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Foamix Reports Second Quarter 2018 Financial Results and Provides Corporate Update

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REHOVOT, Israel, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) ("Foamix" 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 its financial results for the second quarter and six months ended June 30, 2018.

Clinical and Corporate Update:

  • The final patient was enrolled and dosed in the third Phase 3 study (FX2017-22) investigating FMX101, the Company's minocycline foam 4%, in patients with moderate-to-severe acne.
    - Top-line results are expected in the third quarter of 2018.
  • The final patient has been enrolled and dosed in two Phase 3 clinical studies (FX2016-11 and FX2016-12) evaluating the safety and efficacy of FMX103, topical minocycline foam 1.5%, for the treatment of papulopustular rosacea. 
    - Top-line results are expected early in the fourth quarter of 2018.
  • In April 2018, the Company raised net proceeds of approximately $16.1 million, through a direct registered offering of approximately 2.9 million shares at a price of $5.50 per share to OrbiMed Partners Master Fund Limited.

Cash & Investments
At June 30, 2018, the Company had $56.4 million in cash and investments compared to $76.4 million at December 31, 2017.  During the second quarter, the Company raised net proceeds of $16.1 million, after deducting offering expenses, in a registered share offering with OrbiMed Partners Master Fund Limited.  The Company believes that its existing cash and investments will be sufficient to fund operating expenses and capital expenditure requirements for the third Phase 3 clinical trial for FMX101 and NDA filing for FMX101, and for the two Phase 3 clinical trials for FMX103, which it expects to complete in 2019.

Financial Results for the Second Quarter Ended June 30, 2018
Revenues
Revenues for the second quarter of 2018 were $964,000 an increase of $166,000, or 20.8%, from $798,000 in the second quarter of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea® Foam (azelaic acid 15%).

Operating Expenses
Research and Development Expenses
Research and development expenses for the second quarter were $16.8 million, a $2.9 million, or 20.9%, increase from $13.9 million in the second quarter of 2017.  The increase in R&D expenses resulted primarily from an increase of $3.0 million in costs relating predominantly to FMX101 and FMX103 clinical trials, and an increase of $688,000 in payroll and payroll-related expenses including share-based compensation primarily due to an increase in headcount and salary raises, off-set by a decrease of $1.0 million in compensation to one of the Company's co-founders in the second quarter of 2017.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the second quarter of 2018 were $2.9 million, a decrease of $542,000, or 15.5%, compared to $3.5 million in the second quarter of 2017. The decrease in selling, general and administrative expenses resulted primarily from a decrease of $1.2 million in compensation to one of the Company's co-founders in the second quarter of 2017, off-set by an increase of $280,000 in payroll and other payroll-related expenses including share-based compensation mostly due to an increase in headcount and salary raises, an increase of $360,000 in advisory and professional fees and an increase of $150,000 in rent, maintenance and office expenses.

Net Loss
For the quarter ended June 30, 2018, the Company recorded a net loss of $18.6 million, or ($0.46) per share, basic and diluted, compared with a loss of $16.4 million or ($0.44) per share, basic and diluted, for the three months ended June 30, 2017.

Financial Results for the First Half Ended June 30, 2018
Revenues
Revenues for the six months ended June 30, 2018 were $1.9 million, an increase of $145,000, or 8.4%, from $1.7 million in the first six months of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea® Foam.

Operating Expenses
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2018 were $39.7 million, a $13.1 million, or 49.2%, increase from $26.6 million in the first six months of 2017.  The increase in research and development expenses resulted primarily from an increase of $12.2 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation primarily due to a change in the measurement of share-based compensation expenses of a consultant and an increase in headcount and salary raises, off-set by a decrease of $1.2 million in compensation to one of the Company's co-founders in the first half of 2017 and an increase of $383,000 in travel-related expenses.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the six months ended June 30, 2018 were $6.7 million, an increase of $437,000, or 6.9%, compared to $6.3 million in the same six month period of 2017.  The increase in selling, general and administrative expenses resulted primarily from an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation, mostly due to an increase in headcount, salary raises and accounting modification relating to share-based compensation expenses of a consultant, off-set by a decrease of $1.5 million in compensation to one of the Company's co-founders in the first half of 2017; an increase of $526,000 in advisory and professional services expenses, off-set by a decrease of $112,000 in travel-related expenses.

Net Loss
For the six months ended June 30, 2018, the Company recorded a net loss of $44.6 million, or ($1.15) per share, basic and diluted, compared with a loss of $30.8 million, or ($0.82) per share, basic and diluted, for the six months ended June 30, 2017.

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 leading clinical stage product candidates are FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative foam technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including Bayer HealthCare and others.

Foamix uses its website (www.Foamix.com) as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix's website in addition to following its press releases, filings with the Securities & Exchange Commission ("SEC"), public conference calls, and webcasts.

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 created by those sections. 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 in clinical trials or announcement of results, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne and dermatology markets, denial of reimbursement by third party payors or inability to raise additional capital, our ability to recruit and retain key employees and our ability to stay in compliance with applicable laws, rules and regulations. We discuss many of these risks in greater detail in our annual and other periodic filings with the SEC, including under the heading "Risk Factors" in our most recent 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.

Contact:                                                        
Ilan Hadar, CFO & Country Manager            
Foamix Pharmaceuticals Ltd.                         
+972-8-9316233                                             
ilan.hadar@foamixpharma.com                      

U.S. Investor Relations
Michael Rice
LifeSci Advisors, LLC
646-597-6979
mrice@lifesciadvisors.com 

 


FOAMIX PHARMACEUTICALS LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except per share data)
(Unaudited)

  June 30, 2018   December 31, 2017
Assets    
CURRENT ASSETS:    
Cash and cash equivalents $ 11,702   $ 15,956
Restricted cash   250     250
Short term bank deposits   19,632     19,443
Investment in marketable securities   22,831     31,797
Restricted investment in marketable securities   275     290
Accounts receivable:    
Trade   975     996
Other   491     772
TOTAL CURRENT ASSETS   56,156     69,504
     
NON-CURRENT ASSETS:    
Investment in marketable securities   1,572     8,533
Restricted investment in marketable securities   136     143
Property and equipment, net   2,166     2,042
Other   44     32
TOTAL NON-CURRENT ASSETS   3,918     10,750
     
TOTAL ASSETS $ 60,074   $ 80,254


  June 30, 2018   December 31, 2017
Liabilities and shareholders' equity    
CURRENT LIABILITIES:    
Accounts payable and accruals:    
Trade $ 12,357     $ 6,436  
Deferred revenues   -       62  
Other   2,729       3,730  
TOTAL CURRENT LIABILITIES   15,086       10,228  
     
LONG-TERM LIABILITIES:    
Liability for employee severance benefits   377       437  
Other liabilities   714       988  
TOTAL LONG-TERM LIABILITIES   1,091       1,425  
TOTAL LIABILITIES   16,177       11,653  
COMMITMENTS    
SHAREHOLDERS' EQUITY:    
Ordinary Shares, NIS 0.16 par value - authorized: 90,000,000 Ordinary Shares as of June 30, 2018 and December 31, 2017; issued and outstanding: 40,693,479 and 37,498,128 Ordinary Shares as of June 30, 2018 and December 31, 2017, respectively   1,721       1,576  
Additional paid-in capital   228,154       208,364  
Accumulated deficit   (185,851 )     (141,281 )
Accumulated other comprehensive loss   (127 )     (58 )
TOTAL SHAREHOLDERS' EQUITY   43,897       68,601  
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 60,074     $ 80,254  
               

 

FOAMIX PHARMACEUTICALS LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except per share data)
(Unaudited)

  Six months ended June 30,     Three months ended June 30,
   2018     2017     2018    2017
REVENUES $ 1,870     $ 1,725       $ 964     $ 798  
OPERATING EXPENSES:        
Research and development   39,667       26,615         16,842       13,940  
Selling, general and administrative   6,710       6,273         2,909       3,451  
TOTAL OPERATING EXPENSES   46,377       32,888         19,751       17,391  
OPERATING LOSS   44,507       31,163         18,787       16,593  
FINANCE INCOME, net   (352 )     (544 )       (279 )     (287 )
LOSS BEFORE INCOME TAX   44,155       30,619         18,508       16,306  
INCOME TAX   450       152         120       81  
NET LOSS FOR THE PERIOD $ 44,605     $ 30,771       $ 18,628     $ 16,387  
         
LOSS PER SHARE BASIC AND DILUTED $ 1.15     $ 0.82       $ 0.46     $ 0.44  
         
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS   38,821       37,304         40,102       37,420  

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