REHOVOT, Israel, March 18, 2015 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), ("Foamix Pharmaceuticals"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, announced financial results for the twelve months ended December 31, 2014.
2014 Financial Highlights:
- Revenues were $5.4 million for the year ended December 31, 2014, compared with $1.4 million in 2013.
- Operating loss for the year was $1.6 million, as compared to an operating loss of $1.4 million in the prior year.
- Net loss was $11.5 million or $0.79 per basic and diluted share, compared with $2.4 million or $0.22 per basic and diluted share in 2013, the increase in net loss was primarily due to the increase in non-cash finance expenses on convertible loans and warrants.
- On September 17, 2014, the Company successfully completed an initial public offering on NASDAQ. Total net proceeds, including the exercise of the "green shoe" by the underwriters, were approximately $41.1 million.
- Cash, equivalents, and marketable securities at December 31, 2014 were $50 million, compared to $2.3 million at December 31, 2013.
2014 Clinical and Corporate Highlights:
- Established a U.S. subsidiary, Foamix Pharmaceuticals Inc., and appointed a senior U.S. leadership team.
- Commenced a series of non-clinical safety assessment studies to support the initiation of our planned Phase III trials in acne.
- In Q4, 2014 we initiated a clinical trial to study FDX104 for the prevention of severe acne-like rash associated with chemotherapies known as epidermal growth factor receptor inhibitors (EGFRI).
- Strengthened our intellectual property position with the issuance of various additional patents covering multiple technology platforms, including our minocycline and doxycycline foams.
- As of March 1, 2015, we had 79 granted patents and over 100 patent applications worldwide covering our foam-based platforms and other technology.
- In the Unites States we currently have 37 granted patents, of which five patents cover our minocycline and doxycycline foams.
- Received a $2.5 milestone payment from Bayer HealthCare in connection with our ongoing license agreement with Bayer for the development of an azelaic acid foam product.
"2014 was a transformational year for Foamix, with significant progress towards our goal of becoming a leading dermatology company," said Dov Tamarkin, Chief Executive Officer of Foamix Pharmaceuticals. "We successfully completed an IPO, raising net proceeds of approximately $41.1 million. We believe these funds will be sufficient to complete our Phase 3 clinical program for our lead product candidate, FMX101 for the treatment of moderate-to-severe acne, and also advance our clinical programs in rosacea, impetigo and cancer rash."
For further details on the Company's financials, please refer to Form 20-F Annual Report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934, filed with the SEC.
|Conference Call & Webcast|
|Wednesday, March 18, 2015 @ 8:00am Eastern/5:00am Pacific|
|Replays available until April 1, 2015|
About Foamix Pharmaceuticals Ltd.
Foamix Pharmaceuticals is a clinical-stage specialty pharmaceutical company focused on developing and commercializing its proprietary minocycline foam for the treatment of acne and other skin conditions. Foamix Pharmaceuticals' lead product candidate FMX101 for moderate-to-severe acne is a novel topical foam formulation of the antibiotic minocycline. Foamix Pharmaceuticals also has early-stage stable foam formulations of various drugs for the treatment of common dermatological indications.
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 recent Form 20-F Annual Report for the year ended December 31, 2014, and elsewhere in the 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.
|Consolidated Statement of Operations Data – Year Ended December 31|
|(in thousands of U.S. dollars)|
|Revenues||$ 5,414||$ 1,404|
|Cost of revenues||527||453|
|Research and Development||3,557||1,086|
|Selling, general and administrative||2,964||1,221|
|Total Operating Expenses||6,521||2,307|
|Finance Expenses, net||9,844||1,075|
|Net Loss||$ 11,484||$ 2,431|
|Consolidated Balance Sheet Data|
|(in thousands of U.S. dollars)|
| As of |
| As of |
|Balance sheet data:|
|Cash, cash equivalents and investment in marketable securities||$49,966||$2,308|
|Total long-term liabilities||381||4,917|
|Total shareholders' equity (capital deficiency)||$48,762||$ (3,582)|