Investors

Forward Pharma Reports First Quarter 2016 Financial and Operational Results
“We continue to make consistent progress in 2016,” said
First Quarter ended
The net loss for the first quarter of 2016 was
Research and development costs for the three month periods ended
General and administrative costs for the three month periods ended March 31, 2016 and 2015 were
Non-cash stock based compensation expense included in total operating expenses was
IP Update
We continue to advance our intellectual property portfolio. The following summarizes the current status of and recent developments concerning several of our U.S. and European patents and patent applications:
- U.S. IP: On August 19, 2015, the USPTO re-declared the interference between
Forward Pharma and a subsidiary ofBiogen, Inc. regarding claims to the treatment of multiple sclerosis, or MS, with a 480 mg daily dose of DMF, the active ingredient in Tecfidera®. The USPTO confirmedForward Pharma 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. In August 2015, the parties filed priority statements and motions related to validity and benefit. The parties filed oppositions to motions onJune 1 , 2016. Upcoming milestones include:August 8, 2016 : Deadline to file all repliesNovember 30, 2016 : Default oral argument
- Erosion matrix: On
May 11, 2016 , the EPO granted our European Application EP12193798.1, which was thereby assigned patent number EP2564839. This patent contains claims directed to a pharmaceutical formulation in the form of an erosion matrix tablet having a particular composition and will expire in 2030. FP187 is an erosion matrix formulation that falls within the granted claims. The grant of the patent triggers a nine month window for opponents to oppose the patent. A separate patent in our erosion matrix patent family, EP2379063 (covering matrix formulations with a thin enteric coating), has been upheld by theOpposition Division of the EPO following a hearing onApril 5 , 2016. Multiple third parties, including Biogen, had opposed the patent. One or more of the opponents may appeal this decision.
Clinical Update
Our development plan for our lead drug, FP187, is focused on the relapsing-remitting multiple sclerosis (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. Consistent with our previous guidance, 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.
Our nonclinical development plan for our lead drug, FP187, is designed to support regulatory submissions with a complete toxicology package.
Corporate Update
Forward recently announced that Dr.
Forward Pharma A/S | ||||||||
Condensed Consolidated Statement of Profit or Loss | ||||||||
(in thousands, except per share amounts) | ||||||||
Three Months Ended | ||||||||
March 31st | ||||||||
2016 | 2015 | |||||||
Research and development | $ | (9,682 | ) | $ | (4,320 | ) | ||
General and administrative | (2,958 | ) | (4,069 | ) | ||||
Total operating expenses | (12,640 | ) | (8,389 | ) | ||||
Foreign exchange (loss) gain | (4,291 | ) | 14,310 | |||||
Other | 80 | 105 | ||||||
Net (loss) income | $ | (16,851 | ) | $ | 6,026 | |||
Net (loss) income per ordinary share | ||||||||
Basic | $ | (0.36 | ) | $ | 0.13 | |||
Diluted | $ | (0.36 | ) | $ | 0.12 | |||
Weighted-average shares used basic | 46,872 | 46,514 | ||||||
Weighted-average shares used diluted | 46,872 | 49,007 | ||||||
The condensed consolidated statement of profit and loss included herein for the three months ended
Forward Pharma A/S | ||||||||
Reconciliation of net (loss) income as reported to non-GAAP net (loss) income | ||||||||
(in thousands, except per share amounts) | ||||||||
Three Months Ended | ||||||||
March 31st | ||||||||
2016 | 2015 | |||||||
Net (loss) income as reported | $ | (16,851 | ) | $ | 6,026 | |||
Adjustments for non-cash items: | ||||||||
Share-based compensation | 3,571 | 2,169 | ||||||
Foreign exchange loss (gain) | 4,291 | (14,310 | ) | |||||
Non-GAAP net (loss) | $ | (8,989 | ) | $ | (6,115 | ) | ||
Non-GAAP net (loss) per share information: | ||||||||
Weighted-average shares used basic | 46,872 | 46,514 | ||||||
Weighted-average shares used diluted | 46,872 | 49,007 | ||||||
Non-GAAP basic per share (net) loss | $ | (0.19 | ) | $ | (0.13 | ) | ||
Non-GAAP diluted per share (net) loss | $ | (0.19 | ) | $ | (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 Statement of Financial Position | ||||||||
(in thousands) | ||||||||
March 31st | December 31st | |||||||
2016 | 2015 | |||||||
Assets | ||||||||
Cash, cash equivalents and available-for-sale financial assets | $ | 170,800 | $ | 176,652 | ||||
Other assets | 6,063 | 6,252 | ||||||
Total assets | $ | 176,863 | $ | 182,904 | ||||
Equity and Liabilities | ||||||||
Shareholders' equity | $ | 170,910 | $ | 176,693 | ||||
Liabilities | 5,953 | 6,211 | ||||||
Total equity and liabilities | $ | 176,863 | $ | 182,904 | ||||
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; and our evaluation of alternative Phase 3 clinical strategies in RRMS may not be successful or shorten our time to commercialization and/or reduce costs. These and other factors are identified and described in detail in certain of our filings with the