Investors

Forward Pharma Reports Fourth Quarter and Year End 2014 Financial and Operational Results
"We expect 2015 to be an eventful year for Forward," said
Fourth Quarter and Year End 2014 Financial and Operational Results
The net loss for the fourth quarter of 2014 was
Research and development expenses were
General and administrative expenses were
Non-cash stock-based compensation expense included in total operating expenses was
As of
Recent IP progress and outlook
In 2014, we made significant progress in advancing our intellectual property portfolio. The following summarizes the current status of several of our most important U.S. and European patents and patent applications.
- We are awaiting further action by the USPTO regarding our U.S. patent application No. 11/576,871. A USPTO examiner previously found our claims in this application directed to methods of treating MS using a daily 480 mg dose of DMF to be allowable and has recommended that an interference be declared against Biogen's U.S. patent No. 8,399,514.
- We have two pending U.S. patent applications relating to the 480 mg dose of DMF that we believe may soon be allowed, one of which (14/213,399) claims particular up-titration schedules of using DMF to treat MS, and the other of which (14/212,503) claims treating MS using particular compositions containing DMF and that also specifies levels of a DMF metabolite called mono methyl fumarate (MMF) in the bloodstream.
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Our erosion matrix patent issued on
December 9, 2014 with patent number 8,906,420. This patent expires inJanuary 2030 and covers the formulation of FP187. -
On
November 18, 2014 , we filed a lawsuit against Biogen alleging infringement of our German utility model. An oral proceeding inGermany is scheduled forFebruary 16, 2016 .
Clinical progress and outlook
Our development plan for our lead drug, FP187, includes preparation for a Phase 3 program in multiple sclerosis, psoriasis or both, as well as other clinical programs. Forward anticipates the following development activities related to clinical trials for FP187:
- continue to pursue development of FP187 for the treatment of MS and/or psoriasis and commence a Phase 3 trial within the next 12 months;
- initiate a Phase 1 bridging study to investigate the pharmacokinetic profile of a new tablet formulation of FP187; and
- initiate a Phase 1 fed/fast pharmacokinetic trial in 2Q15 which is a regulatory requirement for controlled release drugs.
About
Our principal executive offices are located at Østergade 24A, 1, 1100 Copenhagen K,
Forward Pharma A/S | ||||
Condensed Consolidated Statement of Operations | ||||
(in thousands, expect per share amounts) | ||||
Year Ended | Three Months Ended | |||
December 31st | December 31st | |||
2014 | 2013 | 2014 | 2013 | |
Research and development | $ (10,547) | $ (8,018) | $ (3,931) | $ (1,704) |
General and adminstrative | (9,154) | (1,014) | (3,998) | (387) |
Total operating expenses (1) | (19,701) | (9,032) | (7,929) | (2,091) |
Fair value adjustments | (4,791) | (6,676) | 84 | (8,802) |
Foreign exchange gain | 5,589 | -- | 5,589 | -- |
Other | (113) | 12 | 285 | (89) |
Net (loss) | (19,016) | (15,696) | (1,971) | (10,982) |
Preferential distribution | (42,734) | -- | (42,734) | -- |
Net (loss) used to compute per share amounts | $ (61,750) | $ (15,696) | $ (44,705) | $ (10,982) |
Net (loss) per ordinary share | ||||
Basic and diluted (2) | $ (1.79) | $ (0.54) | $ (1.01) | $ (0.38) |
Weighted-average shares | ||||
Basic and diluted | 34,490 | 29,004 | 44,094 | 29,089 |
(1) Operating expenses include share based compensation: $6.0 million and $2.5 million for 2014 and 4Q14, respectively, versus $579,000 and $220,000 for 2013 and 4Q13, respectively. | ||||
(2) The net loss used to compute the per share amounts for the year and quarter ended December 31, 2014 has been increased by a non-cash preferential distribution of approximately $42.7 million. | ||||
Forward Pharma A/S | ||||
Condensed Consolidated Statement of Operations | ||||
(in thousands) | ||||
December 31, | ||||
2014 | 2013 | |||
Assets | ||||
Cash, cash equivalents and marketable securities | $ 223,484 | $ 2,955 | ||
Other assets | 1,825 | 644 | ||
Total assets | $ 225,309 | $ 3,599 | ||
Equity and Liabilities | ||||
Shareholder equity (deficit) | $ 222,394 | $ (26,415) | ||
Liabilities | 2,915 | 30,014 | ||
Total equity and liabilities | $ 225,309 | $ 3,599 |
Forward Pharma A/S Media Contact:
SK@forward-pharma.com
+1 914-752-3542
lroth@theruthgroup.com
+1 646-536-7014
Forward Looking Statements:
Certain statements in this press release may constitute "forward-looking statements" of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements which contain language such as "believe,""expect," "hope," "would" and "potential." Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company's ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; the Company's ability to prevail in or obtain a favorable decision in any such action; the Company's ability to recover damages in any such action; uncertainties relating to our development plans and activities, including the results, timing, cost and location thereof; risks and uncertainties related to the scope, validity and enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property right of third parties. These and other factors are identified and described in detail in certain of our filings with the