Foamix Reports Second Quarter 2019 Financial Results and Provides Corporate Update
REHOVOT,
“We continue to make excellent progress advancing our late stage pipeline in dermatology and in making preparations to become a commercial organization,” said
Second Quarter and Recent Corporate and Regulatory Update:
- Submitted a New Drug Application (“NDA”) to U.S.
FDA for FMX103 for the treatment of moderate-to-severe papulopustular rosacea- 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.
- Publication of Phase 3 study FX2017-22 (“Study 22) of FMX101 in acne in the
Journal of the American Academy of Dermatology .- 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.
- Study 22 was conducted by Foamix to support the NDA submission of FMX101, which is currently under review by the
- 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 . - 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
- Secured up to
$64 million in financing in transactions withPerceptive Advisors and OrbiMed.
Financial Results for the Second Quarter Ended
Revenues
The Company reported no revenues for the quarter ended
Research and Development Expenses
Research and development expenses for the quarter ended
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the quarter ended
Net Loss
Net loss for the second quarter ended
Cash & Cash Equivalents
At
Financial Results for the Six Months Ended
Revenues
Total revenues decreased by
Research and Development Expenses
The Company’s research and development expenses for the six months ended
Selling, General and Administrative Expenses
Selling, general and administrative expenses for the six months ended
Net Loss
Net loss for the six months ended
Conference Call & Webcast | |
Thursday, August 8th @ 8:30amET | |
Toll Free: | 855-327-6838 |
International: | 604-235-2082 |
Conference ID: | 10007347 |
Webcast: | http://public.viavid.com/index.php?id=135538 |
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 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.
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
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 the Company’s cash runway and expectations regarding future uses of cash, the clinical development, potential regulatory approval and commercial launch of FMX101, including the potential timing of
Contact: | U.S. Investor Relations |
Ilan Hadar | Michael Rice |
Foamix Pharmaceuticals Ltd. | LifeSci Advisors, LLC |
+972-8-9316233 | 646-597-6979 |
IR@foamixpharma.com | mrice@lifesciadvisors.com |
FOAMIX PHARMACEUTICALS LTD. | ||||||
CONSOLIDATED BALANCE SHEETS | ||||||
(U.S. dollars in thousands) | ||||||
Jun-30 | Dec-31 | |||||
2019 | 2018 | |||||
A s s e t s | ||||||
CURRENT ASSETS: | ||||||
Cash and cash equivalents | $39,085 | $27,868 | ||||
Restricted cash | 250 | 250 | ||||
Short term bank deposits | 16,187 | 24,047 | ||||
Investment in marketable securities | 14,091 | 46,669 | ||||
Restricted investment in marketable securities | 282 | 268 | ||||
Accounts receivable: | ||||||
Trade | 308 | 1,066 | ||||
Other | 1,511 | 999 | ||||
TOTAL CURRENT ASSETS | 71,714 | 101,167 | ||||
NON-CURRENT ASSETS: | ||||||
Investment in marketable securities | - | 150 | ||||
Restricted investment in marketable securities | 139 | 133 | ||||
Property and equipment, net | 2,497 | 2,235 | ||||
Operating lease right of use assets | 1,858 | - | ||||
Other | 18 | 46 | ||||
TOTAL NON-CURRENT ASSETS | 4,512 | 2,564 | ||||
TOTAL ASSETS | $76,226 | $103,731 | ||||
Jun-30 | Dec-31 | |||||
2019 | 2018 | |||||
Liabilities and shareholders’ equity | ||||||
CURRENT LIABILITIES: | ||||||
Accounts payable and accruals: | ||||||
Trade | $9,434 | $6,327 | ||||
Operating lease liabilities | 999 | - | ||||
Other | 3,664 | 4,141 | ||||
TOTAL CURRENT LIABILITIES | 14,097 | 10,468 | ||||
LONG-TERM LIABILITIES: | ||||||
Liability for employee severance benefits | 409 | 367 | ||||
Operating lease liabilities | 882 | - | ||||
Other liabilities | 456 | 714 | ||||
TOTAL LONG-TERM LIABILITIES | 1,747 | 1,081 | ||||
TOTAL LIABILITIES | 15,844 | 11,549 | ||||
COMMITMENTS | ||||||
SHAREHOLDERS' EQUITY: | ||||||
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 | 2,331 | ||||
Additional paid-in capital | 307,653 | 305,303 | ||||
Accumulated deficit | -249,606 | -215,409 | ||||
Accumulated other comprehensive loss | (1 | ) | (43 | ) | ||
TOTAL SHAREHOLDERS' EQUITY | 60,382 | 92,182 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $76,226 | $103,731 |
FOAMIX PHARMACEUTICALS LTD. | ||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||
(U.S. dollars in thousands, except per share data) | ||||||||||||
Six months ended | Three months ended | |||||||||||
June 30 | Jun-30 | |||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||
REVENUES | $308 | $1,870 | - | $964 | ||||||||
OPERATING EXPENSES: | ||||||||||||
Research and development | 23,404 | 39,667 | 12,556 | 16,842 | ||||||||
Selling, general and administrative | 12,147 | 6,710 | 6,803 | 2,909 | ||||||||
TOTAL OPERATING EXPENSES | 35,551 | 46,377 | 19,359 | 19,751 | ||||||||
OPERATING LOSS | 35,243 | 44,507 | 19,359 | 18,787 | ||||||||
FINANCE INCOME, net | (870 | ) | (352 | ) | (366 | ) | (279 | ) | ||||
LOSS BEFORE INCOME TAX | 34,373 | 44,155 | 18,993 | 18,508 | ||||||||
INCOME TAX | (176 | ) | 450 | - | 120 | |||||||
NET LOSS FOR THE PERIOD | $34,197 | $44,605 | $18,993 | $18,628 | ||||||||
LOSS PER SHARE BASIC AND DILUTED | $0.63 | $1.15 | $0.35 | $0.46 | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE IN THOUSANDS | 54,401 | 38,821 | 54,426 | 40,102 |
Source: Foamix, Ltd.