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Forward Pharma Reports Third Quarter 2015 Financial and Operational Results

COPENHAGEN, Denmark, Nov. 25, 2015 (GLOBE NEWSWIRE) -- Forward Pharma A/S (NASDAQ:FWP) ("We" or "Forward" or "Company"), today reported financial results for the third quarter ended September 30, 2015. Net loss for the third quarter ended September 30, 2015 was $15.8 million, or $0.34 per share versus $8.6 million, or $0.27 per share for the third quarter of 2014. On a non-GAAP basis, after removing the effect of non-cash income and expense items, our third quarter net loss for 2015 would have been $11.5 million, or $0.25 per share versus a net loss of $2.5 million or $0.08 per share for the third quarter of 2014. As of September 30, 2015, the Company had $190 million in cash, cash equivalents and marketable securities, with no debt outstanding.

"Our progress is accelerating both on the clinical development and intellectual property fronts," said Peder Andersen, Chief Executive Officer of Forward. "The interference proceeding in the U.S. is moving ahead as we prepare to move FP187 into Phase 3 in 2016."

Third Quarter ended September 30, 2015 Financial and Operational Results

The net loss for the third quarter of 2015 was $15.8 million compared to a net loss of $8.6 million for the third quarter of 2014.

Research and development expenses were $10.8 million for the quarter ended September 30, 2015 compared to $1.8 million for the same period in 2014. The increase in research and development expenses in the third quarter 2015 versus the comparable period in 2014 was due primarily to a $4.7 million increase in clinical and pre-clinical expenses with the expansion of development activities to include several preclinical studies, Phase 1 trials as well as preparation for our planned Phase 3 trial of FP187 in RRMS. Additionally, legal cost within R&D expense increased by $2.3 million as we continued to advance our intellectual property portfolio and conducted the interference case at the U.S. Patent and Trademark Office. We anticipate that R&D expense will increase in future quarters as our clinical programs and patent prosecution (including our interference proceeding) advance.

General and administrative expenses were $4.6 million for the third quarter of 2015 compared to $2.5 million for the same period in 2014. The increase in general and administrative expenses was due to a combination of increased stock based compensation expense, legal fees and costs associated with being a public company, offset by a decrease in costs related to our initial public offering which we completed in 2014. We anticipate that G&A expense will increase in future quarters as we expand our business.

Non-cash stock based compensation expense included in total operating expenses was $3.8 million for the third quarter of 2015 versus $2.0 million for the same period in 2014.

As of September 30, 2015, the Company had $190 million in cash, cash equivalents and marketable securities.

Recent IP progress and outlook

In the third quarter, we continued to make 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:

  • On August 19, 2015, the USPTO re-declared the interference between Forward and Biogen MA, 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 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. The USPTO also ruled in Forward's favor that Biogen is not entitled to benefit of its U.S. provisional application filing date of February 8, 2007. Biogen has since moved to revive its abandoned non-provisional application to make a claim of priority to that U.S. provisional application, which motion is not yet fully briefed. In August 2015, the parties filed priority statements and motions related to validity and benefit. Oppositions to motions are due June 1, 2016 and an oral argument is scheduled for January 9, 2017.
  • The Regional Court of Dusseldorf has scheduled oral proceedings for March 24, 2016 regarding a lawsuit we filed against Biogen in Germany that includes an allegation of infringement of our European '355 patent by Biogen's marketing of Tecfidera® in Germany with a label instructing a daily dose of 480 mg for the treatment of MS. We seek damages for Biogen's sales of Tecfidera® in Germany.

Clinical progress and outlook

Our development plan for our lead drug, FP187, includes preparation for a Phase 3 program in RRMS and running further Phase 1 regulatory trials. Our nonclinical development plan for our lead drug, FP187, is designed to support marketing authorization submission with a full regulatory toxicology study package. We have completed or are currently running a total of 35 pre-clinical studies and will continue the conduct of long-term toxicity studies, including two carcinogenicity studies, reproduction toxicity studies, and studies to explore the absorption, distribution, metabolism and excretion of orally administered FP187.

Forward Pharma A/S
Condensed Consolidated Statement of Operations
(in thousands, expect per share amounts)
Three Months Ended
September 30th
2015 2014
Research and development $ (10,785) $ (1,795)
General and administrative (4,644) (2,538)
Total operating expenses (15,429) (4,333)
Fair value adjustments -- (3,888)
Foreign exchange (loss) (446) (176)
Interest income (expense) 117 (208)
Net (loss) before taxes (15,758) (8,605)
Income tax benefit -- 55
Net (loss) used to compute per share amounts $ (15,758) $ (8,550)
Net (loss) per ordinary share
Basic and diluted $ (0.34) $ (0.27)
Weighted-average shares used basic and diluted 46,872 32,110
Forward Pharma A/S
Reconciliation of net (loss) as reported to non-GAAP net (loss)
(in thousands, except per share amounts)
Three Months Ended
September 30th
2015 2014
Net (loss) as reported $ (15,758) $ (8,550)
Adjustments for non-cash items:
Share based compensation 3,775 1,955
Foreign exchange loss (gain) 446 176
Fair value adjustment to convertible notes -- 3,905
Fair value adjustment shareholder warrants -- (17)
Non-GAAP net (loss) $ (11,537) $ (2,531)
Non-GAAP net (loss) per share information:
Weighted-average shares used 46,872 32,110
Non-GAAP basic and diluted per share (net) loss $ (0.25) $ (0.08)
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 convertible notes and 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)
September 30th December 31st
2015 2014
Assets
Cash, cash equivalents and available-for-sale financial assets $ 190,138 $ 223,484
Other assets 4,870 1,825
Total assets $ 195,008 $ 225,309
Equity and Liabilities
Shareholders' equity $ 187,775 $ 222,394
Liabilities 7,233 2,915
Total equity and liabilities $ 195,008 $ 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 Forward Pharma:

Forward Pharma A/S is a Danish biopharmaceutical company developing FP187, a proprietary formulation of DMF (dimethyl fumarate) for the treatment of inflammatory and neurological indications. Since our founding in 2005, we have worked to advance unique formulations of DMF, which is an immune modulator, as a therapeutic agent to improve the health and well-being of patients with immune disorders including multiple sclerosis. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose.

Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (symbol: FWP). For more information about the Company's products and developments, please visit our web site at http://www.forward-pharma.com.

Forward Pharma A/S Media Contact:
Sharon Klahre, Director, Investor Relations
Forward Pharma USA, LLC
7 Skyline Drive
Hawthorne, NY 10532
SK@forward-pharma.com
+1 914-752-3542

The Ruth Group
Lee Roth
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; 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 United States Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2014.

Source:Forward Pharma