99.1
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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.
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FOAMIX PHARMACEUTICALS LTD.
(Registrant)
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By:
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/s/ Ilan Hadar
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Name: Ilan Hadar
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Title: Chief Financial Officer
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News Release
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Target enrollment for the ongoing Phase 3 trials of FMX101 in patients with moderate-to-severe acne (900 patients) has been reached.
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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.
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Final patient enrollment is expected to be complete by end of November 2016.
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The Company expects to release topline results during the first half of 2017.
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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.
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U.S. Sales of Finacea® Foam, azelaic acid 15% for the treatment of rosacea, continue to grow.
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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.
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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.
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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.
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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.
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Foamix’s intellectual property portfolio continues to expand. The Company currently has 145 patents issued worldwide and 49 patents issued in the United States.
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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.
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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.
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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.
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Operating expenses totaled $8.5 million, compared with $3.6 million in the three months ended September 30, 2015.
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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.
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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.
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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.
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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.
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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.
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Operating expenses totaled $18.6 million, compared with $11.4 million in the nine months ended September 30, 2015.
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Net loss was $18.5 million or $0.60 per share, basic and diluted, compared with a loss of $11.1 million or $0.41 per share, basic and diluted, for the nine months ended September 30, 2015.
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Contact:
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U.S. Investor Relations
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Ilan Hadar, CFO
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Michael Rice
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Foamix Pharmaceuticals Ltd.
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LifeSci Advisors, LLC
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+972-8-9316233
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646-597-6979
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ilan.hadar@foamixpharma.com
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mrice@lifesciadvisors.com
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September 30,
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December 31,
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|||||||
2016
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2015
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A s s e t s
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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75,605
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$
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18,795
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Short term bank deposits
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28,225
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13,107
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Investment in marketable securities
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25,842
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23,693
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Restricted investment in marketable securities
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956
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769
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||||||
Accounts receivable:
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Trade
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2,544
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314
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Other
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263
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471
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TOTAL CURRENT ASSETS
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133,435
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57,149
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NON-CURRENT ASSETS:
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Investment in marketable securities
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9,507
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32,285
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Investment in long term bank deposits
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-
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15,130
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Property and equipment, net
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845
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646
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Other
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35
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35
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TOTAL NON-CURRENT ASSETS
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10,387
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48,096
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TOTAL ASSETS
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$
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143,822
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$
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105,245
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September 30,
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December 31,
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|||||||
2016
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2015
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Liabilities and shareholders’ equity
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CURRENT LIABILITIES:
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Current maturities of bank borrowing
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$
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28
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$
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31
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Accounts payable and accruals:
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Trade
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3,094
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1,353
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Deferred revenues
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-
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29
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Other
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3,945
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2,169
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Loan from the BIRD foundation
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-
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476
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TOTAL CURRENT LIABILITIES
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7,067
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4,058
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LONG-TERM LIABILITIES:
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Bank borrowing
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-
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20
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||||||
Liability for employee severance benefits
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388
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365
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TOTAL LONG-TERM LIABILITIES
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388
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385
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TOTAL LIABILITIES
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7,455
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4,443
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COMMITMENTS
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SHAREHOLDERS' EQUITY:
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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
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1,537
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1,284
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Additional paid-in capital
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199,500
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145,878
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Accumulated deficit
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(64,735
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)
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(46,230
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)
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Accumulated other comprehensive income (loss)
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65
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(130
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)
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TOTAL SHAREHOLDERS' EQUITY
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136,367
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100,802
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
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143,822
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$
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105,245
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Nine months ended
September 30
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Three months ended
September 30
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|||||||||||||||
2016
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2015
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2016
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2015
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REVENUES
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$
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4,041
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$
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579
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$
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2,544
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$
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22
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COST OF REVENUES
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51
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46
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8
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10
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GROSS PROFIT
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3,990
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533
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2,536
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12
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OPERATING EXPENSES:
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Research and development
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16,232
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6,900
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5,932
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1,985
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Selling, general and administrative
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6,388
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5,026
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2,550
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1,631
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TOTAL OPERATING EXPENSES
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22,620
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11,926
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8,482
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3,616
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OPERATING LOSS
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18,630
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11,393
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5,946
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3,604
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FINANCE INCOME, net
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(353
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)
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(269
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)
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(193
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)
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(203
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)
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LOSS BEFORE INCOME TAX
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18,277
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11,124
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5,753
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3,401
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INCOME TAX
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228
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9
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51
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-
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NET LOSS FOR THE PERIOD
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$
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18,505
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$
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11,133
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$
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5,804
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$
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3,401
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LOSS PER SHARE BASIC AND DILUTED
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$
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0.60
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$
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0.41
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$
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0.19
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$
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0.11
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WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS
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30,673
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27,430
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30,703
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30,547
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Nine months ended
September 30
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Three months ended
September 30
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|||||||||||||||
2016
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2015
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2016
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2015
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NET LOSS
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$
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18,505
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$
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11,133
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$
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5,804
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$
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3,401
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OTHER COMPREHENSIVE INCOME:
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Net unrealized losses (gains) from marketable securities
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(164
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)
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(27
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)
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3
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(9
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)
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Gains (losses) on marketable securities reclassified into net loss
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4
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(67
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)
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-
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-
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|||||||||||
Net unrealized losses (gains) on derivative financial instruments
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(48
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)
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2
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(22
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)
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60
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||||||||||
Gains on derivative financial instruments reclassified into net loss
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13
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-
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9
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-
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TOTAL OTHER COMPREHENSIVE LOSS (INCOME) |
(195
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)
|
(92
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)
|
(10
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)
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51
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|||||||||
TOTAL COMPREHENSIVE LOSS
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$
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18,310
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$
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11,041
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$
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5,794
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$
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3,452
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Nine months ended
September 30
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||||||||
2016
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2015
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CASH FLOWS FROM OPERATING ACTIVITIES:
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Net Loss
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$
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18,505
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$
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11,133
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Adjustments required to reconcile net loss to net cash used in operating activities:
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Depreciation and amortization
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103
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58
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Changes in marketable securities and bank deposits, net
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180
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67
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||||||
Changes in accrued liability for employee severance benefits, net of retirement fund profit
|
23
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15
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||||||
Share-based compensation
|
2,071
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1,226
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||||||
Non-cash finance expenses (income), net
|
(2
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)
|
53
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|||||
Changes in operating asset and liabilities:
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||||||||
Decrease (increase) in trade and other receivable
|
(2,022
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)
|
128
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|||||
Increase in other non-current assets
|
-
|
(1
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)
|
|||||
Increase (decrease) in accounts payable and accruals
|
3,523
|
883
|
||||||
Net cash used in operating activities
|
(14,629
|
)
|
(8,704
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)
|
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CASH FLOWS FROM INVESTING ACTIVITIES:
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||||||||
Purchase of fixed assets
|
(302
|
)
|
(246
|
)
|
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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 -
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||||||||
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
|