Investors

Forward Pharma Reports Fourth Quarter and Year End 2015 Financial and Operational Results
“We continue to advance our clinical and intellectual property objectives including strengthening our clinical development team,” said
Fourth Quarter ended
The net loss for the fourth 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
IP Update
We continue to advance 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:
- U.S. IP: Interference schedule accelerated with oral arguments scheduled for
November 2016 . OnAugust 19, 2015 , the USPTO re-declared the interference between Forward and a subsidiary ofBiogen, Inc. regarding claims to the treatment of multiple sclerosis, or MS, with a 480 mg daily dose of DMF (dimethyl fumarate), the active ingredient in Tecfidera®. The USPTO confirmed Forward as the senior party based on having an earlier benefit date of our U.S. Patent Application No. 11/576,871. Biogen was deemed the junior party with respect to its U.S. Patent No. 8,399,514. InAugust 2015 , the parties filed priority statements and motions related to validity and benefit. Oppositions to motions are dueJune 1, 2016 and the oral argument is now scheduled forNovember 30, 2016 (previously January 2017).
- European IP: Hearing in
Germany postponed under an agreement with Biogen. On November 18, 2014, we filed a lawsuit against Biogen Idec GmbH, Biogen Idec International GmbH and Biogen Idec Ltd. in the Regional Court in Düsseldorf,Germany , asserting infringement of our utility model by Biogen’s marketing of Tecfidera® inGermany with a label instructing a daily dose of 480 mg for the treatment of MS. On May 22, 2015, we expanded the existing lawsuit to include the assertion of infringement of our European patent EP2801355. The ’355 patent covers, among other things, the treatment of MS with 480 mg per day of DMF using pH‑controlled compositions, which have an enteric coating. We seek damages for Biogen’s sales of Tecfidera® inGermany . If the court agrees with our assertion, we expect the court will declare that we would be entitled to damages and/or compensation for unjust enrichment. An oral hearing inGermany originally scheduled for March 24, 2016 at the Regional Court in Düsseldorf has been stayed (i.e. postponed) under a mutual agreement between the two parties. That stay will expire, in the case of the ’355 patent, upon an initial decision in the European Patent Office (EPO) opposition proceedings against the ’355 patent, and in the case of the utility model, upon a decision in both the ’355 EPO opposition proceedings and the utility model cancellation proceedings.
Clinical Update
Our development plan for our lead drug, FP187, is focused on the RRMS indication. In consultation with a clinical research organization, we are continuing to prepare for a single beta interferon-controlled Phase 3 trial in RRMS. In parallel, we are evaluating alternative Phase 3 clinical strategies in RRMS, which could shorten our time to commercialization and/or reduce costs. We expect to complete these evaluations during 2016, in anticipation of beginning the Phase 3 trial in the second half of 2016.
We are currently performing additional Phase 1 studies on FP187 to evaluate its in vivo release profile as well as tolerability. In addition, we are planning to conduct a human mass‑balance/metabolic profile study, which is a requirement of regulatory agencies.
Our nonclinical development plan for our lead drug, FP187, is designed to support regulatory submissions with a full toxicology study package.
Corporate Update
Forward Pharma A/S | |||||||||||||||||
Condensed Consolidated Statement of Operations | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
Year Ended | Three Months Ended | ||||||||||||||||
December 31st |
December 31st | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Research and development | $ | (33,727 | ) | $ | (10,547 | ) | $ | (8,623 | ) | $ | (3,931 | ) | |||||
General and administrative | (15,852 | ) | (9,154 | ) | (3,592 | ) | (3,998 | ) | |||||||||
Total operating expenses | (49,579 | ) | (19,701 | ) | (12,215 | ) | (7,929 | ) | |||||||||
Foreign exchange gain | 11,933 | 5,589 | 2,328 | 5,748 | |||||||||||||
Other | 306 | (5,154 | ) | (30 | ) | 72 | |||||||||||
Net (loss) before taxes | (37,340 | ) | (19,266 | ) | (9,917 | ) | (2,109 | ) | |||||||||
Income tax benefit | 336 | 250 | 336 | 138 | |||||||||||||
Net (loss) | (37,004 | ) | (19,016 | ) | (9,581 | ) | (1,971 | ) | |||||||||
Preferential distribution | - | (42,734 | ) | - | (42,734 | ) | |||||||||||
Net (loss) | $ | (37,004 | ) | $ | (61,750 | ) | $ | (9,581 | ) | $ | (44,705 | ) | |||||
Net (loss) per ordinary share | |||||||||||||||||
Basic and diluted | $ | (0.79 | ) | $ | (1.79 | ) | $ | (0.20 | ) | $ | (1.01 | ) | |||||
Weighted-average shares used basic and diluted | 46,749 | 34,490 | 46,872 | 44,094 | |||||||||||||
Forward Pharma A/S | |||||||||||||||||
Reconciliation of net (loss) as reported to non-GAAP net (loss) | |||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||
Year Ended | Three Months Ended | ||||||||||||||||
December 31st |
December 31st | ||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||
Net (loss) as reported | $ | (37,004 | ) | $ | (61,750 | ) | $ | (9,581 | ) | $ | (44,705 | ) | |||||
Adjustments for non-cash items: | |||||||||||||||||
Preferential distribution | - | 42,734 | - | 42,734 | |||||||||||||
Share-based compensation | 13,541 | 5,951 | 3,506 | 2,477 | |||||||||||||
Foreign exchange gain | (11,933 | ) | (5,589 | ) | (2,328 | ) | (5,748 | ) | |||||||||
Fair value adjustment to convertible notes | - | 3,823 | - | (20 | ) | ||||||||||||
Fair value adjustment shareholder warrants | - | 968 | - | (82 | ) | ||||||||||||
Non-GAAP net (loss) | $ | (35,396 | ) | $ | (13,863 | ) | $ | (8,403 | ) | $ | (5,344 | ) | |||||
Non-GAAP net (loss) per share information: | |||||||||||||||||
Weighted-average shares used | 46,749 | 34,490 | 46,872 | 44,094 | |||||||||||||
Non-GAAP basic and diluted per share (net) loss | $ | (0.76 | ) | $ | (0.40 | ) | $ | (0.18 | ) | $ | (0.12 | ) | |||||
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
Forward Pharma A/S | |||||||||
Condensed Consolidated Balance Sheets | |||||||||
(in thousands) | |||||||||
December 31st | December 31st | ||||||||
2015 | 2014 | ||||||||
Assets | |||||||||
Cash, cash equivalents and available-for-sale financial assets | $ | 176,652 | $ | 223,484 | |||||
Other assets | 6,252 | 1,825 | |||||||
Total assets | $ | 182,904 | $ | 225,309 | |||||
Equity and Liabilities | |||||||||
Shareholders' equity | $ | 176,693 | $ | 222,394 | |||||
Liabilities | 6,211 | 2,915 | |||||||
Total equity and liabilities | $ | 182,904 | $ | 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 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; our ability to commercialize and generate revenue from our sole clinical candidate, FP187; clinical development, and clinical trials of FP187 may not be successful; completion of required clinical trials may take longer than we anticipate, which could result in increased costs, limit our access to funding and delay or limit our ability to obtain regulatory approval for FP187. These and other factors are identified and described in detail in certain of our filings with the