Investors

Forward Pharma Reports Second Quarter 2016 Financial and Operational Results
“We have had a very productive year so far,” said
Second Quarter ended
The net loss for the second quarter of 2016 was
Research and development costs for the three month periods ended
General and administrative costs for the three month periods ended
Non-cash stock based compensation expense included in total operating expenses was
Intellectual Property Update
We continue to advance our intellectual property portfolio. As previously reported, on August 19, 2015, the USPTO re-declared the interference between
Clinical Update
Our development plan for our lead drug, FP187, is focused primarily 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 as we continue to upscale production of FP187 during 2016, in anticipation of beginning the Phase 3 trial in the first half of 2017.
We are currently performing additional Phase 1 studies on FP187.
Our nonclinical development plan for FP187 is designed to support regulatory submissions with a complete toxicology package.
Forward Pharma A/S | ||||||||
Condensed Consolidated Statement of Profit or Loss | ||||||||
(in thousands, except per share amounts) | ||||||||
Three Months Ended | ||||||||
June 30th | ||||||||
2016 | 2015 | |||||||
Research and development | $ | (13,460 | ) | $ | (9,999 | ) | ||
General and administrative | (3,195 | ) | (3,547 | ) | ||||
Total operating expenses | (16,655 | ) | (13,546 | ) | ||||
Foreign exchange gain (loss) | 1,422 | (4,259 | ) | |||||
Other | 84 | 114 | ||||||
Net (loss) | $ | (15,149 | ) | $ | (17,691 | ) | ||
Net (loss) per share, basic and diluted | $ | (0.32 | ) | $ | (0.38 | ) | ||
Weighted average shares used to compute net (loss) per share basic and diluted | 46,933 | 46,733 | ||||||
Forward Pharma A/S | |||||||||||
Reconciliation of net (loss) as reported to non-generally accepted accounting principles (“GAAP”) net (loss) | |||||||||||
(in thousands, except per share amounts) | |||||||||||
Three Months Ended | |||||||||||
June 30th | |||||||||||
2016 |
2015 |
||||||||||
Net (loss) as reported | $ | (15,149 | ) | $ | (17,691 | ) | |||||
Adjustments for non-cash items: | |||||||||||
Share-based compensation | 3,759 | 4,091 | |||||||||
Foreign exchange (gain) loss | (1,422 | ) | 4,259 | ||||||||
Non-GAAP net (loss) | $ | (12,812 | ) | $ | (9,341 | ) | |||||
Non-GAAP net (loss) per share, basic and diluted | $ | (0.27 | ) | $ | (0.20 | ) | |||||
Weighted average shares used to compute non-GAAP net (loss) per share basic and diluted | 46,933 | 46,733 | |||||||||
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 as issued by the
Forward Pharma A/S | ||||||||
Condensed Consolidated Statement of Financial Position |
||||||||
(in thousands) | ||||||||
June 30th | December 31st | |||||||
2016 |
2015 |
|||||||
Assets | ||||||||
Cash, cash equivalents and marketable securities | $ | 161,559 | $ | 176,652 | ||||
Other assets | 4,682 | 6,252 | ||||||
Total assets | $ | 166,241 | $ | 182,904 | ||||
Equity and Liabilities | ||||||||
Shareholders' equity | $ | 155,907 | $ | 176,693 | ||||
Liabilities | 10,334 | 6,211 | ||||||
Total equity and liabilities | $ | 166,241 | $ | 182,904 | ||||
Relevant Intellectual Property Sources:
USPTO Interference with Biogen: The related documents 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