REHOVOT, Israel, Nov. 14, 2014 (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, announces financial results for the three and nine months ended September 30th, 2014.
Financial highlights of the first nine months of 2014 include:
- Revenues for the nine months ended September 30th, 2014 were $2.4 million compared with $700,000 for the nine months ended September 30th, 2013.
- Operating loss for the nine months ended September 30th, 2014 was $1.5 million compared with $1.6 million for the nine months ended September 30th, 2013.
- Net loss for the nine months ended September 30th, 2014 was $11.3 million compared with $2.2 million for the nine months ended September 30th, 2013. The increase in net loss is due to non-cash finance expenses.
Notable financial developments during the period of June 30th, 2014 through the date of this release:
- We consummated an initial underwritten public offering of our ordinary shares on September 17, 2014, in which we received net proceeds of $35.6 million.
- We became entitled to a contingent payment via a development and license agreement with a large customer and therefore, as per our agreement, we received an amount of $2.5 million.
- The underwriters exercised their ‘green shoe’ option on October 17, 2014 and purchased an additional 968,200 ordinary shares at a price of $6 per share. The proceeds from the exercise of the option, net of underwriters’ commission, were $5.4 million, bringing the total net proceeds from the initial public offering to approximately $41.0 million.
Notable clinical and business developments for the period of June 30th, 2014 through the date of this release:
- We completed a pharmacokinetic trial for FMX101, in which subjects received FMX101 under maximum use condition.
- We initiated a clinical trial to study the ability of FDX-104 to prevent the severe acne-like rash associated with epithelial growth factor receptor inhibitor chemotherapies.
- We initiated scale-up studies with our chosen commercial manufacturer for FMX-101.
- We entered the final stage of selection of the clinical research organization (CRO) for our Phase III clinical trials with FMX-101 for treatment of moderate-to-severe acne.
Management Overview
We are working towards the launch, planned for mid-2015, of a Phase III trial with our lead product candidate FMX 101, a 4% minocycline foam formulation for treatment of moderate-to-severe acne. In 2013, we completed a dose-ranging Phase II clinical trial of FMX101 in Israel, involving 150 patients aged 12 to 25 with moderate-to-severe acne. This trial demonstrated both clinically and statistically significant efficacy versus the control placebo group, with FMX101 reducing inflammatory acne lesions by 71% in only six weeks and non-inflammatory lesions by 73% in 12 weeks. In addition, no drug-related systemic side effects were observed. During the third quarter of 2014 we further expanded and advanced our clinical development programs. This included initiating a pharmacokinetic trial for FMX101 and entering the final stage of selecting the CRO for our Phase III clinical trials for FMX101, as well as initiation of a clinical trial for FDX104.
Third Quarter Financial Results
Revenues
Total revenues for the third quarter of 2014 were $415,000 compared with $410,000 for the third quarter of 2013. No material changes were noted in revenues.
Operating Expenses
Our operating expenses for the three months ended September 30, 2014 and 2013 were as follows:
| Three months ended September 30, | ||
| 2014 | 2013 | |
| (in thousands) | ||
| Research and development | $ 1,064 | $ 170 |
| Selling, general and administrative | 804 | 277 |
| Total operating expenses | $ 1,868 | $ 447 |
Research and Development Expenses
Research and development expenses increased by $894,000, or 526%, from $170,000 in the three months ended September 30, 2013 to $1.1 million in the three months ended September 30, 2014. The increase in R&D expenses resulted primarily from an increase of $413,000 in costs related to clinical trial development activity for FMX101 and FDX104, and an increase of $426,000 in payroll and related expenses due to an increase in the number of R&D employees and implementation of a bonus scheme.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $527,000, or 190%, from $277,000 in the three months ended September 30, 2013 to $804,000 in the three months ended September 30, 2014. The increase in SG&A expenses resulted primarily from an increase of $236,000 in payroll and related expenses, an increase of $75,000 in legal and financial consulting fees and an increase of $102,000 in investor relations expenses.
Finance Expenses
Finance expenses increased by $5.9 million, or 1714%, from $344,000 in the three months ended September 30, 2013 to $6.2 million in the three months ended September 30, 2014. The finance expenses for the third quarter of 2014 consist primarily of the $6.3 million non-cash expense increase in fair value of warrants whereas the finance expenses for the third quarter of 2013 consists primarily of finance expenses relating to the convertible loans converted in May 2014.
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