Forward Pharma A/S (NASDAQ:FWP) (“we,” “Forward” or the “Company”
and, together with its subsidiaries, the “Group”), today reported
consolidated financial results for the year ended December 31,
2021. Our net loss for the year ended December 31, 2021 was $1.9
million, or $0.02 per share, versus a net loss of $6.4 million, or
$0.07 per share, for the year ended December 31, 2020. Our
research, development, general and administrative costs increased
from $3.4 million for the year ended December 31, 2020 to $3.9
million for the year ended December 31, 2021. Our net loss for the
year ended December 31, 2021 was favorably impacted by a non-cash
foreign exchange gain of $2.2 million that is primarily related to
our U.S. Dollar cash holdings and the strengthening of the U.S.
Dollar compared to the Danish Kroner.
Operating Results for the Years Ended December 31, 2021
and 2020
Our research and development costs for the years ended
December 31, 2021 and 2020 were $226,000 and $327,000,
respectively. The decrease in research and development costs for
the year ended December 31, 2021 is the result of lower costs
incurred in connection with the EP2801355 patent (“‘355 Patent”)
opposition in Europe (“Opposition Proceeding”) and lower
share-based compensation.
Our general and administrative costs for the years ended
December 31, 2021 and 2020 were $3.6 million and
$3.1 million, respectively. The increase in general and
administrative costs for the year ended December 31, 2021 is
the result of increased professional fees and insurance costs
offset by a reduction in share-based compensation.
During the year ended December 31, 2021, the Group recognized a
foreign exchange gain of $2.2 million, which resulted primarily
from the strengthening of the U.S. Dollar compared to the Danish
Kroner during the period. During the year ended December 31, 2020,
the Group recognized a foreign exchange loss of $3.0 million, which
resulted primarily from the weakening of the U.S. Dollar compared
to the Danish Kroner during the period.
Financial Position as of December 31, 2021
At December 31, 2021, the Group had cash and cash equivalents of
$70.8 million and working capital of $70.8 million. The Group has
no material long-term obligations. We believe we have sufficient
liquidity to allow us to meet our planned operating activities in
the normal course of business for the next several years.
Unforeseen events, including a negative outcome in the tax audit
being conducted in Germany, could negatively affect our ability to
fund planned operations in the future.
Update on Intellectual Property Proceedings
On January 29, 2018, the Opposition Division of the
European Patent Office (“EPO”) concluded the oral proceedings
concerning our ‘355 Patent. The Opposition Division revoked the
‘355 Patent after considering third-party oppositions from several
opponents. We subsequently appealed the Opposition Division’s
decision to the Technical Board of Appeal (“TBA”) of the EPO and
after several postponements resulting from the coronavirus
pandemic, the TBA heard our appeal on September 6, 2021. At the
conclusion of the hearing on September 6, 2021, the TBA dismissed
our appeal.
On January 27, 2022, we submitted a petition for review (the
“Petition”) to the Enlarged Board of Appeal (the “EBA”) of the EPO,
which requests that the EBA review the decision of the TBA in an
effort to overturn the TBA’s unfavorable ruling. We expect the EBA
to decide whether to accept our Petition within about 6 to 12
months from the submission date. If the EBA accepts the Petition,
the EBA will then need to rule on the matter. If the ruling of the
EBA is favorable, the TBA will have to decide again on our appeal.
The TBA may either confirm its previous decision or change its
decision, after which the TBA may remit the case to the Opposition
Division to resolve the remaining elements of the original
Opposition Proceeding. In the favorable scenario, the steps from
EBA acceptance of the Petition to completion of a new opposition
proceeding is expected to take up to four years and possibly
longer. The likelihood of the Petition being successful is low. The
denial of the Petition would end the Opposition Proceeding in favor
of the opponents. For all practical purposes, such denial of the
Petition would represent an unsuccessful outcome of the Opposition
Proceeding, resulting in no royalties being due to the Company from
Biogen based on Biogen’s net sales outside the United States, as
defined in the settlement and license agreement entered into with
subsidiaries of Biogen Inc. and certain other parties thereto.
Annual Report on Form 20-F
Investors are encouraged to read Forward’s Annual Report on Form
20-F that was filed today with the U.S. Securities and Exchange
Commission. Forward’s Annual Report includes important information
about the Group that is not disclosed herein including, but not
limited to, risk factors and our audited financial statements as of
December 31, 2021 and 2020 and for each of the years then
ended.
Forward Pharma A/S |
|
|
|
|
Condensed Consolidated
Statement of Profit or Loss |
|
|
|
|
(in thousands, except
per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
December 31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Research and development |
|
$(226) |
|
$(327) |
General and
administrative |
|
(3,648) |
|
(3,059) |
Operating loss |
|
(3,874) |
|
(3,386) |
|
|
|
|
|
Foreign exchange gain (loss),
net |
|
2,170 |
|
(2,970) |
Other finance expense,
net |
|
(188) |
|
(93) |
|
|
|
|
|
Net loss |
|
$(1,892) |
|
$(6,449) |
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$(0.02) |
|
$(0.07) |
|
|
|
|
|
Weighted average number of
shares used to compute net loss per share basic and diluted |
|
97,768 |
|
95,997 |
|
|
|
|
|
Forward
Pharma A/S |
Condensed
Consolidated Statement of Financial Position |
(in
thousands) |
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2021 |
|
2020 |
|
Assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$70,770 |
|
$79,087 |
|
Other assets |
|
635 |
|
627 |
|
Total assets |
|
$71,405 |
|
$79,714 |
|
|
|
|
|
|
|
Equity and Liabilities: |
|
|
|
|
|
Shareholders' equity |
|
$70,797 |
|
$78,644 |
|
Liabilities |
|
608 |
|
1,070 |
|
Total equity and
liabilities |
|
$71,405 |
|
$79,714 |
|
|
|
|
|
|
|
About Forward Pharma:Forward Pharma
A/S is a Danish biopharmaceutical company that commenced
development in 2005 of a proprietary formulation of DMF for the
treatment of inflammatory and neurological indications. The
Company granted to Biogen an irrevocable license to all of its IP
through the License Agreement and received from Biogen a
non-refundable cash fee of $1.25 billion in February
2017, with the return of EUR 917.7 million to shareholders through
a capital reduction in September 2017. The Company has the
opportunity to receive royalties from Biogen on Biogen’s net sales
of Tecfidera® or other DMF products for multiple sclerosis
outside the U.S., dependent on, among other things, a favorable
outcome in Europe with respect to the Opposition Proceeding,
including any appeal thereto.
The principal executive offices are located at Østergade 24A,
1st floor, 1100 Copenhagen K, Denmark and our American Depositary
Shares are publicly traded on the Nasdaq Capital Market (FWP). For
more information about the Company, please visit our website at
http://www.forward-pharma.com.
Forward Pharma A/S Investor Relations
Contact:Forward Pharma A/SClaus Bo Svendsen, MD, PhDChief
Executive Officer
Investor Relationsinvestors@forward-pharma.com
Solebury TroutMike Biegambiega@soleburytrout.com
Forward Pharma A/S
Forward Looking Statements:
Certain statements in this press release may constitute
“forward-looking statements” of Forward Pharma A/S 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,” “estimate,” “would,” “may,” “plan,” 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, risks related to the following: our ability to obtain,
maintain, enforce and defend issued patents with royalty-bearing
claims; our ability to prevail in or obtain a favorable decision in
the ‘355 patent European Opposition Proceeding, after all appeals,
including the outcome of the Petition; the expected timing for key
activities and an ultimate ruling in such legal proceedings; our
ability to defend our tax filing positions; the outcome of the
German tax audit, the solvency of our subsidiaries and the
sufficiency of the Company's cash resources. Certain of these and
other risk 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, 2021. We are providing this information
as of the date of this release and do not undertake any obligation
to update any forward-looking statements contained in this press
release as a result of new information, future events or
otherwise.
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