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Forward Pharma Reports Second Quarter 2015 Financial and Operational Results
"We continue to make progress at
Second Quarter ended
The net loss for the second quarter of 2015 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 the second quarter, we have made significant progress in advancing our intellectual property portfolio. The following summarizes the current status of and recent developments concerning several of our most important U.S. and European patents and patent applications:
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In
April 2015 , the USPTO declared an interference betweenForward andBiogen, Inc. regarding claims to the treatment of multiple sclerosis, or MS, with a 480 mg daily dose of DMF, the active ingredient in Tecfidera®. We received senior party status based on having an earlier benefit date of our U.S. Patent Application No. 11/576,871, and Biogen was deemed the junior party with respect to its U.S. Patent No. 8,399,514. OnAugust 19, 2015 , the USPTO redeclared the interference, confirming Forward as the senior party and ruling in Forward's favor that Biogen is not entitled to benefit of its U.S. provisional application filing date ofFebruary 8 , 2007. Biogen has requested reconsideration of the USPTO's decision. InAugust 2015 , the parties filed priority statements and motions related to validity and benefit.
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On
May 20, 2015 , the European Patent Office issued one of our patent applications inEurope covering the treatment of MS with the 480 mg daily dose of DMF. This patent application issued with the patent number EP2801355 ('355 patent). This patent could be opposed by the filing of an opposition proceeding in the EPO within nine months of the date of grant, orFebruary 20 , 2016.
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On
May 26, 2015 , we expanded an existing lawsuit filed by us against Biogen in theRegional Court of Dusseldorf , to include an allegation of infringement of our European '355 patent by Biogen's marketing of Tecfidera® inGermany with a label instructing a daily dose of 480 mg for the treatment of MS. We seek damages for Biogen's sales of Tecfidera® inGermany . The court has scheduled oral proceedings forMarch 24, 2016 .
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Our European patent EP2316430, which covers DMF formulations with certain in vitro dissolution profiles, was revoked by the
Opposition Division of the European Patent Office inJuly 2015 for the reason that the claims contain subject matter not derivable from the original application as filed. The Opposition Division has not decided on novelty or inventive step. We have filed an appeal against this decision, which will only become effective if and when confirmed by the Board of Appeal.
Clinical progress and outlook
Our development plan for our lead drug, FP187, includes preparation for Phase 3 programs in RRMS and psoriasis. We are currently continuing our pre-clinical regulatory program and conducting additional Phase 1 clinical studies. We expect to commence a Phase 3 RRMS trial in the first half of 2016.
| Forward Pharma A/S | ||
| Condensed Consolidated Statement of Operations | ||
| (in thousands, expect per share amounts) | ||
| Three Months Ended | ||
| June 30th | ||
| 2015 | 2014 | |
| Research and development | $ (9,999) | $ (2,476) |
| General and administrative | (3,547) | (719) |
| Total operating expenses | (13,546) | (3,195) |
| Fair value adjustments | -- | (1) |
| Foreign exchange gain (loss) | (4,259) | 2 |
| Interest income | 115 | -- |
| Other finance costs | (1) | -- |
| Net (loss) before taxes | (17,691) | (3,194) |
| Income tax benefit | -- | 28 |
| Net (loss) used to compute per share amounts | $ (17,691) | $ (3,166) |
| Net (loss) per ordinary share | ||
| Basic and diluted | $ (0.38) | $ (0.10) |
| Weighted-average shares used basic and diluted | 46,733 | 31,976 |
| Forward Pharma A/S | ||
| Reconciliation of net (loss) as reported to non-GAAP net (loss) | ||
| (in thousands, except per share amounts) | ||
| Three Months Ended | ||
| June 30th | ||
| 2015 | 2014 | |
| Net (loss) as reported | $ (17,691) | $ (3,166) |
| Adjustments for non-cash items: | ||
| Share based compensation | 4,091 | 1,334 |
| Foreign exchange loss (gain) | 4,259 | (2) |
| Fair value adjustment shareholder warrants | -- | 1 |
| Non-GAAP net (loss) | $ (9,341) | $ (1,833) |
| Non-GAAP net (loss) per share information: | ||
| Weighted-average shares used | 46,733 | 31,976 |
| Non-GAAP basic and diluted per share (net) loss | $ (0.20) | $ (0.06) |
| This press release uses a non-GAAP measure of net loss that is a financial measure that is not calculated in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). The Company believes that the presentation of non-GAAP net loss is useful to investors because it excludes non-cash items that do not affect the Company's liquidity and period to period changes, most of which are not within the control of the Company. Non-cash items include: (i) share-based compensation expense; (ii) non-cash foreign exchange gains or (losses) and (iii) fair value adjustments of shareholder warrants. However, there are limitations in the use of non-GAAP financial measures as they exclude certain income and expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measure may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented herein should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with IFRS. | ||
| Forward Pharma A/S | ||
| Condensed Consolidated Balance Sheets | ||
| (in thousands) | ||
| June 30th | December 31st | |
| 2015 | 2014 | |
| Assets | ||
| Cash, cash equivalents and available-for-sale financial assets | $ 202,531 | $ 223,484 |
| Other assets | 2,881 | 1,825 |
| Total assets | $ 205,412 | $ 225,309 |
| Equity and Liabilities | ||
| Shareholders' equity | $ 199,521 | $ 222,394 |
| Liabilities | 5,891 | 2,915 |
| Total equity and liabilities | $ 205,412 | $ 225,309 |
Relevant Intellectual Property Sources:
USPTO Interference with Biogen: The motions are publicly available on the USPTO interference website at https://acts.uspto.gov/ifiling/PublicView.jsp, using interference number 106023.
Forward Pharma U.S. and European patent and patent applications can be found by using the following links:
USPTO: http://www.uspto.gov/
USPTO Public Pair: http://portal.uspto.gov/pair/PublicPair
EPO: https://register.epo.org/regviewer
About
Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K,
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," "anticipate," "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 issuance and term of term of patents; the Company's ability to prevail in or obtain a favorable decision in any patent interference or infringement action; the Company's ability to recover damages in any patent infringement action; uncertainties relating to our development plans and activities, including the commencement of any clinical trial and 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 rights of third parties. These and other factors are identified and described in detail in certain of our filings with the