Investors

Forward Pharma Reports Third Quarter 2016 Financial and Operational Results
“We continue to advance our clinical programs and our intellectual property portfolio and look forward to the oral argument on our interference case to be held tomorrow at the USPTO,” said
Third Quarter ended
The net loss for the third 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 our Phase 3 trial in RRMS. In addition to the single beta interferon-controlled design, we are evaluating options for an alternative Phase 3 clinical strategy 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 mid-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 | |||||||
September 30th | |||||||
2016 | 2015 | ||||||
Research and development | $ | (7,658 | ) | $ | (10,785 | ) | |
General and administrative | (3,176 | ) | (4,644 | ) | |||
Total operating expenses | (10,834 | ) | (15,429 | ) | |||
Foreign exchange (loss) | (430 | ) | (446 | ) | |||
Other | 80 | 117 | |||||
Net (loss) before taxes | (11,184 | ) | (15,758 | ) | |||
Income tax benefit | 204 | 0 | |||||
Net (loss) | $ | (10,980 | ) | $ | (15,758 | ) | |
Net (loss) per share, basic and diluted | $ | (0.23 | ) | $ | (0.34 | ) | |
Weighted average shares used to compute net (loss) per share basic and diluted | 47,101 | 46,872 | |||||
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 | |||||||
September 30th | |||||||
2016 | 2015 | ||||||
Net (loss) as reported | $ | (10,980 | ) | $ | (15,758 | ) | |
Adjustments for non-cash items: | |||||||
Share-based compensation | 3,259 | 3,775 | |||||
Foreign exchange loss | 430 | 446 | |||||
Non-GAAP net (loss) | $ | (7,291 | ) | $ | (11,537 | ) | |
Non-GAAP net (loss) per share, basic and diluted | $ | (0.15 | ) | $ | (0.25 | ) | |
Weighted average shares used to compute non-GAAP net (loss) per share basic and diluted | 47,101 | 46,872 | |||||
This press release uses a non-GAAP financial measure of net loss 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) | |||||||
September 30th | December 31st | ||||||
2016 | 2015 | ||||||
Assets | |||||||
Cash, cash equivalents and marketable securities | $ | 150,174 | $ | 176,652 | |||
Other assets | 3,556 | 6,252 | |||||
Total assets | $ | 153,730 | $ | 182,904 | |||
Equity and Liabilities | |||||||
Shareholders' equity | $ | 148,614 | $ | 176,693 | |||
Liabilities | 5,116 | 6,211 | |||||
Total equity and liabilities | $ | 153,730 | $ | 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 patents 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