0001178913-16-006956.txt : 20161115 0001178913-16-006956.hdr.sgml : 20161115 20161115160614 ACCESSION NUMBER: 0001178913-16-006956 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20161115 FILED AS OF DATE: 20161115 DATE AS OF CHANGE: 20161115 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Foamix Pharmaceuticals Ltd. CENTRAL INDEX KEY: 0001606645 STANDARD INDUSTRIAL CLASSIFICATION: MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36621 FILM NUMBER: 161999750 BUSINESS ADDRESS: STREET 1: 2 HOLZMAN ST. STREET 2: WEIZMANN SCIENCE PARK CITY: REHOVOT STATE: L3 ZIP: 76704 BUSINESS PHONE: 97289316233 MAIL ADDRESS: STREET 1: 2 HOLZMAN ST. STREET 2: WEIZMANN SCIENCE PARK CITY: REHOVOT STATE: L3 ZIP: 76704 FORMER COMPANY: FORMER CONFORMED NAME: Foamix Ltd. DATE OF NAME CHANGE: 20140428 6-K 1 zk1619208.htm 6-K


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16
OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2016

Commission file number: 001-36621

FOAMIX PHARMACEUTICALS LTD.
(Translation of registrant's name into English)

2 Holzman Street, Weizmann Science Park
Rehovot, Israel
(Address of principal executive office)
_____________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.   
 
Form 20-F   Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
 

 
CONTENTS

This report on Form 6-K of the registrant consists of a press release issued by the registrant on November 15, 2016, announcing the registrant’s third quarter financial results for the period ending September 30, 2016, and including the registrant’s unaudited condensed consolidated balance sheets, statements of operations and statements of cash flow, attached hereto and incorporated by reference herein.

The information contained in this Form 6-K is incorporated by reference into (i) the registration statement on Form S-8 (number 333-199486) of the registrant, filed with the Securities and Exchange Commission, and (ii) the registration statement on Form F-3 (333-207543) of the registrant, filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

Exhibit

99.1
Press release issued by the registrant on November 15, 2016 announcing the registrant’s third quarter financial results for the period ending September 30, 2016.
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
FOAMIX PHARMACEUTICALS  LTD.
(Registrant)
 
 
 
By:
/s/ Ilan Hadar
 
 
 
Name: Ilan Hadar
 
 
 
Title: Chief Financial Officer 
 
 
Date: November 15, 2016
 
2

 
EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1

Exhibit 99.1
 
News Release
 
 
November 15, 2016
 
Foamix Reports Third Quarter 2016 Financial Results and Provides Business Update

Conference Call and Webcast on Wednesday, November 16, 2016 at 8:30am Eastern / 5:30am Pacific

Rehovot, Israel November 15, 2016 – Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) (“Foamix Pharmaceuticals” or the “Company”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced today financial results for the three and nine months ended September 30, 2016.

Clinical, business and corporate developments for the three months ended September 30, 2016 and to date:
 
·
Target enrollment for the ongoing Phase 3 trials of FMX101 in patients with moderate-to-severe acne (900 patients) has been reached.
o
Additional over-enrollment of patients will continue to accommodate those patients who currently are in the screening process for the two (2) Phase 3 clinical trials.
o
Final patient enrollment is expected to be complete by end of November 2016.
o
The Company expects to release topline results during the first half of 2017.
·
The Phase 2 for FMX103 in patients with papulopustular rosacea was completed in September 2016, four months ahead of the planned schedule. FMX103 demonstrated high clinically and statistically significant efficacy in treating moderate-to-severe rosacea, and it appeared to be safe and well tolerated.
·
U.S. Sales of Finacea® Foam, azelaic acid 15% for the treatment of rosacea, continue to grow.
o
Based on sales of Finacea® Foam reported by Bayer HealthCare AG for Q3, 2016 Foamix is entitled to royalty payments of $794,000, up 6% from the second quarter of 2016.
o
Foamix is also entitled to additional contingent payments totaling $1.75 million, due to Bayer’s achievement of net sales in excess of the target set for this product.
o
Finacea® Foam was developed through a research and development collaboration between Foamix and Bayer, utilizing Foamix's proprietary foam technology platform. The drug was launched by Bayer in the USA in September, 2015.
·
On September 30, 2016, Foamix completed a successful follow-on public equity offering at a price per share of $9.50, raising $58.1 million including the exercise of the underwriters’ option (that was exercised in October 2016) to purchase an additional 411,959 shares. Net proceeds to the Company (including from the underwriters’ option), after expenses and underwriter fees, totaled $54.1 million.
·
Foamix’s intellectual property portfolio continues to expand. The Company currently has 145 patents issued worldwide and 49 patents issued in the United States.
 
Financial highlights for the three months ended September 30, 2016:
 
·
Total revenues were $2.5 million compared with $22,000 for the three months ended September 30, 2015. The revenues in the quarter included royalty payments of $794,000 from Bayer HealthCare AG for the sales of Finacea® Foam and additional contingent payments totaling $1.75 million, due to Bayer’s achievement of net sales in excess of the target set for this product.
 

·
Research and development expenses were $5.9 million, compared with $2.0 million in the three months ended September 30, 2015. This increase resulted primarily from an increase in costs relating to the FMX101 and FMX103 clinical trials as well as an increase in payroll and related expenses due to an increase in the number of R&D employees.
·
Selling, general and administrative expenses were $2.6 million, compared with $1.6 million in the three months ended September 30, 2015. The increase in selling, general and administrative expenses resulted primarily from increases in payroll and other payroll-related expenses, market research costs, expenses related to the Company’s board of directors (including stock-based compensation) and patent and trademark expenses.
·
Operating expenses totaled $8.5 million, compared with $3.6 million in the three months ended September 30, 2015.
·
Net loss was $5.8 million or $0.19 per share, basic and diluted, compared with a loss of $3.4 million or $0.11 per share, basic and diluted, for the three months ended September 30, 2015.
·
Cash, cash equivalents, short and long-term investments as of September 30, 2016 totaled $140.1 million, compared with approximately $103.8 million as of December 31, 2015.

Financial highlights for the nine months ended September 30, 2016:
 
·
Total revenues were $4.0 million compared with $579,000 for the nine months ended September 30, 2015. Revenues for the nine months ended September 30, 2016 included mostly royalty payments in the amount of $2.2 million from Bayer HealthCare AG for the sales of Finacea® Foam and additional contingent payments totaling $1.75 million, due to Bayer’s achievement of net sales in excess of the target set for this product.
·
Research and development expenses were $16.2 million, compared with $6.9 million in the nine months ended September 30, 2015. The increase in research and development expenses relates to the Company’s Phase 3 clinical trials for FMX101, its lead product candidate for treatment of moderate-to-severe acne, the completion of Phase 2 clinical trials for FMX103, the Company’s lead product candidate for treatment of papulopustular rosacea, an increase in costs of advisers and consultants relating to R&D clinical trials, as well as an increase in payroll and related expenses due to an increase in the number of R&D employees.
·
Selling, general and administrative expenses were $6.4 million, compared with $5.0 million in the nine months ended September 30, 2015. The increase in selling, general and administrative expenses resulted primarily from an increase in payroll, payroll-related expenses, market research expenses and travel expenses.
·
Operating expenses totaled $18.6 million, compared with $11.4 million in the nine months ended September 30, 2015.
·
Net loss was $18.5 million or $0.60 per share, basic and diluted, compared with a loss of $11.1 million or $0.41 per share, basic and diluted, for the nine months ended September 30, 2015.

Management overview

During the third quarter of 2016 we continued to progress the development of our lead clinical-stage product candidates, FMX101 for the treatment of moderate-to-severe acne, and FMX103 for the treatment of moderate-to-severe papulopustular rosacea.

Regarding FMX101, in early May 2016, we commenced our Phase 3 clinical trials for the treatment of moderate-to-severe acne.

The Phase 3 program consists of two multi-center trials, each with a target enrollment of 450 patients with moderate-to-severe acne.  Patients are being randomized on a 2:1 basis (active vs vehicle), initially into a 12-week double-blind vehicle-controlled phase where patients will be treated once daily with either 4% minocycline foam or vehicle.  The double-blind portion of the studies will be followed by 9 months of open-label treatment with the active 4% foam to evaluate the safety of intermittent use of FMX101.


The two co-primary efficacy endpoints are (1) the absolute change from baseline in inflammatory lesion counts in each treatment group at week 12; and (2) the proportion of patients achieving success at week 12 as defined by an Investigator’s Global Assessment (IGA) score of “clear” or “almost clear” (score of 0 or 1) and at least a 2-grade improvement (decrease) from baseline at week 12. Safety evaluation will include reported adverse events, assessments of tolerability, clinical laboratory tests and vital signs.

Target enrollment for the two Phase 3 trials of FMX101 (900 patients) has been reached.  We will allow for additional patients who are currently in the screening process for the Phase 3 clinical trials to finish that process and also be enrolled. We anticipate final patient enrollment to be completed by the end of November, 2016; and we maintain our expectation to report top-line results from the blinded portion of these trials in the first half of 2017.

FMX101 has the potential to be the first clinically-viable topical formulation of minocycline. This product candidate is being developed in the U.S. under the FDA’s abbreviated 505(b)(2) pathway.

FMX103, for the treatment of moderate-to-severe papulopustular rosacea, has the same active ingredient, minocycline, as our lead candidate, FMX101.

In September 2016, we announced the topline results of a Phase 2 clinical trial of FMX103 for the treatment of moderate-to-severe papulopustular rosacea. The double-blind, randomized, placebo-controlled Phase 2 trial included 233 patients with moderate-to-severe rosacea enrolled at 18 sites in Germany. Patients were randomized to receive either 1 of 2 doses of FMX103 minocycline foam (3% or 1.5%) or vehicle foam once daily over 12 weeks, followed up by a 4-week post-treatment evaluation.  Clinically and statistically significant differences were demonstrated for improvement in the efficacy endpoints (reduction in the number of inflammatory lesions – papules and pustules, and improvement of Investigator Global Assessment score) for FMX103 compared with the vehicle-treated group.

We intend to meet with the FDA to review the results of our Phase 2 clinical trial of FMX103 and discuss next steps in progressing into a Phase 3 program, which we hope to commence in 2017.

Development activities continue for both FMX102 (minocycline foam for the treatment of impetigo) and FDX104 (doxycycline foam for the management of acne-like rash associated with EGFRI use). We will provide updates on these programs as they materialize.

During the Q3, 2016 our patent portfolio expanded and we currently have 145 patents issued worldwide and 49 patents issued in the United States.

In addition to our internal drug development pipeline, we have development and license agreements relating to our proprietary foam technology with other pharmaceutical companies, including Bayer Healthcare, Merz, Allergan and Prestium, which was recently acquired by Mylan, in various stages of development and commercialization. Our agreements with these licensees entitle us to development fees, contingent payments and royalties upon commercialization.

In September 2015, Bayer Healthcare began selling Finacea® Foam (azelaic acid 15% for the treatment of rosacea) in the U.S.  Finacea® foam is a prescription foam product which was developed as part of a research and development collaboration between Foamix and Bayer, utilizing Foamix's proprietary foam technology platform. According to our license agreement with Bayer, we are entitled to royalties and certain contingent payments upon commercialization of Finacea Foam. For the three months ended September 30, 2016, we were entitled to royalties from Bayer Healthcare in an amount of $794,000, up 6% from the second quarter of 2016. Furthermore, the Company is entitled to additional payments of $1.75 million due to achievement of certain revenue level by Bayer, based on Bayer’s net sales of Finacea® Foam during such period.


Financial results for the three months ended September 30, 2016
 
Revenues
Total revenues for the three month ended September 30, 2016 were $2.5 million compared with $22,000 for the three months ended September 30, 2015. The revenues in the quarter included royalty payments from Bayer HealthCare AG for the sales of Finacea® Foam of $794,000 and additional contingent payments totaling $1.75 million, due to Bayer’s achievement of net sales in excess of the target set for this product. Revenues for the three months ended September 30, 2015 included payments for development projects with other customers.

Operating Expenses
Our operating expenses for the three months ended September 30, 2016 and 2015 were as follows:

Research and Development Expenses
Research and development expenses increased by $3.9 million, or 195%, from $2.0 million in the three months ended September 30, 2015 to $5.9 million in the three months ended September 30, 2016. The increase in research and development expenses resulted primarily from an increase of $3.3 million in costs relating to the FMX101 and FMX103 clinical trials and an increase of $567,000 in payroll and payroll related expenses due to an increase in the number of R&D employees (including bonuses and stock-based compensation).

Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $919,000, or 57%, from $1.6 million in the three months ended September 30, 2015 to $2.6 million in the three months ended September 30, 2016. The increase in selling, general and administrative expenses resulted primarily from an increase of $439,000 in payroll and other payroll-related expenses (including bonuses and stock-based compensation) and $296,000 in market research costs; an increase of $72,000 in expenses related to the Company’s board of directors (including stock-based compensation) and a $58,000 increase in patent and trademark expenses;

Finance Income, Net
For the three months ended September 30, 2016 we recorded financial income of $193,000 as opposed to financial income of $203,000 recorded for the three months ended September 30, 2015. The financial income in the three months ended September 30, 2016 and 2015 resulted mostly from interest and financial gains from our cash investments.

Net Loss
For the three months ended September 30, 2016 we recorded a loss of $5.8 million or $0.19 per share, basic and diluted, compared with a loss of $3.4 million or $0.11 per share, basic and diluted, for the three months ended September 30, 2015.

Financial results for the nine months ended September 30, 2016
 
Revenues
Total revenues for the nine months ended September 30, 2016 were $4.0 million compared with $579,000 for the nine months ended September 30, 2015. Revenues for the nine months ended September 30, 2016 included mostly royalty payments in the amount of $2.2 million, from Bayer HealthCare AG for the sales of Finacea® Foam and additional contingent payments totaling $1.75 million, due to Bayer’s achievement of net sales in excess of the target set for this product. Revenues for the nine months ended September 30, 2015 included payments for development projects with other customers.


Operating Expenses
Our operating expenses for the nine months ended September 30, 2016 and 2015 were as follows:

Research and Development Expenses
Research and development expenses increased by $9.3 million, or 135%, from $6.9 million in the nine months ended September 30, 2015 to $16.2 million in the nine months ended September 30, 2016. The increase in research and development expenses resulted primarily from an increase of $7.6 million in costs relating to the FMX101 and FMX103 clinical trials; an increase of $1.4 million in payroll and payroll related expenses (including bonuses and stock-based compensation) due to an increase in the number of R&D employees; and an increase of $272,000 in advisory and consulting expenses.

Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $1.4 million or 28%, from $5.0 million in the nine months ended September 30, 2015 to $6.4 million in the nine months ended September 30, 2016. The increase in selling, general and administrative expenses resulted primarily from an increase of $673,000 in payroll and other payroll-related expenses (including bonuses and stock-based compensation); an increase of $389,000 in market research expenses; an increase of $77,000 in expenses related to the Company’s board of directors (including stock-based compensation); and an increase of $177,000 in travel expenses;

Finance Income, net
For the nine months ended September 30, 2016 we recorded financial income of $353,000 compared to $269,000 recorded for the nine months ended September 30, 2015. The increase in financial income resulted from an increase in interest and financial gains from our cash investments, partially offset by expenses on the loan received from BIRD foundation and fully repaid during the second quarter of 2016.

Net Loss
For the nine months ended September 30, 2016 we recorded a loss of $18.5 million or $0.60 per share, basic and diluted, compared with a loss of $11.1 million or $0.41 per share, basic and diluted, for the nine months ended September 30, 2015.

Liquidity and Capital Resources
As of September 30, 2016, we had cash, cash equivalents, short and long-term investments of $140.1 million, compared with $103.8 million as of December 31, 2015. The increase was mostly due to the successful follow-on public equity offering which closed on September 30, 2016 at a price per share of $9.50, raising $54.1 million. Net proceeds, after expenses and underwriter fees, totaled $50.4 million (before the exercise of the underwriters’ option in October 2016), offset by operating expenses primarily relating to the clinical trials. During the nine months ended September 30, 2016 we used $14.6 million in cash in our operations compared to $8.7 million used in operating activities in the nine months ended September 30, 2015.

Conference Call
Management will host an investment community conference call on November 16, 2016 at 8:30 a.m. Eastern / 5:30 a.m. Pacific / 3:30 p.m. Israel to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing Domestic: 888-224-1005; International: +1-913-312-0863. Conference ID: 7822862.  Webcast: http://public.viavid.com/index.php?id=121499

A replay of the call will be accessible two hours after its completion through November 30, 2016 by dialing Domestic: 844-512-2921; International: +1-412-317-6671; Passcode: 7822862. The call will also be archived for 90 days at www.streetevents.com and www.foamixpharma.com.

About Foamix
Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our clinical stage product candidates include FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne, FMX102 for the treatment of impetigo, FMX 103 for the treatment of rosacea and FDX104, our doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.


In addition, we have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare, Merz, Allergan and Mylan.
 
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.  Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations.  Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions.  Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne market, denial of reimbursement by third party payors or inability to raise additional capital. We discuss many of these risks in greater detail under the heading “Risk Factors” in our most recent Annual Report on Form 20-F (File No. 161477078) filed on March 7, 2016, and elsewhere in that Annual Report. Although we believe these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

Erbitux® is a registered trademark of Eli Lilly and Company. Vectibix® is a registered trademark of Amgen Inc. Finacea® is a registered trademark of Bayer Healthcare.

Contact:
U.S. Investor Relations
Ilan Hadar, CFO
Michael Rice
Foamix Pharmaceuticals Ltd.
LifeSci Advisors, LLC
+972-8-9316233
646-597-6979
ilan.hadar@foamixpharma.com
mrice@lifesciadvisors.com


FOAMIX PHARMACEUTICALS LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
 
   
September 30,
   
December 31,
 
   
2016
   
2015
 
A s s e t s
           
CURRENT ASSETS:
           
Cash and cash equivalents
 
$
75,605
   
$
18,795
 
Short term bank deposits
   
28,225
     
13,107
 
Investment in marketable securities
   
25,842
     
23,693
 
Restricted investment in marketable securities
   
956
     
769
 
Accounts receivable:
               
Trade
   
2,544
     
314
 
Other
   
263
     
471
 
TOTAL  CURRENT ASSETS
   
133,435
     
57,149
 
                 
NON-CURRENT ASSETS:
               
Investment in marketable securities
   
9,507
     
32,285
 
Investment in long term bank deposits
   
-
     
15,130
 
Property and equipment, net
   
845
     
646
 
Other
   
35
     
35
 
TOTAL  NON-CURRENT ASSETS
   
10,387
     
48,096
 
                 
TOTAL  ASSETS
 
$
143,822
   
$
105,245
 


 
FOAMIX PHARMACEUTICALS LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
 
   
September 30,
   
December 31,
 
   
2016
   
2015
 
Liabilities and shareholders’ equity
           
             
CURRENT LIABILITIES:
           
Current maturities of bank borrowing
 
$
28
   
$
31
 
Accounts payable and accruals:
               
Trade
   
3,094
     
1,353
 
Deferred revenues
   
-
     
29
 
Other
   
3,945
     
2,169
 
Loan from the BIRD foundation
   
-
     
476
 
TOTAL  CURRENT LIABILITIES
   
7,067
     
4,058
 
                 
LONG-TERM LIABILITIES:
               
Bank borrowing
   
-
     
20
 
Liability for employee severance benefits
   
388
     
365
 
TOTAL  LONG-TERM LIABILITIES
   
388
     
385
 
TOTAL  LIABILITIES
   
7,455
     
4,443
 
COMMITMENTS
               
SHAREHOLDERS' EQUITY:
               
Ordinary Shares, NIS 0.16 par value - authorized: 50,000,000  Ordinary Shares as of September 30, 2016 and December 31, 2015; issued and outstanding: 36,599,397 and 30,639,134 Ordinary Shares as of September 30, 2016 and December 31, 2015, respectively
   
1,537
     
1,284
 
Additional paid-in capital
   
199,500
     
145,878
 
Accumulated deficit
   
(64,735
)
   
(46,230
)
Accumulated other comprehensive income (loss)
   
65
     
(130
)
TOTAL  SHAREHOLDERS' EQUITY
   
136,367
     
100,802
 
TOTAL  LIABILITIES AND SHAREHOLDERS’ EQUITY
   
143,822
   
$
105,245
 


 
FOAMIX PHARMACEUTICALS LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
 (U.S. dollars in thousands, except per share data)
(Unaudited)
 
   
Nine months ended
September 30
   
Three months ended
September 30
 
   
2016
   
2015
   
2016
   
2015
 
REVENUES
 
$
4,041
   
$
579
   
$
2,544
   
$
22
 
COST OF REVENUES
   
51
     
46
     
8
     
10
 
GROSS PROFIT
   
3,990
     
533
     
2,536
     
12
 
OPERATING EXPENSES:
                               
Research and development
   
16,232
     
6,900
     
5,932
     
1,985
 
Selling, general and administrative
   
6,388
     
5,026
     
2,550
     
1,631
 
TOTAL OPERATING EXPENSES
   
22,620
     
11,926
     
8,482
     
3,616
 
OPERATING LOSS
   
18,630
     
11,393
     
5,946
     
3,604
 
FINANCE INCOME, net
   
(353
)
   
(269
)
   
(193
)
   
(203
)
LOSS BEFORE INCOME TAX
   
18,277
     
11,124
     
5,753
     
3,401
 
INCOME TAX
   
228
     
9
     
51
     
-
 
NET LOSS FOR THE PERIOD
 
$
18,505
   
$
11,133
   
$
5,804
   
$
3,401
 
                                 
LOSS PER SHARE BASIC AND DILUTED
 
$
0.60
   
$
0.41
   
$
0.19
   
$
0.11
 
                                 
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS
   
30,673
     
27,430
     
30,703
     
30,547
 



 
FOAMIX PHARMACEUTICALS LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
 (U.S. dollars in thousands)
(Unaudited)

   
Nine months ended
September 30
   
Three months ended
September 30
 
   
2016
   
2015
   
2016
   
2015
 
NET LOSS
 
$
18,505
   
$
11,133
   
$
5,804
   
$
3,401
 
OTHER COMPREHENSIVE INCOME:
                               
Net unrealized losses (gains) from marketable securities
   
(164
)
   
(27
)
   
3
     
(9
)
Gains (losses) on marketable securities reclassified into net loss
   
4
     
(67
)
   
-
     
-
 
Net unrealized losses (gains) on derivative financial instruments
   
(48
)
   
2
     
(22
)
   
60
 
Gains on derivative financial instruments reclassified into net loss
   
13
     
-
     
9
     
-
 
                                 
TOTAL OTHER COMPREHENSIVE LOSS (INCOME)    
(195
)
   
(92
)
   
(10
)
   
51
 
TOTAL COMPREHENSIVE LOSS
 
$
18,310
   
$
11,041
   
$
5,794
   
$
3,452
 



 
FOAMIX PHARMACEUTICALS LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
(Unaudited)
 
   
Nine months ended
September 30
 
   
2016
   
2015
 
CASH FLOWS FROM OPERATING ACTIVITIES:
           
Net Loss
 
$
18,505
   
$
11,133
 
Adjustments required to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
   
103
     
58
 
Changes in marketable securities and bank deposits, net
   
180
     
67
 
Changes in accrued liability for employee severance benefits, net of retirement fund profit
   
23
     
15
 
Share-based compensation
   
2,071
     
1,226
 
Non-cash finance expenses (income), net
   
(2
)
   
53
 
Changes in operating asset and liabilities:
               
Decrease (increase) in trade and other receivable
   
(2,022
)
   
128
 
Increase in other non-current assets
   
-
     
(1
)
Increase (decrease) in accounts payable and accruals
   
3,523
     
883
 
Net cash used in operating activities
   
(14,629
)
   
(8,704
)
CASH FLOWS FROM INVESTING ACTIVITIES:
               
Purchase of fixed assets
   
(302
)
   
(246
)
Investment in bank deposits
   
(700
)
   
(28,025
)
Investment in marketable securities
   
(13,000
)
   
(65,913
)
Proceeds from sale and maturity of marketable securities and bank deposits
   
34,134
     
18,053
 
Net cash provided by (used in) investing activities
   
20,132
     
(76,131
)
CASH FLOWS FROM FINANCING ACTIVITIES:
               
Proceeds from issuance of ordinary shares through public offerings, net of issuance costs
   
50,453
     
64,202
 
Proceeds from exercise of warrants
   
1,296
     
2,189
 
Proceeds from exercise of options
   
55
     
317
 
Payments in respect of BIRD loan
   
(476
)
   
-
 
Payments in respect of bank borrowings
   
(24
)
   
(23
)
Net cash provided by financing activities
   
51,304
     
66,685
 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
56,807
     
(18,150
)
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS
   
3
     
-
 
CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD
   
18,795
     
43,008
 
CASH AND CASH EQUIVALENTS AT END OF THE PERIOD
 
$
75,605
   
$
24,858
 
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS -
               
Cashless exercise of warrants
 
$
-
   
$
4
 
                 
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
               
Cash paid for taxes
 
$
141
   
$
9
 
Interest received
 
$
769
   
$
742
 
Interest paid
 
$
238
   
$
1
 
 
 


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