Press Release Details


Foamix Reports First Quarter 2019 Financial Results and Provides Corporate Update

May 7, 2019 at 4:21 PM EDT

FDA Accepts NDA for FMX101, Sets October 20, 2019 as PDUFA Action Date

Conference Call Scheduled for Wednesday May 8th at8:30am Eastern Time

REHOVOT, Israel and BRIDGEWATER, N.J., May 07, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) (“Foamix Pharmaceuticals” or the “Company”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced financial results for the first quarter ended March 31, 2019 and provided a corporate update.

“Foamix has achieved a number of important milestones so far in 2019,” said David Domzalski, CEO of Foamix. “The New Drug Application (NDA) for our most advanced candidate, FMX101 for acne, has been accepted for review by the FDA, putting us on track for our first potential approval in the U.S. in October this year. We are also on track to file our second NDA, for FMX103 in papulopustular rosacea, by mid-year.  Our pipeline is also advancing, and we are building our sales and marketing capabilities as we prepare to launch FMX101 early next year.”   

First Quarter and Recent Corporate and Regulatory Update:

  • The U.S. Food & Drug Administration (FDA) accepted for review the NDA for FMX101.  Foamix is seeking approval of FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older.
    - The FDA has set October 20th, 2019 as the Prescription Drug User Fee Act (PDUFA) action date.
  • Two posters featuring FMX101 have been accepted for presentation at the Annual Meeting of the Society for Investigative Dermatology to be held May 8-11, 2019, in Chicago:
    - The Impact of FMX101 on the Physical Properties of Human Sebum: Comparison of an Oil-Based Formulation vs an Oil-in-Water Emulsion
    - Assessing Bacterial Susceptibility of FMX101 4% Topical Minocycline Foam
  • Reported top-line results from study FX2016-13 which evaluated the long-term safety of FMX103 in moderate-to-severe papulopustular rosacea. This 40-week open-label safety study provided positive safety data with continuing development of efficacy beyond the initial 12 weeks of therapy.  Eighty one point six percent (81.6%) of patients who completed the study achieved clear or almost clear skin at Week 52.
  • Announced, along with LEO Pharma A/S, the settlement of the Hatch-Waxman litigation with Perrigo, relating to Finacea® foam.  Terms of the settlement were not disclosed.

Financial Results for the First Quarter Ended March 31, 2019
Revenues
Total revenues for the first quarter ended March 31, 2019 were $308 thousand, a $598 thousand, or 66% decrease, from the $906 thousand in total revenues recorded in the first quarter ended March 31, 2018, as a result of a decrease in the royalty payment from our partner LEO Pharma A/S for sales of Finacea® foam.   

Research and Development Expenses
Research and development expenses for the first quarter ended March 31, 2019 were $10.8 million, a $12.0 million, or 52.6% decrease, compared to $22.8 million for the first quarter ended March 31, 2018. The decrease in research and development expenses resulted primarily from a decrease of $13.8 million in clinical trial costs due to the completion of the FMX101 and FMX103 clinical trials, offset by an increase of $1.2 million in payroll, payroll-related and consultant expenses.

Selling, General and Administrative Expenses
General and administrative expenses for the first quarter ended March 31, 2019 were $5.3 million, an increase of $1.5 million, or 39.4%, compared to $3.8 million for the first quarter ended March 31, 2018. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.4 million in expenses mostly relating to pre-commercialization activities and market research.

Net Loss
Net loss for the first quarter ended March 31, 2019 was $15.2 million, or $0.28 per diluted share, compared to a net loss of $26.0 million, or $0.69 per diluted share, in the first quarter ended March 31, 2018, a decrease of $10.8 million, or 42%.

Cash & Cash Equivalents
At March 31, 2019, the Company had cash and cash equivalents of $82.9 million, compared to cash and cash equivalents of $99.4 million at December 31, 2018. The Company currently anticipates that its existing cash and investments we will be able to fund planned operating expenses and capital expenditure requirements through mid-2020.  These planned expenses include: (a) any pre-commercialization and launch preparations for FMX101, assuming the Company receives regulatory approval, (b) full development and filing of an NDA for FMX103, which the Company expects to submit in mid-2019 and (c) certain pipeline development activities.

Conference Call & Webcast
Wednesday, May 8th @ 8:30am Eastern Time
Toll Free: 877-407-0784
International: 201-689-8560
Conference ID: 13689852
Webcast: http://public.viavid.com/index.php?id=134118

A replay of the call will be archived on the Company’s website at www.foamix.com promptly after the conference call.

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 being developed for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam being developed for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative topical technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies.

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, public conference calls, and webcasts.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the Company’s expectations regarding its cash runway and expectations regarding future uses of cash; the review, potential regulatory approval and commercial launch of FMX101, including the potential timing of FDA review of the Company’s NDA seeking approval of FMX101; and statements regarding the regulatory submission and clinical development of the Company’s other product candidates including FMX103. All statements other than statements of historical facts are forward-looking statements. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, determination by the FDA that results from the Company’s clinical trials are not sufficient to support registration or marketing approval of its product candidates; the risk that its product candidates will not be successfully developed, approved or commercialized; unexpected delays in clinical trials or announcement of results; the Company’s ability to effectively and timely conduct clinical trials in light of excess costs or unfavorable results of clinical trials; additional competition in the dermatology markets; risks associated with denial of reimbursement by third party payors; expectations regarding the Company’s commercialization efforts and the sufficiency and availability of funding to support its business strategy and operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the Company’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the Securities and Exchange Commission. Although the Company believes these forward-looking statements are reasonable, they speak only as of the date of this release and it undertakes no obligation to update this information 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                                             
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.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
  March 31,
    December 31,
 
    2019       2018  
A s s e t s    
CURRENT ASSETS:    
Cash and cash equivalents $ 18,994     $ 27,868  
Restricted cash   250       250  
Short term bank deposits   24,155       24,047  
Investment in marketable securities   39,122       46,669  
Restricted investment in marketable securities   276       268  
Accounts receivable:      
Trade   1,168       1,066  
Other   1,209       999  
TOTAL  CURRENT ASSETS   85,174       101,167  
       
NON-CURRENT ASSETS:      
Investment in marketable securities   -       150  
Restricted investment in marketable securities   137       133  
Property and equipment, net   2,297       2,235  
Operating lease right of use assets   1,934       -  
Other   17       46  
TOTAL  NON-CURRENT ASSETS   4,385       2,564  
       
TOTAL  ASSETS $ 89,559     $ 103,731  
       
  March 31,
    December 31,
 
    2019       2018  
Liabilities and shareholders’ equity    
CURRENT LIABILITIES:    
Accounts payable and accruals:    
Trade $   5,657     $   6,327  
Operating lease liabilities     914        -  
Other     2,859         4,141  
TOTAL  CURRENT LIABILITIES     9,430         10,468  
       
LONG-TERM LIABILITIES:      
Liability for employee severance benefits     397         367  
Operating lease liabilities     1,023        -  
Other liabilities     714         714  
TOTAL  LONG-TERM LIABILITIES     2,134         1,081  
TOTAL  LIABILITIES     11,564         11,549  
COMMITMENTS      
SHAREHOLDERS' EQUITY:      
       
Ordinary Shares, NIS 0.16 par value - authorized: 90,000,000 Ordinary Shares as of March 31, 2019 and December 31, 2018; issued and outstanding: 54,419,323 and 54,351,140 Ordinary Shares as of March 31, 2019 and December 31, 2018, respectively     2,334         2,331  
               
Additional paid-in capital     306,266         305,303  
Accumulated deficit     (230,613 )       (215,409 )
Accumulated other comprehensive income (loss)     8         (43 )
TOTAL  SHAREHOLDERS' EQUITY     77,995         92,182  
TOTAL  LIABILITIES AND SHAREHOLDERS’ EQUITY $   89,559     $   103,731  



FOAMIX PHARMACEUTICALS LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
 (U.S. dollars in thousands, except per share data)
     
  Three months ended March 31,
   2019    2018
     
REVENUES $ 308   $ 906  
OPERATING EXPENSES:    
Research and development   10,848     22,825  
Selling, general and administrative   5,344     3,801  
TOTAL OPERATING EXPENSES   16,192     26,626  
OPERATING LOSS   15,884     25,720  
FINANCE INCOME, net   (504   (73 )
LOSS BEFORE INCOME TAX   15,380     25,647  
INCOME TAX   (176   330  
NET LOSS FOR THE YEAR $ 15,204   $ 25,977  
     
LOSS PER SHARE BASIC AND DILUTED $ 0.28   $ 0.69  
     
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS   54,370     37,541  


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Source: Foamix, Ltd.