|
367
|
||||||
Operating lease liabilities
|
882
|
-
|
||||||
Other liabilities
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456
|
714
|
||||||
TOTAL LONG-TERM LIABILITIES
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1,747
|
1,081
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||||||
TOTAL LIABILITIES
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15,844
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11,549
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COMMITMENTS
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||||||||
SHAREHOLDERS' EQUITY:
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||||||||
Ordinary Shares, NIS 0.16 par value - authorized: 135,000,000 and 90,000,000 Ordinary Shares as of June 30,
2019 and December 31, 2018, respectively; issued and outstanding: 54,455,969 and 54,351,140 Ordinary Shares as of June 30, 2019 and December 31, 2018, respectively
|
2,336
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2,331
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||||||
Additional paid-in capital
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307,653
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305,303
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Accumulated deficit
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(249,606
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) |
(215,409
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) |
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Accumulated other comprehensive loss
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(1
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)
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(43
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)
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TOTAL SHAREHOLDERS' EQUITY
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60,382
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92,182
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||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
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$
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76,226
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$
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103,731
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FOAMIX PHARMACEUTICALS LTD.
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||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS
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||||||||||||||||
(U.S. dollars in thousands, except per share data)
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||||||||||||||||
Six months ended
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Three months ended
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|||||||||||||||
June 30
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Jun-30
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|||||||||||||||
2019
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2018
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2019
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2018
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|||||||||||||
REVENUES
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$
|
308
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$
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1,870
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-
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$
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964
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|||||||||
OPERATING EXPENSES:
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||||||||||||||||
Research and development
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23,404
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39,667
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12,556
|
16,842
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||||||||||||
Selling, general and administrative
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12,147
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6,710
|
6,803
|
2,909
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||||||||||||
TOTAL OPERATING EXPENSES
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35,551
|
46,377
|
19,359
|
19,751
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||||||||||||
OPERATING LOSS
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35,243
|
44,507
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19,359
|
18,787
|
||||||||||||
FINANCE INCOME, net
|
(870
|
)
|
(352
|
)
|
(366
|
)
|
(279
|
)
|
||||||||
LOSS BEFORE INCOME TAX
|
34,373
|
44,155
|
18,993
|
18,508
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||||||||||||
INCOME TAX
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(176
|
)
|
450
|
-
|
120
|
|||||||||||
NET LOSS FOR THE PERIOD
|
$
|
34,197
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$
|
44,605
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$
|
18,993
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$
|
18,628
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||||||||
LOSS PER SHARE BASIC AND DILUTED
|
$
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0.63
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$
|
1.15
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$
|
0.35
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$
|
0.46
|
||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED
LOSS PER SHARE IN THOUSANDS
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54,401
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38,821
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54,426
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40,102
|