Use these links to rapidly review the document
TABLE OF CONTENTS
Index to Consolidated Financial Statements
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
o
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
For the fiscal year ended December 31, 2018
OR
o
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report
Commission file number 001-36686
Forward Pharma A/S
(Exact name of Registrant as specified in its charter)
Forward Pharma A/S
(Translation of Registrant's name into English)
Denmark
(Jurisdiction of incorporation or organization)
Østergade 24A, 1st floor
1100 Copenhagen K
Denmark
(Address of principal executive offices)
Claus Bo Svendsen
Chief Executive Officer
Østergade 24A, 1st floor
1100 Copenhagen K
Denmark
Tel: +45 3344 4242
E-mail: investors@forward-pharma.com
(Name, Telephone, E-mail and/or Facsimile Number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class
Ordinary shares, nominal value 0.01 DKK(1)
Name of each exchange on which registered
Nasdaq Global Select Market
(1)
Each ADS represents two ordinary shares
Securities registered or to be registered pursuant to Section 12(g) of the Act.
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.
Not Applicable
(Title of Class)
Not Applicable
(Title of Class)
Indicate the number of outstanding shares of each of the issuer's classes of capital or common stock as of the close of the period covered by the annual report.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. o Yes ☒ No
Ordinary shares: 95,073,864
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. o Yes ☒ No
Note—Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes o No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during
the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of "accelerated filer," "large
accelerated filer," and "emerging growth company" in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o
Accelerated filer o
Non-accelerated filer ☒
Emerging growth company ☒
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. o
†The term "new or revised financial accounting standard" refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP o International Financial Reporting Standards as issued by Other o
the International Accounting Standards Board ☒
If "Other" has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)
o Yes ☒ No
o Item 17 o Item 18
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of
securities under a plan confirmed by a court.
o Yes o No
Table of Contents
Forward Pharma A/S
TABLE OF CONTENTS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
ITEM 3. KEY INFORMATION
A. Selected Financial Information
B. Capitalization
C. Reason for the Offering
D. Risk Factors
ITEM 4. INFORMATION ON THE COMPANY
A. History and Development of the Company
B. Business Overview
C. Organizational Structure
D. Property, Plant and Equipment
ITEM 4A. UNRESOLVED STAFF COMMENTS
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
A. Operating Results Overview
B. Liquidity and Capital Resources
C. Research and Development and Patents
D. Trend Information
E. Off-balance Sheet Arrangements
F. Tabular Disclosure of Contractual Obligations
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
B. Compensation
C. Board Practices
D. Employees
E. Share ownership
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
B. Related Party Transactions
C. Interests of Experts and Counsel
ITEM 8. FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
B. Significant Changes
ITEM 9. THE OFFER AND LISTING
A. Offering and Listing Details
B. Plan of Distribution
C. Markets
D. Selling Shareholders
E. Dilution
F. Expenses of the Issue
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
B. Memorandum and Articles of Association
C. Material Contracts
D. Exchange Controls
E. Taxation
F. Dividends and Paying Agents
Page
1
2
2
2
2
2
3
3
3
24
24
25
35
35
35
35
36
51
53
53
53
54
55
55
60
64
64
64
65
65
67
68
68
68
68
68
68
68
69
69
69
69
69
69
69
70
71
71
79
Table of Contents
G. Statement by Experts
H. Documents on Display
I. Subsidiary Information
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT RISK
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
B. Warrants and Rights
C. Other Securities
D. American Depositary Shares
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
A. Defaults
B. Arrears and Delinquencies
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
ITEM 15. CONTROLS AND PROCEDURES
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
ITEM 16B. CODE OF ETHICS
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT
ITEM 16G. CORPORATE GOVERNANCE
ITEM 16H. MINE SAFETY DISCLOSURE
PART III
ITEM 17. FINANCIAL STATEMENTS
ITEM 18. FINANCIAL STATEMENTS
ITEM 19. EXHIBITS
Page
79
80
80
80
81
81
81
81
81
83
83
83
83
83
83
84
85
85
85
85
85
85
86
87
87
87
87
Unless otherwise indicated or the context otherwise requires, all references in this Annual Report on Form 20-F (the "Annual Report") to "Forward Pharma
A/S" or the "Parent" refer to Forward Pharma A/S and all references in this report to the "Group" refer to Forward Pharma A/S, together with its subsidiaries. All
references in this report to "Forward Pharma," the "Company," "we," "our," "ours," "us" or similar terms refer to Forward Pharma A/S or Forward Pharma A/S
together with its subsidiaries, as required by the context.
Table of Contents
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this Annual Report
can be identified by the use of forward-looking words such as "anticipate," "believe," "could," "expect," "may," "should," "plan," "intend," "estimate," "will,"
"would," and "potential," among others.
Forward-looking statements appear in a number of places in this Annual Report and include, but are not limited to, statements regarding our intent, belief or
current expectations. Forward-looking statements are based on our management's beliefs and assumptions and on information currently available to our
management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-
looking statements due to various factors. These risks and uncertainties include, but are not limited to, factors relating to:
•
•
•
•
•
•
•
•
whether and when we will receive any additional payments under our Settlement and License Agreement with two subsidiaries of Biogen Inc.;
the timing, outcome and impact of administrative, court and other proceedings, including any appeals, related to the patents and intellectual
property associated with the Company, including the European Patent Office opposition proceeding with Biogen Inc. relating to EP2801355;
our ability to successfully protect, defend and enforce the intellectual property associated with the Company;
our estimates regarding expenses, future revenues, capital requirements and the need for additional financing;
our ability to defend our tax filing position in any tax audits;
our ability to hire and retain qualified personnel;
our ability to continue as a going concern; and
other risk factors identified under "Risk Factors."
Forward-looking statements speak only as of the date they are made, and except as required by law, we do not undertake any obligation to update them in
light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to
reflect the occurrence of unanticipated events.
1
Table of Contents
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
PART I
Not applicable.
ITEM 3. KEY INFORMATION
A. Selected Financial Information
The selected financial information set forth below for the years ended December 31, 2018, 2017 and 2016, and as of December 31, 2018 and 2017, is derived
from our audited consolidated financial statements included elsewhere in this Annual Report. The selected financial information set forth below for the years
ended December 31, 2015 and 2014, and as of December 31, 2016, 2015 and 2014, is derived from our audited consolidated financial statements not included in
this Annual Report. We prepare our audited consolidated financial statements in accordance with International Financial Reporting Standards, or IFRS, as issued
by the International Accounting Standards Board, or IASB. This financial information should be read in conjunction with our "Management's Discussion and
Analysis of Financial Condition and Results of Operations" and our audited consolidated financial statements, including the notes thereto, included in this Annual
Report.
Consolidated Statement of Profit or Loss Data
(USD in thousands, except per share data)
Revenue from the License Agreement
Cost of the Aditech Pharma AG patent agreement
Research and development costs
General and administrative costs
Operating (loss) income
Fair value adjustment to net settlement obligations to shareholder
2018
—
—
(2,748)
(9,535)
2017
1,250,000
Year ended December 31,
2016
2015
2014
—
—
—
—
(25,000)
(20,496) (41,052) (33,727) (10,547)
(9,154)
(17,107) (14,382) (15,852)
(55,434) (49,579) (19,701)
—
—
(12,283) 1,187,397
warrants
—
—
—
—
(968)
Fair value adjustment to convertible loans
Exchange rate gain (loss), net
Interest income from available-for-sale financial assets
Interest expense
Other finance income (expense)
(Loss) income before tax
Income tax benefit (expense)
—
2,713
—
—
644
—
(241)
227
—
(2,895)
—
598
389
—
(92)
—
11,933
438
—
(132)
(3,823)
5,589
63
(416)
(10)
(54,539) (37,340) (19,266)
250
336
(8,926) 1,184,488
204
(267,395) 21,203
Net (loss) income for the year
Net (loss) income per share(1)(2)
Basic
Dilutive
(8,722)
917,093
(33,336) (37,004) (19,016)
(0.09)
(0.09)
2.41
2.30
(0.06)
(0.06)
(0.07)
(0.07)
(0.05)
(0.05)
Weighted-average shares outstanding used to calculate net (loss)
income per share
Basic
Dilutive
94,671
94,671
380,133
398,943
540,650
540,650
537,614
537,614
396,635
396,635
(1)
During August 2017, the Company's shareholders approved a 10 for 1 share split, or Share Split. All share and per share information
disclosed above, as well as throughout this Annual Report, has been
2
Table of Contents
adjusted to reflect the Share Split as if it had occurred at the beginning of the earliest period presented. Following the Share Split, the
nominal value of an ordinary share of the Company is 0.01 DKK. In addition, as discussed in more detail elsewhere in this Annual
Report, there was a capital reduction that was effected by the annulment of 80% of the ordinary shares outstanding and was deemed, for
IFRS purposes, to have been at a 15% premium, or 15% Premium. For purposes of computing the per share amounts only, the 15%
Premium has been accounted for in a manner similar to the Share Split and reflected in the above per share amounts as if it had occurred
at the beginning of the earliest period presented. The combined effect of the Share Split and the 15% Premium is as if a 11.5 for 1 share
split had occurred at the beginning of the earliest period presented. See Notes 3.5 and 5.1 of the audited consolidated financial statements
of the Company for additional information.
(2)
During 2014, certain shareholders of the Company received a preferential distribution in the form of additional shares of Company stock
in consideration for amendments to certain contractual rights held by such shareholders. The additional shares of Company stock had a
fair value of $42.7 million. For purposes of computing the loss per share for 2014, the preferential distribution increased the net loss used
to compute the per share amount by $42.7 million. The preferential distribution had no effect on cash or cash flows of the Company.
Consolidated Statement of Financial Position Data
(USD in thousands)
Cash, cash equivalents and available-for-sale financial assets
Working capital(3)
Total assets
Accumulated deficit
Total shareholders' equity
As of December 31,
2018
82,542
82,212
83,332
(5,686)
82,214
2017
109,554
89,706
111,008
2016
138,723
132,465
163,143
2014
223,484
90,480
225,309
(2,373) (147,400) (131,175) (107,712)
222,394
89,680
2015
176,652
93,590
182,904
155,802
176,693
(3)
Working capital is defined as total current assets less total current liabilities.
Exchange Rate Information
Our business is primarily conducted in Denmark. The functional currency of Forward Pharma A/S is the Danish Kroner, or DKK, the functional currency of
Forward Pharma FA ApS is the DKK, the functional currency of Forward Pharma Operations ApS is the DKK, the functional currency of Forward
Pharma GmbH is the Euro and the functional currency of Forward Pharma USA, LLC is the United States, or U.S., Dollar. Forward Pharma A/S reports its
consolidated financial statements in U.S. Dollars.
B. Capitalization
Not applicable.
C. Reason for the Offering
Not applicable.
D. Risk Factors
Our business faces significant risks and uncertainties. You should carefully consider all of the information set forth in this Annual Report on Form 20-F and
other documents we file with or furnish to the SEC, including the following risk factors, before deciding to invest or making any decision with respect to your
investment in any of our securities. Our business, financial condition or results of operations could be materially and adversely affected if any of these risks
occurs. This Annual Report also contains
3
Table of Contents
forward-looking statements that involve risks and uncertainties. See "Cautionary Note Regarding Forward-Looking Statements." Our actual results could differ
materially and adversely from those anticipated in these forward-looking statements as a result of certain factors.
Risks Related to Our Business and Industry
There can be no assurance that we will prevail in the opposition proceeding involving our EP2801355 patent after any appeals or, if we do prevail, that the
resulting claims of our EP2801355 patent will be royalty bearing under the Settlement and License Agreement with Biogen.
We are involved in an opposition proceeding regarding EP2801355, or EP'355 patent, with several opponents including a subsidiary of Biogen Inc. (all
subsidiaries of Biogen Inc., together with Biogen Inc., hereafter collectively referred to as "Biogen"), or the Opposition Proceeding. On January 29, 2018, the
European Patent Office, or EPO, revoked the EP'355 patent following the oral hearing in the Opposition Proceeding. On March 22, 2018, the Opposition Division
issued its written decision with detailed reasons for the decision. On May 7, 2018, the Company submitted its notice of appeal, and on August 1, 2018, the
Company submitted the detailed grounds for the appeal. The duration of the appeal process is estimated to be approximately three years; however, delays can
occur that would extend the estimated duration of the appeal process. There can be no assurance that we will be successful in the Opposition Proceeding after any
appeals. If the Company is unsuccessful in the Opposition Proceeding, the Company would not be entitled to future royalties on Biogen's net sales outside the
U.S. If the Company prevails in such appeal, we expect the Technical Board of Appeal to remand the case to the Opposition Division, in order for the Opposition
Division to resolve the remaining elements of the original opposition.
Even if we prevail, after any appeals, in the Opposition Proceeding, there can be no assurance that we will receive additional payments under the License
Agreement with Biogen.
Even if we prevail, after any appeals, in the Opposition Proceeding, there can be no assurance that any of the conditions for payment of a royalty under our
Settlement and License Agreement, dated as of January 17, 2017, or the License Agreement, with two subsidiaries of Biogen that became effective on February 1,
2017, will be satisfied or that we will receive any additional payments. For example, we could prevail in the Opposition Proceeding, after any appeals, but fail as
a result of that proceeding to obtain issuance of a patent with a claim that covers treatment for multiple sclerosis, or MS, by orally administering 480 mg per day
of dimethyl fumarate, or DMF, in which case we would not be entitled to any royalties from Biogen with respect to sales outside of the U.S. Moreover, even if we
prevail, after any appeals, in the Opposition Proceeding, we will only be eligible to receive royalties outside of the U.S. if one or more of our patent(s) remains
valid and would (but for the License Agreement) be infringed, at relevant times and on a country-by-country basis, by Biogen's sales outside the U.S. of DMF-
containing products indicated for treating MS and other conditions of the License Agreement are satisfied.
In addition, we may be required in any arbitration or suit brought in the County of New York in the State of New York according to the dispute resolution
provisions of the License Agreement, to incur significant expense to prove, on a country-by-country basis, that any DMF-containing products indicated for
treating MS sold by Biogen would (but for the License Agreement) infringe our patent(s) existing at that time. Additionally, among the conditions that need to be
satisfied for any royalty to be payable by Biogen to the Company in a particular country is the absence of generic entry in that country having a particular impact
as defined in the License Agreement. Even if our royalty-eligible patents were to remain valid, there can be no assurance that we would obtain royalties beyond
20 years from their effective filing date. In particular, there can be no assurance that we will receive or maintain Supplementary Protection Certificates, or SPCs,
for any of our European patents.
4
Table of Contents
We are likely to derive all or a significant portion of our future revenues, if any, from Biogen and our future success depends on continued market acceptance
of Tecfidera® as well as continued performance by Biogen of its obligations under the License Agreement.
We anticipate that all or a significant portion of our future revenues, if any, may consist of royalties from Biogen from sales of Tecfidera® outside of the U.S.
We have no control over the sales efforts of Biogen, and its future marketing of Tecfidera® might not be successful. Reductions in the sales volume or average
selling price of Tecfidera® for any reason could have a material adverse effect on our business. We also depend on Biogen to perform all of its non-royalty
payment obligations under the License Agreement.
Failure to materially comply with the terms and conditions of the License Agreement could result in a loss of future royalty revenues.
Under the terms of the License Agreement, we are required to perform certain obligations, including maintaining sufficient capital to continue the
Company's operations as a going concern and solvent entity. Failure by the Company to materially comply with its obligations under the License Agreement
could cause the Company to lose its potential right to royalties from Biogen under the License Agreement.
Our future growth and ability to compete depend on retaining our key personnel and recruiting additional qualified personnel.
Our success depends upon the continued contributions of our management. These individuals currently include the members of our board of directors,
consisting of our Chairman, Florian Schönharting, as well as Torsten Goesch, Grant Hellier Lawrence, Jakob Mosegaard Larsen, and Duncan Moore.
Additionally, our Chief Executive Officer, Claus Bo Svendsen, and our Vice President, Finance and Controller, Forward Pharma USA, LLC, Thomas Carbone.
The loss of directors or key executives could have a material adverse effect on our business. In addition, the competition for qualified personnel in the
biopharmaceutical field is intense, and our future success may depend upon our ability to attract, retain and motivate managerial employees and consultants. We
face competition for personnel from other companies, universities, public and private research institutions and other organizations. If our recruitment and
retention efforts are unsuccessful, it may be difficult for us to implement our business strategy, which could have a material adverse effect on our business.
Changes in privacy laws could have an adverse effect on our business.
The regulatory framework for privacy and cybersecurity issues worldwide is rapidly evolving and is likely to remain uncertain for the foreseeable future. In
May 2016, the European Union adopted the General Data Protection Regulation, or GDPR, which imposes more stringent data protection requirements and will
provide for greater penalties for noncompliance. We may be required to incur significant costs to comply with privacy and data security laws, rules and
regulations, including the GDPR. Any inability to adequately address privacy and security concerns or comply with applicable privacy and data security laws,
rules and regulations could have an adverse effect on our business prospects, results of operations and/or financial position.
Our business and operations may be materially adversely affected in the event of computer system failures or security breaches.
Despite the implementation of security measures, our internal computer systems, and those of any third-party vendor on which we rely from time to time, are
vulnerable to damage from computer viruses, unauthorized access, cyber-attacks, natural disasters, fire, terrorism, war and telecommunication
5
Table of Contents
and electrical failures. If such an event were to occur and interrupt our operations, it could result in a material disruption to our operations. To the extent that any
disruption or security breach results in a loss of or damage to our data or applications, loss of trade secrets or inappropriate disclosure of confidential or
proprietary information, including protected health information or personal data of employees or former employees, we could incur liability. We may also be
vulnerable to cyber-attacks by hackers or other malfeasance. This type of breach of our cybersecurity may compromise our confidential information or our
financial information and adversely affect our business or result in legal proceedings.
Risks Related to Intellectual Property
We no longer have full control over the licensed intellectual property associated with the Company.
Pursuant to the License Agreement, in 2017 we effected a corporate restructuring whereby we transferred our intellectual property to FWP IP ApS, a Danish
limited liability company. The capital stock of FWP IP ApS was subsequently transferred to and is now held by FWP HoldCo ApS, a Danish limited liability
company, which is owned and controlled by FWP Fonden, a newly formed independent Danish foundation. The boards of directors of FWP Fonden, FWP
HoldCo ApS and FWP IP ApS are identical and each consist of three members, comprised of one independent member and one member appointed by each of
Forward Pharma and Biogen. All actions of FWP Fonden, FWP HoldCo ApS and FWP IP ApS require the unanimous approval of their respective boards of
directors. As a result, we no longer have full control over the licensed intellectual property associated with the Company. Even though we have agreed with
Biogen and FWP IP ApS that FWP IP ApS will be required to take actions with respect to the transferred intellectual property, which now consists only of the
non-U.S. intellectual property associated with the Company, in accordance with the provisions of the License Agreement, there can be no assurance that it will do
so or that the prosecution of the intellectual property will be pursued in a manner that maximizes the value of the intellectual property over time. Further, in the
event that FWP IP ApS, which holds the transferred intellectual property, would materially breach its obligations under the License Agreement, Biogen would
have a right to purchase all of the issued and outstanding shares of FWP IP ApS at a price corresponding to its intrinsic value at the time of exercise. Finally, in
the event FWP Fonden were to file for bankruptcy, a bankruptcy trustee would have substantial discretion to transfer or sell the assets of the foundation. In either
such event, we could lose any right to control the transferred intellectual property, which could have a materially adverse effect on our business.
There can be no assurance that even if we are successful in the opposition and appeal proceedings involving the patents associated with the Company
currently pending before the EPO, we will not be subject to subsequent or parallel invalidity proceedings involving these same or other patents associated
with the Company before a national court in any of the European Patent Convention member states where the patents were validated, which subsequent or
parallel proceedings could result in the challenged patents being subject to continued uncertainty as to their validity until such proceedings have been fully
concluded. We cannot at this time anticipate how long any such proceedings may last or when, if at all, the patents currently under challenge will finally be
declared to be valid or not.
The possibility of parallel validity proceedings in national courts and in the EPO is inherent in the legal arrangements under the European Patent Convention
under which the EPO was established. If a third party files an opposition to a European patent with the EPO and also, in parallel, initiates a revocation action (also
called a "nullity action" or "validity proceeding") against the same patent before a national court, certain national courts may exercise their discretion to either
(i) stay the national proceedings, in order to await the outcome of the EPO opposition proceedings, or (ii) allow the revocation proceedings to go ahead, without
awaiting the outcome of the EPO proceedings. The rules and practices differ from country to country within the member states of the European Patent
6
Table of Contents
Convention. For example, certain countries will stay the main proceeding until a final decision has been reached by the EPO whereas in other countries a stay is
not automatic, and in such cases the courts may continue the proceedings notwithstanding the opposition. In Germany, for example, national nullity proceedings
cannot be started before the German Federal Patent Court until the EPO opposition proceedings have been concluded or the opposition period has expired. As a
result, it is possible that certain of the patents now subject to opposition proceedings before the EPO will, even if we are ultimately successful before the EPO,
again become subject to a revocation action in a country like Germany, which means the challenged patents could be subject to continued uncertainty in the EU as
to their validity until such proceedings have been fully concluded. We cannot at this time anticipate how long any such proceedings may last or when, if at all, the
patents currently under challenge will finally be declared to be valid or not. Furthermore, even if we are successful in the Opposition Proceeding, we will only be
eligible to receive royalties outside of the U.S. if the patent(s) remain valid at relevant times on a country-by-country basis, provided that other conditions of the
License Agreement are satisfied.
We rely on Biogen for the filing, prosecution and maintenance of certain of the non-U.S. licensed intellectual property and if Biogen fails to adequately
protect such intellectual property, our rights to the intellectual property associated with the Company and our ability to receive future royalties from Biogen
may be harmed.
Under the License Agreement, Biogen has assumed the filing, prosecution and maintenance of all of the non-U.S. licensed intellectual property associated
with the Company, except for the EP'355 patent. While Biogen is obligated to take all reasonable measures to diligently file, prosecute and maintain the non-U.S.
licensed intellectual property for which it is responsible, there can be no assurances that Biogen will protect the intellectual property to the same degree as the
Company. If Biogen fails to adequately protect the non-U.S. licensed intellectual property, the Company could lose such intellectual property rights. Additionally,
if the non-U.S. licensed intellectual property is harmed, any future royalty payments from Biogen on the non-U.S. licensed intellectual property may be
negatively impacted.
We may be required to pay significant fees to the EPO and our attorneys to file, prosecute, maintain and defend certain of the licensed intellectual property
with no assurance of receiving future royalties from Biogen.
In certain circumstances under the License Agreement, the Company may assume the filing, prosecution and maintenance of certain of the Company's non-
U.S. licensed intellectual property in order to protect its interests in such intellectual property, including participating in European opposition proceedings, unless
and until Biogen either re-assumes the filing, prosecution and maintenance of such non-U.S. licensed intellectual property or exercises its option to purchase all of
the Company's non-U.S. licensed intellectual property. To do so, the Company would have to incur significant fees, including attorneys' fees, to file, prosecute
and maintain such non-U.S. licensed intellectual property and may not be entitled to receive any royalties from Biogen.
We may become involved in lawsuits to protect, defend and enforce the patents or other intellectual property associated with the Company, which could be
expensive, time-consuming and, if unsuccessful, could result in issued patents covering our product candidate being found invalid or unenforceable.
Competitors may infringe the patents or other intellectual property associated with the Company. To counter such infringement, we may file claims or be
required to join or assist claims filed by Biogen, and any related litigation and/or prosecution of such claims may be expensive and time-consuming. Any claims
asserted against perceived infringers could provoke these parties to assert claims alleging that we infringe their intellectual property. In addition, in a patent
infringement proceeding, or a parallel opposition, nullity or cancellation proceeding, it may be decided that a patent associated with the Company is invalid in
whole or in part, unenforceable, or construes the patent's claims narrowly
7
Table of Contents
allowing the other party to commercialize competing products on the grounds that the patents associated with the Company do not cover such products.
Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and
could distract our personnel from their normal responsibilities. Such litigation or proceedings could substantially increase our operating expenses. We may not
have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some competitors may be able to sustain the costs of such
litigation or proceedings more effectively than we can because of their substantially greater financial resources. The effects of patent litigation or other
proceedings could, therefore, have a material adverse effect on our ability to compete in the marketplace.
Third parties may claim rights including ownership rights in the intellectual property associated with the Company.
None of the named inventors on the patent and patent applications associated with the Company were our employees at the time of the filing of the Core
Composition Patent family that we acquired from Aditech Pharma AB (together with its successor-in-interest, Swiss company Aditech Pharma AG, or Aditech).
Two of the named inventors of the priority applications in the Core Composition Patent family were consultants of Aditech and, while obligated under their
consulting agreements to assign their rights in the Core Composition Patent family to Aditech, were employed by other institutions at the time they were named
as inventors. While such institutions have not made any claims to ownership, there can be no assurance they will not do so in the future.
Later-filed patent families were filed by us, but some of the named inventors were acting only in a consultant capacity to us. Some of these consultants,
while obligated under their consulting agreements to assign their rights in such patent families to us, were employed by other institutions prior to or at the time
they made their inventions. While such institutions have not made any ownership claims to the inventions disclosed in the later-filed patent families, there can be
no assurance they will not do so in the future.
Named inventors on our patent applications, whether filed by us or acquired from Aditech, could also challenge whether their property rights were properly
assigned. Further, other individuals (including persons not known to us or their employers) could make claims or assertions that they are inventors and/or owners
of the intellectual property associated with the Company.
Under mandatory Danish law, a salaried employee having made a patentable invention (and products that may be registered as utility models) through his
service with an employer has the rights to such invention, provided, however, that the rights to the patentable invention upon the employer's request must be
transferred to the employer, to the extent not otherwise agreed, provided that the use of such patentable invention falls within the "working area" of the employer
or it is a result of a specific assignment given by the employer to the employee. Following notification from the employee of the invention, the employer has four
months to decide whether to apply for a patent, in whole or in part, for the invention in the employer's name. Such a transfer of the invention to the employer
entitles the employee to a "reasonable compensation." The fee will be fixed considering the value of the invention and its consequences for the employer, the
employee's terms of employment and the impact that the employee's service has had for the invention. In the event that the value of the invention does not exceed
what the employee, taking his working conditions as a whole into account, reasonably could be expected to achieve, the employee is not entitled to any fee. The
compensation payable by the employer is not subject to any maximum amount and may be paid either as a lump sum or as a continuing royalty payment based
on, for example, the number of items produced based on the invention. An employee's claim for compensation may become time-barred or forfeited due to the
employee's passive behavior. The general relative time-barring deadline under Danish law is five years
8
Table of Contents
with respect to claims based on employment matters, whereas the general absolute deadline for such claims is 10 years.
Some of the named inventors on the newer applications associated with the Company (not the Core Composition Patent or Erosion Matrix Patent) are or
were employees of our German subsidiary, Forward Pharma GmbH, and thus are subject to German employment law. German employment law governs the
transfer/assignment of any intellectual property rights generated by such employees. In particular, any inventions eligible for patent protection made by such
employees are subject to the provisions of the German Act on Employees' Inventions (Gesetz über Arbeitnehmererfindungen), which regulates the ownership of,
and compensation for, inventions made by employees. The law provides for a formal procedure for the transfer of an employee's rights to patentable inventions
which result from performance of the tasks the employee is charged with at the employer or which are based to a significant extent on the experiences or works of
the employer, upon the employer's request within a certain period of time after notification by the employee.
We believe that all inventive contributions made by employees of Forward Pharma GmbH were made after the amended version of the German Act on
Employees' Inventions came into force on October 1, 2009, and thus the amended version of the law exclusively applies to such inventions. Prior to October 1,
2009, such formal procedure had been susceptible to faults. The amendments to the law facilitate the transfer of rights in employees' inventions to the employer
by replacing the former opt-in approach with an opt-out approach.
Following the transfer of rights, an employee is entitled to a claim for "reasonable compensation" to be calculated on an individual basis (e.g., revenue
achieved through protection of the patent). In addition, the German Act on Employees' Invention provides for certain obligations on the employer including the
obligation to apply for patent protection in Germany, the obligation to release the invention for application in those countries where the employer does not want to
apply for a patent and the obligation to offer to the employee granted patents or pending patent applications if the employer intends to abandon rights in any
country.
We face the risk that disputes can occur between us and employees or ex-employees of Forward Pharma GmbH pertaining to alleged non-adherence to the
provisions of this act. Such disputes may be costly to defend and take up our management's time and efforts whether we prevail or fail in such dispute. If we are
required to pay additional compensation or face other disputes under the German Act on Employees' Inventions, in particular in case of a failed transfer of rights,
our results of operations could be adversely affected.
Intellectual property rights have limitations and may not adequately protect our business.
The degree of future protection afforded by the intellectual property rights associated with the Company is uncertain because intellectual property rights have
limitations, and may not adequately protect our business. The following examples are illustrative:
•
•
•
•
Others may be able to commercialize DMF-containing products that are not covered by the claims of the patents or patent applications associated
with the Company.
Others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing the
patents or patent applications that we own, license or will own or license.
We might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own,
license or will own or license.
We might not have been the first to file patent applications on the inventions disclosed in those applications.
9
Table of Contents
•
•
•
•
•
It is possible that the pending patent applications associated with the Company will not lead to issued patents.
Issued patents that we own, license or will own or license may not provide us with any competitive advantage, or may be held invalid or
unenforceable, as a result of legal challenges by our competitors.
Our competitors might conduct research and development activities in countries where we do not have patent rights, or in countries where research
and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in our
major commercial markets.
Ownership of the patents or patent applications associated with the Company may be challenged by third parties.
The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business.
Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products or
product candidates.
The complexity and uncertainty of European patent laws have increased in recent years. In Europe, a new unitary patent system may soon be introduced,
which would significantly impact European patents, including those granted before the introduction of such a system. In addition, the European patent system is
relatively stringent in the type of amendments that are allowed during prosecution and opposition proceedings. Changes in patent law or patent jurisprudence
could limit our ability or the ability of FWP IP ApS to obtain new patents in the future that may be important for our business.
We may not be able to adequately prevent disclosure of trade secrets and protect other proprietary information.
We consider proprietary trade secrets and/or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets
and/or confidential know-how to protect proprietary technology, especially where patent protection is believed by us to be of limited value. However, trade
secrets and/or confidential know-how can be difficult to maintain as confidential.
To protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, consultants, contractors and
advisors to enter into confidentiality agreements with us. However, current or former employees, consultants, contractors and advisors may unintentionally or
willfully disclose our confidential information to competitors, and confidentiality agreements may not provide an adequate remedy in the event of unauthorized
disclosure of confidential information. Enforcing a claim that a third party obtained illegally and is using trade secrets and/or confidential know-how is expensive,
time-consuming and unpredictable. The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction.
Failure to obtain or maintain trade secrets and/or confidential know-how could adversely affect our competitive position. Moreover, our competitors may
independently develop substantially equivalent proprietary information and may even apply for patent protection in respect of the same. If successful in obtaining
such patent protection, our competitors could limit our use of trade secrets and/or confidential know-how.
10
Table of Contents
Risks Related to Our Financial Position and Capital Needs
With the exception of 2017, we have a history of operating losses and we may not achieve or sustain profitability.
Since the Company's inception, with the exception of 2017 when we received a nonrecurring cash fee of $1.25 billion, or Non-refundable Fee, from Biogen
in connection with the License Agreement, we have incurred net losses and negative cash flows from operations. We expect to incur net losses and negative cash
flows from operations through at least 2020 and possibly longer. There is no assurance that we will ever have operating revenues, net income or positive cash
flows from operations in the future. The Group's ability to generate future operating revenue is currently limited to royalties that are contingently due the
Company under the License Agreement only if we prevail, including all appeals, in the Opposition Proceeding. If we fail to prevail in the Opposition Proceeding,
it is highly unlikely we will have operating revenues and our ability to continue as a going concern long-term would be uncertain.
Historically, we have financed our operations through our initial public offering completed in October 2014, private placements of equity securities, a
government grant, and debt financing arrangements. We have never generated and do not anticipate generating any revenues from our own product sales. We
believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the next twelve
months. Should the Company experience unforeseen expenses or other usages of cash, the effect would negatively impact management's ability to fund
operations and continue as a going concern. If the Company were to need to raise capital to fund ongoing operations, there can be no assurances that such funding
would be available on acceptable terms, if at all. The long-term success of the Company will be based on successfully defending the intellectual property
associated with the Company in the Opposition Proceeding. There can be no assurance that the Company will successfully defend the intellectual property,
achieve or sustain positive cash flows from operations or become profitable.
Even if we do generate revenue, including from future royalties on sales, we may never achieve or sustain profitability on a consistent basis or at all. Our
failure to sustain profitability could depress the market price of our ordinary shares and American Depositary Shares, or ADSs, and could impair our ability to
raise capital or continue our operations. A decline in the market price of our ordinary shares and ADSs also could cause you to lose all or a part of your
investment.
Negative results from tax audits could result in additional taxes, interest and penalties becoming due that could negatively impact our financial position and
results of operations
The Company's Danish, German and United States tax returns are subject to periodic audit by the local tax authorities. Such audits could result in the tax
authorities disagreeing with the tax filing positions taken by the Group. Currently, the Danish and German tax authorities are conducting a joint tax audit of out
Danish and German tax returns and we expect their audit will focus on, amongst other things, intercompany transactions where the tax authorities could challenge
whether pricing of such transactions were at arm's length. In addition, the Company made certain cash payments to equity award holders during the year ended
December 31, 2017 that totalled 36.2 million EUR ($43.4 million based on the December 31, 2017 exchange rate). Management believes these payments are tax
deductible expenses; however, the tax authorities could disagree. Management believes that appropriate tax filing provisions have been taken by the Company
and its subsidiaries; however, if the Group is unable to defend the tax filing positions taken, additional taxes, interest and penalty would be assessed against the
Group and such amounts could have a material adverse effect on our financial position and results of operations.
11
Table of Contents
We may be required to raise additional capital to fund our operations, and we may not be able to do so on terms acceptable to us, or at all.
We are required under the terms of the License Agreement to maintain sufficient capital to continue the Company as a going concern and a solvent entity,
plus an additional $5.0 million until such time as the Company has complied with certain obligations under the License Agreement. While we currently believe
we have sufficient resources to enable us to comply with our obligations under the License Agreement and continue as a going concern beyond the next twelve
months, unforeseen events could negatively affect our estimates and assumptions about how much capital will be required for us to meet our near and long-term
obligations under the Licensing Agreement and to continue as a going concern. If our current estimates and assumptions prove to be wrong and we need to raise
additional capital to meet our obligations under the License Agreement and remain a going concern, we cannot assure you that we will be able to raise additional
working capital as needed on terms acceptable to us, if at all. If we are unable to raise capital as needed, we may be required to reduce the scope of our operations,
which could harm our financial condition and operating results, or cease our operations entirely. In addition, if we fail to prevail in the Opposition Proceeding,
including all appeals, future revenues are unlikely and the Company's ability to continue as a going concern long-term would be uncertain.
In the event we need to seek additional funds, we may raise additional capital through the sale of equity or convertible debt securities. In such an event, the
ownership interests of our existing equity holders will be diluted, and the terms of any new securities may include liquidation or other preferences that adversely
affect the rights of our existing equity holders. In addition, the issuance of additional equity securities by us, or the possibility of such issuance, may cause the
market price of our ADSs to decline. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific
actions such as, but not limited to, incurring additional debt, making capital expenditures, declaring and paying dividends or making capital reductions.
Exchange rate fluctuations or abandonment of the Euro currency may materially affect our results of operations and financial condition.
Due to the international scope of our operations and the fact that a substantial amount of our cash is currently denominated in U.S. Dollars and Euros,
fluctuations in exchange rates, particularly between the Danish Kroner, the Euro, British Pound and the U.S. Dollar, may adversely affect us. Although we are
based in Denmark, we have sourced many services from several countries outside Denmark where the transactions are settled in currencies that are not the Danish
Kroner. Further, potential future revenue may be derived from abroad. As a result, our business is affected by fluctuations in foreign exchange rates between the
Danish Kroner, the Euro, British Pound, the U.S. Dollar or other currencies, and the effects could have a significant impact on our reported results of operations
and cash flows from period to period. For example, in the years ended December 31, 2018, 2017 and 2016, we recognized foreign exchange gains (losses) of
$2.7 million, ($241,000) and $598,000 respectively. While the we benefited from changes in foreign exchange rates in 2018 and 2016, it is possible that the
foreign exchange losses we experienced in 2017 could reoccur. Any reoccurrences of foreign exchange losses would negatively affect the Group and the effect
could be material. Currently, we do not have any exchange rate hedging arrangements in place and do not currently have plans to implement any hedging
arrangements. Losses incurred by the Company, including those caused by foreign exchange, could have a negative effect on the trading price of the ADSs.
Developments relating to Biogen, Tecfidera®, our competitors or their products could materially and adversely affect our business, results of operations,
business prospects and the market price of our ADSs.
In the event that our competitors or others in the pharmaceutical industry, including Biogen, experience developments relating to their business, products or
product candidates, our business, results
12
Table of Contents
of operations, business prospects and the market price of our ADSs could suffer. In particular, if we are eligible to receive royalties on sales of Tecfidera®, our
future success will depend on the continued market acceptance of Tecfidera® and adverse events, or the perception of adverse events, relating to Biogen or
Tecfidera® would have material adverse effects on us. For example, on July 24, 2015, Biogen announced that it was revising its previous annual financial
guidance for 2015 with respect to its expected revenue growth in 2015 compared to 2014 from a range of 14%-16% to a range of 6%-8%, based largely on
revised expectations for the growth of Tecfidera®, including moderated patient growth in the U.S. market, lower-than-anticipated reimbursement rates in Europe
and lower pricing in Germany. The day of Biogen's announcement, the price of our ADSs dropped by approximately 18%. As a result of entering into the License
Agreement, we expect that the market price of our ADSs will become more significantly affected by announcements made by Biogen, over which we have no
control. Additionally, cases of progressive multifocal leukoencephalopathy have been reported in patients being treated with Tecfidera®, which could raise safety
concerns and harm the market profile of DMF-containing treatments for MS, including Tecfidera®. Similarly, developments relating to other competitors of
Biogen and their products could have significant adverse effects on our business prospects and the market price of our ADSs. For example, competitors may offer
their products at reduced prices or with discounts or rebates that increase pricing pressure with respect to therapies for the treatment of MS.
Related party transactions may be challenged by tax authorities.
The jurisdictions in which we conduct or will conduct business, and in particular Denmark, Germany and the U.S., have detailed transfer pricing rules which
require that all transactions with related parties be priced using arm's-length pricing principles. The taxation authorities in these jurisdictions could challenge our
arm's-length related-party transfer pricing practices. For example, prior to the consummation of the License Agreement with Biogen, Forward Pharma GmbH and
Forward Pharma A/S terminated their internal license agreement and agreed that Forward Pharma GmbH should be paid an arm's-length compensation for said
termination. International transfer pricing is an area of taxation that depends heavily on the underlying facts and circumstances and generally involves a
significant degree of judgment. The Danish and German tax authorities have commenced a joint tax audit of the Group's Danish and German tax returns covering
the five-year period ending December 31, 2017. It is uncertain when, or if, a tax audit will commence in the United States. Any audits conducted by the tax
authorities will focus on the intercompany recognition of revenue and expense to ensure that such transactions were conducted at arm's length. While
Management believes that the tax positions taken with regard to intercompany transactions are in accordance with tax regulations and that appropriate tax
provisions have been made in the Company's financial statements, there is no assurance that the Company and/or Forward Pharma GmbH will successfully
defend the tax positions taken and that additional taxes, interest or penalties will not be incurred. There is also the risk that the tax authorities could impose
additional taxable income or disallow the deductibility of expenses on intercompany cross-border transactions resulting in higher tax obligations in one or more
tax jurisdictions. Management's experience has been that the tax authorities can be aggressive in taking positions that would increase taxable income and/or
disallow deductible expenses reported. If the local tax authorities are successful in increasing taxable income and/or disallowing the deduction of expenses in one
or more localities, it would result in the Group experiencing a higher effective tax rate that could be material. The imposition of additional taxes, interest and/or
penalties resulting from a tax audit would negatively impact the Company's financial position, operating results and cash flows and the impact could be material.
13
Table of Contents
We may need to return the proceeds of a government grant if it is found that we did not fully comply with all terms and conditions
As part of the project for the development of new or innovative products and procedures in the Free State of Saxony, Germany, the Sächsische Aufbaubank
—Förderbank, or SAB, awarded Forward Pharma GmbH a grant, or the Grant, of €3.8 million ($4.4 million based on the December 31, 2018 exchange rate) that
subsidized certain product development costs incurred by Forward Pharma GmbH, during the period from March 2007 to December 2008. While the SAB has
conducted an audit of the use of proceeds and confirmed that Forward Pharma GmbH had complied with all the terms and conditions of the Grant, the SAB
maintains the right to revoke the Grant and demand repayment of the Grant, plus interest, in the event the SAB in the future determines that Forward
Pharma GmbH failed to fully comply with all the terms and conditions of the Grant. While we believe that Forward Pharma GmbH is in full compliance with all
the terms and conditions of the Grant, there is always a risk that the SAB in the future could disagree and demand repayment of the Grant plus interest. If we were
required to repay the Grant, it would have a material negative effect on our financial position and operating results.
If we fail to retain accounting and financial staff with appropriate experience, our ability to maintain the financial controls required of a public company
may be adversely affected.
We currently rely on employed and third-party accounting professionals to assist us with our financial accounting and compliance obligations. If we are
unable to retain financial professionals with appropriate experience to maintain our financial control and reporting obligations as a public company, our business
may be adversely impacted.
Risks Related to Our Ordinary Shares and ADSs
Holders of our ADSs have different rights than holders of our ordinary shares.
We have issued to our security holders ADSs and ordinary shares, each of which afford their holders different rights. Currently, only our ADSs are publicly
traded (on the Nasdaq Global Select Market). An ADS holder will not be treated as one of our shareholders and will not have shareholder rights. Danish law
governs shareholder rights. Our depositary, Bank of New York Mellon, is the holder of the ordinary shares underlying outstanding ADSs. Holders of ADSs only
have ADS holder rights. The deposit agreement among us, the depositary and ADS holders sets out ADS holder rights as well as the rights and obligations of the
depositary.
The market price of the ADSs may be volatile and may fluctuate due to factors beyond our control.
The price of equity securities of publicly traded emerging biopharmaceutical and drug discovery and development companies has been highly volatile and is
likely to remain highly volatile in the future. The market price of the ADSs may fluctuate significantly due to a variety of factors, including:
•
•
•
•
•
•
•
developments in the Opposition Proceeding;
developments concerning proprietary rights, including patents and litigation matters;
technological innovations or commercial product introductions by our competitors;
changes in government regulations;
public concern relating to the commercial value or safety of Tecfidera®;
financing or other corporate transactions;
publication of research reports or comments by securities or industry analysts;
14
Table of Contents
•
•
general market conditions in the pharmaceutical industry or in the economy as a whole; or
other events and factors beyond our control.
In addition, the stock market in general has recently experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to
the operating performance of individual companies. Broad market and industry factors may materially affect the market price of companies' equity securities,
including ours, regardless of actual operating performance.
Our ADSs are currently listed for trading on the Nasdaq Global Select Market. Nasdaq Listing Rule 5450(a)(1) requires that we maintain a minimum bid
price of our ADSs of $1.00 per ADS for continued listing. Our ADSs in the past have traded below $1.00 and while the recent trading price of our ADSs has been
above $1.00, there is no assurance that the trading price will stay above $1.00. We actively monitor the price of our ADSs and will consider available options,
including, but not limited to, changing the ADS ratio, to maintain compliance with the continued listing standards of Nasdaq. We cannot assure that we will stay
in compliance with Nasdaq's continued listing standards. If we fail to comply with the continued listing standards of the Nasdaq Stock Market, we will not be able
to remain listed on that stock exchange, which could have a material adverse effect on the price of our ADSs.
If we fail to maintain the listing of our ADSs with a U.S. national securities exchange, the liquidity of our ADSs could be adversely affected.
If our ADSs are delisted by Nasdaq, our ADSs may be eligible to trade on the OTC Bulletin Board or another over-the-counter market. Any such alternative
would likely result in it being more difficult for us to raise additional capital through the public or private sale of equity securities and for investors to dispose of,
or obtain accurate quotations as to the market value of, our ADSs. In addition, there can be no assurance that our ADSs would be eligible for trading on any such
alternative exchange or markets.
There may be a lack of liquidity and market for our ordinary shares and ADSs.
A lack of liquidity in the markets may develop for our ADSs, which would negatively affect the ability of the holders to sell our ADSs or the price at which
holders of our ADSs will be able to sell them. Future trading prices of our ADSs will depend on many factors including, among other things, prevailing interest
rates, our operating results and the market for similar securities.
Our ordinary shares underlying the ADSs are not listed on any public securities exchange. Future sales by our existing shareholders could limit the ability of
an ADS holder to sell the ADSs at the price and time such holder desires. Any such limited trading market may also increase the price volatility of the ADSs or
the ordinary shares underlying the ADSs.
Our ordinary shares are controlled by insiders, who could have significant influence over the outcome of corporate actions requiring board and shareholder
approval.
Our Chairman, Florian Schönharting, and director, Torsten Goesch, indirectly beneficially own approximately 73% of our ordinary shares, of which
approximately 54% is beneficially owned by Mr. Schönharting. With such concentrated control, Messrs. Schönharting and Goesch, acting individually or in
concert, have significant influence over the outcome of corporate actions requiring board and shareholder approval, including the election of directors, certain
decisions relating to our capital structure, amendments to our Articles of Association, and the approval of mergers and other significant corporate actions or
transactions. The interests of these insiders may not always coincide with our interests or the interests of our other shareholders or holders of the ADSs and those
other shareholders and holders of the ADSs may have no effective voice in the management of the Company.
15
Table of Contents
Certain of our principal shareholders as well as NB FP Investment II K/S have entered into a shareholders' agreement under which they have agreed to take
certain actions that may be adverse to the interests of other shareholders and holders of ADSs.
Certain of our principal shareholders as well as NB FP Investment II K/S have entered into a shareholders' agreement, under which they have agreed to take
certain actions, including with respect to the ability of certain principal shareholders to nominate directors to the board of directors and the obligation to increase
share capital in certain circumstances. The shareholders that are party to the shareholders' agreement control a majority of the voting power of our ordinary
shares, and the actions taken under or pursuant to the shareholders' agreement may conflict with the interests of other shareholders and holders of ADSs.
ADS holders may not be able to exercise their right to vote the ordinary shares underlying the ADSs.
Holders of ADSs may exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the provisions of the
deposit agreement and not as direct shareholders in the Company. The deposit agreement provides that, upon receipt of notice of any meeting of holders of our
ordinary shares, the depositary will fix a record date for the determination of ADS holders who shall be entitled to give instructions for the exercise of voting
rights. Upon timely receipt of notice from us, if we so request, the depositary shall distribute to the holders as of the record date (1) the notice of the meeting or
solicitation of consent or proxy sent by us and (2) a statement as to the manner in which instructions may be given by the holders. However, we may not request
the depositary to distribute this information, which could effectively limit the ability of ADS holders to direct the voting of the ordinary shares underlying their
ADSs.
ADS holders may instruct the depositary of their ADSs to vote the ordinary shares underlying their ADSs. Otherwise, ADS holders will not be able to
exercise their right to vote, unless they withdraw the ordinary shares underlying the ADSs. However, ADS holders may not know about the meeting far enough in
advance to withdraw those ordinary shares. If we ask for ADS holders' instructions, the depositary, upon timely notice from us, will notify ADS holders of the
upcoming vote and arrange to deliver our voting materials to ADS holders. We cannot guarantee ADS holders that they will receive the voting materials in time to
ensure that they can instruct the depositary to vote the ordinary shares underlying the ADSs held by them or to withdraw the ordinary shares underlying the ADSs
so that the ADS holder can vote them. If the depositary does not receive timely voting instructions from the ADS holder, it may give a proxy to a person
designated by us to vote the ordinary shares underlying the ADSs. In addition, the depositary and its agents are not responsible for failing to carry out voting
instructions or for the manner of carrying out voting instructions. This means that ADS holders may not be able to exercise any right to vote, and there may be
nothing ADS holders can do if the ordinary shares underlying their ADSs are not voted as requested.
ADS holders' rights to participate in any future preferential subscription rights or to elect to receive dividends in shares may be limited, which may cause
dilution to their holdings.
According to Danish law, if we issue additional securities for cash, current shareholders will have preferential subscription rights for these securities on a pro
rata basis unless (i) they waive those rights at a meeting of our shareholders (if issued at market value, by at least two-thirds of the votes cast and the share capital
represented at such meeting), (ii) such rights are waived individually by each shareholder, or (iii) the additional securities are issued pursuant to an authorization
granted to our board of directors including a waiver of preemptive rights. However, our ADS holders in the United States will not be entitled to exercise or sell
such rights related to the ordinary shares which they represent unless we register the rights and the securities to which the rights relate under the Securities Act of
1933, as amended, or the Securities Act, or an exemption from the registration requirements is available. In addition, the deposit agreement provides that the
depositary will not make rights available
16
Table of Contents
to our ADS holders unless the distribution to ADS holders of both the rights and any related securities are either registered under the Securities Act or exempted
from registration under the Securities Act. Further, if we offer holders of our ordinary shares the option to receive dividends in either cash or shares, under the
deposit agreement the depositary may require satisfactory assurances from us that extending the offer to holders of ADSs does not require registration of any
securities under the Securities Act before making the option available to holders of ADSs. We are under no obligation to file a registration statement with respect
to any such rights or securities or to endeavor to cause such a registration statement to be declared effective. Moreover, we may not be able to establish an
exemption from registration under the Securities Act. Accordingly, ADS holders may be unable to participate in our rights offerings or to elect to receive
dividends in shares and may experience dilution in their holdings. In addition, if the depositary is unable to sell rights that are not exercised or not distributed or if
the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in which case our ADS holders will receive no value for these rights.
ADS holders may be subject to limitations on the transfer of their ADSs and the withdrawal of the underlying ordinary shares.
ADSs, which may be evidenced by American Depositary Receipts, or ADRs, are transferable on the books of the depositary. However, the depositary may
close its books at any time or from time to time when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver,
transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is
advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any other reason
subject to each ADS holder's right to cancel such holder's ADSs and withdraw the underlying ordinary shares. Temporary delays in the cancellation of ADSs and
withdrawal of the underlying ordinary shares may arise because the depositary has closed its transfer books or we have closed our transfer books, the transfer of
ordinary shares is blocked to permit voting at a shareholders' meeting or we are paying a dividend on our ordinary shares. In addition, ADS holders may not be
able to cancel their ADSs and withdraw the underlying ordinary shares when they owe money for fees, taxes and similar charges and when it is necessary to
prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited
securities.
Future sales, or the perception of future sales, of a substantial number of our ordinary shares or ADSs could adversely affect the price of the ADSs, and
actual sales of our equity will dilute shareholders and ADS holders.
Future sales of a substantial number of our ordinary shares or ADSs, or the perception that such sales will occur, could cause a decline in the market price of
the ADSs. If shareholders sell substantial amounts of shares or ADSs in the public market, or the market perceives that such sales may occur, the market price of
the ADSs and our ability to raise capital through an issue of equity securities in the future could be adversely affected. We have entered into a registration rights
agreement pursuant to which we have agreed under certain circumstances to file a registration statement to register the resale of the shares held by certain of our
existing shareholders, as well as to cooperate in certain public offerings of such shares. In addition, we have registered ordinary shares and ADSs that we may
issue under our 2014 Omnibus Equity Incentive Plan and may register shares under other equity compensation plans. As a result, these ordinary shares can be
freely sold in the public market or otherwise upon issuance, subject to volume limitations applicable to affiliates and lock-up agreements.
17
Table of Contents
We do not expect to pay dividends or other shareholder distributions in the foreseeable future.
While we distributed the proceeds from the Capital Reduction (as defined below) to our ADS holders and shareholders in September 2017, we do not expect
to pay dividends or other shareholder distributions in the foreseeable future. Even if future operations lead to significant levels of distributable profits, any
earnings may be reinvested in our business and dividends or other shareholder distributions, if any, may not be paid until we have an established revenue stream
to support such continuing dividends or other shareholder distributions. Payment of future dividends or other shareholder distributions, if at all, will effectively be
at the discretion of our board of directors, after taking into account various factors including our business prospects, cash requirements and financial performance.
In addition, payment of future dividends may be made only if our shareholders' equity exceeds the sum of share capital plus the reserves required to be
maintained by the License Agreement, Danish law or by our Articles of Association. Accordingly, investors cannot rely on income from dividends or other
shareholder distributions and any returns on an investment in the ADSs may depend entirely upon any future appreciation in the price of the ADSs.
We were an emerging growth company during the period covered by this Annual Report, and we cannot be certain if the reduced reporting requirements
applicable to emerging growth companies will make our ordinary shares less attractive to investors.
We qualified as an "emerging growth company," as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, for the fiscal year ended
December 31, 2018. As an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other
public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the
Sarbanes-Oxley Act of 2002, exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of
any golden parachute payments not previously approved. We cannot predict if investors will find the ADSs less attractive because we have relied on these
exemptions. If some investors find the ADSs less attractive as a result, there may be a less active trading market for the ADSs and the price of the ADSs may be
more volatile.
We are a foreign private issuer and, as a result, we will not be subject to U.S. proxy rules and will be subject to Exchange Act reporting obligations that, to
some extent, are more lenient and less frequent than those of a U.S. domestic public company.
We will report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private issuer status.
Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the Exchange Act that are applicable to U.S.
domestic public companies, including (i) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security
registered under the Exchange Act; (ii) the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and
liability for insiders who profit from trades made in a short period of time; and (iii) the rules under the Exchange Act requiring the filing with the SEC of
quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified
significant events. In addition, foreign private issuers are not required to file their annual report on Form 20-F until 120 days after the end of each fiscal year,
while U.S. domestic issuers that are accelerated filers are required to file their annual report on Form 10-K within 75 days after the end of each fiscal year.
Foreign private issuers are also exempt from Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information.
As a result of the above, our shareholders and ADS holders may not have the same protections afforded to shareholders of companies that are not foreign private
issuers.
18
Table of Contents
We may lose our foreign private issuer status in the future, which could result in significant additional costs and expenses.
The determination of foreign private issuer status is made annually on the last business day of an issuer's most recently completed second fiscal quarter.
Accordingly, we will next make a determination with respect to our foreign private issuer status on June 30, 2019. There is a risk that we will lose our foreign
private issuer status in the future.
We would lose our foreign private issuer status if, for example, more than 50% of our assets are located in the U.S. and we continue to fail to meet additional
requirements necessary to maintain our foreign private issuer status. As of December 31, 2018, approximately $321,000 of our assets were located in the U.S.,
although this may change if we expand our operations in the U.S. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer
may be significantly greater than the costs we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports
and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a
foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S. GAAP and modify certain of
our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion and modifications would involve additional
costs. In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to
foreign private issuers, which could also increase our costs.
If we fail to establish and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial
results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the
trading price of the ADSs.
Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and
procedures, is designed to detect and/or prevent errors and fraud. Any failure to maintain current controls or implement, on a timely basis, new or improved
controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in
connection with Section 404 of the Sarbanes-Oxley Act of 2002, or work performed by our independent registered accounting firm as part of their audit of our
financial statements may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require
prospective or retroactive changes to our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also
cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of the ADSs.
We are required to disclose changes made in our internal control over financial reporting and procedures and our management is required to assess the
effectiveness of these controls annually. An independent assessment of the effectiveness of our internal control over financial reporting could detect problems that
our management's assessment might not. Undetected material weaknesses in our internal control over financial reporting could lead to financial statement
restatements and require us to incur the expense of remediation and could adversely affect the price of our ADSs.
Failure to maintain effective internal control over financial reporting could result in material misstatements in our financial statements which could
negatively impact the price of our ADSs.
In connection with the preparation of our consolidated financial statements for each of the years ended December 31, 2018 and 2017, we carried out an
evaluation of the effectiveness of our internal controls over financial reporting and concluded that there was a material weakness as described in
19
Table of Contents
"Item 15. Controls and Procedures" herein. We cannot assure you that our internal control over financial reporting will be effective in the future or that additional
material weakness will not be discovered.
As a consequence of this material weakness, management concluded that our internal control over financial reporting and, consequently, our disclosure
controls and procedures, were not effective as of December 31, 2018 and 2017. Our management believes that the consolidated financial statements included in
this annual report fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented.
We have taken actions, or Actions, to remediate the causes of the material weakness; However, since the material weakness was associated with specific
transactions that did not occur subsequent to implementing the Actions, there has been no opportunities for us to monitor and test that the Actions taken were
sufficient to mitigate the material weakness. The lack of objective evidence to support that the material weakness has been remediated, necessitates that we
continue to report that the material weakness has not been remediated. Failure to effectively remediate the causes of this material weakness or establish and
maintain effective internal control over financial reporting could result in material misstatements in our financial statements or a failure to meet our reporting
obligations. This, in turn, could negatively impact the Company's financial position, operating results and cash flows, the market price of our ADSs and our
ability to remain listed on the Nasdaq Global Select Market.
Failure to comply with Section 404 of the Sarbanes-Oxley Act could negatively affect our business including the price of our ADSs.
Under the Sarbanes-Oxley Act, we are required to maintain effective disclosure controls and procedures and internal control over financial reporting and to
make a formal assessment of the effectiveness of our internal control over financial reporting. We concluded that our disclosure controls and procedures and
internal controls over financial reporting were not effective as of December 31, 2018 and 2017, and there is no assurance that we will be able remediate the
material weakness and maintain adequate disclosure controls and procedures and internal controls in the future. We may experience situations in the future where
our evaluation and testing processes required by Section 404 of the Sarbanes-Oxley Act, or work performed by independent registered accountants, may identify
one or more material weaknesses in our internal controls over financial reporting that will result in our inability to assert that our internal control over financial
reporting is effective. If we cannot maintain adequate internal controls over financial reporting that provide reasonable assurance of the reliability of the financial
reporting and preparation of our financial statements for external use, we could suffer harm to our reputation, fail to meet our public reporting requirements by
providing timely and accurate financial statements, be required to restate our prior period financial statements, or we may be unable to comply with applicable
stock exchange listing requirements, any of which could adversely affect the price of our ADSs.
If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research about our business, the price of the ADSs and our
trading volume could decline.
The trading market for the ADSs depends in part on the research and reports that securities or industry analysts publish about us or our business. Presently,
the Company is not covered by any analysts. If we are covered by securities or industry analysts in the future and such analysts downgrade our ADSs or publish
inaccurate or unfavorable research about our business, the price of our ADSs would likely decline. If one or more such analysts ceased coverage of our company
or failed to publish reports on us regularly, demand for the ADSs could decrease, which might cause the price of our ADSs and trading volume to decline.
20
Table of Contents
We believe that we were classified as a passive foreign investment company, or a PFIC, from 2014 to 2018 and may be classified as a PFIC in future years. If
we are a PFIC for any taxable year, this could result in adverse U.S. federal income tax consequences to U.S. Holders of our ADSs.
Under the U.S. Internal Revenue Code of 1986, as amended, or the Code, we will be a PFIC for any taxable year in which, after the application of certain
"look-through" rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of "passive income," or (ii) 50% or more of the average
quarterly value of our assets consists of assets that produce, or are held for the production of, "passive income." Passive income generally includes interest,
dividends, rents, certain non-active royalties and capital gains. We believe that we were a PFIC for each of the five years in the period ended December 31, 2018,
and may be classified as a PFIC in future years. Whether we will be a PFIC in any year depends on the composition of our income and assets, and the relative fair
market value of our assets from time to time, which we expect may vary substantially over time. Because (i) we currently own a substantial amount of passive
assets, including cash, and (ii) the value of our assets, including our intangible assets, that generate non-passive income for PFIC purposes, is uncertain and may
vary substantially over time, it is uncertain whether we will be or will not be a PFIC in future years.
If we are a PFIC for any taxable year during which a U.S. Holder, as defined below, holds ADSs, a U.S. Holder may be subject to adverse tax consequences,
including (i) if a mark-to-market election or a qualified electing fund, or QEF, election has not been made with respect to its ADSs, a U.S. Holder may incur
significant additional U.S. federal income taxes on income resulting from distributions on, or any gain from the disposition of, such ADSs, as such income
generally would be allocated over the U.S. Holder's holding period for its ADSs and would be subject to tax at the highest rates of U.S. federal income taxation in
effect for such years, with an interest charge then imposed on the resulting taxes in respect of such income, and (ii) dividends paid by us would not be eligible for
preferential individual rates of U.S. federal income tax. In addition, U.S. Holders that own an interest in a PFIC are required to comply with certain reporting
requirements.
A U.S. Holder may in certain circumstances mitigate adverse tax consequences of the PFIC rules by filing an election to treat the PFIC as a QEF, or, if shares
of the PFIC are "marketable stock" for purposes of the PFIC rules, by making a mark-to-market election with respect to the shares of the PFIC. However, we are
not obligated to comply with the reporting requirements necessary to permit U.S. Holders to elect to treat us as a QEF and accordingly U.S. Holders may not be
able to make QEF elections to avoid the adverse tax consequences of the PFIC rules. Furthermore, if a U.S. Holder were able to make a mark-to-market election
with respect to its ADSs, the U.S. Holder would be required to include annually in its U.S. federal taxable income an amount reflecting any year-end increase in
the value of its ADSs (which may not be matched by cash distributions). Mark-to-market elections will not be available for any of our subsidiaries that are also
PFICs. For further discussion of the adverse U.S. federal income tax consequences of our classification as a PFIC, see "Item 10. Additional Information—
Taxation—U.S. Federal Income Tax Considerations for U.S. Holders."
Risks Related to Danish Law and Our Operations in Denmark
Preemptive rights may not be available to non-Danish shareholders, and any inability of non-Danish shareholders to exercise preemptive rights in respect of
shares issued in any offering by us will cause their proportionate interests to be diluted.
Under Danish law, existing shareholders will have preemptive rights to participate on the basis of their existing share ownership in the issuance of any new
shares for cash consideration, unless those rights are waived by a resolution of the shareholders or the shares are issued pursuant to an authorization granted to the
board of directors including a waiver of preemptive rights. The preemptive rights of the shareholders may be waived by two-thirds of the votes cast and of the
share capital
21
Table of Contents
represented at the general meeting if the share capital increase is made at market price, or, if the share capital increase is made at below market price, by nine-
tenths of the votes cast and of the share capital represented at the general meeting. Certain non-Danish shareholders may not be able to exercise preemptive rights
for their shares due to restrictions included in securities laws of certain countries, including those applicable in the U.S. To the extent that shareholders are not
able to exercise their preemptive rights in respect of the shares in any offering by us, such shareholders' proportional interests will be diluted.
We are a Danish company with limited liability. The rights of our shareholders may be different from the rights of shareholders in companies governed by the
laws of U.S. jurisdictions.
We are a Danish company with limited liability. Our corporate affairs are governed by our Articles of Association and by the laws governing companies
incorporated in Denmark. The rights of shareholders and the responsibilities of members of our board of directors may be different from the rights and obligations
of shareholders and boards of directors in companies governed by the laws of U.S. jurisdictions. In the performance of its duties, our board is required by Danish
law to consider the interests of our Company, its shareholders, its employees and other stakeholders, in all cases with due observation of the principles of
reasonableness and fairness. It is possible that some of these parties will have interests that are different from, or in addition to, the interests of our shareholders.
We are, as a foreign private issuer, not obligated to and do not comply with all the corporate governance requirements of Nasdaq. This may affect the rights
of our shareholders.
We are a foreign private issuer for purposes of U.S. federal securities laws. As a result, in accordance with the listing requirements of Nasdaq, we rely on
home country governance requirements and certain exemptions thereunder rather than relying on the corporate governance requirements of Nasdaq. In
accordance with Danish law and generally accepted business practices, our Articles of Association do not provide quorum requirements generally applicable to
general meetings of shareholders. To this extent, our practice varies from the requirement of Nasdaq Listing Rule 5620(c), which requires an issuer to provide in
its bylaws for a generally applicable quorum, and that such quorum may not be less than one-third of the outstanding voting shares. Although we must provide
shareholders with an agenda and other relevant documents in advance of a general meeting of shareholders, Danish law does not have an applicable regulatory
regime for the solicitation of proxies, and thus our practice will vary from the requirement of Nasdaq Listing Rule 5620(b). Accordingly, our shareholders may
not have the same protections afforded to shareholders of companies that are subject to these Nasdaq requirements.
As a Danish company we must comply with the Danish Companies Act, or DCA. The DCA contains binding provisions for the board of directors,
shareholders and general meetings of shareholders; and financial reporting, auditor, disclosure, compliance and enforcement standards. Certain provisions apply
to our board of directors (e.g., in relation to role, composition, conflicts of interest and independency requirements and remuneration), shareholders and the
general meeting of shareholders (e.g., regarding our obligations to provide information to our shareholders). Further, certain sections of the DCA only apply to
Danish companies listed on a regulated market within the European Economic Area, or EEA, and accordingly do not apply to us. This may affect the rights of our
shareholders.
We have historically filed our Danish tax returns on a standalone basis; however, due to certain changes to our ownership structure made at the start of 2013,
as of January 2013, we began to file our Danish tax returns as part of joint taxation schemes.
During the period January 19, 2013 to December 31, 2015, we were subject to a Danish joint taxation scheme with Tech Growth Invest ApS and entities
under Tech Growth Invest ApS's control,
22
Table of Contents
collectively referred to hereafter as Tech Growth. From the establishment of Forward Pharma FA ApS on December 3, 2015, Forward Pharma FA ApS was part
of the joint taxation scheme with Tech Growth. A subsidiary of Tech Growth Invest ApS experienced a change in ownership on December 31, 2015. The effect of
the change in ownership resulted in the year ended December 31, 2015 being the final year that the Company and Forward Pharma FA ApS were part of the joint
taxation group with Tech Growth. On January 1, 2016, the Company and Forward Pharma FA ApS became members of a new Danish joint taxation group with
NB FP Investment General Partner ApS (collectively the "2016 Tax Group"). Upon their inception during 2017, Forward Pharma Operations ApS and FWP IP
ApS (through the date of the sale of FWP IP ApS (November 22, 2017) to FWP HoldCo ApS, which is owned and controlled by FWP Fonden) became members
of the 2016 Tax Group. The Company remains liable with other entities in the joint taxation group with Tech Growth Invest ApS for Tech Growth's Danish tax
liabilities that can be allocated to the period January 19, 2013 to December 31, 2015 and the Company is liable with other entities in the 2016 Tax Group for
Danish tax liabilities that can be allocated to the three-year period ended December 31, 2018.
All members of a Danish tax group are jointly and severally liable for the group's Danish tax liabilities. However, Danish law requires taxing authorities to
look primarily to the administration company and its wholly owned entities to satisfy Danish tax liabilities and to look to partially owned entities (such as us) only
on a secondary basis. While we do not believe Tech Growth, NB FP Investment General Partner ApS or any other member of the joint taxation scheme has any
material Danish tax liabilities, there can be no assurance that it does not have any such material liabilities, that it will not incur such material liabilities in the
future, or that it will fulfill any such obligations. If Tech Growth Invest ApS, NB FP Investment General Partner ApS or any other entity that is a member of any
of the joint taxation groups has any material Danish tax liabilities that are not satisfied by them or if they, while being members of the respective joint taxation
group, incur any such liabilities in the future, we may be responsible for the payment of such taxes, which could have an adverse effect on our results of
operations.
U.S. federal and/or state income tax may apply to us in the future.
We have taken the position that we are not currently subject to U.S. federal or state income tax. Our Vice President, Finance and Controller, Thomas
Carbone, is employed by Forward Pharma USA, LLC. Pursuant to the U.S. tax laws and the income tax treaty between Denmark and the U.S., we will not be
subject to U.S. tax in connection with any of such employees' activities unless there is a U.S. trade or business being conducted in connection with a permanent
establishment. While we have taken the position that the functions such employees fulfill do not give rise to U.S. tax liability for us, there can be no assurance
that the U.S. tax authorities will agree with such position. If the U.S. Internal Revenue Service disagrees with our position, and/or if the functions of such
employees are expanded in the future, and/or we engage additional personnel located in the U.S. whose functions are sufficiently broad, we may be or may
become subject to U.S. federal and/or state income tax, which might have a material adverse effect on us and our results of operations.
Claims of U.S. civil liabilities may not be enforceable against us.
Forward Pharma A/S is incorporated under the laws of Denmark, and three of its subsidiaries, Forward Pharma Operations ApS, Forward Pharma GmbH
and Forward Pharma FA ApS, are incorporated under the laws of Denmark, Germany and Denmark, respectively. Substantially all of our assets are located
outside the U.S. On a combined basis, the majority of our directors and officers reside outside the U.S. As a result, it may not be possible for investors to effect
service of process within the U.S. upon such persons or to enforce judgments against them or us in U.S. courts, including judgments predicated upon the civil
liability provisions of the federal securities laws of the U.S.
23
Table of Contents
The U.S. does not have a treaty with Denmark or Germany providing for reciprocal recognition and enforcement of judgments, other than arbitration awards,
in civil and commercial matters. Accordingly, a final judgment for the payment of money rendered by a U.S. court based on civil liability will not be directly
enforceable in Denmark or Germany. However, if the party in whose favor such final judgment is rendered brings a new lawsuit in a competent court in Denmark,
that party may submit to the Danish court the final judgment that has been rendered in the U.S. A judgment by a federal or state court in the U.S. will neither be
recognized nor enforced by a Danish court, but such judgment may serve as evidence in a similar action in such court. In addition, the final judgment of a U.S.
court may be recognized and enforced in Germany in compliance with certain requirements including petitioning a German court to recognize and declare such
judgment enforceable. Also, general reciprocity in respect of the mutual recognition of judgments between Germany and the U.S. court that rendered the
concerned judgment must be guaranteed, and the judgment must not violate German (international) public policy.
ITEM 4. INFORMATION ON THE COMPANY
A. History and Development of the Company
Forward Pharma A/S is a Danish biopharmaceutical company that until recently was actively developing FP187®, a proprietary formulation of DMF, for the
treatment of MS and other inflammatory and neurological indications. DMF is an immunomodulator that can be used as a therapeutic to improve the health of
patients with MS and immune disorders.
On February 1, 2017, our License Agreement with Biogen became effective. Pursuant to the License Agreement, Biogen paid us a non-refundable cash fee
of $1.25 billion. The License Agreement provided Biogen with a co-exclusive license in the U.S. and an exclusive license outside the U.S., to the Company's
intellectual property.
Under the terms of the License Agreement, we effected a corporate restructuring in 2017. For more, see "—B. Business Overview—Our Company—
Restructuring."
On March 25, 2019, we received notice from Biogen of their exercise of the option to purchase the intellectual property in the U.S. associated with the
Company pursuant to the License Agreement. We and Biogen have consummated the assignment of the U.S. intellectual property to Biogen upon the execution of
assignment agreements and the payment of a nominal amount by Biogen to FWP IP ApS, and Biogen has assumed ownership and responsibility for the assigned
U.S. intellectual property. In addition, we are no longer able to develop or commercialize any therapy for the treatment of any human disease or condition using
DMF, including FP187®. For more, see "—B. Business Overview—Our Company—License Agreement with Biogen." As discussed throughout this Annual
Report, we have permanently discontinued our development of DMF formulations, including FP187®.
We are a Danish public limited liability company founded in 2005. Our principal executive offices are located at Østergade 24A, 1st Floor, 1100 Copenhagen
K, Denmark. Our telephone number at this address is +45 33 44 42 42.
In 2004, Aditech, controlled by Nordic Biotech General Partner ApS (an affiliate of one of our largest shareholders), assessed the potential for DMF to
become a significant global product. Aditech specifically focused on the development of an improved DMF formulation, with the goal of simplifying the product
compared to then-existing DMF-containing treatments and limiting the side effects typically associated with such treatments.
We were founded for the purpose of developing such an improved DMF formulation while protecting, defending and enforcing a patent family Aditech filed
relating to, among other things, formulations and dosing regimens of DMF. In 2010, we acquired this patent family from Aditech. Under our agreement with
Aditech, we obtained, among other things, Aditech's patents and associated
24
Table of Contents
know-how related to formulations and dosing regimens of DMF. For more, see "—Material Agreements—Aditech Agreements."
We have not made any significant capital expenditures or divestures during the last three financial years, and do not have any significant capital expenditures
or divestitures currently in progress.
B. Business Overview
Our Company
We have focused on DMF's potential as an immunomodulating drug to improve the health of patients with immune disorders for over 10 years, during which
time we assembled a significant intellectual property portfolio. As a result of entering into the License Agreement, combined with the recently announced
unsuccessful outcome in the Interference Proceeding and Biogen's purchase of the intellectual property in the U.S. associated with the Company, we have
permanently discontinued our development of a DMF formulation, except for maintaining our files and records for previously completed research and
development work. We completed an organizational realignment in 2017 to focus on the deliverables under the License Agreement and reduce operating
expenses.
On August 2, 2017, the Company's shareholders approved a 10 for 1 share split and a capital reduction of EUR 917.7 million, or $1.1 billion, which we refer
to as the Capital Reduction. The Capital Reduction was effected by a distribution to shareholders in September 2017, or the Shareholder Distribution. The Capital
Reduction was executed through the annulment of 80% of the ordinary shares outstanding post-Share Split. Following the Share Split and the Capital Reduction,
each ADS was modified to represent two ordinary shares with a nominal value of 0.01 DKK each. Except if disclosed otherwise, all share and per share
information contained this Annual Report as well as the accompanying financial statements has been adjusted to reflect the Share Split as if it had occurred at the
beginning of the earliest period presented. See Notes 3.5 and 5.1 in the accompanying financial statements for additional information.
License Agreement with Biogen
On February 1, 2017, our License Agreement with Biogen and certain additional parties became effective. The License Agreement provided Biogen with a
co-exclusive license in the U.S., and an exclusive license outside the U.S., to the Company's intellectual property, effective as of February 9, 2017.
In accordance with the License Agreement, Biogen paid the Company the Non-refundable Fee of $1.25 billion and could be obligated to pay the Company
royalties in the future subject to the outcome of certain matters discussed below.
The License Agreement did not resolve the Interference Proceeding or the Opposition Proceeding. The Company and Biogen entered into the License
Agreement with the intention to permit the PTAB and the Federal Circuit, as applicable, and the EPO, and the Technical Board of Appeal and the Enlarged Board
of Appeal, as applicable, to make final determinations in the proceedings before them.
Because the Company was unsuccessful in the Interference Proceeding after all appeals, pursuant to the License Agreement, Biogen had the option to elect
to obtain an exclusive license to the intellectual property in the U.S. associated with the Company or to purchase the intellectual property in the U.S. associated
with the Company for a nominal price.
On March 25, 2019, we received notice from Biogen of their exercise of the option to purchase the intellectual property in the U.S. associated with the
Company pursuant to the License Agreement. We and Biogen have consummated the assignment of the U.S. intellectual property to Biogen upon the execution of
assignment agreements and the payment of a nominal amount by Biogen to FWP IP ApS,
25
Table of Contents
and Biogen has assumed ownership and responsibility for the assigned U.S. intellectual property. In addition, we are no longer able to develop or commercialize
any therapy for the treatment of any human disease or condition using DMF, including FP187®. Because we were unsuccessful in the Interference Proceeding
after all appeals, the Company will not be entitled to future royalties on Biogen's net sales in the U.S. Therefore, sources of revenue derived from customers in the
U.S., including product sales of any DMF formulation, are not expected.
If the Company is successful in the Opposition Proceeding (i.e., the Company obtains, as a result of the Opposition Proceeding, and any appeals therefrom, a
patent with a claim covering oral treatment of MS with 480 mg per day of DMF), it will be eligible beginning on January 1, 2021 to collect a 10% royalty
(increasing to 20% from January 1, 2029) until the earlier of the expiration or invalidation of the patents defined in the License Agreement, on a country-by-
country basis on Biogen's net sales outside the U.S. of DMF-containing products indicated for treating MS that, but for the rights granted under the License
Agreement, would infringe a Company patent, provided that other conditions of the License Agreement are satisfied within the time period set forth in the
License Agreement. Among the conditions that need to be satisfied for any royalty to be payable by Biogen to the Company is the absence of generic entry in a
particular country having a particular impact as defined in the License Agreement. If the Company is unsuccessful in the Opposition Proceeding, the Company
would not be entitled to future royalties on Biogen's net sales outside the U.S.
Restructuring
Under the terms of the License Agreement, the Company restructured its operations on June 30, 2017 whereby the Company transferred to Forward Pharma
Operations ApS (a newly created and wholly owned Danish limited liability company) certain assets and liabilities, including the legal and beneficial rights, title
and interest to defined intellectual property, and Forward Pharma Operations ApS transferred the intellectual property to FWP IP ApS (a newly created and
wholly owned Danish limited liability company). The final step in the restructuring was completed on November 22, 2017 when the capital stock of FWP IP ApS
was sold to FWP HoldCo ApS, a newly formed Danish limited liability company that is owned and controlled by FWP Fonden, a newly formed independent
Danish foundation. FWP HoldCo ApS paid Forward Pharma Operations ApS 336,000 DKK ($54,000 based on the December 31, 2017 exchange rate) as
consideration for the capital stock of FWP IP ApS. FWP Fonden's three-member board includes one independent director and one director appointed from each of
the Company and Biogen. Accordingly, the Company does not control FWP Fonden. During the year ended December 31, 2017, the Company contributed
5 million DKK ($805,000 based on the December 31, 2017 exchange rate) as the initial capitalization of FWP Fonden and is obligated to pay 100,000 DKK
($15,000 based on the December 31, 2018 exchange rate) annually to FWP IP ApS in exchange for FWP IP ApS agreeing to hold, prosecute and maintain the
transferred intellectual property, which now consists only of the non-U.S. intellectual property associated with the Company, in accordance with certain
agreements. In connection with the initial capitalization of FWP Fonden, the Company's annual funding obligations to FWP IP ApS and the sale of the capital
stock of FWP IP ApS to FWP HoldCo ApS, the Company incurred a net expense of $759,000 that is included in general and administrative expenses for the year
ended December 31, 2017. In the future, the Company is only obligated to remit the annual funding of 100,000 DKK to FWP IP ApS through the last to expire, or
invalidation of, the licensed patents underlying the transferred intellectual property; however, the Company's obligation to remit the annual funding would be
discontinued earlier if certain events, as defined in the License Agreement, occur. In addition to its annual funding obligations, the License Agreement requires
the Company to fund the cost to file, prosecute and maintain European patent EP 2801355 (until the date on which the Opposition Proceeding has reached a final,
unappealable conclusion) and to participate in an intellectual property advisory committee. The Company was required to fund the cost to file, prosecute and
maintain the U.S. patents associated with the Company prior to Biogen purchasing such intellectual property.
26
Table of Contents
Key Intellectual Property Involved in Interference Proceeding
One of the key patent applications previously associated with the Company in the U.S. is the '871 application. The '871 application claims the use of 480 mg
of DMF per day as a treatment for MS. On April 13, 2015, an administrative patent judge at the PTAB, declared an interference between our '871 application and
Biogen's '514 patent, which has claims that also cover a method of treating MS using about a 480 mg daily dose of DMF. The oral argument for the Interference
Proceeding took place on November 30, 2016. On March 31, 2017, the PTAB issued a decision in the Interference Proceeding in favor of Biogen. The PTAB
ruled that the claims of the '871 application are not patentable due to a lack of adequate written description. The Company appealed the decision to the Federal
Circuit. The Federal Circuit appeal was concluded in Biogen's favor on January 9, 2019, thereby ending the Interference, and resulting in the termination of the
prosecution of the '871 application, as all options for appeal according to the License Agreement have been exhausted.
Key Intellectual Property Involved in Opposition Proceeding
European patent EP2801355, or the EP'355 patent, covers, among other things, the treatment of MS with 480 mg per day of DMF using pH-controlled
compositions that have an enteric coating. The EPO completed their review of this application and issued this patent on May 20, 2015. This patent was opposed
by several parties in an opposition proceeding, which is a special proceeding heard by the EPO where one or more third parties request that the patent, or a part
thereof, be revoked. On January 29, 2018, the European Patent Office, or EPO, revoked the EP'355 patent on one of the alleged grounds of invalidity following
the oral hearing in the Opposition Proceeding. On March 22, 2018, the Opposition Division issued its written decision with detailed reasons for the decision. On
May 7, 2018, the Company submitted its notice of appeal, and on August 1, 2018, the Company submitted detailed grounds for the appeal. The duration of the
appeal process is estimated to be approximately three years; however, delays can occur that would extend the estimated duration of the appeal process.
There can be no assurance that we will be successful in the Opposition Proceeding after any appeals. If the Company is unsuccessful in the Opposition
Proceeding, the Company would not be entitled to future royalties on Biogen's net sales outside the U.S. If the Company prevails in the appeal against the
decision of January 29, 2018, we expect the Technical Board of Appeal to remand the case to the Opposition Division, in order for the Opposition Division to
resolve the remaining elements of the original opposition. While the appeal and any remanded issues have not been resolved, the decision of the Opposition
Division to revoke the EP'355 patent is "frozen." Assuming that the patent is ultimately maintained following the final conclusion of the Opposition Proceeding,
including any appeals, the EP'355 patent has a maximum duration until October 2025 (subject to possible SPC extension—see below).
Our Product Development Strategy
Historically, the Company's product development efforts were focused on advancing unique formulations and dosing regimens of DMF, an
immunomodulator, as a therapeutic to improve the health of patients with immune disorders, including psoriasis and MS. Prior to entering into the License
Agreement, we were actively developing FP187 ®, a proprietary formulation of DMF, for the treatment of MS patients. On March 1, 2017, we announced plans
to complete the research and development work that was in process prior to the effective date of the License Agreement and pursue an organizational realignment
to reduce personnel and operating expenses, including the suspension of further development of FP187®. This organizational realignment was substantially
completed by September 30, 2017. We do not currently have any commercialized products on the market nor under development. As a result of entering into the
License Agreement, combined with the recently announced unsuccessful outcome in the Interference Proceeding and Biogen's purchase of the
27
Table of Contents
intellectual property in the U.S. associated with the Company, our research and development efforts involving DMF products, including FP187®, have been
permanently discontinued.
Our Intellectual Property Strategy
We believe the patents and patent applications associated with the Company are valuable assets. To the extent required or permitted by the License
Agreement, we intend to protect, defend and/or enforce the intellectual property associated with the Company.
The intellectual property associated with the Company includes patents and patent applications in Europe and certain countries in Asia. We divide the
intellectual property portfolio associated with the Company primarily into two patent families, which we refer to as the "Core Composition Patent" family and the
"Erosion Matrix Patent" family.
The Core Composition Patent family, based on international application PCT/DK2005/000648, filed on October 7, 2005, with priority to October 8, 2004,
discloses, among other things, formulations and dosing regimens of DMF, including the use of a dose of 480 mg of DMF per day to treat MS. As described under
"Risk Factors" and elsewhere in this Annual Report, whether the Core Composition Patent family discloses the use of a dose of 480 mg of DMF per day to treat
MS has been challenged in some European Opposition Proceedings.
The Erosion Matrix Patent family, based on international application PCT/EP2010/050172, filed on January 8, 2010, with priority to January 9, 2009,
discloses, among other things, delayed and slow-release formulations of DMF in FP187® as used in our set of Phase 1 clinical trials and a Phase 2 clinical trial.
The following table highlights key aspects of the current status of certain applications and patents within the Core Composition Patent and Erosion Matrix
Patent families:
Patent / Application
EP2801355
Patent Family
Status
Core Composition Revoked on January 29, 2018 by the EPO Opposition Division. The
Company has appealed this decision (see below). Contains claims directed to
the treatment of MS with 480 mg per day of DMF using pH-controlled
compositions that have an enteric coating.
EP1799196
EP2965751
Core Composition Revoked on September 18, 2018 by the EPO Opposition Division. The
written decision was received on February 15, 2019 and the two-month
deadline to appeal the decision ends on April 15, 2019.
Core Composition Pending (contains claims directed to compositions containing DMF wherein
the daily dosage is from 480 to 600 mg and the DMF is released depending
on pH for the treatment of a number of diseases). The EPO issued a notice of
intention to grant this patent on June 26, 2018. A request for further
processing was granted on March 13, 2019.
EP2801354
Core Composition Granted (contains claims directed to controlled-release compositions that
release DMF according to a specific in vitro release profile). Oppositions to
this patent have been filed by third parties with the EPO. An oral hearing has
been scheduled for May 7, 2019.
28
Table of Contents
Patent / Application
EP2792349
Patent Family
Status
Core Composition Pending (contains claims directed to controlled-release compositions
containing DMF wherein the daily dosage is 480 mg for use in treatment of a
number of diseases). The EPO has issued notices of intention to grant this
patent on September 13, 2017, May 30, 2018, and February 27, 2019.
EP2316430
EP3093012
Core Composition Revoked by EPO Technical Board of Appeal on May 3, 2018.
Core Composition Pending (contains claims directed to pharmaceutical compositions
comprising DMF in an amount of 50 to 90% by weight of the composition).
The EPO has issued notices of intention to grant this patent on May 8, 2017,
February 15, 2018, and November 21, 2018.
JP2018-017332
Core Composition Pending (contains claims directed to controlled-release pharmaceutical
EP2379063
Erosion Matrix
EP3295936
Erosion Matrix
EP2564839
Erosion Matrix
compositions comprising one or more of fumaric acid esters such as DMF
and/or MMF).
Granted (contains claims directed to matrix formulations with a thin enteric
coating). Oppositions filed by third parties were rejected by the EPO in the
first instance and the patent was maintained. A number of opponents have
appealed, and the oral proceedings for the appeal have been scheduled for
April 18, 2019.
Pending (contains claims directed to a pharmaceutical formulation in the
form of an erosion matrix tablet having a particular composition). The
application published on March 21, 2018. A reply to the preliminary written
search and opinion was filed on September 20, 2018.
Granted (contains claims directed to a pharmaceutical formulation in the form
of an erosion matrix tablet having a particular composition). The patent was
maintained following the hearing of the Opposition Division on June 7, 2018.
The opponent has appealed against this decision. A reply to the appeal was
filed on January 11, 2019.
JP5788331
Erosion Matrix
Granted (contains claims directed to a pharmaceutical formulation in the form
of an erosion matrix tablet having a particular composition).
JP2015-149886
Erosion Matrix
Pending (contains claims directed to a pharmaceutical formulation in the
form of an erosion matrix tablet having a particular composition).
29
Table of Contents
Core Composition Patent Family
European Intellectual Property
European Patent EP2801355. The EP'355 patent covers, among other things, the treatment of MS with 480 mg per day of DMF using pH-controlled
compositions that have an enteric coating. The EPO completed its review of this application and issued this patent on May 20, 2015. This patent was opposed by
several parties in opposition proceedings, which are special proceedings heard by the EPO where one or more third parties request that the patent, or a part
thereof, be revoked. On January 29, 2018, the European Patent Office, or EPO, revoked the EP'355 patent on one of the alleged grounds of invalidity following
the oral hearing in the Opposition Proceeding. On March 22, 2018, the Opposition Division issued its written decision with detailed reasons for the decision, on
May 7, 2018, the Company submitted its notice of appeal, and on August 1, 2018, the Company submitted the detailed grounds for the appeal. The duration of the
appeal process is estimated to be approximately three years; however, delays can occur that would extend the estimated duration of the appeal process. There can
be no assurance that we will be successful in the Opposition Proceeding after any appeals. If the Company is unsuccessful in the Opposition Proceeding, the
Company would not be entitled to future royalties on Biogen's net sales outside the U.S. If the Company prevails in the appeal against the decision of January 29,
2018, we expect the Technical Board of Appeal to remand the case to the Opposition Division, in order for the Opposition Division to resolve the remaining
elements of the original opposition. While the appeal and any remanded issues have not been resolved, the decision of the Opposition Division to revoke the
EP'355 patent is "frozen." Assuming that the patent is ultimately maintained following the final conclusion of the Opposition Proceeding, including any appeals,
the EP'355 patent has a maximum duration until October 2025 (subject to possible SPC extension—see below). This is the first issued patent associated with the
Company covering the use of 480 mg per day of DMF to treat MS. Although Biogen may not challenge the validity of the EP'355 patent in national proceedings,
the validity of the national parts of the EP'355 patent could be challenged by other third parties in the respective national courts, and in some countries these
validity challenges can run in parallel with EPO opposition and appeal proceedings. See "Risk Factors—Risks Related to Intellectual Property—There can be no
assurance that even if we are successful in the opposition and appeal proceedings involving the patents associated with the Company currently pending before the
EPO, we will not be subject to subsequent or parallel invalidity proceedings involving these same or other patents associated with the Company before a national
court in any of the European Patent Convention member states where the patents were validated, which subsequent or parallel proceedings could result in the
challenged patents being subject to continued uncertainty as to their validity until such proceedings have been fully concluded. We cannot at this time anticipate
how long any such proceedings may last or when, if at all, the patents currently under challenge will finally be declared to be valid or not."
SPC Applications. In a number of countries in the EU, we have applied for national SPCs in reliance on the EP'355 patent and the EU marketing
authorization for Biogen's product Tecfidera®. If these applications are successful, the resultant SPCs will effectively extend the duration of the EP'355 patent,
insofar as it covers Tecfidera®, from October 2025 until January 2029. So far, the SPC applications have been granted in Cyprus, France, Greece, Hungary,
Ireland, Italy, Latvia, Luxembourg, Slovenia, Spain and Sweden. This is possible because the case law of the Court of Justice for the European Union currently
allows patent holders to obtain SPCs in reliance on marketing authorizations held by third parties. If the case law were to change such that this is no longer a
possibility, we would expect any such SPCs granted in our favor to be revoked. Further, if an EU national court were to hold (subject to any appeal) that the
claims of the EP'355 patent do not cover Tecfidera®, we would expect the national court to revoke any SPC granted in our favor in that country.
European Patent EP1799196. The European patent EP1799196 associated with the Company, or the EP'196 patent, covers, among other things, controlled
release compositions that release DMF
30
Table of Contents
according to a specific in vitro release profile. The patent was granted on June 22, 2016. Oppositions to this patent have been filed by third parties with the EPO.
On September 18, 2018, the EPO revoked the EP'196 Patent following an oral hearing in the opposition proceedings. The written decision was received on
February 15, 2019 and the two-month deadline to appeal the decision ends on April 15, 2019.
European Patent Application EP2965751. Another key patent application in the EU is EP2965751, formerly EP15166243.4, or the EP'751 application. The
EP'751 application covers, among other things, compositions containing DMF where the daily dosage is 480 to 600 mg and the DMF is released depending on
pH. The EPO has completed its initial review of this application and issued a negative search report on January 13, 2016. We responded to the search report on
July 13, 2016. A third-party observation was filed on September 20, 2016. We responded to the third-party observation on November 16, 2016. A negative office
action was issued on February 10, 2017, which we understood to have been the result of a clerical error. We responded on August 10, 2017 to correct the error.
The EPO issued a notice of intention to grant this patent on June 26, 2018. A request for further processing was granted on March 13, 2019.
European Patent EP2801354. A key patent in the EU is EP2801354, or the EP'354 patent. The EP'354 patent covers, among other things, controlled-
release compositions that release DMF according to a specific in vitro release profile. The patent was granted on February 8, 2017. Oppositions to this patent have
been filed by third parties with the EPO. An oral hearing has been scheduled for May 7, 2019.
European Patent Application EP2792349. Another key patent application in the EU is EP2792349, formerly EP14172396.5, or the EP'349 application. The
EP'349 application covers, among other things, controlled-release compositions containing DMF where the daily dosage is 480mg for use in treatment of a
number of diseases. The EPO has issued notices of intention to grant this patent on September 13, 2017, May 30, 2018 and February 27, 2019.
European Patent EP2316430. The European patent EP2316430 associated with the Company covered DMF formulations with certain in vitro dissolution
profiles. By a decision issued in July 2015, the Opposition Division of the EPO revoked EP2316430, in particular, for the reason that the claims allegedly contain
subject matter not directly and unambiguously derivable from the original application as filed. The Opposition Division of the EPO did not adjudicate on the
issues of novelty or inventive step. This patent was revoked by the EPO Technical Board of Appeal on May 3, 2018. No further appeal is possible.
European Patent Application EP3093012. Another key patent application in the EU is EP3093012, formerly EP16001391.8, or the EP'012 application. The
EP'012 application covers, among other things, controlled-release pharmaceutical compositions comprising DMF in an amount of 50 - 90% by weight of the
composition. The EPO has issued notices of intention to grant this patent on May 8, 2017, February 15, 2018 and November 21, 2018.
Erosion Matrix Patent Family
European Patent EP2379063. A patent from the Erosion Matrix Patent family associated with the Company, EP2379063 (covering matrix formulations
with a thin enteric coating), has been granted by the EPO. Multiple third parties, including Biogen, opposed this patent before the EPO. Those oppositions were
rejected by the EPO and the patent was maintained in its entirety at a hearing on April 5, 2016. The decision has been appealed and oral proceedings for the
appeal have been scheduled for April 18, 2019. The Preliminary Opinion of the Board of Appeal was communicated on March 12, 2019 and the preliminary, non-
binding opinion of the Board was that the patent lacked an inventive step.
31
Table of Contents
European Patent EP2564839 (containing claims directed to a pharmaceutical formulation in the form of an erosion matrix tablet having a particular
composition). The EPO issued this patent on May 11, 2016. The patent was maintained following the hearing of the Opposition Division on June 7, 2018. The
opponent has appealed against this decision. A reply to the appeal was filed on January 11, 2019.
European Patent Application EP3295936. A pending application (containing claims directed to a pharmaceutical formulation in the form of an erosion
matrix tablet having a particular composition) was published on March 21, 2018 under publication number EP3295936. A reply to the preliminary written search
and opinion was filed on September 20, 2018.
Clinical Development Summary
Since inception, the focus of our clinical development was on a DMF formulation for the treatment of MS. As a result of entering into the License
Agreement, combined with the recently announced unsuccessful outcome in the Interference Proceeding and Biogen's purchase of the intellectual property in the
U.S. associated with the Company, we have permanently discontinued our development of a DMF formulation, except for maintaining our files and records for
previously completed research and development work.
Material Agreements
Biogen License Agreement
As discussed above, on February 1, 2017, our License Agreement with Biogen and certain additional parties became effective. The License Agreement
provided Biogen with a co-exclusive license in the U.S., and an exclusive license outside the U.S., to the Company's intellectual property, effective as of
February 9, 2017.
In accordance with the License Agreement, Biogen paid the Company a non-refundable cash fee of $1.25 billion and could be obligated to pay the Company
royalties provided that other conditions of the License Agreement are satisfied. See "—Our Company—License Agreement with Biogen."
On March 25, 2019, we received notice from Biogen of their exercise of the option to purchase the intellectual property in the U.S. associated with the
Company pursuant to the License Agreement. We and Biogen have consummated the assignment of the U.S. intellectual property to Biogen upon the execution of
assignment agreements and the payment of a nominal amount by Biogen to FWP IP ApS, and Biogen has assumed ownership and responsibility for the assigned
U.S. intellectual property. In addition, we are no longer able to develop or commercialize any therapy for the treatment of any human disease or condition using
DMF, including FP187®.
Aditech Agreements
In 2004, Aditech, controlled by Nordic Biotech General Partner ApS (an affiliate of one of our largest shareholders), began developing and filing patents for,
among other things, formulations and dosing regimens of DMF. In 2005, we entered into a patent license agreement with Aditech to license this patent family
from Aditech. In 2010, we acquired this patent family from Aditech pursuant to a patent transfer agreement that replaced the patent license agreement. Under our
agreement with Aditech, we obtained, among other things, Aditech's patents and associated know-how related to formulations and dosing regimens of DMF,
subject to both diligence and minimum annual expenditure (EUR 1.0 million per year) obligations on our part.
In connection with our execution of the License Agreement, we entered into an addendum to the patent transfer agreement with Aditech pursuant to which
Aditech agreed to waive its rights to, among other things, terminate the patent transfer agreement (which rights gave Aditech an option to receive back, for no
consideration, all of our DMF-related assets in the event of the Company's liquidation or
32
Table of Contents
bankruptcy, material breach by the Company of the patent transfer agreement or the Company's failure to meet its obligations with respect to the development and
commercialization of the patent rights as set forth in the patent transfer agreement).
In addition, the addendum to the patent transfer agreement, or the Addendum, clarifies the royalties payable to Aditech in connection with any proceeds
received by the Company from Biogen under the License Agreement. The Addendum specifies that Aditech is entitled to 2% of the Non-refundable Fee (or
$25 million). This was paid to Aditech in 2017. The Addendum further specifies that Aditech is entitled to additional compensation should the Company receive
royalties from Biogen under the License Agreement. If royalties are paid to the Company in accordance with the License Agreement, Aditech will be entitled to
receive a cash payment equal to 2% of the same base amount with respect to which the Company's royalty percentage is calculated, accruing from the same
period of time as any royalty payment payable by Biogen to the Company (prior to taking into account taxes, duties and VAT, if any).
Competition
We are engaged in segments of the pharmaceutical and biotechnological industries that are highly competitive and rapidly changing. Large pharmaceutical,
specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are
commercializing or pursuing the development of products that target multiple sclerosis. Our future success may depend on the continued market acceptance of
Tecfidera®. We expect approved MS treatments, such as Tecfidera®, will continue to face intense and increasing competition as new and improved products
enter the MS markets and advanced technologies become available. Competition from any newly approved products (whether branded, generics or biosimilars)
may reduce Tecfidera® sales, which in turn may reduce possible royalties payable by Biogen to us. Several companies are developing additional treatments for
multiple sclerosis, and late-stage clinical candidates include, but are not limited to, generic versions of existing medications and Celgene's ozanimod. Competition
among products approved for sale is based, among other things, on safety and effectiveness, the timing and scope of regulatory approvals, the availability and cost
of supply, marketing and sales capabilities, reimbursement coverage, price, patent position and other factors.
Environmental, Health and Safety
Our operations are subject to a number of environmental acts and regulations. We believe that we are materially in compliance with all applicable
environmental laws and regulations. Currently, there are no pending environmental issues that we believe could reasonably be expected to have a material adverse
effect on our business, financial position, results of operations or future growth prospects.
We consider it important to maintain a good working environment and comply with the regulatory requirements regarding working environment. This
consists of the physical and psychological working environment, including heating, ventilation, air conditioning and air circulation and exhaust systems, as well
as office furniture and equipment design and functionality, and other general health and safety systems, including control of the facility. We are from time to time
subject to inspections by the Danish Working Environment Authority for compliance with the Danish Working Environment Act.
Facilities
Our corporate headquarters are located at Østergade 24A, 1st floor, 1100 Copenhagen K, Denmark where we lease approximately 2,400 square feet of office
space from Nordic Biotech Advisors ApS, an affiliate of certain of our principal shareholders, for administrative activities. In 2018, we paid 601,000 DKK
(approximately $95,000), including value added tax, or VAT, for such premises. Forward Pharma FA ApS and Forward Pharma Operations ApS, our Danish
subsidiaries, are also located at
33
Table of Contents
Østergade 24A, 1st floor, 1100 Copenhagen K, Denmark. For more information, see "—Related Party Transactions—Leased Premises."
Forward Pharma GmbH, our German subsidiary, had approximately 700 square feet of office space for administrative activities in Leipzig, Germany until its
lease cancellation effective March 31, 2018. In 2018, we paid EUR 6,000 (approximately $7,000) for such premises (excluding fees paid for electricity and
cleaning fees).
Forward Pharma USA, LLC, our U.S. subsidiary, is located in Suffern, New York and has office space of approximately 140 square feet. In 2018, we paid
$10,000 for such premises. Until March 31, 2018, Forward Pharma USA, LLC had an office space of approximately 450 square feet in Hawthorne, New York.
Our lease payments for 2018 for these premises were $9,000.
The Company's long-term office lease commitments are not material.
Employees
As of March 31, 2019, we had five employees. At each date shown, we had the following employees, broken out by department and geography:
At December 31,
2017
2016
2018
At March 31,
2019
Function:
Clinical and regulatory affairs
Engineering and production
Management and administration
Total
Geography:
Germany
Denmark
United States
Total
3
3
7
13
4
6
3
13
0
1
4
5
2
2
1
5
0
1
4
5
1
3
1
5
0
1
4
5
1
3
1
5
One of our employees is represented by a labor union. We have never experienced any work stoppages.
All other operational tasks are or have been outsourced to consultant experts or consulting service companies, such as patent and legal experts. We engage
approximately 15 individuals and firms as consultants and experts.
In the U.S., our activities and personnel are focused on U.S. public company accounting, reporting and compliance, and related administrative functions to
support Forward Pharma A/S.
Insurance
We maintain all insurance coverage required under applicable law, including in relation to our previous research and pre-clinical and clinical development.
We believe that we currently maintain appropriate insurance coverage, and that our current insurance coverage is in line with insurance coverage for
comparable companies.
34
Table of Contents
Legal Proceedings
We may, from time to time, become involved in legal proceedings in the ordinary course of business. Except for the Opposition Proceeding, we are not
currently a party to, and have not been in the recent past subject to any material legal proceeding (including proceedings pending or threatened) that we believe
could have an adverse effect on our business, operating results or financial condition. See "Item 5. Operating and Financial Review and Prospects—Operating
Results Overview—Intellectual Property Proceedings and the License Agreement—Interference Proceeding" for more information on the Interference
Proceeding.
Opposition proceedings and appeals therefrom against four of the European patents associated with the Company are currently ongoing and in addition we
are involved in the Opposition Proceeding concerning EP'355, including any appeals. There can be no assurance that these patent proceedings or other future
legal proceedings will not have an adverse effect on our business, operating results or financial condition. See "Item 5. Operating and Financial Review and
Prospects—Operating Results Overview—Intellectual Property Proceedings and the License Agreement—Opposition Proceeding" for more information on the
Opposition Proceeding.
C. Organizational Structure
The registrant corporation, Forward Pharma A/S, has two wholly owned subsidiaries, Forward Pharma USA, LLC, incorporated in the state of Delaware, and
Forward Pharma Operations ApS, incorporated in Denmark. Forward Pharma Operations ApS has two wholly owned subsidiaries, Forward Pharma FA ApS,
incorporated in Denmark, and Forward Pharma GmbH, incorporated in Germany. All of our operations are conducted within Forward Pharma A/S or one of our
directly or indirectly owned subsidiaries.
D. Property, Plant and Equipment
See "—Business Overview—Facilities" for a description of our leased premises. Our equipment includes computers, office equipment, furniture and
manufacturing equipment with a net book value at December 31, 2018 and 2017, of zero and $12,000, respectively. In connection with winding down of research
and development efforts in 2017, our manufacturing equipment was deemed impaired and accordingly during the year ended December 31, 2017 the book value
of our manufacturing equipment was reduced to zero. None of our equipment is leased and there are no liens or encumbrances on our equipment.
We currently do not have any material commitments to acquire fixed assets nor are there plans to acquire fixed assets in the future; however, we may, from
time to time, need to replace office equipment such as computers. The estimated cost to replace office equipment, if needed, is not expected to be significant. We
currently do not have any long-term supply agreements with our vendors.
ITEM 4A. UNRESOLVED STAFF COMMENTS
None.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with the information under "Selected
Financial Information" and our audited consolidated financial statements, including the notes thereto, included in this Annual Report. The following discussion is
based on our consolidated financial information prepared in accordance with IFRS as issued
35
Table of Contents
by the IASB, which might differ in material respects from generally accepted accounting principles in other jurisdictions. The following discussion includes
forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-
looking statements as a result of many factors, including but not limited to those described under "Risk Factors" and elsewhere in this Annual Report.
A. Operating Results Overview
Overview
Forward Pharma A/S is a Danish biopharmaceutical company that was founded in 2005 to advance unique formulations and dosing regimens of DMF, an
immunomodulator, as a therapeutic to improve the health of patients with immune disorders, including MS. We are a company with a limited number of
employees and outsource the majority of our activities to external service providers. We are currently composed of a Danish incorporated parent company,
Forward Pharma A/S, its two wholly owned subsidiaries, Forward Pharma USA, LLC, incorporated in the state of Delaware, and Forward Pharma Operations
ApS, incorporated in Denmark, and two wholly owned subsidiaries of Forward Pharma Operations ApS, Forward Pharma GmbH, incorporated in Germany and
Forward Pharma FA ApS, incorporated in Denmark. During 2017, as part of the restructuring that is discussed below, FWP IP ApS was established on June 30,
2017 as a wholly owned subsidiary of Forward Pharma Operations ApS and sold on November 22, 2017. As discussed in more detail elsewhere herein, the
Company entered into the License Agreement with Biogen that became effective on February 1, 2017. Prior to entering into the License Agreement, the Company
was actively developing FP187®, a proprietary formulation of DMF, for the treatment of MS. The Company announced on March 1, 2017 plans to complete the
remaining research and development efforts of FP187 ® and pursue an organizational realignment to reduce personnel and operating expenses by mid-year 2017.
The organizational realignment was substantially completed by September 30, 2017. As a result of entering into the License Agreement, combined with the
recently announced unsuccessful outcome in the Interference Proceeding and Biogen's purchase of the intellectual property in the U.S. associated with the
Company, we have permanently discontinued our development of DMF formulations, including FP187®. Therefore, sources of revenue derived from customers
in the United States, including product sales of a DMF formulation, are not expected.
The Company currently estimates that there will be adequate liquidity to continue as a going concern beyond the next twelve months; however, unforeseen
events could negatively affect this estimate and the impact could be material. If the Company fails to prevail in the Opposition Proceeding, including all appeals,
future revenues are unlikely, the Company's ability to continue as a going concern long-term would be uncertain and management would consider, amongst other
things, an orderly wind-down of operations. Management currently estimates that the duration of the Opposition Proceeding is approximately three years, or
longer. During the coming years, until such time as the Opposition Proceeding is concluded, management estimates that operating activities of the Company will
remain at current levels, or decline slightly, as we continue to defend and protect the intellectual property associated with the Company and evaluate possible
further cost reductions.
Currently, there are no plans for future distributions of funds to our shareholders.
Restructuring
Under the terms of the License Agreement, the Company restructured its operations on June 30, 2017 whereby the Company transferred to Forward Pharma
Operations ApS (a newly created and wholly owned Danish limited liability company) certain assets and liabilities, including the legal and beneficial rights, title
and interest to defined intellectual property, and Forward Pharma Operations ApS transferred the intellectual property to FWP IP ApS (a newly created and
wholly owned Danish
36
Table of Contents
limited liability company). The final step in the restructuring was completed on November 22, 2017 when the capital stock of FWP IP ApS was sold to FWP
HoldCo ApS, a newly formed Danish limited liability company that is owned and controlled by FWP Fonden, a newly formed independent Danish foundation.
FWP HoldCo ApS paid Forward Pharma Operations ApS 336,000 DKK ($54,000 based on the December 31, 2017 exchange rate) as consideration for the capital
stock of FWP IP ApS. FWP Fonden's three-member board includes one independent director and one director appointed from each of the Company and Biogen.
Accordingly, the Company does not control FWP Fonden. During the year ended December 31, 2017, the Company contributed 5 million DKK ($805,000 based
on the December 31, 2017 exchange rate) as the initial capitalization of FWP Fonden and is obligated to pay 100,000 DKK ($15,000 based on the December 31,
2018 exchange rate) annually to FWP IP ApS in exchange for FWP IP ApS agreeing to hold, prosecute and maintain the transferred intellectual property, which
now consists only of the non-U.S. intellectual property associated with the Company, in accordance with certain agreements. In connection with the initial
capitalization of FWP Fonden, the Company's annual funding obligations to FWP IP ApS and the sale of the capital stock of FWP IP ApS to FWP HoldCo ApS,
the Company incurred a net expense of $759,000 that is included in general and administrative expenses for the year ended December 31, 2017. In the future, the
Company is only obligated to remit the annual funding of 100,000 DKK to FWP IP ApS through the last to expire, or invalidation of, the licensed patents
underlying the transferred intellectual property; however, the Company's obligation to remit the annual funding would be discontinued earlier if certain events, as
defined in the License Agreement, occur. In addition to its annual funding obligations, the License Agreement requires the Company to fund the cost to file,
prosecute and maintain the European patent EP 2801355 (until the date on which the Opposition Proceeding has reached a final, unappealable conclusion) and to
participate in an intellectual property advisory committee. The Company was required to fund the cost to file, prosecute and maintain the U.S. patents associated
with the Company prior to Biogen purchasing such intellectual property.
Share Split and Shareholder Distribution
On August 2, 2017, the Company's shareholders approved 10 for 1 share split and a capital reduction of EUR 917.7 million, or $1.1 billion. The Capital
Reduction was effected by a distribution to shareholders in September 2017. The Capital Reduction was executed through the annulment of 80% of the ordinary
shares outstanding post Share Split. Following the Share Split and the Capital Reduction, each ADS was modified to represent two ordinary shares. Each ordinary
share subsequent to the Share Split has a nominal value of 0.01 DKK. See Notes 3.5 and 5.1 in the accompanying financial statements for additional information.
Amendment to the Company's Articles of Association
In November 2017, the shareholders of the Company approved an amendment to the Company's articles of association, which modified the terms of certain
outstanding options and warrants granted by the Company to mitigate the dilution to such awards caused by the Shareholder Distribution. In November 2017, a
similar amendment was approved by the board of directors of the Company in respect to certain deferred share awards granted by the Company (the amended
options, warrants and deferred shares are collectively referred to as the "Awards" and the amendments of the Awards are collectively referred to as the
"Amendment"). The overall effect of the Amendment provided for cash payments to Award holders of EUR 36.2 million ($43.4 million based on the
December 31, 2017 exchange rate) and a reduction in the number of outstanding Awards by 28.8 million. As a result of the Amendment, the Company recognized
during 2017 compensation expense of $11.7 million and a reduction to shareholder equity of $32.2 million. See Notes 3.3 and 5.1 in the accompanying financial
statements for additional information.
37
Table of Contents
Intellectual Property Proceedings and the License Agreement
On February 1, 2017, the License Agreement with Biogen and certain additional parties became effective. The License Agreement provided Biogen with a
co-exclusive license in the United States, and an exclusive license outside the United States, to the IP, effective as of February 9, 2017.
In accordance with the License Agreement, Biogen paid the Company a non-refundable fee of $1.25 billion ("Non-refundable Fee") in February 2017.
On March 25, 2019, we received notice from Biogen of their exercise of the option to purchase the intellectual property in the U.S. associated with the
Company pursuant to the License Agreement. We and Biogen have consummated the assignment of the U.S. intellectual property to Biogen upon the execution of
assignment agreements and the payment of a nominal amount by Biogen to FWP IP ApS, and Biogen has assumed ownership and responsibility for the assigned
U.S. intellectual property. In addition, we are no longer able to develop or commercialize any therapy for the treatment of any human disease or condition using
DMF, including FP187®.
Background
On April 13, 2015, an administrative patent judge at the United States Patent Trial and Appeal Board ("PTAB") declared Patent Interference No. 106,023
(the "Interference Proceeding") between the Company's United States Patent Application No. 11/567,871 and United States Patent No. 8,399,514B2 held by a
subsidiary of Biogen Inc. The License Agreement did not resolve the Interference Proceeding between the Company and Biogen or the pending opposition
proceeding against the Company's European patent EP2801355 (the "Opposition Proceeding"). Rather, the PTAB and the United States Court of Appeals for the
Federal Circuit (the "Federal Circuit"), as applicable, and the Opposition Division, the Technical Board of Appeal and the Enlarged Board of Appeal of the
European Patent Office (the "EPO"), as applicable, will make or have made final determinations in the Interference Proceeding and Opposition Proceeding,
respectively. As discussed further below, the final determinations in the proceedings would determine whether future royalties are due the Company in accordance
with the License Agreement. An unsuccessful outcome in the Interference Proceeding would result in the Company not being entitled to royalties based on
Biogen's future net sales in the United States, as defined in the License Agreement, and an unsuccessful outcome in the Opposition Proceeding would result in the
Company not being entitled to royalties on Biogen's future net sales outside the United States, as defined in the License Agreement.
Interference Proceeding
On March 31, 2017, the PTAB issued a decision in the Interference Proceeding in favor of Biogen. The PTAB ruled that the claims of the Company's United
States Patent Application No. 11/567,871 are not patentable due to a lack of adequate written description. On May 30, 2017, the Company filed a notice of appeal
with the Federal Circuit seeking to have the PTAB's decision overturned and the Interference Proceeding reinstated. On October 24, 2018, the Federal Circuit
affirmed the PTAB's decision. On November 21, 2018, the Company filed a petition for rehearing of the Federal Circuit's decision. The rehearing request was
denied on January 2, 2019 and the Federal Circuit's decision became final on January 9, 2019. The Federal Circuit's final decision ends the Interference
Proceeding in favor of Biogen.
Because the Company was unsuccessful in the Interference Proceeding after all appeals, pursuant to the License Agreement, Biogen had the option to elect
to obtain an exclusive license to the intellectual property in the U.S. associated with the Company or to purchase the intellectual property in the U.S. associated
with the Company for a nominal price.
38
Table of Contents
On March 25, 2019, we received notice from Biogen of their exercise of the option to purchase the intellectual property in the U.S. associated with the
Company pursuant to the License Agreement. We and Biogen have consummated the assignment of the U.S. intellectual property to Biogen upon the execution of
assignment agreements and the payment of a nominal amount by Biogen to FWP IP ApS, and Biogen has assumed ownership and responsibility for the assigned
U.S. intellectual property. In addition, we are no longer able to develop or commercialize any therapy for the treatment of any human disease or condition using
DMF, including FP187®. Because we were unsuccessful in the Interference Proceeding after all appeals, the Company will not be entitled to future royalties on
Biogen's net sales in the U.S. Therefore, sources of revenue derived from customers in the U.S., including product sales of any DMF formulation, are not
expected.
Opposition Proceeding
If the Company is successful in the Opposition Proceeding (i.e., the Company obtains, as a result of the Opposition Proceeding, and any appeals therefrom, a
patent with a claim covering oral treatment of MS with 480 mg/day of DMF), it would be eligible beginning on January 1, 2021 to collect a 10% royalty
(increasing to 20% from January 1, 2029) until the earlier of the expiration or invalidation of the patents defined in the License Agreement, on a country-by-
country basis on Biogen's net sales outside the United States of DMF-containing products indicated for treating MS that, but for the license granted under the
License Agreement, would infringe a Company patent, provided that other conditions of the License Agreement are satisfied. Among the conditions that need to
be satisfied for any royalty to be payable by Biogen to the Company is the absence of generic entry in a particular geography having a particular impact as
defined in the License Agreement. If the Company is unsuccessful in the Opposition Proceeding and any appeals therefrom, the Company would not be entitled to
future royalties on Biogen's net sales outside the United States.
On January 29, 2018, the Opposition Division of the EPO concluded the oral proceeding concerning patent EP2801355 and issued an initial decision in the
Opposition Proceeding. The Opposition Division revoked patent EP2801355 after considering third-party oppositions from several opponents. On March 22,
2018, the Opposition Division issued its written decision with detailed reasons for the decision, on May 7, 2018, the Company submitted its notice of appeal, and
on August 1, 2018, the Company submitted the detailed grounds for the appeal. If the Company prevails in such appeal, it is expected that the Technical Board of
Appeal will remand the case to the Opposition Division, in order for the Opposition Division to resolve the remaining elements of the original opposition. The
duration of the appeal process is estimated to be approximately three years. However, delays can occur that would extend the estimated duration of the appeal
process.
Trend Information
We do not have any commercialized products on the market. As a result of entering into the License Agreement, combined with the recently announced
unsuccessful outcome in the Interference Proceeding and Biogen's purchase of the intellectual property in the U.S. associated with the Company, we have
permanently discontinued our development of DMF formulations, including FP187®. At this time, the Company's only potential source of future revenue is
contingent on a favorable outcome of the Opposition Proceeding. A successful outcome in the Opposition Proceeding is highly uncertain, but if it were to occur,
the Company would be entitled to royalties, provided other conditions are met, based on Biogen's net sales of Tecfidera® outside the U.S. as defined by the
License Agreement. Accordingly, we expect any trends in the biopharmaceutical market to have an impact on our business, particularly, trends that effect the
market for, or price of, Tecfidera® sales outside the U.S.
39
Table of Contents
Financial Operations Overview
Revenue
As discussed further below, the Company's only source of operating revenue to date has come from the License Agreement and we will likely not generate
operating revenue in the future unless we prevail in the Opposition Proceeding. The Company's ability to generate operating revenues in the future is highly
uncertain and it is possible that we may never recognize operating revenue in the future.
The Company elected to adopt IFRS 15 Revenue from Contracts with Customer, or IFRS 15, on January 1, 2017. Under IFRS 15 the Company recognizes
revenue to reflect the transfer of goods or services to customers in an amount that reflects the consideration to which the Company expects to receive in exchange
for such goods or services. Prior to entering to the License Agreement, the Company did not have revenue from contracts with customers that were within the
scope of IFRS 15 and therefore the initial adoption of IFRS 15 had no effect on previously reported financial statements nor was an adjustment made to the
Company's accumulated deficit at January 1, 2017. The only contract that the Company is party to that is within the scope of IFRS 15 is the License Agreement.
Management concluded that the Non-refundable Fee should be recognized as revenue in full in 2017. In reaching this conclusion, various judgments were
made, including the identification of the Company's performance obligations within the License Agreement and whether these performance obligations are
distinct. Management concluded that the performance obligations in the License Agreement were related to the right granted to Biogen to use the licensed
intellectual property both in the United States as well as in the rest of the world and concluded that these performance obligations were met at the time the
License Agreement was consummated, as Biogen was granted full use of the licensed intellectual property whether under a co-exclusive license or an exclusive
license. At the time the License Agreement became effective, the Company was required to (i) to fund the cost to file, prosecute and maintain the United States
patents and European patent EP 2801355 associated with the Company, (ii) to participate in an intellectual property advisory committee and (iii) to provide the
annual funding of 100,000 DKK (collectively "Defense Costs"). Effective upon Biogen purchasing the U.S. patents previously associated with the Company, the
Company is no longer required to fund the cost to file, prosecute and maintain such intellectual property. The period the Company is obligated to fund the
Defense Costs is defined in the License Agreement and could include the period from the effective date of the License Agreement through the last to expire, or
invalidation of, the licensed patents; however, the Company's obligation to fund Defense Costs would be discontinued earlier if certain events, as defined in the
License Agreement, occur. Management concluded that the Company's obligation to defend the intellectual property does not represent a separate performance
obligation as such activities are deemed to be costs to protect the value of the license granted to Biogen. Since Biogen received full unrestricted use of the
Company's intellectual property at the time the License Agreement was consummated and since the Company currently has no plans to nor is it obligated to
further develop the underlying licensed intellectual property, the License Agreement is deemed to provide Biogen with a right to use the Company's intellectual
property upon the consummation of the License Agreement.
Research and development costs
Historical research and development costs related primarily to the development of DMF formulations for the treatment of psoriasis and MS, and they consist
primarily of:
•
salaries for research and development staff and fees to consultants, as well as expenses incurred by all such personnel; expenses related to share-
based compensation to employees and others; the costs of our extensive use of external third-party experts (e.g., consultants for the relapsing
forms of MS indication) for our product development efforts; and the outsourcing of specific development tasks to contract manufacturing
organizations, or CMOs;
40
Table of Contents
•
•
•
costs for formulation, development and production of tablets in new doses for use in clinical trials; and production of DMF by our external CMOs,
including the costs of testing related to increasing the batch sizes and manufacturing capability of our CMOs in order for us to be able to scale to
anticipated next level or later commercial production levels and the costs of limited initial testing of new tablet strengths and forms for the
treatment of relapsing forms of MS;
fees and other costs paid to clinical research organizations, or CROs, in connection with pre-clinical testing, formulation and product testing of
tablets; and the fees and costs associated with the performance of clinical trials in relapsing forms of MS and psoriasis, that were outsourced to
CROs, in anticipation of planning and running the clinical trials for us, and helping us to gather and maintain all required clinical data for
regulatory purposes; and
fees and expenses incurred to prepare and file patent applications and other intellectual property claims, responding to patent office actions, and
conducting patent opposition and interference proceedings and other activities aimed at enhancing and protecting our intellectual property estate
provided such fees and expenses relate to intellectual property-related activities that reside within the USPTO, EPO or other country-specific
patent registry offices (collectively referred to as "Patent Fees"). If expenses incurred are associated with the Company's intellectual property-
related activities carried out in the courts to protect, defend and enforce granted patent rights against third parties (not residing within the USPTO,
EPO or other country-specific patent registry offices) they are classified within general and administrative expenses.
As a result of entering into the License Agreement, combined with the recently announced unsuccessful outcome in the Interference Proceeding and Biogen's
purchase of the intellectual property in the U.S. associated with the Company, we have permanently discontinued our research and development efforts involving
DMF products, including FP187®. Prospectively, research and development activities will primarily relate to Patent Fees; however, we do expect to incur minor
costs to meet remaining regulatory requirements associated with the wind-down of our research and development efforts.
General and administrative costs
Our general and administrative costs consist primarily of:
•
•
•
•
•
•
•
salaries and expenses for employees other than research and development staff, as well as expenses related to share-based compensation awards
granted to certain employees;
professional fees for auditors, legal counsel and other consulting expenses not related to research and development activities;
in 2017, costs of the restructuring;
cost of facilities, communication and office expenses;
investor relations and other costs associated with our public listing of our ADSs on Nasdaq;
information technology related expenses; and
expenses associated with intellectual property-related activities carried out in the courts to protect, defend and enforce patent rights granted against
third parties (not residing within the USPTO, EPO or other country-specific patent registry offices).
We incur significant costs as the result of our public listing including the cost to maintain and enhance our infrastructure in order to comply with regulatory
requirements including disclosure controls and procedures. Such costs include maintaining an organization of internal and external professionals who have the
necessary experience and skills to address the complex rules and regulations we are required to comply with. The professionals we engage include legal and
accounting advisors, auditors and investor relations firms amongst others. There are many other costs we incur to maintain our public listing such as liability
insurance and depositary and stock exchange fees.
41
Table of Contents
Non-operating income and (expenses)
Components of non-operating income and (expenses) consisted primarily of:
•
•
•
gains/losses from changes in foreign exchange rates related to certain financial assets and liabilities
interest income earned on available-for-sale financial assets and USD cash holdings; and
bank fees, including negative interest on Euro and DKK cash holdings.
Results of Operations
Comparison of the years ended December 31, 2018 and 2017
Year ended December 31,
2018
2017
Change
favorable
(unfavorable)
Revenue from the License Agreement
Cost of the Aditech Pharma AG patent transfer agreement
Research and development costs
General and administrative costs
Operating (loss) income
Exchange rate gains (losses)
Interest income from available-for-sale financial assets
Other finance costs
(Loss) income before tax
Income tax benefit (expense)
Net (loss) income
—
—
(2,748)
(9,535)
(USD in thousands)
1,250,000
(25,000)
(20,496)
(17,107)
(12,283) 1,187,397
2,713
—
644
(241)
227
(2,895)
(8,926) 1,184,488
204
(8,722)
(267,395)
917,093
(1,250,000)
25,000
17,748
7,572
(1,199,680)
2,954
(227)
3,539
(1,193,414)
267,599
(925,815)
Revenue from License Agreement for the years ended December 31, 2018 and 2017
During the year ended December 31, 2017, the Company recognized as revenue the $1.25 billion nonrecurring Non-refundable Fee that was received during
February 2017. During the year ended December 31, 2018, the Group did not earn any revenues under the License Agreement nor from other sources.
Accordingly, there were no revenues recognized during the year ended December 31, 2018.
The License Agreement does not obligate Biogen to remit additional amounts to the Company unless the Company prevails in the Opposition Proceeding,
including any appeals, and certain other conditions of the License Agreement are satisfied. It is highly uncertain whether the Company will prevail in the
Opposition Proceeding and therefore it is possible that additional revenues may not be realized from the License Agreement or any other source. In the event the
Company does prevail in the Opposition Proceeding, Biogen would be obligated to remit future royalties to the Company as defined in the License Agreement,
provided that other conditions of the License Agreement are satisfied. If the Company fails to prevail in the Opposition Proceeding, future revenues are unlikely
and the long-term ability of the Company to continue as a going concern is uncertain. See Note 1.2 to the financial statements for additional information.
Cost of the Aditech Pharma AG agreement for the years ended December 31, 2018 and 2017
The terms of the agreement between Aditech Pharma AG ("Aditech") and the Company, including the addendum to the agreement ("Addendum") executed
in January 2017, provided for Aditech to
42
Table of Contents
receive a royalty equal to 2% of the Non-refundable Fee, which equaled $25 million. During the year ended December 31, 2018, there were no amounts due
Aditech.
Should the Company prevail in the Opposition Proceeding, additional compensation may be due to Aditech. Such additional compensation will equal 2% of
the same base amount with respect to which the Company's royalty percentage is calculated, accruing from the same period of time as any royalty payment
payable by Biogen to the Company (prior to taking into account taxes, duties and VAT, if any.) See Note 6.2 to the financial statements for additional information.
Research and development costs for the years ended December 31, 2018 and 2017
Research and development costs for the years ended December 31, 2018 and 2017 were $2.7 million and $20.5 million, respectively. The decrease in
research and development costs for the year ended December 31, 2018 of $17.7 million is the result of lower costs incurred in connection with the Interference
and Opposition Proceedings, lower share-based compensation and the wind-down of our development efforts of FP187 ®. Fees to patent advisors and other
patent-related costs decreased from $2.7 million in the year ended December 31, 2017 to $826,000 in the year ended December 31, 2018. The decrease is the
result of reduced activities subsequent to the PTAB's issuance of the decision in the Interference Proceeding in favor of Biogen on March 31, 2017 and the
conclusion of the oral proceeding before the Opposition Division of the EPO concerning patent EP2801355 where the Opposition Division revoked patent
EP2801355 on January 29, 2018. Share-based compensation, including the effect of the Amendment of Awards, as discussed above, decreased from $14.4 million
in the year ended December 31, 2017 to $1.5 million in the year ended December 31, 2018. The decrease in share-based compensation resulted in part from the
non-reoccurrence of $9.5 million of expenses recognized in 2017 in connection with the Amendment of Awards, the nonrecurring benefit of $1.8 million
recognized in 2017 in connection with equity awards that were forfeited by terminated employees and the balance relates to equity awards that were issued during
the years ended December 31, 2017, 2016 and 2015 that included graded vesting provisions resulting in expense recognition that decreases in the latter years of
vesting. The balance of the decrease in research and development cost during the year ended December 31, 2018 is the result of winding down FP187 ®
development activities including all preclinical, clinical and contract manufacturing activities that were in process prior to the effective date of the License
Agreement.
We currently expect that our research and development costs will remain at, or slightly below, current levels in the future; however, considering the high
level of uncertainty associated with estimating the nature and timing of costs to be incurred to continue the Opposition Proceeding, including any appeals, it is
possible that unforeseen events could occur that could have a material effect on our estimated expenditures. Prospectively, research and development activities
will primarily relate to Patent Fees and we expect to incur minor costs to comply with regulatory requirements associated with the wind-down of the research and
development efforts of earlier product candidates. We may experience significant fluctuations in our expenses, period-to-period, as the result of the varying nature
of the services expected to be provided by our patent advisor in connection with the Opposition Proceeding.
General and administrative costs for the years ended December 31, 2018 and 2017
General and administrative costs for the years ended December 31, 2018 and 2017 were $9.5 million and $17.1 million, respectively. The decrease in general
and administrative costs in the year ended December 31, 2018 of $7.6 million resulted primarily from a decrease in legal and accounting costs, lower patent
advisory fees incurred in connection with the Interference Proceeding, the absence in 2018 of nonrecurring costs incurred in connection with the formation of
FWP IP ApS in 2017 and an overall reduction in overhead costs. Legal and accounting fees were $6.9 million in the year ended December 31, 2017 compared to
$2.2 million for the year ended December 31, 2018. During the year
43
Table of Contents
ended December 31, 2017, the Company had significant nonrecurring needs for legal and accounting advice in connection with entering into and complying with
the License Agreement. There was no similar need for such services during the year ended December 31, 2018. Patent advisory fees incurred in connection with
the Interference Proceeding were $1.2 million in the year ended December 31, 2017 compared to $453,000 for the year ended December 31, 2018. The reduction
in patent advisory fees reflects less demand for such services in 2018. During the year ended December 31, 2017, we incurred a nonrecurring charge of $759,000
in connection with the formation of FWP IP Aps as discussed above. Share-based compensation, including the effect of the Amendment of Awards, as discussed
above, increased from $4.4 million in the year ended December 31, 2017 to $4.6 million in the year ended December 31, 2018. The increase in share-based
compensation resulted from a number of offsetting items, including the nonrecurring benefit of $5.8 million recognized in 2017 in connection with equity awards
that were forfeited by terminated employees, net of the non-reoccurrence of $2.2 million of expenses recognized in 2017 in connection with the amendment of
equity awards and the impact of equity awards that were issued during the years ended December 31, 2017, 2016 and 2015 that included graded vesting
provisions resulting in expense recognition that decreases in the latter years of vesting. The balance of the decrease in general and administrative cost during the
year ended December 31, 2018 is the result of cost-cutting measures put in place.
We currently expect that our general and administrative costs will remain at current levels; however, unforeseen events could occur that could have a
material effect on our estimated expenditures.
Non-operating income (expense) for the years ended December 31, 2018 and 2017
During the year ended December 31, 2018, the Group recognized a foreign exchange gain of $2.7 million. The $2.7 million foreign exchange gain resulted
primarily from the strengthening of the USD compared to the DKK during the period that is reflected as a non-cash foreign exchange gain when the USD cash is
converted to the functional currency of the Parent and Operations at December 31, 2018. During the year ended December 31, 2017, the Company recognized a
foreign exchange loss of $241,000. The $241,000 foreign exchange loss resulted primarily from the negative effect of the weakening of the USD to the DKK
during the period that is reflected as a non-cash foreign exchange loss when the USD cash and cash equivalents are converted to DKK at December 31, 2017.
During the year ended December 31, 2017, the Company recognized interest income from available-for-sale financial assets of $227,000. During the year
ended December 31, 2018, the Company did not hold available-for-sale financial assets.
Other finance income (expense) primarily includes interest income on USD cash deposits net of bank fees ("negative interest") on EUR and DKK cash
deposits. The favorable change during the year ended December 31, 2018 is the result of lower bank fees incurred in 2018 on lower EUR cash holdings during
2018 subsequent to the Capital Reduction in September 2017 and increased interest income on USD cash deposits resulting from higher rates in 2018.
Income tax (benefit) expense for the years ended December 31, 2018 and 2017
The tax benefit recognized during the year ended December 31, 2018 of $204,000 results in part from a change in estimate of $161,000 and the balance
relates to changes in deferred tax balances during the year. The effective tax rate for the year ended December 31, 2018 was 2.3%, which is lower than the Danish
statutory tax rate of 22.0%. The lower effective tax rate in 2018 is primarily the result of unrecognized deferred tax assets that do not meet the recognition
requirement as discussed below. The income tax expense for the year ended December 31, 2017 totaled $267.4 million. The tax expense for the year ended
December 31, 2017 resulted from the receipt of the Non-refundable Fee, partially
44
Table of Contents
offset by operating expense, resulting in pretax income of $1.2 billion. The effective tax rate for the year ended December 31, 2017 was 22.6%, which is slightly
higher than the Danish statutory tax rate of 22.0%. The difference between the effective tax rate and the statutory tax rate is primarily derived from a higher tax
rate in Germany, where the Group has taxable nexus in addition to Denmark, and certain nondeductible items related to share-based compensation and the
Shareholder Distribution.
Since there is significant uncertainty as to whether the Group will have taxable income in the future, deferred tax assets that are available at December 31,
2018 do not meet the criteria for financial statement recognition and accordingly have not been recognized in the accompanying consolidated financial
statements.
There is an ongoing joint tax audit being conducted by the Danish and German tax authorities of the Group's Danish and German tax returns for each of the
five years in the period ending December 31, 2017. While management believes the tax filing positions taken were correct, there is always the risk that the tax
authorities could disagree resulting in additional taxes, interest and penalty being assessed and the amount could be material. See below as well as Note 3.4 to the
financial statements for additional information.
Comparison of the years ended December 31, 2017 and 2016
Year ended December 31,
Change
favorable
(unfavorable)
2016
(USD in thousands)
2017
Revenue from the License Agreement
Cost of the Aditech Pharma AG patent transfer agreement
Research and development costs
General and administrative costs
Operating income (loss)
Exchange rate (losses) gains
Interest income
Other finance costs
Income (loss) before tax
Income tax (expense) benefit
Net income (loss)
—
—
1,250,000
(25,000)
(20,496) (41,052)
(17,107) (14,382)
(55,434)
1,187,397
(241)
227
(2,895)
598
389
(92)
(54,539)
1,184,488
(267,395) 21,203
917,093
(33,336)
1,250,000
(25,000)
20,556
(2,725)
1,242,831
(839)
(162)
(2,803)
1,239,027
(288,598)
950,429
Revenue from License Agreement for the years ended December 31, 2017 and 2016
During the year ended December 31, 2017, the Company recognized as revenue the $1.25 billion nonrecurring Non-refundable Fee that was received during
February 2017. Prior to entering into the License Agreement, the Company did not have contracts with customers and, accordingly, there was no revenue
recognized during the year ended December 31, 2016 or since the Company was founded in 2005.
Cost of Aditech Pharma AG agreement for the years ended December 31, 2017 and 2016
The terms of the patent transfer agreement between Aditech and the Company, including the Addendum executed in January 2017, provided for Aditech to
receive a payment equal to 2% of the Non-refundable Fee, or $25 million, during the year ended December 31, 2017. During the year ended December 31, 2016,
there were no amounts due Aditech.
45
Table of Contents
Research and development costs for the years ended December 31, 2017 and 2016
Research and development costs for the years ended December 31, 2017 and 2016 were $20.5 million and $41.1 million, respectively. The decrease in
research and development costs for the year ended December 31, 2017 of $20.6 million is the result of lower costs incurred in connection with the Interference
Proceeding, lower share-based compensation and the winding down of our development efforts of FP187®. The decrease was offset by $9.5 million of additional
compensation expense recognized during the year ended December 31, 2017 in connection with the Amendment of Awards as discussed above. Fees to patent
advisors and other patent-related costs decreased from $16.3 million in the year ended December 31, 2016 to $2.7 million in the year ended December 31, 2017.
Fees to patent advisors and other patent-related costs include the cost to conduct the Interference Proceeding. The decrease is the result of reduced activities
subsequent to the oral argument on November 30, 2016 for the Interference Proceeding and the PTAB's issuance of the decision in the Interference Proceeding in
favor of Biogen on March 31, 2017. Share-based compensation decreased from $8.0 million in the year ended December 31, 2016 to $4.9 million in the year
ended December 31, 2017 in connection with the vesting of equity awards issued during the years ended December 31, 2016 and 2015 that included graded
vesting provisions resulting in expense recognition that decreases in the latter years of vesting combined with the favorable effect related to the benefit recognized
during the year ended December 31, 2017 in connection with equity awards that were forfeited as the result of employee terminations where the forfeited equity
awards were initially expected to vest in full. The balance of the decrease in research and development cost during the year ended December 31, 2017 is the result
of winding down FP187® development costs including all preclinical, clinical and contract manufacturing efforts that were in process prior to the effective date
of the License Agreement.
General and administrative costs for the years ended December 31, 2017 and 2016
General and administrative costs for the years ended December 31, 2017 and 2016 were $17.1 million and $14.4 million, respectively. The increase in
general and administrative costs in the year ended December 31, 2017 of $2.7 million resulted from increased legal and accounting costs, compensation expense
and costs related to the restructuring. A decrease in share-based compensation offset these increases. Legal and accounting fees were $6.9 million in the year
ended December 31, 2017 compared to $4.4 million in the year ended December 31, 2016. The increase in legal and accounting fees is related to the License
Agreement and the restructuring. During the year ended December 31, 2017, the Company recognized $2.2 million of additional compensation expense in
connection with the Amendment of Awards and $759,000 in connection with the formation of the foundation, FWP Fonden, and the sale of FWP IP ApS as
discussed above. Share-based compensation decreased from $6.3 million in the year ended December 31, 2016 to $2.2 million in the year ended December 31,
2017. The favorable change was related to the benefit recognized during the year ended December 31, 2017 in connection with equity awards that were forfeited
as the result of employee terminations where the forfeited equity awards were initially expected to vest in full.
Non-operating (expense) income for the years ended December 31, 2017 and 2016
During the year ended December 31, 2017, the Company recognized a foreign exchange loss of $241,000. The $241,000 foreign exchange loss resulted
primarily from the negative effect of the weakening of the USD to the DKK during the period that is reflected as a non-cash foreign exchange loss when the USD
cash and cash equivalents are converted to DKK at December 31, 2017. During the year ended December 31, 2016, the Company recognized a foreign exchange
gain of $598,000. The $598,000 non-cash foreign exchange gain resulted primarily from the strengthening of the USD compared to the DKK during the period
that is reflected as a non-cash foreign exchange gain when the
46
Table of Contents
USD cash, cash equivalents and available-for-sale financial assets are converted to DKK at December 31, 2016.
During the years ended December 31, 2017 and 2016, the Company recognized interest income from available-for-sale financial assets of $227,000 and
$389,000, respectively. The decrease in the year ended December 31, 2017 is the result of lower amounts invested in available-for-sale financial assets during the
period. Subsequent to October 2017, the Company did not hold available-for-sale financial assets.
Other finance expense includes bank fees ("negative interest") that increased in the year ended December 31, 2017 as the result of the Company holding
significant cash deposits during the period.
Income tax expense (benefit) for the years ended December 31, 2017 and 2016
Income tax expense for the year ended December 31, 2017 totaled $267.4 million. During the year ended December 31, 2016, the Company recognized a tax
benefit of $21.2 million. The tax expense for the year ended December 31, 2017 resulted from the receipt of the Non-refundable Fee, partially offset by operating
expenses, giving rise to pretax income of $1.2 billion. The effective tax rate for the period is 22.6%, which is slightly higher than the Danish statutory tax rate of
22.0%. The difference between the effective tax rate and the statutory tax rate is primarily the result of higher tax rate in Germany, where the Company has
taxable nexus in addition to Denmark, and certain nondeductible items related to share-based compensation and the Shareholder Distribution. Taxable profits are
not assured beyond the year ending December 31, 2017; therefore, temporary differences that will be available to offset taxable profits after December 31, 2017
do not meet the criteria for financial statement recognition and therefore the related deferred tax assets have not been recognized. The income tax benefit for the
year ended December 31, 2016 resulted from the recognition of deferred tax assets that prior to 2016 did not meet the criteria for recognition.
Government, Economic, Fiscal, Monetary or Political Initiatives That May Materially Affect Our Operations
We have not identified any current government, economic, fiscal, monetary or political initiatives that would be expected to materially affect our operations.
Critical Accounting Policies
Our management's discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which we
have prepared in accordance with IFRS as issued by the IASB. The preparation of these financial statements requires us to make estimates and assumptions that
affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the
revenues and expenses reported during each period. Actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in the notes to our audited consolidated financial statements appearing elsewhere in this
Annual Report, we believe that the following accounting policies are the most critical to aid you in understanding and evaluating our financial condition and
results of operations.
Share-based compensation
The fair value of equity awards (the share-based compensation arrangements we have historically used have included deferred shares, share options and
warrants) issued to our employees, board members, consultants and non-employee consultants in connection with their services provided to us
47
Table of Contents
are recognized by us as compensation expenses over the applicable service period which is also the vesting period.
The Company determines the initial fair value and subsequent accounting for equity awards granted to the Company's employees, consultants and directors
using an option pricing model (Black-Scholes) that requires management to use many subjective assumptions. The subjective nature of the assumptions requires
management to use significant judgment, and small changes in any individual assumption or in combination with other assumptions may yield significantly
different results. The most significant assumptions included the following: the expected period an equity award will be outstanding and the peer group we use to
determine volatility. Before the Company's ADSs were quoted on an active market, the underlying fair value share price used to value equity awards was
determined by applying a discounted cash flow, or DCF, model based on estimated long-term future cash flows that are inherently uncertain. Subsequent to the
Company's IPO, determining the initial fair value and subsequent accounting for equity awards will continue to require significant judgment regarding expected
life and volatility of an equity award; however, as a public listed company there is objective evidence of the fair value of an ordinary share on the date an equity
award is granted and therefore DCF valuations are not used subsequent to our IPO in October 2014. As a public listed entity, in the future after there has been an
extended period of historical trading activity of the Company's ADSs, the Company will determine the fair value of an equity award using an option valuation
model that incorporates the historical trading attributes of the Company's ADSs including the volatility and the expected life of an equity award.
Income taxes
We recognize deferred tax assets, including the tax base of tax loss carry forwards, if our management assesses that these taxes can be offset against positive
taxable income within a foreseeable future. Significant management judgment is required to determine the amount of deferred tax assets that can be recognized
based upon the likely timing and level of future taxable profits together with future tax planning strategies. Such a judgment will be made on an ongoing basis and
is based on historical results of operations, budgets and business plans, including any planned commercial activities. Prior to December 31, 2016, we did not
recognize deferred tax assets, since we historically have experienced recurring losses and there was uncertainty of future taxable income. However, considering
the License Agreement, it became probable at December 31, 2016 that the Company would have taxable income in 2017 thereby enabling the Company to
recognize certain deferred tax assets that historically did not meet the criteria for recognition. In reaching the conclusion to recognize deferred tax assets at
December 31, 2016, numerous judgments were made including the close proximity of the date the License Agreement was executed to December 31, 2016 and
the magnitude of the Non-refundable Fee compared to the projected total expenses in 2017. The deferred tax benefit recognized during the year ended
December 31, 2016 was primarily related to net operating loss carry forwards. Taxable profits are not assured beyond the year ending December 31, 2017;
therefore, temporary differences that will be available to offset taxable profits after December 31, 2017 do not meet the criteria for financial statement recognition
and therefore the related deferred tax assets have not been recognized.
We are subject to income taxes in Denmark and Germany. Significant judgment is required in determining the timing of recognition of current taxes payable
as well as deferred tax assets and liabilities. There are transactions and calculations for which the ultimate tax determination is uncertain. Where the final tax
outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and
liabilities in the period in which such determination is made. The Company's Danish, German and U.S. tax returns are subject to periodic audit by the local tax
authorities. Such audits could result in the tax authorities disagreeing with the tax filing positions taken by the Group that would expose the Group to additional
taxes being
48
Table of Contents
assessed, including interest and penalties, that could be material. There are numerous transactions between the Company, Forward Pharma Operations ApS, FWP
IP ApS, Forward Pharma GmbH and Forward Pharma USA, LLC where the tax authorities could challenge whether pricing of such transactions were at arm's
length. Management believes that appropriate tax filing provisions have been taken by the Company and its subsidiaries; however, there is always a risk that the
tax authorities could disagree with the tax filing positions taken resulting in additional taxes, interest and penalty becoming due and such amount could be
material.
We have taken the position that we are not subject to U.S. federal or state income tax. In reaching this conclusion, significant judgment was used in
evaluating the nature of our operations in the U.S., the interpretation of the U.S. and Danish tax laws, and the income tax treaty between the U.S. and Denmark.
Management believes that the tax filing provisions taken in the U.S. and Denmark regarding Forward Pharma USA, LLC are correct; however, there is always a
risk that the U.S. or Danish tax authorities could disagree with the tax filing positions taken resulting in additional taxes, interest and penalty becoming due and
such amount could be material.
As a result of the receipt of the Non-refundable Fee and the resulting taxable income in 2017, the Danish and German tax authorities have commenced tax
audits of the Group's Danish and German tax returns covering the five-year period ending December 31, 2017. The tax audits are expected to focus on the
intercompany recognition of revenue and expense to ensure that such transactions were conducted at arm's length. There is a risk that the tax authorities could
impose additional taxable income or disallow the deductibility of expenses on intercompany cross-border transactions resulting in higher tax obligations in one or
more tax jurisdictions. Management's experience has been that the taxing authorities can be aggressive in taking positions that would increase taxable income
and/or disallow deductible expenses reported. If the tax authorities are successful in increasing taxable income and/or disallowing deductible expenses in one or
more jurisdictions, it would result in the Group experiencing a higher effective tax rate that could be material. Management believes that the tax positions taken
with regards to intercompany transactions are in accordance with tax regulations and that appropriate tax provisions have been made in the accompanying
financial statements; however, there is always a risk that the Danish and/or the German tax authorities could disagree with the tax filing positions taken resulting
in additional taxes, interest and penalty becoming due and such amount could be material. The Danish and German tax authorities are conducting a joint tax audit
of the Group's Danish and German tax returns. Conducting a joint tax audit is expected to reduce the burden and cost to the Group of undergoing two audits that
address similar transactions and to accelerate the resolution of disagreements through the mutual agreement procedure ("MAP") by early involvement of
Competent Authorities, if necessary. There is no assurance that the joint audit will achieve expected benefits.
During the year ended December 31, 2017, the Company made certain cash payments (the "Deduction") to equity award holders in accordance with
amendments to the Company's article of association that were approved by the Company's shareholders and board of directors (See Note 3.3 to the financial
statements for additional information.) The Company believes the Deduction, that totaled 36.2 million EUR ($43.4 million based on the December 31, 2017
exchange rate), represents, for tax reporting purposes, compensation for services rendered to the Company and is tax deductible for Danish tax purposes for the
year ended December 31, 2017. Management believes that the tax positions taken with regards to the Deduction is in accordance with tax regulations and that
appropriate tax provisions have been made in the accompanying financial statements; however, there is always a risk that the Danish authorities could disagree
with the tax filing positions taken resulting in additional taxes, interest and penalty becoming due and such amount could be material. There were similar cash
payments made to equity award holders during the year ended December 31, 2018 that totaled 650,000 EUR ($761,000); however, such amounts have been
accounted for as unrecognized
49
Table of Contents
deductible temporary differences at December 31, 2018 and reflected in the accompanying financial statements as unused tax losses in Denmark.
As of December 31, 2018, we have unused tax loss carry forwards in Denmark and Germany of 27.9 million DKK ($4.3 million based on the December 31,
2018 exchange rate) and EUR 12.0 million ($13.8 million based on the December 31, 2018 exchange rate) respectively. The Danish and German tax loss carry
forwards have no expiry date. For Danish tax purposes, the Company's ability to use tax loss carry forwards in any one year is limited to 100% of the first
8.2 million DKK ($1.3 million based on the December 31, 2018 exchange rate) of taxable income plus 60% of taxable income above 8.2 million DKK. For
German tax purposes, Forward Pharma GmbH's ability to use tax loss carry forwards in any one year is limited to 100% of the first EUR 1 million ($1.1 million
based on the December 31, 2018 exchange rate) of taxable income plus 60% of taxable income above EUR 1 million.
For more, see "Risk Factors—Risks Related to Danish Law and Our Operations in Denmark" and Note 3.4 in the accompanying financial statements for
additional information.
Recent Accounting Pronouncements
Standards effective in 2018:
The IASB issued new standards, amendments to standards and interpretations that were effective in 2018, or the 2018 New Standards. None of the 2018
New Standards affected the Company's consolidated financial statements.
Standards issued but not yet effective:
The IASB issued new standards, amendments to standards and interpretations that become effective on or after January 1, 2019 (collectively "New
Standards"). None of the New Standards are currently expected to have a material effect on the Group's financial statements; including, as discussed below, the
future adoption of IFRS 16 Leases ("IFRS 16").
IFRS 16 introduces a single lessee accounting model and requires a lessee to recognize assets and liabilities for all leases with a term of more than twelve
months, unless the underlying asset is of low value. A lessee is required to recognize a right-of-use asset representing its right to use the underlying leased asset
and a lease liability representing its obligation to make lease payments. IFRS 16 has an effective date of January 1, 2019. The Group does not have long-term
leases that are material and therefore the future adoption of IFRS 16 will not have a material effect on the Group's consolidated financial statements.
JOBS Act Exemptions
On April 5, 2012, the JOBS Act was signed into law in the U.S. The JOBS Act contains provisions that, among other things, reduce certain reporting
requirements for an emerging growth company. As an emerging growth company, we have elected to take advantage of the following exemptions:
•
•
not providing an auditor attestation report on our internal control over financial reporting; and
not providing all of the compensation disclosure that is required of non-emerging growth public companies under the U.S. Dodd-Frank Wall Street
Reform and Consumer Protection Act of 2010.
The JOBS Act permits an emerging growth company such as us to take advantage of an extended transition period to comply with new or revised accounting
standards applicable to public companies. We are choosing to "opt out" of this provision and, as a result, we are complying with new or revised
50
Table of Contents
accounting standards as required when they are adopted. This decision to opt out of the extended transition period under the JOBS Act is irrevocable.
Subsequent to December 31, 2018, we no longer qualify as an emerging growth company under the JOBS Act.
B. Liquidity and Capital Resources
Comparison of the Years ended December 31, 2018 and 2017
The table below summarizes our consolidated statement of cash flows for each of the years ended December 31, 2018 and 2017:
Year ended
December 31,
2018
2017
(USD in thousands)
Net cash flows (used in) provided by operating activities
Net cash flows provided by investing activities
Net cash flows (used in) financing activities
Net (decrease) in cash and cash equivalents
Net foreign exchange differences
Cash and cash equivalents beginning of year
Cash and cash equivalents end of year
3
(14,787)
939,947
85,365
(8,120) (1,118,691)
(93,379)
145,035
57,898
109,554
(22,904)
(4,108)
109,554
82,542
Net cash flows used in operating activities for the year ended December 31, 2018 totaled $14.8 million compared net cash flows provided by operating
activities for the year ended December 31, 2017 of $939.9 million. The cash flows used in operating activities for the year ended December 31, 2018 were due to
the loss incurred for the year combined with the payment of liabilities recognized at the end of 2017, including tax obligations, offset by non-cash share-based
compensation of $6.2 million. The cash flows provided by operating activities for the year ended December 31, 2017 were due to the receipt of the nonrecurring
Non-refundable Fee of $1.25 billion offset by operating costs and income taxes.
The cash inflow provided by investing activities of $3,000 for the year ended December 31, 2018 is the receipt of a rent security deposit associated with
vacated office space. The net cash flows provided by investing activities of $85.4 million for the year ended December 31, 2017 reflects the cash inflows from the
maturity of available-for-sale financial assets of $85.4 million offset by the purchase of equipment of $3,000.
Cash flows used in financing activities for the year ended December 31, 2018 totaled $8.1 million. Such use of cash was the result of cash outflows for the
repurchase of equity awards, of $8.1 million, offset by the receipt of $1,000 in connection with the exercise of warrants. Cash flows used in financing activities
for the year ended December 31, 2017 totaled $1.1 billion. Such use of cash was the result of cash outflows for the Shareholder Distribution, of $1.1 billion, and
the repurchase of equity awards, of $24.8 million, offset by the receipt of $49,000 in connection with the exercise of warrants.
51
Table of Contents
Comparison of the Years ended December 31, 2017 and 2016
The table below summarizes our consolidated statement of cash flows for each of the years ended December 31, 2017 and 2016:
Year ended
December 31,
Net cash flows provided by (used in) operating activities
Net cash flows provided by investing activities
Net cash flows (used in) provided by financing activities
Net (decrease) increase in cash and cash equivalents
Net foreign exchange differences
Cash and cash equivalents beginning of year
Cash and cash equivalents end of year
2016
2017
(USD in thousands)
939,947
85,365
(34,105)
41,170
114
7,179
(1,550)
52,269
57,898
(1,118,691)
(93,379)
145,035
57,898
109,554
Net cash flows provided by operating activities totaled $939.9 million in the year ended December 31, 2017 compared to net cash flows used in operating
activities of $34.1 million in the year ended December 31, 2016. The increase in 2017 in cash flows provided by operating activities is due to the receipt of the
Non-refundable Fee of $1.25 billion offset by the consideration paid to Aditech Pharma AG of $25 million, other operating costs and income taxes.
The net cash flows provided by investing activities relate to cash inflows from the maturity of available-for-sale financial assets of $85.4 million and
$41.2 million for the years ended December 31, 2017 and 2016, respectively. In addition, there were cash outflows for the purchase of equipment in the years
ended December 31, 2017 and 2016 of $3,000 and $31,000, respectively.
Cash flows used in financing activities for the year ended December 31, 2017 totaled $1.1 billion. Such use of cash was the result of cash outflows for the
Shareholder Distribution, of $1.1 billion, and the repurchase of equity awards, of $24.8 million, offset by the receipt of $49,000 in connection with the exercise of
warrants. The cash inflows provided by financing activities for the year ended December 31, 2016 totaled $114,000 and were the result of the proceeds received
in connection with the exercise of warrants and issuance of deferred shares.
Funding Requirements and Capital Resources
We believe that our cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the next twelve
months. We currently estimate that our use of cash for the year ending December 31, 2019 will range from $4 million to $6 million. We have based this estimate
on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. There is a high level of uncertainty in
estimating the costs we will incur to continue the Opposition Proceeding and to defend and protect the intellectual property associated with the Company. There
are other uncertainties that could negatively affect our estimated cash spend in 2019 including, but not limited to, an unforeseen negative outcome of the joint tax
audit in process in Denmark and Germany (see Note 3.4 to the financial statements for additional information). Accordingly, our estimated use of cash for the
year ending December 31, 2019 could change near-term and the change could be material. We have no long-term financial commitments, such as lines of credit or
guarantees, which are expected to affect our liquidity, other than an office rental lease, which we consider immaterial.
52
Table of Contents
Our present and future funding requirements will depend on many factors, including, among other things:
•
•
•
•
the outcome of the Opposition Proceeding, including any appeals;
our efforts to secure and protect the intellectual property associated with the Company with the objective of obtaining and maintaining royalty-
bearing patents;
the joint tax audit of our Danish and German tax returns; and
the costs to maintain the infrastructure necessary for a publicly listed company.
Capital Expenditures
Our capital expenditures in the past have not been significant and we currently do not have any significant capital expenditures planned for 2019 or
thereafter.
C. Research and Development and Patents
See "Item 4. Information on the Company—B. Business Overview" and "Item 5.A. Operating results."
D. Trend Information
See "Item 5.A. Operating results."
E. Off-balance Sheet Arrangements
In 2004, a private company Aditech Pharma AB (together with its successor-in-interest Aditech Pharma AG, "Aditech"), controlled by NB FP Investment
K/S and its affiliates (a related party), began developing and filing patents for, among other things, formulations and dosing regimens of DMF. In 2005, the
Company entered into a patent license agreement with Aditech to license this patent family from Aditech. In 2010, the Company acquired this patent family from
Aditech pursuant to a patent transfer agreement (the "Transfer Agreement") that replaced the patent license agreement. Under the Transfer Agreement, the
Company obtained, among other things, Aditech's patents and associated know-how related to DMF formulations and delivery systems (the "Aditech IP"). In
connection with the License Agreement, the Company and Aditech executed an addendum to the Transfer Agreement (the "Addendum"). The Addendum
clarified certain ambiguities with respect to the compensation due to Aditech in the event the Company would enter into the License Agreement and also provided
for Aditech to waive certain rights under the Transfer Agreement. The Addendum specifies that Aditech receives 2% of the Non-refundable Fee (or $25 million)
and is entitled to additional compensation should the Company receive royalties from Biogen under the License Agreement. If royalties are paid to the Company
in accordance with the License Agreement, Aditech will be entitled to receive a cash payment equal to 2% of the same base amount with respect to which the
Company's royalty percentage is calculated, accruing from the same period of time as any royalty payment payable by Biogen to the Company (prior to taking
into account taxes, duties and VAT, if any).
Under the terms of the License Agreement, and as discussed in more detail elsewhere herein, the Company restructured its operations on June 30, 2017. The
restructuring provided for, among other things, the transfer of certain assets and liabilities to Forward Pharma Operations ApS, including the legal and beneficial
rights, title and interest to certain intellectual property, for Forward Pharma Operations ApS to transfer such intellectual property to FWP IP ApS and for Forward
Pharma Operations ApS to sell FWP IP ApS to FWP HoldCo ApS. In connection therewith, a number of agreements were executed between the Company,
Biogen, Forward Pharma Operations ApS and
53
Table of Contents
FWP IP ApS including the IPR Services, Administration, Funding and Novation Agreement, or IPR Agreement.
The IPR Agreement requires Forward Pharma Operations ApS to pay an annual fee to FWP IP ApS of 100,000 DKK ($15,000 based on the December 31,
2018 exchange rate) as consideration for FWP IP ApS agreeing to hold, prosecute and maintain the transferred intellectual property. Forward Pharma Operations
ApS is obligated to remit the annual fee through the last to expire, or invalidation of, the licensed patents underlying the transferred intellectual property;
however, Forward Pharma Operations ApS' obligation to remit the annual fee would be discontinued early if certain events occur as defined in the License
Agreement.
Forward Pharma USA, LLC has a twelve-month office lease that expires on March 31, 2020. The monthly rent is approximately $1,150.
Forward Pharma A/S has entered into a lease with Nordic Biotech Advisors ApS for certain office space that houses the Company's corporate headquarters
in Copenhagen, Denmark. The amount payable under the lease is variable based on a defined formula and the agreement can be cancelled by either party with six
months' prior written notice. For the year ended December 31, 2018, we paid 601,000 DKK (approximately $92,000 based on the December 31, 2018 exchange
rate), including VAT, for the use of such premises and we estimate that amounts due under the lease for 2019 will not be materially different.
F. Tabular Disclosure of Contractual Obligations
Contractual Obligations and Commitments
The table below sets forth our contractual obligations and commercial commitments as of December 31, 2018.
Payments due by period
Non-cancellable contractual obligations*
Operating lease obligations
Total
Less than
1 year
$
$
$
17 $
51 $
68 $
Between
2 and 5 years
(USD in thousands)
17 $
3
20 $
48 $
—
48 $
Between
1 and 2 years
More than
5 years
Total
93 $ 175
— $
54
93 $ 229
(*)
Includes the annual fee of 100,000 DKK due to FWP IP assuming a conversion rate to U.S. Dollars of 6.5195 as quoted by the Danish
National Bank for December 31, 2018. The annual fee has been estimated through the end of 2029; however, such obligation to fund
could be terminated earlier or later as defined in the License Agreement.
The table above does not include amounts that would be payable to Aditech if we collect royalties from Biogen in accordance with the License Agreement.
The amount, if any, and timing of potential payments to Aditech cannot be estimated at this time but could be material. See Note 6.2 in the accompanying
financial statements for additional information.
The table above excludes $967,000 that is contingently payable to certain employees, including the CEO, directors and a consultant if certain service
requirements are met as defined in the underlying agreements. If the service requirements are met, the amounts due accrue pro rata through May 2020 and under
certain conditions, the amounts could be paid sooner. In addition, the table also excludes $890,000 that is contingently payable, as defined in the underlying
agreements, to the CEO and a consultant if there is a favorable outcome in the Opposition Proceeding and certain service requirements are met. We are unable to
estimate when or if there will be favorable outcome of the Opposition Proceeding. See Note 3.3 in the accompanying financial statements and the disclosure
above regarding the Amendment for additional information.
54
Table of Contents
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Directors and Senior Management
The following table sets forth information regarding our board of directors and senior management. Unless otherwise stated, the business address for our
executive officers and directors is Østergade 24A, 1st floor, 1100 Copenhagen K, Denmark.
Name
Florian Schönharting
Claus Bo Svendsen
Thomas Carbone
Torsten Goesch
Grant Hellier Lawrence
Jakob Mosegaard Larsen
Duncan Moore
Position
Age
50 Chairman
42 Chief Executive Officer
61 Vice President, Finance and Controller, Forward Pharma USA, LLC
59 Director
57 Director
46 Director
60 Director
Florian Schönharting, Chairman
Mr. Schönharting is currently the chairman of our board of directors and has served on the board since our incorporation in July 2005. Mr. Schönharting is
our co-founder. He has also founded or co-founded several other biopharmaceutical companies, including Genmab A/S, Veloxis A/S (f/k/a Life Cycle Pharma
A/S) and Zealand Pharma A/S. Mr. Schönharting has more than 25 years of investment executive experience in public and private equity funds involved in the
biopharmaceutical industry. He actively managed BI Healthcare SICAV and BI Bioteknologi SICAV for eight years. Mr. Schönharting currently manages the
following funds and certain affiliates of these funds: NB Public Equity K/S, Nordic Biotech K/S, Nordic Biotech Opportunity Fund K/S (NBOF), NB FP
Investment I K/S (NBFPI) and NB FP Investment II K/S (NBFPII). Mr. Schönharting is also manager of Tech Growth Invest ApS. Mr. Schönharting has an M.Sc.
(Econ) from Copenhagen Business School.
Claus Bo Svendsen, Chief Executive Officer (Principal Executive Officer & Principal Financial Officer)
Dr. Svendsen has served as our Chief Executive Officer since March 2017. Within Forward Pharma, his previous role as Executive Vice President included
responsibility for corporate functions, portfolio strategy, regulatory interactions and medical and scientific input across all phases of clinical trials. Prior to joining
Forward Pharma in 2015, he held positions of increasing seniority in the Danish pharmaceutical company Novo Nordisk A/S, including roles of Global Medical
Director for Victoza® (liraglutide) and for Saxenda® in its regulatory and pre-launch phase for weight management. From 2007 to 2009, he worked as a Medical
Analyst in Nordic Biotech Advisors ApS, dealing with due diligence of potential investment opportunities. He received a M.D. from University of Copenhagen in
2003, and additionally completed a Ph.D. in sarcoidosis pathobiology in 2009. He has worked in several countries with a clinical background mainly in internal
medicine, and is a recipient of a Young Investigator Award from the Foundation for Sarcoidosis Research in 2009. Dr. Svendsen is an author of 27 publications in
international, peer-reviewed journals and over 50 abstracts presented at international congresses on pathobiology of sarcoidosis, methods in molecular biology,
and medical treatment of diabetes and obesity.
Thomas Carbone, Vice President, Finance and Controller, Forward Pharma USA, LLC (Principal Accounting Officer)
Mr. Carbone has served as the Vice President, Finance and Controller of Forward Pharma USA, LLC since August 2014. Prior to joining us, he spent over
30 years providing auditing and
55
Table of Contents
accounting services to a diversified client base of public and private companies, including many in the biotechnology and pharmaceutical industries. Mr. Carbone
has extensive experience with the reporting requirements for publicly listed companies and the complex rules and regulations that public companies must comply
with. He has been involved in numerous public offerings of debt and equity securities, including many initial public offerings. His most recent role was Partner at
a nationally recognized public accounting firm.
Torsten Goesch, Director
Dr. Goesch has served on our board of directors since June 2006. He has also been the director of Rosetta Capital I, LP a secondary life sciences investor
since 2002. In this function, Dr. Goesch is responsible for the management of several Rosetta Capital I, LP investments and has served as a member of the board
of directors of many biopharmaceutical companies, including Enobia Ltd and Cytochroma Ltd. Dr. Goesch is also the founder and former Managing Director of
TRG Invest, a Munich-based consulting business serving companies in the life science sector. Additionally, Dr. Goesch served as the General Manager for the
German Speaking Countries at Biogen from 1997 to 1999, and before that was the Commercial Head of Merck KGaA's worldwide generics drug business, Merck
Generics. He practiced as a physician of internal medicine at the University Hospital Hamburg-Eppendorf from 1988 to 1990, focusing on nephrology,
immunology and oncology. Dr. Goesch has a Master of Management from the J.L. Kellogg Graduate School of Management at Northwestern University, as well
as an M.D. and Ph.D. from Heinrich Heine University Dusseldorf.
Grant Hellier Lawrence, Director
Mr. Lawrence has served on our board of directors since July 2015. Mr. Lawrence is currently Managing Director and CFO at Nunc A/S, a Thermo Fisher
Scientific company. He has more than 15 years of financial and information technology management experience within global Life Science manufacturing and
commercial companies, where he has provided overall leadership and strategic direction with a proven record of driving sustained business and financial
performance. Prior to joining Thermo Fisher Scientific, Mr. Lawrence worked for FMC and Pioneer Electronic Corporation. Mr. Lawrence holds a Diploma in
Mechanical Engineering (1984) and graduated from the University of South Africa with a Bachelor of Commerce Degree in Accounting and Business
Administration (1989).
Jakob Mosegaard Larsen, Director
Mr. Larsen has served on our board of directors since July 2015. Mr. Larsen is currently a partner at Copenhagen-based law firm Mazanti-Andersen Korsø
Jensen Law Firm LLP. Prior to January 1, 2016, Mr. Larsen was a Partner at Copenhagen-based the law firm Nielsen Nørager Law Firm LLP. Mr. Larsen serves
as a trusted advisor of Danish and international private equity and venture fund managers. He has several years of experience acting as a legal adviser of biotech
and life science companies. Mr. Larsen is chairman of the Danish Venture Capital and Private Equity Association's (DVCA) Legal Committee and serves as
DVCA's representative on Invest Europe's Legal and Regulatory Committee. He graduated from Copenhagen University with a Master's Degree in Law and holds
an executive MBA from Copenhagen Business School. From 2005 to December 31, 2015 (or for those entities that were established after 2005, since their
inception), Nielsen Nørager Law Firm LLP acted as our Danish legal counsel and legal counsel to the Nordic Biotech funds that currently are our shareholders,
and the advisory company and the general partners of those funds. Subsequent to December 31, 2015, Mazanti-Andersen Korsø Jensen Law Firm LLP has
become our Danish legal counsel and legal counsel to the Nordic Biotech funds, the advisory company and the general partners of those funds. As a former
partner in Nielsen Nørager Law Firm LLP and now as a partner at Mazanti-Andersen Korsø Jensen, Mr. Larsen has been and remains extensively involved in the
56
Table of Contents
provision of these legal services. Since 2011, Mr. Larsen has also served as a member of the board of directors of the advisory company of two of the Nordic
Biotech funds that currently are our shareholders. Mr. Larsen serves on our board of directors in his individual capacity and not as a representative of any of the
law firms.
Duncan Moore, Director
Dr. Moore has served on our board of directors since May 2016. Dr. Moore is a partner at East West Capital Partners since May 2008. Previously, Dr. Moore
was a top-ranked pharmaceutical analyst at Morgan Stanley from 1991 to 2008 and was a Managing Director from 1997 to 2008 leading the firm's global
healthcare equity research team. Whilst at the University of Cambridge he co-founded a medical diagnostics company called Ultra Clone with two colleagues
which led to the beginnings of a 20-year career in healthcare capital markets analysis. In 1986, he was involved in setting up the BankInvest biotechnology funds
and was on its scientific advisory board. Dr. Moore was educated in Edinburgh and went to the University of Leeds where he studied Biochemistry and
Microbiology. He has a M.Phil. and Ph.D. from the University of Cambridge where he was also a post-doctoral research fellow. Currently, he is an active investor
in biomedical companies as Chairman of Lamellar Biomedical, Oncology Ventures and StepJockey. In addition, he has board positions at Cycle Pharma and
Braidlock.
Composition and Practices of the Board of Directors
The board of directors has the overall responsibility for our corporate management. The board of directors determines our policies regarding business
strategy, organization, accounting and finance, and the board of directors appoints and supervises our executive officers. The majority of the members of the
board of directors must be directors who are not executive officers, and no executive officer may be chairman or vice-chairman of the board of directors. The
chairman is elected among and by the directors.
According to the Articles of Association, the board of directors must consist of not less than three and no more than seven members. Following the annual
general meeting of shareholders of the Company on May 3, 2017, the size of the board was reduced to five members. All members of the board of directors are
elected by our shareholders at the general meeting for one-year terms. At the end of each term, they are eligible for re-election. The board of directors plans to
meet at least two times each year, and meetings can be called when deemed necessary by any of our directors or executive officers or by our auditor.
Under the shareholders' agreement that certain of our shareholders entered into prior to our initial public offering, the shareholders party to such agreement
have agreed that NBFPI will have the right to nominate four directors, Nordic Biotech K/S and NBOF will jointly have the right to nominate one director, and
NBFPII shall have the right to nominate one director to the board.
The Danish Companies Act requires granting employees in Danish companies a right of representation on the board of directors in companies with at least
35 employees. This requirement does not currently apply to us because, as of March 31, 2019, we only have 5 employees.
The board of directors conducts its business in accordance with the Danish Companies Act and its own rules of procedure. The rules of procedure set out,
among other things, that the board of directors shall establish our strategy, policies and activities to achieve its objective in accordance with the Articles of
Association. It also establishes the responsibilities of the board of directors, e.g., that the board of directors shall ensure that our bookkeeping, accounting, asset
management, information technology systems, budgeting and internal controls are properly organized. The rules of procedure also provide guidelines for the
division of responsibilities between the board of directors, the executive officers and the audit committee. The rules of procedure may be amended by a simple
majority vote of the board.
57
Table of Contents
A majority of the directors, including our chairman, must be present to constitute a quorum. Unless otherwise set forth in our Articles of Association,
decisions of the board of directors are decided by a simple majority of votes cast. In the event of a tie vote of the members of the board of directors, the chairman
shall have a casting vote.
Executive Officer
Our Chief Executive Officer Dr. Claus Bo Svendsen is responsible for our day-to-day business and operations.
Board Committees
Audit Committee
We have an audit committee, which was established on August 8, 2014, under our board of directors consisting of Mr. Grant Hellier Lawrence and
Dr. Duncan Moore. Mr. Grant Hellier Lawrence has served on the audit committee since his election to the board of directors in July 2015, and Dr. Duncan Moore
has served on the audit committee since his election to the board of directors in May 2016. Since there are no specific requirements under Danish law on the
composition of our audit committee, we do not comply with Rule 5605(c) of the Nasdaq Marketplace Rules that requires the audit committees of U.S. companies
to have a minimum of three independent directors. Mr. Grant Hellier Lawrence and Dr. Duncan Moore satisfy the director and audit committee "independence"
requirements of each of the Nasdaq Marketplace Rules and Section 10A(m)(3)(B)(i) of the Exchange Act.
The board has adopted a written charter for the audit committee, a copy of which is available on our website at www.forward-pharma.com. As set forth in the
written charter, the principal duties and responsibilities of our audit committee are as follows:
•
•
•
•
•
•
•
making recommendations on the appointment and retention of our independent registered public accounting firm which will audit our consolidated
financial statements, overseeing the independent registered accounting firm's work and advising on the determination of the independent registered
accounting firm's compensation;
reviewing in advance all audit services and non-audit services to be provided to us by our independent registered accounting firm;
recommending procedures for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls,
auditing or compliance matters, as well as for the confidential, anonymous submission by our employees of concerns regarding questionable
accounting or auditing matters;
reviewing and discussing with management and our independent registered accounting firm the results of the annual audit;
conferring with management and our independent registered accounting firm about the scope, adequacy and effectiveness of our internal
accounting controls, the objectivity of our financial reporting and our accounting policies and practices;
overseeing regulatory compliance and related matters; and
reviewing related party transaction matters.
We do not have a compensation committee or a nominations committee, nor is independent director involvement required in the selection of director
nominees or in the determination of executive compensation. Our home country practice differs from Rule 5605 of the Nasdaq Marketplace Rules regarding
independent directors' involvement in these areas, because there are no specific requirements
58
Table of Contents
under applicable Danish law on the establishment of compensation committees or nominations committees, and neither are there any requirements under
applicable Danish law on independent directors' involvement in the selection of director nominees nor in the determination of executive compensation.
Scientific Advisors
We have historically engaged a number of scientific advisors, and we have regularly sought advice and input from these experienced scientific leaders on
matters related to our research and development programs and may continue to do so in the future in relation to our business. Our scientific advisors are experts
across a range of key disciplines relevant to our programs and science.
Code of Business Conduct
We have adopted a written code of business conduct, or code of conduct, which outlines the principles of legal and ethical business conduct under which we
do business. The code of conduct applies to all of our board members and employees. The full text of the code of conduct is available on our website at
www.forward-pharma.com. Any amendments or waivers from the provisions of the code of conduct will be made only after approval by our audit committee and
will be disclosed on our website promptly following the date of such amendment or waiver.
Exemptions from Certain Corporate Governance Requirements of Nasdaq
•
•
•
•
•
•
•
As a foreign private issuer, we are not required to have an audit committee comprised of at least three members. Our audit committee is comprised
of two members.
As a foreign private issuer, we are not required to have a board the majority of which is comprised of independent directors.
As a foreign private issuer, we are not required to adopt a formal written charter or board resolution addressing the process for the nomination of
directors. We do not have a nominations committee, nor have we adopted a board resolution addressing the nominations process.
As a foreign private issuer, we are not required to hold regularly scheduled board meetings at which only independent directors are present.
As a foreign private issuer, no quorum requirement will apply to our meetings of shareholders.
As a foreign private issuer, we are not required to obtain shareholder approval for material revisions to our share-based incentive plans.
As a foreign private issuer, we are not required to solicit proxies or provide proxy statements to Nasdaq pursuant to Nasdaq corporate governance
rules or Danish law. Consistent with Danish law and as provided in our Articles of Association, we will notify holders of our ordinary shares of
meetings with at least two weeks' but not more than four weeks' notice. This notification will contain, among other things, information regarding
business to be transacted at the meeting. In addition, our Articles of Association provide that shareholders must give us not less than six weeks'
advance notice to properly introduce any business at an annual meeting of shareholders.
Other than as noted above, we are in compliance with other Nasdaq corporate governance standards applicable to U.S. domestic issuers.
59
Table of Contents
B. Compensation
Compensation of Executive Officers and Board
For the year ended December 31, 2018, the aggregate compensation paid to our executive officer and members of our board of directors (including share-
based compensation) was $4,314,000. This amount includes $329,000 that was deemed to be the repurchase of equity awards for financial reporting purposes and
accounted for as a reduction in shareholders' equity. A description of the underlying equity awards that were granted to our executive officer and members of our
board of directors during the year ended December 31, 2017 is set forth below under "—Warrant and Other Equity Incentive Programs—Director and Officer
Awards Granted under the Share Plan and Outside the Share Plan." During the year ended December 31, 2018, there were no equity awards granted to our
executive officer or members of our board of directors.
None of our directors are employees of Forward Pharma A/S or its wholly owned subsidiaries, Forward Pharma USA, LLC and Forward Pharma Operations
ApS, or Forward Pharma Operations ApS' wholly owned subsidiaries, Forward Pharma GmbH and Forward Pharma FA ApS, and accordingly, we do not have
any written agreements with them providing for benefits upon termination.
Mr. Larsen, a member of our board of directors, acts as our Danish legal counsel. See "—Director and Officer Awards Granted Under the Share Plan and
Outside the Share Plan" and "Related Party Transactions—Legal Services Provided by Mazanti-Andersen Korsø Jensen Law Firm LLP."
Service and Employment Agreements
We have entered into a written service agreement with our Chief Executive Officer Dr. Claus Bo Svendsen, which contains provisions that we believe are
standard for a company in our industry regarding non-competition, confidentiality of information and assignment of inventions.
Our Vice President, Finance and Controller, Thomas Carbone, commenced working for Forward Pharma USA, LLC on August 18, 2014. Mr. Carbone's
agreement contains, among other things, provisions regarding non-competition, confidentiality of information, and assignment of inventions.
Warrant and Other Equity Incentive Programs
Our employees, consultants and non-employee directors are eligible to participate in our warrant and other equity incentive programs, including our 2014
Omnibus Equity Incentive Compensation Plan described below. Most of our award agreements have specific provisions intended to protect the participant from
any dilution to the financial value of his or her ownership interest that may occur as a result of a distribution or dividend. In some cases, this may cause or require
us to pay cash compensation to the holders of such awards. In addition, we may choose to pay cash compensation to holders of other awards that do not include
such provisions in connection with a distribution or dividend.
2014 Omnibus Equity Incentive Compensation Plan
Our 2014 Omnibus Equity Incentive Compensation Plan, or Share Plan, was approved by our board of directors and shareholders on July 24, 2014, and
certain technical amendments to the Share Plan were subsequently approved by our board and shareholders on August 11, 2014. Our employees, consultants and
non-employee directors are eligible to receive awards under the Share Plan.
Share Reserve and Limitations. The maximum number of ordinary shares currently available for awards pursuant to the Share Plan is 9,936,057 ordinary
shares, of which a maximum of 50% may be granted to an individual participant during a single year. The ordinary shares available for awards under the Share
Plan may be new shares that we issue and/or existing shares, if any, we acquire.
60
Table of Contents
Administration. The Share Plan is administered by our board of directors or, if and when established, a compensation committee appointed by our board of
directors. The board of directors (or the committee, if applicable) has the power to: (i) select the employees, consultants and non-employee directors who will
receive awards pursuant to the Share Plan; (ii) determine the type or types of awards to be granted to each participant; (iii) determine the number of ordinary
shares to which an award will relate, the terms and conditions of any award granted under the Share Plan (including, but not limited to, restrictions as to vesting,
transferability or forfeiture, exercisability or settlement of an award and waivers or accelerations thereof, and waivers of or modifications to performance
conditions relating to an award, based in each case on such considerations as the board of directors (or the committee, if applicable) determines) and all other
matters to be determined in connection with an award; (iv) determine whether, to what extent, and under what circumstances an award may be canceled, forfeited,
or surrendered; (v) determine whether, and to certify that, the performance goals to which the settlement of an award is subject are satisfied; (vi) correct any
defect or supply any omission or reconcile any inconsistency in the Share Plan, and adopt, amend and rescind such rules and regulations as, in its opinion, may be
advisable in the administration of the Share Plan; and (vii) construe and interpret the Share Plan and make all other determinations as it may deem necessary or
advisable for the administration of the Share Plan. It may delegate some or all of its powers to any executive officer of our company or any other person, other
than its authority to grant awards to certain specified executives.
Types of Awards. Awards that can be granted under the Share Plan include ordinary shares, deferred shares, restricted shares and options.
Ordinary Shares. For awards of ordinary shares, a participant receives or subscribes for a grant of ordinary shares that are not subject to any restrictions on
transfer or other vesting conditions. Upon the grant date, the participant will have all of the customary rights of a shareholder with respect to such shares,
including the right to vote such shares and to receive dividends with respect to such shares.
Deferred Shares. For awards of deferred shares, we agree to deliver, subject to certain conditions, a fixed number of our ordinary shares to the participant
or allow the participant to subscribe for such fixed number of our ordinary shares at the end of a specified deferral period or periods. During such period or
periods, the participant will have no rights as a shareholder with respect to any such shares. Except as provided in an award agreement, no dividends will be paid
with respect to deferred shares during the applicable deferral period, and the participant will have no future right to any dividend paid during such period.
However, most of our award agreements have specific provisions requiring the board of directors (or the committee, if applicable) to adjust the number of shares
and exercise or grant price relating to those awards in the event of a dividend which are intended to protect the participant from any dilution of the financial value
of his or her ownership interest that may occur as a result of a distribution or dividend.
Restricted Shares. For awards of restricted shares, a participant receives or subscribes for a grant of our ordinary shares that are subject to certain
restrictions, including forfeiture of such shares upon the occurrence of certain events. During the restriction period, holders of restricted shares will have the right
to vote such shares. During the restriction period, any dividends or distributions paid with respect to any restricted shares are subject to the same restrictions as
apply to such restricted shares and will be paid to the participant only if and when the applicable restriction period lapses.
Share Options. Share options granted under the Share Plan may be either incentive stock options or non-qualified options. The exercise price of an option
(whether to subscribe for new shares or purchase existing shares we hold) will be determined by the board of directors (or the committee, as applicable), but,
except as provided in an award agreement, must be at least 100% of the fair market value of our ordinary shares on the date of the grant (110% in the case of an
incentive stock option granted to a 10% shareholder). Except as provided in an award agreement, no dividends will be paid
61
Table of Contents
with respect to share options, and the participant will have no future right to any dividend paid prior to exercise of the share options. However, most of our award
agreements have specific provisions requiring the board of directors (or the committee, as applicable) to adjust the number of shares and exercise or grant price
relating to those awards in the event of a dividend which are intended to protect the participant from any dilution to the financial value of his or her ownership
interest that may occur as a result of a distribution or dividend.
Effects of a Change in Control. Upon the occurrence of a change in control, the board of directors (or the committee, as applicable) may, in its discretion:
(i) cancel any outstanding options in exchange for a cash payment of an amount (including zero) equal to the difference between the then fair market value of the
option less the applicable option price; (ii) after having given the participant a chance to exercise any vested outstanding options, terminate any or all of the
participant's unexercised options; (iii) cause the surviving corporation to assume all outstanding options or replace all outstanding options with economically
comparable awards; or (iv) take such other action as the board of directors (or the committee, as applicable) determines appropriate; provided that such action
substantially preserves the economic value of such options determined as of immediately prior to such change in control.
Effects of Certain Corporate Transactions. In the event of a recapitalization, forward or reverse stock split, reorganization, dissolution, division, merger,
consolidation, spin-off, combination, share exchange, or other corporate transaction or event that affects our ordinary shares, the board of directors (or the
committee, as applicable) will adjust, recapitalize or modify (i) the number and kind of shares, including any ADRs and ADSs in respect of any such shares,
which may thereafter be issued in connection with awards, (ii) the number and kind of ordinary shares, including any ADRs and ADSs in respect of any such
shares, issuable in respect of outstanding awards, (iii) the aggregate number and kind of ordinary shares, including any ADRs and ADSs in respect of any such
shares, available under the Share Plan, and (iv) the exercise or grant price relating to any award. Notwithstanding the foregoing, no such adjustment will take
place merely as a result of the issuance of awards pursuant to the Share Plan in the normal course (even if, to the extent permitted by the Share Plan, such awards
have an exercise price less than fair market value of the underlying shares, or other shares, including, without limitation, any ADRs and ADSs in respect of any
such shares, on the grant date). In the event of a change in our capital structure by reason of (i) a capital increase (including, without limitation, the issuance of
additional ordinary shares or other shares in us, warrants to subscribe for our shares, or awards under the Share Plan), (ii) a capital decrease (including, without
limitation, any repurchase of our shares or the cancellation or termination of warrants to subscribe for our shares or the cancellation or termination of awards
under the Share Plan), (iii) our issuance of bonus or compensatory shares, (iv) our issuance of convertible debt instruments or (v) dividends, neither the purchase
price or exercise price of awards under the Share Plan nor the number of shares which may be subscribed or purchased pursuant to the Awards under the Share
Plan may be adjusted unless otherwise specifically provided for in an award agreement, in all cases, even if the transaction giving rise to such change in our
capital structure takes place at a price below the fair market value of our shares at time of the transaction. However, most of our award agreements have specific
provisions requiring the board of directors (or the committee, if applicable) to adjust the number of shares and exercise or grant price relating to those awards in
the event of a dividend or the issuance of bonus shares to all of the Company's shareholders on a pro rata basis which are intended to protect the participant from
any dilution of the financial value of his or her ownership interest that may occur as a result of a change in the Company's capital structure.
Clawback. Any award granted under the Share Plan, including an award of ordinary shares, will be subject to mandatory repayment by the participant to
our company pursuant to the terms of any company "clawback" or recoupment policy that is directly applicable to the Share Plan and set forth in an award
agreement or required by law to be applicable to the participant.
62
Table of Contents
Transfer Restrictions. No award or other right or interest of a participant under the Share Plan may be pledged, encumbered, or hypothecated to, or in favor
of, or subject to any lien, obligation, or liability of such participant to, any party, other than us, or assigned or transferred by such participant otherwise than by
will or the laws of descent and distribution, and such awards and rights will be exercisable during the lifetime of the participant only by the participant or his or
her guardian or legal representative. Notwithstanding the foregoing, the board of directors, in its discretion, may provide that awards or other rights or interests of
a participant granted pursuant to the Share Plan be transferable, without consideration, to immediate family members, to trusts for the benefit of such immediate
family members and to partnerships in which such family members are the only partners. In addition, a participant may, in the manner established by the board of
directors, designate a beneficiary to exercise the rights of the participant, and to receive any distribution, with respect to any award upon the death of the
participant.
Director and Officer Awards Granted Under the Share Plan and Outside the Share Plan
In June 2017, the Company granted 990,000 options (after adjusting for the Share Split and the Capital Reduction) that have an exercise price of 0.01 DKK
(after adjusting for the Share Split and the Capital Reduction) to certain directors and employees of the Company. The 990,000 options include:
•
•
•
600,000 options granted to Claus Bo Svendsen;
240,000 options granted to Thomas Carbone; and
50,000 options granted to each of Jakob M. Larsen, Grant H. Lawrence and Duncan Moore (the 990,000 options are collectively referred to as the
"2017 Awards").
The 2017 Awards vest monthly over 36 months commencing on June 1, 2017; however, each award contains a provision whereby the option holder cannot
exercise prior to a defined date. Vesting and/or exercise periods are accelerated under certain defined situations, including a change in control. The terms of the
2017 Awards include antidilution protection to the holders in the event there is a distribution to the shareholders as defined in the underlying award agreements.
As a result of the Capital Reduction and the antidilution protection, the holders of the 2017 Awards received a total of 371,000 EUR ($434,000) during the
year ended December 31, 2018, including $263,000 to Claus Bo Svendsen, $105,000 to Thomas Carbone and $22,000 to each of Jakob M. Larsen, Grant H.
Lawrence and Duncan Moore. As of December 31, 2018, the Company's remaining obligation to the 2017 Award holders as the result of the antidilution
provision, if vesting occurs in full, is 526,000 EUR ($601,000 based on the December 31, 2018 exchange rate) including $365,000 due Claus Bo Svendsen,
$146,000 due Thomas Carbone and $30,000 due each of Jakob M. Larsen, Grant H. Lawrence and Duncan Moore. The remaining obligation due to the 2017
Award holders, assuming vesting occurs in full, is payable semi-annually on a pro rata basis over the remaining vesting period that ends on May 31, 2020. See
Note 3.3 in the accompanying financial statements for additional information. The 2017 Awards granted to Mr. Carbone were awarded under the Share Plan and
the balance of the 2017 Awards were granted outside the Share Plan but governed, in all respects, as if they were awarded under the Share Plan.
Insurance and Indemnification
We have entered into indemnification agreements with our executive officers, certain other employees and members of our board of directors, undertaking to
indemnify them, including with respect to liabilities resulting from our initial public offering to the extent that these liabilities are not covered by insurance. In
addition, we have entered into insurance policies that insure our directors, executive officers and certain other employees for certain actions taken in their
professional capacity
63
Table of Contents
and a separate insurance policy insuring our directors and officers against liabilities resulting from our initial public offering, subject to specified exceptions.
C. Board Practices
See "Item 6. Directors, Senior Management and Employees—A. Executive Officers and Directors" and "—B. Compensation."
D. Employees
As of December 31, 2018, we had five employees of which four are in Europe and one is in the U.S. One employee holds an M.D. and a Ph.D. degree. One
of our employees is represented by a labor union while none of our employees are covered under a collective bargaining agreement. We consider our relations
with our employees to be good.
E. Share ownership
The following table sets forth information with respect to the beneficial ownership of our ordinary shares and ADSs by our directors and executive officers
as of April 1, 2019.
Directors and Executive Officers
Florian Schönharting(2)
Torsten Goesch(3)
Jakob M. Larsen(4)
Grant H. Lawrence(5)
Duncan Moore(6)
Claus Bo Svendsen(7)
# of Shares
51,647,900
17,576,400
178,280
178,280
265,662
—
% of issued
Shares(1)
54.32%
18.49%
*
*
*
*
*
(1)
(2)
(3)
Represents less than 1%.
Ordinary shares which may be acquired upon exercise of options or warrants which are currently exercisable or which become exercisable
within 60 days after April 1, 2019 (i.e., May 31, 2019) are deemed beneficially owned by the holders of such options or warrants and are
deemed outstanding for the purpose of computing the percentage of ownership of such person, but are not treated as outstanding for the
purpose of computing the percentage of ownership of any other person. As of April 1, 2019, we had 95,073,864 ordinary shares
outstanding.
Consists of ordinary shares held by Nordic Biotech K/S, Nordic Biotech Opportunity Fund K/S, NB FP Investment K/S and NB FP
Investment II K/S. Through his ownership of Holdingselskabet af 1 januar 2016 ApS and Tech Growth Invest ApS, Mr. Schönharting
controls 45% of the ownership interests in Nordic Biotech General Partner ApS (which is the general partner of both Nordic Biotech K/S
and Nordic Biotech Opportunity Fund K/S). In addition, he is the sole member of the Investment Committee of NB FP Investment K/S
and NB FP Investment II K/S, and therefore Mr. Schönharting may be deemed to share beneficial ownership of the securities beneficially
owned by Nordic Biotech K/S, Nordic Biotech Opportunity Fund K/S, NB FP Investment K/S and NB FP Investment II K/S.
Mr. Schönharting disclaims beneficial ownership of such securities except to the extent of his pecuniary interest therein.
Consists of ordinary shares held by Rosetta Capital I, LP. Mr. Goesch has full investment and voting power over all of the shares held by
Rosetta Capital I, LP (an affiliate of BioScience Managers Limited), and so may be deemed to share beneficial ownership of the securities
owned by the fund. The address for Rosetta Capital I, LP is c/o Corporation Service Company, 2711 Centerville Road, Suite 400,
Wilmington, County of New Castle, Delaware, U.S. Mr. Goesch
64
Table of Contents
disclaims beneficial ownership of such securities except to the extent of his pecuniary interest therein.
(4)
(5)
(6)
(7)
Includes options to purchase up to 178,280 shares at an exercise price of $6.92 per share that may be exercised during the period from
July 1, 2018 to June 30, 2021 (absent a discontinuation of service). Excludes options to purchase up to 50,000 shares at an exercise price
of 0.01 DKK per share that, to the extent they become exercisable by continued service, may be exercised only during the period from
June 20, 2020 to June 19, 2023 (absent a change in control of the Company or discontinuation of service).
Includes options to purchase up to 178,280 shares at an exercise price of $6.92 per share that may be exercised during the period from
July 1, 2018 to June 30, 2021 (absent a discontinuation of service). Excludes options to purchase up to 50,000 shares at an exercise price
of 0.01 DKK per share that, to the extent they become exercisable by continued service, may be exercised only during the period from
June 20, 2020 to June 19, 2023 (absent a change in control of the Company or discontinuation of service).
Includes options to purchase up to 265,662 shares at an exercise price of 0.01 DKK per share that may be exercised during the period
from May 1, 2019 to April 30, 2022 (absent a change in control of the Company or discontinuation of service). Excludes options to
purchase up to 50,000 shares at an exercise price of 0.01 DKK per share that, to the extent they become exercisable by continued service,
may be exercised only during the period from June 20, 2020 to June 19, 2023 (absent a change in control of the Company or
discontinuation of service). Also excludes 121,207 deferred shares that will not become exercisable until October 10, 2020 (absent a
change in control of the Company).
Excludes options to purchase 240,000 shares at an exercise price of $4.51 per share that, to the extent they become exercisable by
continued service, may be exercised only during the period June 1, 2019 to May 31, 2021 (absent a change in control of the Company or
discontinuation of service). Further excludes options to purchase 469,519 shares at an exercise price of 0.01 DKK per share that, to the
extent they become exercisable by continued service, may be exercised only during the period from November 30, 2020 to November 29,
2022 (absent a change in control of the Company or discontinuation of service) and options to purchase 120,000 shares at an exercise
price of $2.24 per share that, to the extent they become exercisable by continued service, may be exercised only during the period from
March 1, 2021 to February 28, 2023 (absent discontinuation of service). Also excludes options to purchase 600,000 shares at an exercise
price of 0.01 DKK per share that, to the extent they become exercisable by continued service, may be exercised only during the period
from June 20, 2020 to June 19, 2023 (absent a change in control of the Company or discontinuation of service) and 40,000 deferred shares
that will not become exercisable before May 31, 2019 (absent a change in control of the Company).
See "Item 6. Directors, Senior Management and Employees—B. Compensation" above for information with respect to the 2014 Omnibus Equity Incentive
Compensation Plan and options held by our directors and executive officers.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
The following table sets forth information with respect to the beneficial ownership of our ordinary shares and ADSs by our major shareholders, which means
shareholders that beneficially own 5% or more of our ordinary shares, as of April 1, 2019, April 1, 2018 and April 1, 2017, each being the most
65
Table of Contents
recent practicable date before reporting for the last three fiscal years based on information available to the Company.
2017
2018
2019
Name
Nordic Biotech K/S(1)
Nordic Biotech Opportunity
Fund K/S(1)
NB FP Investment K/S(2)
Rosetta Capital I, LP
The Bank of New York Mellon(3)
The Baupost Group, L.L.C.(4)
BVF Partners L.P. and its affiliates(5)
# of Shares
12,125,340
10,588,990
2,507,360
8,788,200
11,342,130
5,367,300
—
% of issued
Shares
# of Shares
% of issued
Shares
# of Shares
% of issued
Shares*
25.87% 24,250,680
25.70% 24,250,680
25.51%
22.59% 21,177,980
5.35% 5,014,720
18.75% 17,576,400
24.20% 22,968,570
—
11.54%
—% 10,642,834
22.44% 21,177,980
5.31% 5,014,720
18.63% 17,576,400
24.34% 22,968,570
—
11.30% 18,092,758
—%
22.28%
5.27%
18.49%
24.16%
—%
19.03%
*
(1)
(2)
(3)
(4)
(5)
Based on 95,073,864 ordinary shares outstanding as of April 1, 2019.
Nordic Biotech General Partners ApS is the general partner of Nordic Biotech K/S and Nordic Biotech Opportunity Fund K/S and has
voting and dispositive power with respect to, and may be deemed to be the beneficial owner of, the shares held by Nordic Biotech K/S
and Nordic Biotech Opportunity Fund K/S. Florian Schönharting controls 45% of the ownership interests in Nordic Biotech General
Partner ApS and therefore may be deemed to share beneficial ownership of the securities beneficially owned by Nordic Biotech General
Partners ApS, including the shares held by Nordic Biotech K/S and Nordic Biotech Opportunity Fund K/S.
Mr. Schönharting is the sole member of the Investment Committee of NB FP Investment K/S, and as such has voting and dispositive
power with respect to, and may be deemed to be the beneficial owner of, shares held by NB FP Investment K/S.
The Bank of New York Mellon is acting as depositary bank in our ADS-program and is holding the shares in such capacity. Shares
represented by ADSs that are beneficially owned by other major holders are also included in The Bank of New York Mellon's reported
ownership.
The information in the table and this note is derived from a Schedule 13G and Schedule 13G/A filed by The Baupost Group L.L.C., SAK
Corporation and Seth A. Klarman with the SEC on November 10, 2014 and February 9, 2018, respectively. Based on information
contained in the Schedule 13G and Schedule 13G/A, each of The Baupost Group L.L.C., SAK Corporation and Seth A. Klarman share
voting and dispositive power over all ADSs they are deemed to beneficially own. The ordinary shares underlying these ADSs are held by
The Bank of New York Mellon as depositary and are also included within this table as shares held by The Bank of New York Mellon. Per
the Schedule 13G/A filed on February 9, 2018, The Baupost Group L.L.C., SAK Corporation and Seth A. Klarman are no longer major
shareholders of the Company. The business address of each of The Baupost Group L.L.C., SAK Corporation and Seth A. Klarman is
10 St. James Avenue, Suite 1700, Boston, Massachusetts, 02116.
The information in the table and this note is derived from a Schedule 13G/A filed by jointly by BVF Partners L.P. ("Partners"), BVF Inc.,
Mark N. Lampert, Biotechnology Value Fund, L.P. ("BVF"), Biotechnology Value Fund II, L.P. ("BVF2"), Biotechnology Value Trading
Fund OS LP ("Trading Fund OS"), BVF Partners OS Ltd. ("Partners OS" and together with Partners, BVF, BVF2 and Trading Fund OS,
the "BVF Entities") with the SEC on February 14, 2019. Based on information contained in the Schedule 13G/A, as of December 31,
2018 (i) BVF beneficially owned 8,494,376 shares, (ii) BVF2 beneficially owned 6,507,411 shares, and (iii) Trading Fund OS beneficially
owned 1,407,948 shares. Partners OS, as the general partner of Trading Fund OS, may be deemed to beneficially own the 1,407,948
Shares beneficially owned by Trading Fund OS. Partners, as the general partner of BVF, BVF2, the investment manager of Trading Fund
OS, and the sole member of Partners OS, may be deemed to beneficially own the 18,092,758 Shares beneficially owned in the aggregate
by BVF, BVF2, Trading Fund OS, and certain Partners managed accounts (the "Partners Managed Accounts"), including 1,683,023
Shares, of which 514,342 are represented by ADSs, held in the Partners Managed Accounts. BVF Inc., as the general partner of Partners,
may be deemed to beneficially own the 18,092,758 Shares beneficially owned by Partners. Mr. Lampert, as a director and officer of
BVF Inc., may be deemed to beneficially own the 18,092,758 Shares beneficially owned by BVF Inc. Partners OS disclaims beneficial
ownership of the Shares beneficially owned by Trading Fund OS. Each of Partners, BVF Inc. and Mr. Lampert disclaims beneficial
ownership of the Shares beneficially owned by BVF, BVF2, Trading Fund OS, and the Partners Managed Accounts. The ordinary shares
underlying these ADSs are held by The Bank
66
Table of Contents
of New York Mellon as depositary and are also included within this table as shares held by The Bank of New York Mellon. The business
address of each of BVF, BVF2, Partners, BVF Inc. and Mark N. Lampert is 1 Sansome Street, 30th Floor, San Francisco,
California 94104. The business address of each of Trading Fund OS and Partners OS is PO Box 309 Ugland House, Grand Cayman,
KY1-1104, Cayman Islands.
As of April 1, 2019, there were a total of 17 holders of record of our ordinary shares, including the Bank of New York Mellon who is acting as depositary
bank for our ADS program. Seven holders of record of our ordinary shares had addresses in the U.S., representing 44.46% of our ordinary shares. As of April 1,
2019, there were a total of two holders of record of our ADSs, both of which had addresses in the U.S.
Our shareholders do not have different voting rights. We are not aware of any arrangement that may, at a subsequent date, result in a change in control of our
company.
B. Related Party Transactions
The following is a description of the related party transactions that we have entered into since January 1, 2017 with any of the members of our board of
directors, our executive officers, our major shareholders or our affiliates.
Leased Premises
We sublease our headquarters in Copenhagen, Denmark from the management company of two of our major shareholders, Nordic Biotech Advisors ApS. In
2018 and 2017, we paid 601,000 DKK ($95,000 based on the average exchange rate for the year) and 567,000 DKK ($85,000 based on the average exchange rate
for the year), including VAT, respectively, for such premises.
Employment Agreements and Equity Grants
We have entered into employment agreements with our executive officers, and issued warrants, deferred shares and share options to our executive officers
and members of our board of directors. See "Item 6. Directors, Senior Management and Employees" for more information.
Indemnification Agreements
We have entered into indemnification agreements with members of our board of directors and certain officers.
Legal Services Provided by Mazanti-Andersen Korsø Jensen Law Firm LLP
Mazanti-Andersen Korsø Jensen Law Firm LLP acts as our Danish legal counsel and legal counsel to the Nordic Biotech funds that currently are our
shareholders, and the advisory company and the general partners of those funds. Mr. Larsen, a member of our board of directors, is a partner at Mazanti-Andersen
Korsø Jensen Law Firm LLP. Mazanti-Andersen Korsø Jensen Law Firm LLP charged us for services it rendered on an hourly basis and expenses incurred. For
the year ended December 31, 2018, we incurred legal expenses for services rendered by Mazanti-Andersen Korsø Jensen Law Firm LLP of 2,504,000 DKK
(approximately $396,000 based on the exchange rate for the year ended December 31, 2018). Mr. Larsen is also a member of the board of directors of the
advisory company of two of the Nordic Biotech funds that currently are our shareholders.
Consulting Agreements with Certain Directors
We have entered into a consulting agreement with Dr. Duncan Moore who is a member of our board of directors.
67
Table of Contents
Pursuant to the consulting agreement with Dr. Moore, Dr. Moore will act as an advisor for the chairman of the board of directors and will perform director-
level consulting services as requested by the board of directors from time to time. The consulting agreement with Dr. Moore expires on October 10, 2020. As
compensation for the consulting services, the Company granted Dr. Moore a deferred share award with respect to 121,207 shares (following the Share Split and
the Capital Reduction). The deferred shares vest over a period of four years, with 25% of the shares vesting on the first four anniversaries of October 10, 2016. In
addition, subject to Dr. Moore's continuing service to the Company as a consultant, 100% of the unvested deferred shares will vest and be issued to Dr. Moore
immediately prior to a change in control.
Dr. Moore is not entitled to any compensation under his consulting agreement other than the deferred share awards discussed above.
Aditech Agreements
In 2010, we entered into a patent transfer agreement with Aditech, and in January 2017, we entered into an addendum to this agreement. See "Item 4.
Information on the Company—Business Overview—Material Agreements" for more information.
IPR Agreement.
The IPR Agreement requires Forward Pharma Operations ApS, our wholly owned subsidiary, to pay an annual fee to FWP IP ApS, which was a wholly
owned subsidiary of Forward Pharma Operations ApS until November 22, 2017, of 100,000 DKK ($15,000 based on the December 31, 2018 exchange rate) as
consideration for FWP IP ApS agreeing to hold, prosecute and maintain the transferred intellectual property. Forward Pharma Operations ApS is obligated to
remit the annual fee through the last to expire, or invalidation of, the licensed patents underlying the transferred intellectual property; however, Forward Pharma
Operations ApS' obligation to remit the annual fee would be discontinued early if certain events occur as defined in the License Agreement.
C. Interests of Experts and Counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. Consolidated Statements and Other Financial Information
See "Item 18. Financial Statements," which contains our financial statements prepared in accordance with IFRS.
B. Significant Changes
No matters to report.
ITEM 9. THE OFFER AND LISTING
A. Offering and Listing Details
See "Item 9. C. Markets" for information regarding our ADSs.
B. Plan of Distribution
Not applicable.
68
Table of Contents
C. Markets
ADSs representing our ordinary shares began trading on the Nasdaq Global Select Exchange on October 15, 2014 under the symbol FWP. Effective as of
September 11, 2017, the Company changed the ADS ratio from one ADS per one ordinary share to one ADS per two ordinary shares.
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Memorandum and Articles of Association
Since October 14, 2014, our Articles of Association were amended as follows:
•
•
•
•
•
•
•
•
•
on November 14, 2014, the Company's nominal share capital was increased from 4,581,376 DKK to 4,651,374 DKK;
on March 24, 2015, to add the terms applicable to warrants previously granted to certain of our directors and employees;
on April 13, 2015, to increase the share capital in connection with the issuance of 142,150 shares to Joel Sendek;
on April 20, 2015, to extend the exercise period for warrants that allow for the subscription of 333,720 shares and to increase the board of
directors' authorization to issue warrants to employees and consultants by 1.7 million warrants and underlying shares;
on June 23, 2015, to implement the terms applicable to warrants granted to a number of persons engaged or employed with the Company or a
subsidiary of the Company, issue of shares to two warrant holders that had exercised their warrants and amendments due to lapse of certain
warrants;
on November 24, 2015, to implement the terms applicable to warrants granted to a number of persons engaged or employed with the Company or
a subsidiary of the Company;
on May 6, 2016, to increase the allowable maximum number of board members, to increase and amend the board of directors' authorization to
issue warrants and to reduce the board of directors' authorization to increase the company's share capital;
on June 1, 2016, to implement the terms applicable to warrants granted to a number of persons engaged or employed with the Company or a
subsidiary of the Company, to issue shares to a warrant holder that had exercised its warrants and amendments due to lapse of certain warrants;
on July 29, 2016, to increase the share capital in connection with the issuance of 142,155 shares to Joel Sendek;
69
Table of Contents
•
•
•
•
•
•
•
•
•
•
on August 30, 2016, to implement the terms applicable to warrants granted to a person employed with the Company;
on March 29, 2017, to implement the terms applicable to warrants granted to Claus Bo Svendsen and to issue shares to a warrant holder that had
exercised its warrants;
on May 3, 2017, to reflect that the Company's statutory Danish annual report is prepared and presented in English;
on August 2, 2017, to make a share split in the ratio 1/10 (the Share Split);
on September 1, 2017, to decrease the share capital at a premium rate and pay the proceeds to the shareholders at a rate of EUR 19.45 per share of
nominally 0.10 DKK (corresponding to EUR 2.43125 per share of nominally 0.01 DKK that was annulled) (the Capital Reduction);
on November 21, 2017, to adopt principles for the adjustment of certain award terms and compensation of certain award holders due to the
changes in the Company's capital structure etc. resolved on the Company's extraordinary general meeting on August 2, 2017;
on November 28, 2017, to implement the terms applicable to warrants granted to employees, board members and a consultant of the Company (the
June 2016 Warrants);
on April 4, 2018, to implement the terms applicable to warrants granted to Claus Bo Svendsen;
on June 12, 2018, to issue shares to two warrant holders that had exercised their warrants, include Jan van de Winkel, a former director of the
Company; and
On September 18, 2018, to implement the terms applicable to warrants granted to an employee of the Company and to issue shares to a warrant
holder that had exercised its warrants.
Except as set forth above, the description of our Articles of Association as in effect upon the closing of our IPO contained in the prospectus dated
October 14, 2014 that forms part of our registration statement on Form F-1 (File No. 333-198013) originally filed with the SEC on August 11, 2014, as amended,
is incorporated by reference into this Annual Report on Form 20-F. Such description sets forth a summary of certain provisions of our Articles of Association as
currently in effect.
C. Material Contracts
Except for the agreements and contracts described below and elsewhere in this Annual Report, including under the sections "Item 4. Information on the
Company—B. Business Overview—Material Agreements" and "Item 7. Major Shareholders and Related Party Transactions—B. Related Party Transactions," we
are not currently, and have not been in the last two years, party to any material contract, other than contracts entered into in the ordinary course of business.
Registration Rights
Certain holders of our ordinary shares, including those ordinary shares that were issued upon conversion of our Class A shares and Class B shares, are
entitled to certain rights with respect to registration of such shares under the Securities Act. These shares are referred to as Registrable Securities. The holders of
these Registrable Securities possess the registration rights pursuant to the terms of a registration rights agreement dated as of September 11, 2014.
The registration of ordinary shares pursuant to the exercise of registration rights would enable the holders to trade these shares without restriction under the
Securities Act when the applicable registration statement is declared effective. Unless our ordinary shares are listed on a national securities exchange or trading
system and a market for our ordinary shares not held in the form of ADSs exists, any Registrable Securities sold pursuant to an exercise of the registration rights
will be
70
Table of Contents
sold in the form of ADSs. Subject to any limitations under Danish law, we will pay the registration expenses, other than underwriting discounts, selling
commissions and share transfer taxes, of the shares registered pursuant to the demand, piggyback and Form F-3 registrations provided for in the registration rights
agreement.
September 2014 Shareholders' Agreement
In connection with the consummation of our initial public offering, Nordic Biotech K/S, NBOF, NBFPI and NBFPII, which were holders of approximately
55% of our ordinary shares outstanding after consummation of our initial public offering, entered into a new shareholders' agreement dated September 8, 2014.
The key terms of the shareholders' agreement are as follows:
•
•
•
•
•
Appointment of the Board: Providing NBFPI with the right to nominate four directors (including the chairman), NBOF and Nordic Biotech K/S,
collectively with the right to nominate one director, and NBFPII with the right to nominate one director;
Veto rights of NBFPI: Prohibiting the other parties to the shareholders' agreement from voting in favor of certain key decisions without the
approval of NBFPI;
No dividends: Providing that dividends are not expected to be paid prior to an exit event as set forth in the shareholders' agreement;
Drag-along rights: Providing NBFPI with drag-along and exit rights in certain situations; and
Capital increases: Providing NBFPI with the right to cause the other parties to approve an increase in share capital in certain situations.
D. Exchange Controls
There are no governmental laws, decrees, regulations or other legislation in the Kingdom of Denmark that affect or restrict the import or export of capital
(including foreign exchange control), the remittance of dividends, interest or other payments to non-resident holders of our ordinary shares or ADSs.
E. Taxation
The following summary contains a general description of certain Danish and U.S. federal income tax consequences of the acquisition, ownership and
disposition of the ADSs, but it does not purport to be a comprehensive description of all the tax considerations that may be relevant to a decision to acquire or
dispose of ADSs. The summary is based upon the tax laws of Denmark and regulations thereunder and on the tax laws of the U.S. and regulations thereunder as
of the date hereof, which are subject to change.
Danish Tax Considerations
The following discussion is a summary of the material Danish tax considerations relating to the purchase, ownership and disposition of the ADSs.
Taxation in Denmark
This summary is for general information only and does not purport to constitute exhaustive tax or legal advice. The information is summarized based on the
tax laws of Denmark in effect and applied as at the date hereof and is subject to change as a result of changes in Danish legislation, including legislation that
could have a retroactive effect, or new legislation. It is specifically noted that the description does not address all possible tax consequences of an investment in
our ADSs. Therefore,
71
Table of Contents
this summary may not be relevant, for example, to investors subject to the Danish Act on Pension Investment Return Taxation (i.e. pension savings) and
professional investors, certain institutional investors, insurance companies, pension companies, banks, stockbrokers and individuals and companies carrying on
business of purchasing and selling shares to whom special tax rules apply. The summary only sets out the tax position of the direct owners of the ADSs and
further assumes that the direct owners are the beneficial owners of the ADSs and any dividends thereon. Sales are assumed to be sales to a third party.
Current and prospective investors in our ADSs are advised to consult their tax advisers regarding the applicable tax consequences of acquiring, holding and
disposing of our ADSs based on their circumstances. Current and prospective investors who may be affected by the tax laws of other jurisdictions should also
consult their tax advisers with respect to the tax consequences applicable to their particular circumstances as such consequences may differ significantly from
those described herein.
The following summary is based on the Danish tax law as applied and interpreted by Danish tax courts and as published and in effect on the date hereof,
without prejudice to any amendments introduced at a later date and implemented with or without retroactive effect.
For the purpose of this paragraph, "Danish Taxes" means taxes of whatever nature levied by or on behalf of Denmark or any of its subdivisions or taxing
authorities.
Taxation of Shareholders Resident in Denmark
When considering the taxation of Danish tax resident holders of the ADSs (companies and individuals), it is assumed that for tax purposes Danish resident
holders of the ADSs should be treated as holders of unlisted shares in Forward Pharma A/S. It is currently not clear under the Danish tax legislation or case law
how the listed ADSs are to be treated for tax purposes. For the purpose of the below comments, it is assumed that the ADSs listed in the U.S. should be treated as
non-listed shares.
Purchase of ADSs
The purchase of ADSs has no tax effect.
Sale of ADSs—Individuals
Gains on the sale of shares are taxed at a rate of 27% on the first 52,900 DKK in 2018 (for cohabiting spouses a total of 105,800 DKK), and at a rate of 42%
on share income over 52,900 DKK (for cohabiting spouses a total of 105,800 DKK). In 2019, the sale of shares will be taxed as share income at a rate of 27% on
the first 54,000 DKK (for cohabiting spouses a total of 108,000 DKK), and at a rate of 42% on share income over DKK 54,000 (for cohabiting spouses a total of
108,000 DKK). All amounts are subject to annual adjustments and include all share income derived by the individual or cohabiting spouses, respectively.
Gains and losses on the sale of shares are made up as the difference between the purchase price and the sales price. The purchase price is based on the
average purchase price for the shares in that particular company. Losses on non-listed shares may be offset against other share income derived by the individual
and must be offset against cohabiting spouses' share income before the share income becomes negative. In case the share income becomes negative, a negative tax
on the share income will be calculated and offset against the individual's other final taxes. Unused negative tax on share income will be offset against a cohabiting
spouse's final taxes. If the negative tax on share income cannot be offset against a cohabiting spouse's final taxes, the negative tax can be carried forward
indefinitely and offset against future year's taxes.
72
Table of Contents
Sale of ADSs—Companies
A distinction is made between "Subsidiary Shares," "Group Shares," "Tax-exempt Portfolio Shares" and "Taxable Portfolio Shares" with respect to taxation
of capital gains derived from the sale of the ADSs.
•
•
•
•
"Subsidiary Shares" are generally defined as shares held by a shareholder with a direct holding of 10% or more of the share capital of a company.
"Group Shares" are generally defined as shares held in a company in which the shareholder of the company and the company are subject to Danish
joint taxation or meet the criteria for international taxation under Danish law, usually implying that they control, directly or indirectly, more than
50% of the votes.
"Tax-exempt Portfolio Shares" are shares of unlisted companies not falling within the definitions of "Subsidiary Shares" or "Group Shares" (for
example, if the shareholder holds less than 10% and the Shares are not Group Shares), provided that the shares are not owned by a life insurance
company.
"Taxable Portfolio Shares" are shares that do not qualify as Subsidiary Shares, Group Shares or Tax-exempt Portfolio Shares.
It is noted that the above ownership thresholds are applied on the basis of the nominal value of all shares issued by Forward Pharma A/S, and not on the
basis of the nominal value of ADSs issued.
Capital gains derived from the sale of Subsidiary Shares, Group Shares and Tax-exempt Portfolio Shares are exempt from taxation, irrespective of the
holding period.
Losses on Subsidiary Shares, Group Shares and Tax-exempt Portfolio Shares are not tax deductible.
Special anti-avoidance rules apply to certain holding companies holding Subsidiary Shares, Group Shares or Tax-exempt Portfolio Shares. Further, certain
anti-avoidance rules apply to the treatment of Tax-exempt Portfolio Shares, in case the assumed nature of the Portfolio Shares changes. These rules are not
described herein.
Capital gains from the sale of Taxable Portfolio Shares are taxable at the corporate income tax rate of 22% irrespective of ownership periods in 2017 and
2018 Losses on such shares are deductible only against gains on taxable Portfolio Shares unless the mark-to-market principle is applied.
Dividends—Individuals
Dividends paid to private individuals who are tax residents of Denmark are taxed as share income at the applicable rates. It must be noted that all share
income must be included when calculating whether the amounts mentioned above in "Sale of ADSs—Individuals" are exceeded.
Dividends paid to individuals are generally subject to withholding tax, which is the responsibility of the company, at a rate of 27%.
Dividends—Companies
The distinction described above among "Subsidiary Shares," "Group Shares," "Tax-exempt Portfolio Shares" and "Taxable Portfolio Shares" as set forth in
"Sale of Offer ADSs—Companies" above, is also made with respect to taxation of dividends on shares.
Dividends paid to companies are generally subject to corporate tax at a current rate of 22%. However, no corporate tax is levied on dividends derived from
Subsidiary Shares and Group Shares. The 22% rate applies to dividends derived from Taxable Portfolio Shares and Tax-exempt Portfolio
73
Table of Contents
Shares. However, only 70% of dividends from Tax-exempt Portfolio Shares are taxable whereby the effective tax rate is 15.4%.
Taxation of Shareholders Resident Outside Denmark
Purchase of ADSs
The purchase of ADSs has no tax effect.
Sale of ADSs
A non-resident of Denmark, irrespective of whether the non-resident is a private individual or corporate shareholder, will normally not be subject to Danish
tax on any capital gains realized on the sale of shares irrespective of the holding period. Where a non-resident of Denmark holds shares that can be attributed to a
permanent establishment in Denmark, such gains are taxable pursuant to the rules applying to a Danish tax resident.
Dividends
Under Danish law, dividends paid in respect of shares are generally subject to Danish withholding tax at a rate of 27%, irrespective of whether the non-
resident shareholder is a private individual or a company. Non-residents of Denmark are not subject to additional Danish income tax in respect of dividends
received on the shares.
With respect to dividends distributed to a foreign company as the beneficial owner, no tax is withheld on dividends derived from Subsidiary Shares or Group
Shares as defined in "Taxation of Shareholders Resident in Denmark—Sale of ADSs—Companies" above. In respect of subsidiary shares, the 0% withholding tax
rate on dividends is conditional upon that tax must be eliminated or reduced according to Council Directive 2011/96/EEC (EU Parent Subsidiary Directive) or a
double tax treaty with the jurisdiction in which the dividend receiving company is tax resident. With respect to Group Shares, it is a requirement that the company
receiving the dividends is a resident of an EU or EEA country and that withholding taxes on dividends would have been eliminated or reduced according to
Council Directive 2011/96/EEC (EU Parent Subsidiary Directive) or a double tax treaty with the jurisdiction in which the dividend receiving company is resident,
if Group Shares had been Subsidiary Shares.
Corporate shareholders of Taxable or Tax-exempt Portfolio Shares and individuals who receive dividends are subject to Danish tax on such dividends at a
rate of 27%. In respect of companies the effective tax rate is 22%, i.e. 5% can be reclaimed. If the shareholder (corporate or individual) holds less than 10% of the
nominal share capital in the company and the shareholder is resident in a jurisdiction that has a double taxation treaty convention or other agreement on exchange
of information in tax cases, dividends are generally subject to a tax rate of 15% (a lower rate may be applicable under the double taxation treaty in question). If
the shareholder is tax resident outside the EU, it is an additional requirement for eligibility for the 15% tax rate that the shareholder (together with affiliates
shareholders) holds less than 10% of the nominal share capital of the company. As a result of the 27% withholding, shareholders eligible for the 15% tax rate
would need to claim a refund on the excess amount withheld.
If a foreign shareholder is a tax resident within the EU/EEA or in a country that has a double tax treaty with Denmark, and the shares held by the company
are allocated to a Danish permanent establishment, then the dividends should be tax-exempt if the shares held fall within the definition of Group Shares and
Subsidiary Shares as defined in "Taxation of Shareholders Resident in Denmark—Sale of ADSs—Companies" above. If a foreign shareholder is not a tax resident
within the EU/EEA or in a country that has a double tax treaty with Denmark, or if the dividends are derived from Taxable
74
Table of Contents
Portfolio Shares and Tax-exempt Portfolio Shares, the 22% rate applies. However, only 70% of any dividends from Tax-exempt Portfolio Shares are taxable,
resulting in an effective tax rate of 15.4%.
Denmark has executed double tax treaties with approximately 90 countries, including the U.S. and almost all members of the EU (excluding France and
Spain). If Denmark has entered into a double tax treaty with the country in which the shareholder is resident, the shareholder may, through certain certification
procedures, seek a refund from the Danish tax authorities of the tax withheld in excess of the tax (typically 15%) to which Denmark is entitled under the relevant
tax treaty, by completing the relevant online request to the Danish tax authorities. The treaty between Denmark and the U.S. generally provides for a 15% rate.
Share Transfer Tax
No Danish share transfer tax is payable.
U.S. Federal Income Tax Considerations for U.S. Holders
The following is a description of the material U.S. federal income tax consequences to the U.S. Holders described below of owning and disposing of the
ADSs. It is not a comprehensive description of all tax considerations that may be relevant to a particular person's decision to acquire or dispose of securities. This
discussion applies only to a U.S. Holder that holds the ADSs as capital assets for tax purposes. In addition, it does not describe all of the tax consequences that
may be relevant in light of a U.S. Holder's particular circumstances, including alternative minimum tax consequences and tax consequences applicable to U.S.
Holders subject to special rules, such as:
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
insurance companies;
banks or certain financial institutions;
dealers or traders in securities who use a mark-to-market method of tax accounting;
governmental organizations;
persons holding the ADSs as part of a hedging transaction, "straddle," wash sale, conversion transaction or integrated transaction or persons
entering into a constructive sale with respect to the ADSs;
regulated investment companies;
real estate investment trusts, grantor trusts or other trusts;
persons whose "functional currency" for U.S. federal income tax purposes is not the U.S. Dollar;
brokers or dealer in securities or currencies;
individuals who are former U.S. citizens or former long-term residents;
tax-exempt entities, including "individual retirement accounts" and "Roth IRAs" and other tax-deferred accounts;
partnerships, S corporations or other entities or arrangements classified as partnerships for U.S. federal income tax purposes or persons holding
ADSs through any such entities;
persons liable for alternative minimum tax;
persons that own or are deemed to own either 10% or more of our voting shares or 10% of the value of our shares; and
persons holding the ADSs in connection with a trade or business conducted outside the U.S.
75
Table of Contents
If an entity that is classified as a partnership for U.S. federal income tax purposes holds the ADSs, the U.S. federal income tax treatment of a partner will
generally depend on the status of the partner and the activities of the partnership. Partnerships holding the ADSs and partners in such partnerships are encouraged
to consult their own tax advisers as to the particular U.S. federal income tax consequences of holding and disposing of the ADSs.
The discussion is based on the Code, its legislative history, administrative pronouncements and published rulings, judicial decisions, final, temporary and
proposed U.S. Treasury Regulations, and the income tax treaty between Denmark and the U.S., or the "Treaty," all as of the date hereof, changes to any of which
may affect the tax consequences described herein—possibly with retroactive effect.
A "U.S. Holder," for purposes of the U.S. federal income tax discussion below, is a beneficial owner of the ADSs as capital assets within the meaning of
Section 1221 of the Code, who is eligible for the benefits of the Treaty and is:
(1) an individual who is a citizen or resident of the U.S. for U.S. federal income tax purposes;
(2) a corporation, or other entity taxable as a corporation, created or organized in or under the laws of the U.S., any state therein or the District of
Columbia;
(3) an estate, the income of which is subject to U.S. federal income tax regardless of its source; or
(4) a trust, if (A) a U.S. court is able to exercise its primary supervision over the trust's administration and one or more U.S. persons (as such term is
defined under the Code) have authority to control all substantial decisions of the trust, or (B) the trust has a valid election in place under all applicable
U.S. Treasury Regulations to treat the trust as a U.S. person (as such term is defined under the Code).
For U.S. federal income tax purposes, U.S. Holders of ADSs will be treated as the beneficial owners of the underlying shares represented by the ADSs and
an exchange of ADSs for our ordinary shares will not be subject to U.S. federal income tax.
U.S. Holders are encouraged to consult their own tax advisers concerning the U.S. federal, state, local and foreign tax consequences of owning and disposing
of the ADSs in their particular circumstances.
Taxation of Distributions
Subject to the PFIC rules described below, distributions paid on the ADSs, other than certain pro rata distributions of the ADSs, will generally be treated as
dividends to the extent paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Because we do not
maintain calculations of our earnings and profits under U.S. federal income tax principles, we expect that distributions generally will be reported to U.S. Holders
as dividends. Under certain situations, subject to applicable limitations, dividends paid to certain non-corporate U.S. Holders may be taxable at preferential rates
applicable to long-term capital gains. The amount of a dividend will include any amounts withheld by us in respect of Danish income taxes. The amount of the
dividend will be treated as foreign-source dividend income to U.S. Holders and will not be eligible for the dividends-received deduction generally available to
U.S. corporations under the Code. Dividends will be included in a U.S. Holder's income on the date the U.S. Holder receives the dividend. The amount of any
dividend income paid in Euros will be the U.S. Dollar amount calculated by reference to the exchange rate in effect on the date of actual or constructive receipt,
regardless of whether the payment is in fact converted into U.S. Dollars. If the dividend is converted into U.S. Dollars on the date of receipt, a U.S. Holder should
not be required to recognize foreign currency gain or loss in
76
Table of Contents
respect of the dividend income. A U.S. Holder may have foreign currency gain or loss if the dividend is converted into U.S. Dollars after the date of receipt.
Subject to applicable limitations, some of which vary depending upon the U.S. Holder's particular circumstances or how long the ADSs have been held,
Danish income taxes withheld from dividends on the ADSs (or ordinary shares underlying the ADSs) at a rate not exceeding the rate provided by the Treaty will
be creditable against the U.S. Holder's U.S. federal income tax liability. The rules governing foreign tax credits are complex and U.S. Holders should consult their
tax advisers regarding their particular circumstances. In lieu of claiming a foreign tax credit, U.S. Holders may, at their election, deduct foreign taxes, including
any Danish income tax, in computing their taxable income, subject to generally applicable limitations under U.S. law. An election to deduct foreign taxes instead
of claiming foreign tax credits applies to all foreign taxes paid or accrued in the taxable year.
Corporations will not be entitled to claim a dividends-received deduction with respect to distributions made by us. Dividends may constitute foreign source
passive income for purposes of the U.S. foreign tax credit rules. U.S. Holders should consult their own tax advisors as to their ability, and the various limitations
on their ability, to claim foreign tax credits in connection with the receipt of dividends.
Sale or Other Taxable Disposition of the ADSs
Subject to the PFIC rules described below, gain or loss realized on the sale or other taxable disposition of the ADSs will be capital gain or loss, and will be
long-term capital gain or loss if the U.S. Holder held the ADSs for more than one year. The amount of the gain or loss will equal the difference between the U.S.
Holder's tax basis in the ADSs disposed of and the amount realized on the disposition, in each case as determined in U.S. Dollars. This gain or loss will generally
be U.S.-source gain or loss for foreign tax credit purposes. The deductibility of capital losses is subject to limitations.
Passive Foreign Investment Company Rules
Under the Code, we will be a PFIC for any taxable year in which, after the application of certain "look-through" rules with respect to subsidiaries, either
(i) 75% or more of our gross income consists of "passive income," or (ii) 50% or more of the average quarterly value of our assets consist of assets that produce,
or are held for the production of, "passive income." Passive income generally includes interest, dividends, rents, certain non-active royalties and capital gains.
Whether we will be a PFIC in any year depends on the composition of our income and assets, and the relative fair market value of our assets from time to time,
which we expect may vary substantially over time. Because (i) we currently own a substantial amount of passive assets, including cash, and (ii) the values of our
assets, including our intangible assets, that generate non-passive income for PFIC purposes, is uncertain and may vary substantially over time, it is uncertain
whether we will be a PFIC in any year. We believe, however, that we were a PFIC for each of the years ended December 31, 2017, 2016, 2015 and 2014, and may
be classified as a PFIC in future years. If we are a PFIC for any year during which a U.S. Holder holds the ADSs, we generally would continue to be treated as a
PFIC with respect to that U.S. Holder for all succeeding years during which the U.S. Holder holds the ADSs, unless we ceased to meet the threshold requirements
for PFIC status and that U.S. Holder made a qualifying "deemed sale" election with respect to the ADSs. If such election is made, the U.S. Holder will be deemed
to have sold the ADSs it holds at their fair market value on the last day of the last taxable year in which we qualified as a PFIC, and any gain from such deemed
sale would be subject to the consequences described below. After the deemed sale election, the ADSs with respect to which the deemed sale election was made
will not be treated as shares in a PFIC unless we subsequently become a PFIC.
If we are a PFIC for any taxable year during which a U.S. Holder holds the ADSs, the U.S. Holder may be subject to adverse tax consequences. Generally,
gain recognized upon a disposition
77
Table of Contents
(including, under certain circumstances, a pledge) of the ADSs by the U.S. Holder would be allocated ratably over the U.S. Holder's holding period for such
ADSs. The amounts allocated to the taxable year of disposition and to years before we became a PFIC would be taxed as ordinary income. The amount allocated
to each other taxable year would be subject to tax at the highest rate in effect for that taxable year for individuals or corporations, as appropriate, and would be
increased by an additional tax equal to interest on the resulting tax deemed deferred with respect to each such other taxable year. Further, to the extent that any
distribution received by a U.S. Holder on its ADSs exceeds 125% of the average of the annual distributions on such ADSs received during the preceding three
years or the U.S. Holder's holding period, whichever is shorter, that distribution would be subject to taxation in the same manner described immediately above
with respect to gain on disposition.
If we are a PFIC for any taxable year during which any of our non-U.S. subsidiaries is also a PFIC, a U.S. Holder of ADSs during such year would be treated
as owning a proportionate amount (by value) of the shares of the lower-tier PFIC for purposes of the application of these rules to such subsidiary. U.S. Holders
should consult their tax advisers regarding the tax consequences if the PFIC rules apply to any of our subsidiaries.
Alternatively, if we are a PFIC and if our ADSs are "regularly traded" on a "qualified exchange," a U.S. Holder may be eligible to make a mark-to-market
election that would result in tax treatment different from the general tax treatment described above. Our ADSs would be treated as "regularly traded" in any
calendar year in which more than a de minimis quantity of the ADSs are traded on a qualified exchange on at least 15 days during each calendar quarter. Nasdaq
is a qualified exchange for this purpose. Additionally, because a mark-to-market election cannot be made for equity interests in any lower-tier PFIC that we may
own, a U.S. Holder that makes a mark-to-market election with respect to us may continue to be subject to the PFIC rules with respect to any indirect investments
held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. If a U.S. Holder makes the mark-to-market election, the U.S.
Holder generally will recognize as ordinary income any excess of the fair market value of the ADSs at the end of each taxable year over their adjusted tax basis,
and will recognize an ordinary loss in respect of any excess of the adjusted tax basis of the ADSs over their fair market value at the end of the taxable year (but
only to the extent of the net amount of income previously included as a result of the mark-to-market election). If a U.S. Holder makes the election, the U.S.
Holder's tax basis in the ADSs will be adjusted to reflect these income or loss amounts. Any gain recognized on the sale or other disposition of ADSs in a year
when we are a PFIC will be treated as ordinary income and any loss will be treated as an ordinary loss (but only to the extent of the net amount of income
previously included as a result of the mark-to-market election).
If a U.S. Holder makes a mark-to-market election it will be effective for the taxable year for which the election is made and all subsequent taxable years
unless the ADSs are no longer regularly traded on a qualified exchange or the IRS consents to the revocation of the election. U.S. Holders are urged to consult
their tax advisers about the availability of the mark-to-market election, and whether making the election would be advisable in their particular circumstances.
Alternatively, a U.S. Holder of stock in a PFIC may make a so-called "Qualified Electing Fund" election to avoid the PFIC rules regarding distributions and
gain described above. U.S. Holders should be aware, however, that we are not required to satisfy the record- keeping and other requirements that would permit
U.S. Holders to make qualified electing fund elections.
In addition, if we are a PFIC or, with respect to particular U.S. Holders, are treated as a PFIC for the taxable year in which we paid a dividend or for the prior
taxable year, the preferential rates discussed above with respect to dividends paid to certain non-corporate U.S. Holders would not apply.
78
Table of Contents
U.S. Holders should consult their tax advisers regarding the potential application of the PFIC rules.
Net Investment Income Tax
In general, a U.S. Holder that is an individual, an estate, or a trust that does not fall into a special class of trusts that is exempt from such tax, is subject to a
3.8% tax on the lesser of (1) the U.S. Holder's "net investment income" for the relevant taxable year and (2) the excess of the U.S. Holder's modified adjusted
gross income for the taxable year over a certain threshold (which in the case of individuals will be between $125,000 and $250,000, depending on the individual's
filing status). A holder's net investment income will include its gross dividend income and its net gains from the disposition of ADSs, unless such dividends or net
gains are derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain passive or trading activities). If
you are a U.S. Holder that is an individual, estate or trust, you are encouraged to consult your tax advisers regarding the applicability of the net
investment income tax to your income and gains in respect of your investment in the ADSs.
Information Reporting and Backup Withholding
Payments of dividends and sales proceeds received on the sale of other distributions of ADSs that are made within the U.S. or through certain U.S.-related
financial intermediaries generally are subject to information reporting, and may be subject to backup withholding, unless (i) the U.S. Holder is a corporation or
other exempt recipient or (ii) in the case of backup withholding, the U.S. Holder provides a correct taxpayer identification number and certifies that it is not
subject to backup withholding, and otherwise complies with the applicable backup withholding rules.
Backup withholding is not an additional tax. The amount of any backup withholding from a payment to a U.S. Holder will be allowed as a credit against the
holder's U.S. federal income tax liability and may entitle the U.S. Holder to a refund, provided that the required information is timely furnished to the IRS.
If a U.S. Holder owns ADS during any year in which we are a PFIC, such U.S. Holder (including, potentially, indirect holders) generally must file an IRS
Form 8621 with such holder's federal income tax return for that year. Certain U.S. Holders who are individuals may be required to report information relating to
their ownership of an interest in certain foreign financial assets, including shares of a non-U.S. person, generally on Form 8938, subject to exceptions (including
an exception for shares held through a U.S. financial institution).
U.S. Holders should consult their tax advisers regarding their reporting obligations with respect to the ADSs.
THE DISCUSSION ABOVE IS A GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE
TO A CURRENT OR PROSPECTIVE INVESTOR. EACH CURRENT OR PROSPECTIVE INVESTOR IS URGED TO CONSULT ITS OWN TAX
ADVISER ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN ADSs IN LIGHT OF THE INVESTOR'S OWN
CIRCUMSTANCES, INCLUDING THE APPLICABILITY AND EFFECT OF THE TAX LAWS OF ANY STATE, LOCAL OR NON-U.S.
JURISDICTION AND INCLUDING ESTATE, GIFT, AND INHERITANCE LAWS.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
79
Table of Contents
H. Documents on Display
We are subject to the informational requirements of the Exchange Act. Accordingly, we are required to file reports and other information with the SEC,
including annual reports on Form 20-F and reports on Form 6-K in limited circumstances; however, we may elect to make additional information available on
Form 6-K. The SEC maintains an Internet website that contains reports and other information about issuers, like us, that file electronically with the SEC. The
address of that website is www.sec.gov. We make our reports available on our internet website, free of charge, as soon as reasonably practicable after such
material is electronically filed with the SEC. The address of our website is www.forward-pharma.com. No portion of our website is incorporated by reference into
this Annual Report.
I. Subsidiary Information
Not applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT RISK
Quantitative and Qualitative Disclosures about Market Risk
We are exposed to a variety of financial risks: foreign exchange risk, credit risk and liquidity risk.
Market Risk
Foreign currency exchange rate risk
We are exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the USD, GBP, and the Euro.
Forward Pharma A/S's, Forward Pharma Operations ApS' and Forward Pharma FA ApS' functional currency is the DKK, Forward Pharma GmbH's
functional currency is the Euro, and Forward Pharma USA, LLC's functional currency is the USD. Our expenses to date have been largely denominated in GBP,
USD, DKK, and in Euro and therefore we are impacted by changes in foreign currency exchange rates. Our revenue from the License Agreement and our
obligation to Aditech were denominated in USD. It is very common for a group company to conduct cross-border transactions where the functional currency is
not always used, including purchases from vendors in the United Kingdom, where the GBP is used, and the United States, where the USD is used. In addition, the
Company and Forward Pharma Operations ApS, who each use the DKK as their functional currency, have large cash holdings in Euros and USD. Accordingly,
future changes in the exchange rates of the DKK, the Euro, the USD and/or the GBP will expose us to currency gains or losses that will impact the reported
amounts of assets, liabilities, income and expenses and the impact could be material. For the years ended December 31, 2018, 2017 and 2016, we recognized
foreign exchange gains (losses) of $2.7 million, ($241,000) and $598,000 respectively. While we benefited from changes in foreign exchange rates in 2018 and
2016, it is possible that the foreign exchange losses experienced in 2017 could reoccur. Any reoccurrences of foreign exchange losses would negatively affect us
and the effect could be material.
We do not believe there is currently a need to enter into specific contracts to reduce the exposure to changes in foreign exchange rates, such as by entering
into options or forward contracts. We may in the future consider using options or forward contracts to manage currency transaction exposures.
We estimate a 10% increase in the value of the U.S. Dollar relative to the Euro and the DKK would have decreased our net loss for the year ended
December 31, 2018 by $310,000. A 10% decrease in the value of the U.S. Dollar relative to the Euro and the DKK would have increased our net loss for the year
ended December 31, 2018 by a similar amount.
80
Table of Contents
Credit Risk
As of December 31, 2018, our cash and cash equivalents are held primarily at two banks that have Moody's long term debt ratings of Aa3 or better. We do
not invest in equity instruments or derivatives. Our investment criteria require preservation of capital and diversification in high credit rated financial institutions.
Liquidity Risk
As of December 31, 2018, we held cash and cash equivalents totaling $82.5 million, which we believe will be sufficient to provide adequate funding to allow
us to meet our planned operating activities in the normal course of business beyond the year ending December 31, 2019. Unforeseen events could negatively
affect our ability to fund planned operations in the future.
We currently estimate that there will be adequate liquidity to continue as a going concern beyond the next twelve months; however, if we do not prevail in
the Opposition Proceeding, including all appeals, future revenues are unlikely and our ability to continue as a going concern long-term would be uncertain and
management would consider, amongst other things, an orderly wind-down of operations.
We currently have no significant planned capital expenditures nor are there plans to make cash distributions to shareholders.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D. American Depositary Shares
Pursuant to the terms of the deposit agreement, the holders of ADSs will be required to pay the following fees:
Persons depositing or withdrawing ordinary shares or ADSs must pay:
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)
• Issue of ADSs, including issues resulting from a distribution of ordinary
shares or rights or other property
For:
• Cancellation of ADSs for the purpose of withdrawal, including if the
deposit agreement terminates
$0.05 (or less) per ADS
• Any cash distribution to the holder
A fee equivalent to the fee that would be payable if securities distributed to
you had been ordinary shares and the shares had been deposited for issue
of ADSs
• Distribution of securities distributed to holders of deposited securities
which are distributed by the depositary to the holder
$0.05 (or less) per ADS per calendar year
• Depositary services
81
Table of Contents
Persons depositing or withdrawing ordinary shares or ADSs must pay:
Registration or transfer fees
For:
• Transfer and registration of ordinary shares on our share register to or from
the name of the depositary or its agent when a holder deposits or
withdraws shares
Expenses of the depositary
• Cable, telex and facsimile transmissions (when expressly provided in the
deposit agreement)
• Converting foreign currency to U.S. Dollars
Taxes and other governmental charges the depositary or the custodian have to
pay on any ADS or share underlying an ADS, for example, share transfer
taxes, stamp duty or withholding taxes
• As necessary
Any charges incurred by the depositary or its agents for servicing the
• As necessary
deposited securities
The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing ordinary shares or surrendering ADSs for the purpose
of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts
distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from
cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of
its fees by deduction from any cash distribution payable to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide for-
fee services until its fees for those services are paid.
From time to time, the depositary may make payments to us to reimburse or share revenue from the fees collected from ADS holders, or waive fees and
expenses for services provided, generally relating to costs and expenses arising out of establishment and maintenance of the ADS program. In performing its
duties under the deposit agreement, the depositary may use brokers, dealers or other service providers that are affiliates of the depositary and that may earn or
share fees or commissions.
82
Table of Contents
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
PART II
A. Defaults
No matters to report.
B. Arrears and Delinquencies
No matters to report.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
No matters to report.
ITEM 15. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We maintain a set of disclosure controls and other procedures designed to ensure that information required to be disclosed by us in the reports we file or
submit under the Exchange Act are recorded, processed, summarized and reported, within the time periods specified and in accordance with the SEC's rules and
forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us
in the reports that we file or submit under the Exchange Act are accumulated and communicated to our management, including our principal executive and
financial officer, as appropriate to allow timely decisions regarding required disclosure. Our management, with the participation of our principal executive and
financial officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2018.
It should be noted that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and management necessarily applies its judgment and makes assumptions about the likelihood of future events. There can be no assurance that any
design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote. Based on the evaluation of our disclosure controls
and procedures as of December 31, 2018, our principal executive and financial officer concluded that, as of such date, our disclosure controls and procedures
were not effective, as a result of the material weakness in internal controls over financial reporting described below.
Management's Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Under the supervision and with the
participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our
internal control over financial reporting based on the framework in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO). Based on our evaluation under this framework, our management concluded that our internal control over
financial reporting was not effective as of December 31, 2018 due to the material weakness described below.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility
that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.
83
Table of Contents
Based on the evaluation performed as of December 31, 2017, in accordance with the COSO criteria, management identified a material weakness in our
internal control over financial reporting due to the ineffective design of review controls in place related to the appropriate accounting treatment of complex, non-
routine transactions and ineffective segregation of duties over the recording of non-routine transactions primarily as a result of limited resourcing. While
management took actions to remediate the material weakness ("Actions") during the year ended December 31, 2018, as discussed below, no complex non-routine
transactions occurred during the year ended December 31, 2018. Therefore, management was not able to monitor and test whether the Actions taken were
sufficient to remediate the material weakness. As a result of the lack of objective evidence that the Actions taken were sufficient to remediate the material
weakness, management must conclude that the material weakness has not been remediated. Accordingly, based on the evaluation performed as December 31,
2018, in accordance with the COSO criteria, management continues to disclose a material weakness in our internal control over financial reporting due to the
ineffective design of review controls in place related to the appropriate accounting treatment of complex, non-routine transactions and ineffective segregation of
duties over the recording of non-routine transactions.
After considering the Company's current situation and expectations of future operations, management does not expect that a complex non-routine transaction
will occur in the foreseeable future. Without a complex non-routine transaction, management will be unable to monitor or test that the Actions taken were
sufficient to remediate the material weakness. Consequently, it is likely that the material weakness reported herein will continue to be reported in future periods.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of our registered public accounting firm due to the exemption from this requirement for emerging
growth companies established by the JOBS Act.
Changes in Internal Control Over Financial Reporting
As discussed above, management took actions to remediate the material weakness, including the hiring of an outside advisor ("Advisor") to evaluate the
current design of our internal control environment and suggest steps to enhance processes. The Advisor's suggestions have been implemented. In addition, we
also hired an experienced professional who has many years of financial reporting experience working at a subsidiary of a US listed company as well as over ten
years of experience working at a large, international accounting firm. The newly hired professional ("Professional") holds a senior position within the Company's
finance department and is involved in overseeing all the activities of the finance department in Denmark. The Professional reports to the Vice President, Finance
and Controller and has direct access to the Company's Chief Executive Officer. Should the Group enter into a complex non-routine transaction in the future, the
Professional will independently evaluate the technical aspects, in accordance with IFRS, and financial statement implications of such transaction, and ensure that
such transaction is correctly accounted for and disclosed in the Company's consolidated financial statements. The Professional's role within our system of internal
control over financial reporting affords management the ability to enhance segregation of duties by redefining roles and responsibilities of staff to increase
oversight and review capabilities.
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
Our board of Directors has determined that Grant Hellier Lawrence is an audit committee financial expert, as that term is defined by the SEC, and is
independent in accordance with Nasdaq rules.
84
Table of Contents
ITEM 16B. CODE OF ETHICS
We have adopted a Code of Business Conduct and Ethics, which applies to all of our board members and employees, including our principal executive and
financial officer, Claus Bo Svendsen, and principal accounting officer, Thomas Carbone. Our Code of Business Conduct and Ethics is intended to meet the
definition of "code of ethics" under Item 16B of Form 20-F under the Exchange Act.
Our Code of Business Conduct and Ethics is available on our website at www.forward-pharma.com. The information contained on our website is not
incorporated by reference in this Annual Report.
Any amendments or waivers from the provisions of our Code of Business Conduct and Ethics will be made only after approval by our audit committee and
will be disclosed on our website promptly following the date of such amendment or waiver.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Our auditors, Ernst & Young P/S, have performed the following services for the Company during the past two years:
Audit
Audit related
Total
2018
2017
(USD in
thousands)
$ 333 $ 1,096
—
$ 333 $ 1,096
—
All services provided to the Company by Ernst & Young P/S are reviewed and approved by our audit committee in advance of commencement of services.
The amount for 2017 has been revised for changes that occurred subsequent to the filing of our 2017 Form 20-F.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
In 2018, no purchases of our equity securities were made by or on behalf of the Company or any affiliated purchaser.
ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT
Not applicable.
ITEM 16G. CORPORATE GOVERNANCE
Our ADSs are listed on the Nasdaq Global Select Market. However, as a foreign private issuer, we are permitted to follow the corporate governance practices
of our home country in lieu of certain provisions of the Nasdaq Listing Rules.
The material ways in which our corporate governance practices differ from those applicable to U.S. companies under the Nasdaq Listing Rules are:
•
We are not required to have an audit committee comprised of at least three members, and our audit committee is currently comprised of only two
members.
85
Table of Contents
•
•
•
•
•
•
A majority of the members of our board of directors are not required to be "independent directors" as defined in the Nasdaq Listing Rules, and a
majority of the members of our board of directors are not "independent directors."
We are not required to adopt a formal written charter or board resolution addressing the process for the nomination of directors. We do not have a
nominations committee, nor have we adopted a board resolution addressing the nominations process.
We are not required to hold regularly scheduled board meetings at which only independent directors are present.
No quorum requirement applies to our meetings of shareholders.
We are not required to obtain shareholder approval for material revisions to our share-based incentive plans.
We are not required to solicit proxies or provide proxy statements to Nasdaq pursuant to Nasdaq corporate governance rules or Danish law.
Consistent with Danish law and as provided in our Articles of Association, we will notify our holders of our ordinary shares of meetings with at
least two weeks' but not more than four weeks' notice. This notification will contain, among other things, information regarding business to be
transacted at the meeting. In addition, our bylaws provide that shareholders must give us not less than six weeks' advance notice to properly
introduce any business at an annual meeting of shareholders.
Other than as noted above, we are in compliance with other Nasdaq Listing Rules applicable to U.S. domestic issuers.
ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
86
Table of Contents
ITEM 17. FINANCIAL STATEMENTS
We have responded to Item 18 in lieu of this item.
ITEM 18. FINANCIAL STATEMENTS
PART III
The Financial Statements filed as part of this Annual Report begin on page F-1.
ITEM 19. EXHIBITS
Exhibit Index
Exhibit Number
Description
1.1(9)English translation of Amended and Restated Articles of Association, dated September 18, 2018.
2.1(2)Registration Rights Agreement, dated September 11, 2014, between Forward Pharma A/S and each of the
investors listed on Schedule A thereto.
2.2(3)Deposit Agreement between the Registrant and The Bank of New York Mellon, as depositary, dated
October 14, 2014.
2.3(3)Form of American Depositary Receipt (included in Exhibit 2.2).
2.4(2)Shareholders' Agreement, dated September 8, 2014, between Nordic Biotech K/S, Nordic Biotech Opportunity
Fund K/S, NB FP Investment K/S and NB FP Investment II K/S.
4.1(1)Patent Transfer Agreement, dated May 4, 2010, between Forward Pharma A/S and Aditech Pharma AG.
4.2(6)Addendum to Patent Transfer Agreement, dated January 17, 2017, between Forward Pharma A/S and Aditech
Pharma AG.
4.3(1)Form of Director and Officer Indemnification Agreement.
4.4(1)Indemnification Agreement with Joel Sendek.
4.5(4)Forward Pharma A/S 2014 Omnibus Equity Incentive Compensation Plan.
4.6(5)Settlement and License Agreement, dated January 17, 2017, between Forward Pharma A/S, Biogen Swiss
Manufacturing GmbH, Biogen International Holding Ltd. and certain other parties named therein.
4.7(6)Letter Agreement regarding the Settlement and License Agreement, dated January 17, 2017, between Forward
Pharma A/S, Biogen Swiss Manufacturing GmbH, Biogen International Holding Ltd. and certain other parties
named therein.
4.8(6)Letter Agreement regarding the Addendum to Patent Transfer Agreement, dated January 17, 2017, between
Forward Pharma A/S and Aditech Pharma AG.
4.9(6)Form of Shareholders Commitment Agreement.
4.10(8)Call Option Agreement, dated as of November 22, 2017, by and among Forward Pharma A/S, FWP HoldCo
ApS and Biogen Swiss Manufacturing GmbH.
4.11(8)Pledge Agreement, dated as of November 22, 2017, by and among Forward Pharma A/S, FWP HoldCo ApS
and Biogen Swiss Manufacturing GmbH.
87
Table of Contents
Exhibit Number
Description
4.12(8)Share Purchase Agreement, dated as of November 22, 2017, by and between Forward Pharma Operations ApS
and FWP HoldCo ApS.
4.13(7)Asset Contribution Agreement, dated as of June 30, 2017, by and between Forward Pharma A/S and Forward
Pharma Operations ApS.
4.14(7)IPR Services, Administration, Funding and Novation Agreement, dated as of June 30, 2017, by and among
Forward Pharma A/S, Forward Pharma Operations ApS, FWP IP ApS, Biogen Swiss Manufacturing GmbH
and Biogen International Holding Limited.
8.1 List of Subsidiaries.
12.1 Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of
1934, as amended.
12.2 Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of
1934, as amended.
13.1 Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
15.1 Consent of Ernst & Young P/S, Independent Registered Public Accounting Firm.
101.1
Interactive Data Files (XBRL-Related Documents).
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Incorporated by reference from the Registrant's Registration Statement on Form F-1 (Registration No. 333-198013) filed with the SEC on
August 11, 2014.
Incorporated by reference from the Registrant's Amendment No. 1 to Registration Statement on Form F-1 (Registration No. 333-198013)
filed with the SEC on September 12, 2014.
Incorporated by reference from the Registrant's Annual Report on Form 20-F filed with the SEC on March 25, 2015.
Incorporated by reference from the Registrant's Registration Statement on Form S-8 (Registration No. 333-203312) filed with the SEC on
April 9, 2015.
Incorporated by reference from the Registrant's Annual Report on Form 20-F filed with the SEC on April 18, 2017.
Incorporated by reference from the Registrant's Current Report on Form 6-K filed with the SEC on January 17, 2017.
Incorporated by references from the Registrant's Current Report on Form 6-K filed with the SEC on September 26, 2017.
Incorporated by references from the Registrant's Current Report on Form 6-K filed with the SEC on November 22, 2017.
Incorporated by references from the Registrant's Current Report on Form 6-K filed with the SEC on September 18, 2018.
88
Table of Contents
SIGNATURE
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign
this annual report on its behalf.
Date: April 4, 2019
FORWARD PHARMA A/S
By: /s/ CLAUS BO SVENDSEN
Name: Claus Bo Svendsen
Title:
Chief Executive Officer
89
Table of Contents
Forward Pharma A/S
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated statement of financial position as of December 31, 2018 and 2017
Consolidated statement of profit or loss for the years ended December 31, 2018, 2017 and 2016
Consolidated statement of other comprehensive income (loss) for the years ended December 31, 2018, 2017 and 2016
Consolidated statement of changes in shareholders' equity for the years ended December 31, 2018, 2017 and 2016
Consolidated statement of cash flows for the years ended December 31, 2018, 2017 and 2016
Notes to Consolidated Financial Statements
F-2
F-3
F-4
F-5
F-6
F-7
F-8
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of Forward Pharma A/S
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of Forward Pharma A/S (the Company) as of December 31, 2018 and 2017,
the related consolidated statements of profit or loss, other comprehensive (loss) income, changes in shareholders' equity and cash flows for each of the three years
in the period ended December 31, 2018, and the related notes (collectively referred to as the consolidated financial statements). In our opinion, the consolidated
financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2018 and 2017, and the results of its operations
and its cash flows for each of the three years in the period ended December 31, 2018, in conformity with International Financial Reporting Standards as issued by
the International Accounting Standards Board.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and
are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the
Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control
over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and
performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the
overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Ernst & Young P/S
We have served as the Company's auditor since 2005.
Copenhagen, Denmark
April 4, 2019
F-2
Table of Contents
Consolidated Statement of Financial Position
as of December 31, 2018 and 2017
Assets
Equipment
Other non-current asset
Total non-current assets
Prepayments
Other receivables
Income tax receivable
Cash and cash equivalents
Total current assets
Total assets
Equity and Liabilities
Share capital
Other components of equity:
Foreign currency translation reserve
Accumulated deficit
Equity attributable to shareholders of the Parent
Total equity
Non-current liabilities:
Deferred tax
Total non-current liabilities
Trade payables
Income tax payable
Accrued liabilities
Total current liabilities
Total equity and liabilities
December 31,
Notes
2018
2017
USD '000
USD '000
4.1
6.2
4.2
4.3
3.4
5.2
—
2
2
340
266
182
82,542
83,330
83,332
12
5
17
502
518
417
109,554
110,991
111,008
December 31,
Notes
2018
2017
USD '000
USD '000
5.1
152
151
87,748
(5,686)
82,214
82,214
91,902
(2,373)
89,680
89,680
—
—
428
68
622
1,118
83,332
43
43
1,203
7,039
13,043
21,285
111,008
3.4
5.4
3.4
4.4
See accompanying notes to these consolidated financial statements
F-3
Table of Contents
Consolidated Statement of Profit or Loss
for the years ended December 31, 2018, 2017 and 2016
amounts in thousands except per share amounts
Notes
2018
USD
Revenue from settlement and license agreement
Cost of the Aditech Pharma AG agreement
Research and development costs
General and administrative costs
Operating (loss) income
Exchange rate gain (loss), net
Interest income from available-for-sale financial assets
Other finance income (expense)
(Loss) income before tax
Income tax benefit (expense)
Net (loss) income for the year
Net (loss) income for the year attributable to:
Equity holders of the Parent
Per share amounts:
Net (loss) income per share basic
Net (loss) income per share diluted
1.2
1.2, 6.2
3.2, 3.3, 4.1
3.2, 3.3, 4.1, 6.1
5.3
3.4
3.5
3.5
(12,283) 1,187,397
Year ended December 31,
2017
USD
1,250,000
2016
USD
—
—
(2,748)
(9,535)
2,713
—
644
204
(8,722)
—
(25,000)
—
(20,496) (41,052)
(17,107) (14,382)
(55,434)
598
389
(92)
(54,539)
(267,395) 21,203
(33,336)
917,093
(241)
227
(2,895)
(8,926) 1,184,488
(8,722)
917,093
(33,336)
(0.09)
(0.09)
2.41
2.30
(0.06)
(0.06)
See accompanying notes to these consolidated financial statements
F-4
Table of Contents
Consolidated Statement of Other Comprehensive (Loss) Income
for the years ended December 31, 2018, 2017 and 2016
Notes
2018
USD '000
Year ended December 31,
2017
USD '000
2016
USD '000
Net (loss) income for the year
Other comprehensive (loss) income to be reclassified to profit or loss in
subsequent periods:
Change in fair value of available-for-sale financial assets
Exchange differences on translation of foreign operations
Net other comprehensive (loss) income to be reclassified to profit or loss in
subsequent periods
Other comprehensive (loss) income
Total comprehensive (loss) income
Attributable to:
Equity holders of the parent
(8,722)
917,093
(33,336)
2.1
2.1
—
(4,154)
(218)
129,673
116
(4,896)
(4,154)
(4,154)
129,455
129,455
(12,876) 1,046,548
(4,780)
(4,780)
(38,116)
(12,876) 1,046,548
(38,116)
See accompanying notes to these consolidated financial statements
F-5
Table of Contents
Consolidated Statement of Changes in Shareholders' Equity
for the years ended December 31, 2016, 2017 and 2018
Notes
Share
capital
Share
premium
USD '000
USD '000
Foreign
currency
translation
reserve
USD '000
Fair value
adjustment
available-for-
sale financial
assets
USD '000
At January 1, 2016
Net loss for the year
Other comprehensive (loss) income
Total comprehensive (loss) income
Issuance of deferred shares
Exercise of warrants
Share-based payment costs
Tax benefit resulting from share-
based payment costs
Transactions with owners
At December 31, 2016
At January 1, 2017
Net income for the year
Other comprehensive income (loss)
Total comprehensive income (loss)
Shareholder distribution
Distribution to equity award holders
Exercise of warrants
Share-based payment costs
Tax benefit resulting from share-
based payment costs
Transactions with owners
At December 31, 2017
At January 1, 2018
Net loss for the year
Other comprehensive (loss)
Total comprehensive (loss)
Exercise of warrants
Distribution to equity award holders
Share-based payment costs
Transactions with owners
At December 31, 2018
5.1
5.1
3.3
3.4
5.1
3.3
5.1
3.3
3.4
5.1
3.3
3.3
796
—
—
—
2
2
—
—
4
800
800
—
—
—
339,845
—
—
—
—
110
—
—
110
339,955
339,955
—
—
—
(650) (340,003)
—
1
—
—
—
48
—
—
(649) (339,955)
151
151
—
—
—
1
—
—
1
152
—
—
—
—
—
—
—
—
—
—
(32,875)
—
(4,896)
(4,896)
—
—
—
—
—
(37,771)
(37,771)
—
129,673
129,673
—
—
—
—
—
—
91,902
91,902
—
(4,154)
(4,154)
—
—
—
—
87,748
102
—
116
116
—
—
—
—
—
218
218
—
(218)
(218)
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
See accompanying notes to these consolidated financial statements
F-6
Accumulated
deficit
USD '000
Total
equity
USD '000
(131,175)
(33,336)
—
(33,336)
—
—
14,288
176,693
(33,336)
(4,780)
(38,116)
2
112
14,288
2,823
2,823
17,225
17,111
155,802
(147,400)
155,802
(147,400)
917,093
917,093
129,455
—
917,093
1,046,548
(753,274) (1,093,927)
(32,208)
49
7,082
—
7,082
(32,208)
6,334
6,334
(772,066) (1,112,670)
89,680
89,680
(8,722)
(4,154)
(12,876)
1
(761)
6,170
5,410
82,214
(2,373)
(2,373)
(8,722)
—
(8,722)
—
(761)
6,170
5,409
(5,686)
Table of Contents
Consolidated Statement of Cash Flows
for the years ended December 31, 2018, 2017 and 2016
Notes
2018
Year ended December 31,
2017
USD '000
2016
USD '000
USD '000
Operating activities:
(Loss) income before tax
Adjustments to reconcile (loss) income before tax to net cash flows (used in)
(8,926) 1,184,488
(54,539)
provided by operating activities:
Share-based payment costs
Depreciation expense
Other including foreign exchange rate gain (loss)
Cash inflow from interest on available-for-sale financial assets
Cash inflow for taxes
Cash (outflow) for taxes
Decrease in other receivables and prepayments
(Decrease) increase in trade and other payables
Net cash flows (used in) provided by operating activities
Investing activities:
Proceeds from the maturity of available-for-sale financial assets
Reduction in non-current asset
Purchase of equipment
Net cash flows provided by investing activities
Financing activities:
Shares issued for cash
Shareholder distribution
Repurchase of equity awards
Net cash flows (used in) provided by financing activities
Net (decrease) increase in cash and cash equivalents
Net foreign exchange differences
Cash and cash equivalents at January 1
Cash and cash equivalents at December 31
3.3
4.1
4.1
5.1
5.1
3.3
6,170
4
6
—
472
(7,089)
384
(5,808)
(14,787)
—
3
—
3
7,082
227
4,217
571
—
(255,453)
71
(1,256)
939,947
85,368
—
(3)
85,365
49
1
(1,093,927)
—
(8,121)
(24,813)
(8,120) (1,118,691)
(93,379)
145,035
57,898
109,554
(22,904)
(4,108)
109,554
82,542
14,288
109
(986)
1,006
291
—
1,526
4,200
(34,105)
41,201
—
(31)
41,170
114
—
—
114
7,179
(1,550)
52,269
57,898
See accompanying notes to these consolidated financial statements
F-7
Table of Contents
Section 1—Corporate information
1.1 Organization
Notes to Consolidated Financial Statements
Forward Pharma A/S (the "Company" or "Parent") is a limited liability company incorporated and domiciled in Denmark. The registered office is located in
Copenhagen, Denmark. The consolidated financial statements include the Company's directly, and indirectly, owned German, United States and two Danish
subsidiaries, identified as follows: Forward Pharma GmbH ("FP GmbH"), Forward Pharma USA, LLC, Forward Pharma FA ApS and Forward Pharma
Operations ApS ("Operations"), respectively (also see Restructuring below). The Company and its subsidiaries are collectively referred to as the "Group". The
Company's board of directors authorized the issuance of the financial statements included herein on April 2, 2019.
As discussed in more detail in Note 1.2, effective as of February 1, 2017, the Company entered into a Settlement and License Agreement (the "License
Agreement") with two wholly owned subsidiaries of Biogen Inc. (collectively "Biogen"). Prior to entering into the License Agreement, the Company was actively
developing FP187 ®, a proprietary formulation of dimethyl fumarate ("DMF"), for the treatment of multiple sclerosis ("MS") patients. The Company announced
on March 1, 2017 plans to complete the remaining research and development efforts of FP187 ® and pursue an organizational realignment to reduce personnel
and operating expenses by mid-year 2017. The organizational realignment was substantially completed by September 30, 2017. As discussed in Note 1.2, the
Company has permanently discontinued the development of DMF formulations, including FP187 ®.
Under the terms of the License Agreement, the Parent restructured its operations (the "Restructuring") on June 30, 2017 whereby the Parent transferred to
Operations (a newly created wholly owned Danish limited liability company) certain assets and liabilities, including the legal and beneficial rights, title and
interest to defined intellectual property (the "IP"), and Operations transferred the IP to FWP IP ApS ("FWP IP") (a newly created wholly owned Danish limited
liability company). The final step in the Restructuring was completed on November 22, 2017 when the capital stock of FWP IP was sold (the "Sale") to a newly
formed Danish limited liability company (FWP HoldCo ApS, referred to as "HoldCo") owned and controlled by a newly formed independent Danish foundation
(FWP Fonden, referred to as the "Foundation"). In consideration for the capital stock of FWP IP, HoldCo paid Operations 336,000 Danish Kroner ("DKK")
($54,000 based on the December 31, 2017 exchange rate).
The Foundation's three-member board includes one independent director and one director appointed by each of the Parent and Biogen. Accordingly, the
Parent does not control, nor does it have exposure or rights to variable returns from the Foundation, HoldCo or FWP IP. During November 2017, the Group
contributed 5 million DKK ($805,000 based on the December 31, 2017 exchange rate) as the initial capitalization (the "Initial Capitalization") of the Foundation
and is obligated to pay 100,000 DKK ($15,000 based on the December 31, 2018 exchange rate) annually (the "Annual Funding") to FWP IP in exchange for FWP
IP agreeing to hold, prosecute and maintain the IP in accordance with certain agreements. In the future, the Group is only obligated to remit the Annual Funding
through the last to expire, or invalidation of, the licensed patents underlying the IP; however, the Company's obligation to remit the Annual Funding would be
discontinued earlier if certain events, as defined in the License Agreement, occur.
On August 2, 2017, the Company's shareholders approved a 10 for 1 share split (the "Share Split"). Except if disclosed otherwise, all share and per share
information contained in the accompanying financial statements has been adjusted to reflect the Share Split as if it had occurred at
F-8
Table of Contents
Section 1—Corporate information (Continued)
Notes to Consolidated Financial Statements (Continued)
the beginning of the earliest period presented. Subsequent to the Share Split, the nominal value of an ordinary share of the Parent is 0.01 DKK. See Note 3.5 for
additional information regarding share and per share information.
On August 2, 2017, the Company's shareholders approved a capital reduction with a corresponding shareholder distribution of 917.7 million EUR
($1.1 billion) (the "Capital Reduction"). The funds for the Capital Reduction were distributed to shareholders during September 2017. The Capital Reduction was
executed through the annulment of 80% of the ordinary shares outstanding post Share Split. Currently there are no plans to distribute funds to shareholders in the
future.
1.2 Intellectual Property Proceedings and the Settlement and License Agreement
On February 1, 2017, the License Agreement with Biogen and certain additional parties became effective. The License Agreement provided Biogen with a
co-exclusive license in the United States, and an exclusive license outside the United States, to the IP, effective as of February 9, 2017. In accordance with the
License Agreement, Biogen paid the Company a non-refundable fee of $1.25 billion ("Non-refundable Fee") in February 2017.
Background
On April 13, 2015, an administrative patent judge at the United States Patent Trial and Appeal Board ("PTAB") declared Patent Interference No. 106,023
(the "Interference Proceeding") between the Company's United States Patent Application No. 11/567,871 and United States Patent No. 8,399,514B2 held by a
subsidiary of Biogen Inc. The License Agreement did not resolve the Interference Proceeding between the Company and Biogen or the pending opposition
proceeding against the Company's European patent EP2801355 (the "Opposition Proceeding"). The License Agreement contemplated that the PTAB and the
United States Court of Appeals for the Federal Circuit (the "Federal Circuit"), as applicable, and the Opposition Division, the Technical Board of Appeal and the
Enlarged Board of Appeal of the European Patent Office (the "EPO"), as applicable, to make final determinations in the proceedings before them. As discussed
further below, the final determinations in the proceedings would determine whether future royalties are due the Company in accordance with the License
Agreement. An unsuccessful outcome in the Interference Proceeding would result in the Company not being entitled to royalties based on Biogen's future net
sales in the United States, as defined in the License Agreement, and an unsuccessful outcome in the Opposition Proceeding would result in the Company not
being entitled to royalties on Biogen's future net sales outside the United States, as defined in the License Agreement.
Interference Proceeding
On March 31, 2017, the PTAB issued a decision in the Interference Proceeding in favour of Biogen. The PTAB ruled that the claims of the Company's
United States Patent Application No. 11/567,871 are not patentable due to a lack of adequate written description. On May 30, 2017, the Company filed a notice of
appeal with the Federal Circuit seeking to have the PTAB's decision overturned and the Interference Proceeding reinstated. On October 24, 2018, the Federal
Circuit affirmed the PTAB's decision. On November 21, 2018, the Company filed a petition for rehearing of the Federal Circuit's decision. The rehearing request
was denied on January 2, 2019 and the Federal Circuit's decision became final on January 9, 2019. The Federal Circuit's final decision ends the Interference
Proceeding in favour of Biogen. As a result of the unsuccessful outcome of the
F-9
Table of Contents
Section 1—Corporate information (Continued)
Notes to Consolidated Financial Statements (Continued)
Interference Proceeding, the Company will not receive royalties from Biogen based on Biogen's future net sales in the United States as defined in the License
Agreement.
On March 25, 2019, the Company received notice from Biogen of their exercise of the option to purchase the intellectual property in the United States
associated with the Company pursuant to the License Agreement. The Company and Biogen have consummated the assignment of the United States intellectual
property to Biogen upon the execution of assignment agreements and the payment of a nominal amount by Biogen to FWP IP ApS, and Biogen has assumed
ownership and responsibility for the assigned United States intellectual property. In addition, the Company will not be able to develop or commercialize any
therapy for the treatment of any human disease or condition using DMF, including FP187®.
As a result of entering into the License Agreement, combined with the recently announced unsuccessful outcome in the Interference Proceeding and Biogen's
purchase of the intellectual property in the United States associated with the Company, the Company has permanently discontinued the development of DMF
formulations, including FP187®. Therefore, sources of revenue derived from customers in the United States, including product sales of a DMF formulation, are
not expected.
Opposition Proceeding
If the Company is successful in the Opposition Proceeding (i.e., the Company obtains, as a result of the Opposition Proceeding, and any appeals therefrom, a
patent with a claim covering oral treatment of MS with 480 mg/day of DMF), it would be eligible beginning on January 1, 2021 to collect a 10% royalty
(increasing to 20% from January 1, 2029) until the earlier of the expiration or invalidation of the patents defined in the License Agreement, on a country-by-
country basis on Biogen's net sales outside the United States of DMF-containing products indicated for treating MS that, but for the license granted under the
License Agreement, would infringe a Company patent, provided that other conditions of the License Agreement are satisfied. Among the conditions that need to
be satisfied for any royalty to be payable by Biogen to the Company is the absence of generic entry in a particular geography having a particular impact as
defined in the License Agreement. If the Company is unsuccessful in the Opposition Proceeding and any appeals therefrom, the Company would not be entitled to
future royalties on Biogen's net sales outside the United States.
On January 29, 2018, the Opposition Division of the EPO concluded the oral proceeding concerning patent EP2801355 and issued an initial decision in the
Opposition Proceeding. The Opposition Division revoked patent EP2801355 after considering third-party oppositions from several opponents. On March 22,
2018, the Opposition Division issued its written decision with detailed reasons for the decision, on May 7, 2018, the Company submitted its notice of appeal, and
on August 1, 2018, the Company submitted the detailed grounds for the appeal. If the Company prevails in such appeal, it is expected that the Technical Board of
Appeal will remand the case to the Opposition Division, in order for the Opposition Division to resolve the remaining elements of the original opposition. The
duration of the appeal process is estimated to be approximately three years; however, delays can occur that would extend the estimated duration of the appeal
process.
Aditech Pharma AG
The receipt of the Non-refundable Fee in February 2017 triggered a $25 million obligation payable to Aditech Pharma AG in accordance with the addendum
to the patent transfer agreement between the Company and Aditech Pharma AG. See Note 6.2.
F-10
Table of Contents
Notes to Consolidated Financial Statements (Continued)
Section 1—Corporate information (Continued)
1.3 Public listing of American Depositary Shares representing Ordinary Shares
During the fourth quarter of 2014, the Company completed the initial public offering ("IPO") of American Depositary Shares ("ADS") representing ordinary
shares of the Company with a nominal value of 0.10 DKK each in the United States and issued 11.2 million ADSs at a price per ADS of $21.00 to investors. The
IPO proceeds totaled $235.2 million before deducting the underwriters' commission (7% of gross proceeds) and other direct and incremental costs associated with
the IPO. Subsequent to the Share Split and the Capital Reduction, each ADS represents two ordinary shares with a nominal value of 0.01 DKK each. Holders of
ADSs are not entitled to vote while holders of ordinary shares are entitled to one vote per share.
1.4 Going Concern
The Group currently estimates that there will be adequate liquidity to continue as a going concern beyond the next twelve months; however, if the Company
fails to prevail in the Opposition Proceeding, including all appeals, future revenues are unlikely, the Company's ability to continue as a going concern long-term
would be uncertain and management would consider, amongst other things, an orderly wind-down of operations.
Section 2—Basis of Preparation
2.1 Accounting policies
Basis of preparation
The consolidated financial statements of the Group have been prepared in accordance with International Financial Reporting Standards ("IFRS"), as issued
by the International Accounting Standards Board ("IASB").
The consolidated financial statements have been prepared on a historical cost basis, except for available-for-sale financial assets that were measured at fair
value as discussed further below. The consolidated financial statements are presented in United States Dollars ("USD"), and all values are rounded to the nearest
thousand (USD '000), except when otherwise indicated.
Basis of consolidation
The consolidated financial statements comprise the financial statements of the Group as of December 31, 2018 and 2017 and for the years ended
December 31, 2018, 2017 and 2016.
FP GmbH, Forward Pharma USA, LLC and Forward Pharma FA ApS have been consolidated for all periods presented herein. Operations has been
consolidated since its inception on June 30, 2017. FWP IP was consolidated from its inception on June 30, 2017 through November 22, 2017 when the capital
stock of FWP IP was sold to HoldCo.
The Parent's consolidation of each subsidiary will continue until the date the Company no longer controls the subsidiary. The financial statements of the
subsidiaries are prepared for the same reporting period as the Company, using consistent accounting policies. All intra-group balances and transactions are
eliminated in consolidation.
F-11
Table of Contents
Notes to Consolidated Financial Statements (Continued)
Section 2—Basis of Preparation (Continued)
Translation from functional currencies to presentation currency
The Parent's consolidated financial statements are presented in USD which is not the functional currency of the Parent. The Group has elected USD as the
presentation currency due to the fact that the Parent has listed ADSs on the Nasdaq Global Select Exchange in the United States, under the ticker symbol "FWP".
The Parent, Operations, FWP IP and Forward Pharma FA ApS's functional currency is the DKK, FP GmbH's functional currency is the Euro ("EUR") and
Forward Pharma USA, LLC's functional currency is the USD.
Except for the specific income and expense transactions noted below, the translation to the presentation currency for entities with a functional currency
different from the USD, their assets and liabilities are translated to USD using the closing rate as of the date of the statements of financial position while income
and expense items for each statement presenting profit or loss and other comprehensive income are translated into USD at an average exchange rate for the
period. Exchange differences arising from such translation are recognized directly in other comprehensive (loss) income and presented in a separate reserve in
equity.
As a result of the magnitude of the Non-refundable Fee, the amounts due per the Amendment (as defined in Note 3.3), and the amount due Aditech Pharma
AG (see Note 6.2) combined with the weakening of the USD compared to the DKK during the year ended December 31, 2017, the Parent used the spot rate to
translate such transactions to the presentation currency (USD.) The spot rate was used to avoid the distortion of operating results that would have been caused had
the average exchange rate been used. In addition, for the same reason, the average exchange rate for the three-month period ended March 31, 2017 was used to
translate the income tax provision to the presentation currency.
Foreign currencies transactions and balances
The Company and each of its subsidiaries determine their respective functional currency based on facts and circumstances and the technical requirements of
IFRS. Items included in the financial statements of each entity are measured using the functional currency. Transactions in foreign currencies are initially
recorded by the Group entities in their respective functional currency using the spot rate at the date the transaction first qualifies for recognition. Monetary assets
and liabilities denominated in foreign currencies are translated at the functional currency spot rate at each reporting date. Differences arising on settlement or
translation of monetary items denominated in foreign currency are recognized in the statement of profit or loss. For each of the years ended December 31, 2018,
2017 and 2016, the amounts reflected as "Exchange rate gain (loss), net," within the consolidated statement of profit and loss include gross exchange (losses)
gains totaling ($227,000), $9.0 million and ($1.9) million respectively.
Revenue recognition
The Group recognized the Non-refundable Fee in accordance with IFRS 15 Revenue from Contracts with Customers ("IFRS 15"). IFRS 15 addresses the
accounting and disclosure requirements for revenue contracts with customers. The mandatory effective date for adopting IFRS 15 was January 1, 2018; however,
the Group elected to adopt IFRS 15 early on January 1, 2017. In accordance with IFRS 15, the Group recognizes revenue to reflect the transfer of goods or
services to customers in an amount that reflects the consideration that the Group expects to receive in exchange for such goods or services.
F-12
Table of Contents
Section 2—Basis of Preparation (Continued)
Notes to Consolidated Financial Statements (Continued)
Prior to entering to the License Agreement, the Group did not have revenue from contracts with customers that were within the scope of IFRS 15 and
therefore the adoption of IFRS 15 had no effect on previously reported financial statements nor was an adjustment made to the Group's accumulated deficit at
January 1, 2017.
The only contract that the Group is party to that is within the scope of IFRS 15 is the License Agreement. In concluding when the Non-refundable Fee
should be recognized as revenue, various judgments were made, including the identification of the Company's performance obligations within the License
Agreement and whether these performance obligations are distinct. Management concluded that the performance obligations in the License Agreement were
related to the right granted to Biogen to use the licensed IP both in the United States as well as in the rest of the world and concluded that these performance
obligations were met at the time the License Agreement was consummated, as Biogen was granted full use of the licensed IP whether under a co-exclusive license
or an exclusive license. At the time the License Agreement became effective, the Company was required (i) to fund the cost to file, prosecute and maintain the
licensed IP as defined in the License Agreement, (ii) to participate in an intellectual property advisory committee and (iii) to provide the Annual Funding
(collectively "Defense Costs" or "Defend the IP"). The period the Company is obligated to fund the Defense Costs is defined in the License Agreement and could
include the period from the effective date of the License Agreement through the last to expire, or invalidation of, the licensed patents; however, the Company's
obligation to fund Defense Costs would be discontinued earlier if certain events, as defined in the License Agreement, occur. Management concluded that the
Company's obligation to Defend the IP does not represent a separate performance obligation as such activities are deemed to be costs to protect the value of the
license granted to Biogen. Since Biogen received full unrestricted use of the licensed IP at the time the License Agreement was consummated and since the
Company currently has no plans to nor is it obligated to further develop the underlying licensed IP, the License Agreement is deemed to provide Biogen with a
right to use the licensed IP upon the consummation of the License Agreement. Based on the facts and circumstance discussed herein, the Non-refundable Fee was
recognized as revenue when the performance obligations were satisfied.
Effective upon Biogen obtaining ownership of the United States IP, as discussed in Note 1.2, the Company is no longer required to fund Defense Costs
associated with the United States IP.
The License Agreement provides for Biogen to remit to the Company royalties (as defined in Note 1.2) only if the Company is successful in the in the
Interference Proceedings and/or Opposition Proceeding, including all appeals, and provided that other conditions of the License Agreement are satisfied. Should
the Company be entitled to receive royalties from Biogen in the future, such amounts will be recognized as revenue in the period the underlying sales occur. As
described above, the Federal Circuit's final decision has ended the Interference Proceeding in favour of Biogen and as a result the Company will not receive
royalties from Biogen based on Biogen's future net sales in the United States. If the Company is unsuccessful in the Opposition Proceeding and any appeals
therefrom, the Company would not be entitled to future royalties on Biogen's net sales outside the United States.
Share-based payments
Employees, board members and consultants (who provide services similar to employees) of the Group receive remuneration in the form of equity settled
awards whereby services are rendered as consideration for equity awards (warrants, deferred shares or options). The fair value of these equity-settled awards is
determined at the date of grant resulting in a fixed fair value at grant date that
F-13
Table of Contents
Section 2—Basis of Preparation (Continued)
Notes to Consolidated Financial Statements (Continued)
is not adjusted for future changes in the fair value of the equity awards that may occur over the service period. Fair value of warrants and options is determined
using the Black Scholes model while fair value of deferred shares is determined as the fair value of the underlying shares less the present value of expected
dividends.
Non-employee consultants of the Group have received equity settled awards in the form of share options as remuneration for services. The fair value of these
equity-settled awards is measured at the time services are rendered using the Black Scholes model. Under this method, the fair value is determined each quarter
over the service period until the award vests.
The Company has never granted cash settled awards. Generally, equity awards have a term of six years with none exceeding ten years from the date of grant.
Equity awards generally vest over a three to five-year service period and certain equity awards vest contingently on the occurrence of defined events.
The cost of share-based payments is recognized as an expense together with a corresponding increase in equity over the period in which the performance
and/or service conditions are fulfilled. For equity instruments that are modified or replaced, the incremental value, if any, that results from the modification or
replacement is recognized as an expense over the period in which performance and/or service conditions are fulfilled or immediately if there are no performance
and/or service conditions to be fulfilled.
The fair value of equity-settled awards is reported as compensation expense pro rata over the service period to the extent such awards are estimated to vest.
No cost is recognized for awards that do not ultimately vest.
As discussed in more detail in Note 3.3, in order to mitigate the dilution to holders of warrants, deferred shares or options caused by the Capital Reduction,
the Parent's shareholders and board of directors approved adjustments to the terms and conditions governing certain warrants, deferred shares or options. The
adjustments resulted in a combination of cash payments to the holders of the equity awards, reductions in the exercise prices of equity awards and a decrease in
the total number of ordinary shares that may be subscribed for or purchased pursuant to outstanding equity awards.
Employee benefits
Employee benefits are primarily made up of salaries, share-based payments, Group-provided health insurance and Group contributions to a defined
contribution retirement plan. The cost of these benefits is recognized as expenses as services are delivered. The Group's contributions to the employee defined
contribution retirement plan have not been material.
Operating Expenses in the Statement of Profit or Loss
Research and development costs
Research and development costs primarily comprise salary and related expenses, including share-based payment expense, license, patent and other
intellectual property-related costs incurred in connection with patent claims and other intellectual property rights conducted at the patent registry offices (for
example the United States Patent and Trademark Office ("USPTO"), the EPO or other country-specific patent registry offices), manufacturing costs of pre-
commercial product used in
F-14
Table of Contents
Section 2—Basis of Preparation (Continued)
Notes to Consolidated Financial Statements (Continued)
research, clinical costs, and depreciation of equipment, to the extent that such costs are related to the Group's research and development activities.
If expenses incurred are associated with the Group's intellectual property-related activities carried out in the courts to protect, defend and enforce granted
patent rights against third parties (excluding activities and proceedings conducted within the USPTO, EPO or other country-specific patent registry offices)
("Court Expenses") they are classified within general and administrative expenses. Court Expenses incurred for the years ended December 31, 2018, 2017 and
2016 totaled $453,000, $1.2 million and $315,000 respectively.
Capitalized patent and development costs
The Group's research and development activities have concentrated on the development of unique formulations of DMF for the treatment of immune
disorders and include all patent office-related activities regarding the Company's patent estate development (e.g., interference proceeding, oppositions and new
patent development). For all periods presented herein, the Group did not capitalize patent costs or FP187® development costs and consequently expensed such
costs as incurred given the inherent uncertainty in drug development and commercialization.
General and administrative costs
General and administrative costs relate to the administration of the Group and comprise salaries and related expenses, including share-based payment
expense, investor relations, legal and accounting fees, other costs associated with our public listing of ADSs in the United States and depreciation of equipment,
to the extent such expenses are related to the Group's administrative functions as well as Court Expenses. For the year ended December 31, 2017, general and
administrative costs include the expenses associated with the Restructuring.
Government grants
Income from government grants is recognized when there is reasonable assurance that the grant will be received, all contractual conditions have been
complied with and where contingent repayment obligations remain, avoidance of such obligations are within the control of the Group and not probable to occur.
When the grant is intended to subsidize costs incurred by the Group, it is recognized as a deduction in reporting the related expense on a systematic basis over the
periods to which the costs relate. When the grant subsidizes a capital asset, it is recognized as income in equal amounts over the expected useful life of the related
asset. For more information regarding government grants, see Note 6.2.
Current and deferred income taxes
Current income tax
Tax assets and liabilities for the current period are measured at the amount expected to be recovered from or paid to the taxation authorities within one year
from the date of the statement of financial position. The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted at
the reporting date in the countries where the Group operates.
Management periodically evaluates positions taken in the tax returns with respect to situations in which applicable tax regulations are subject to
interpretation or "uncertainty" and establishes provisions
F-15
Table of Contents
Section 2—Basis of Preparation (Continued)
Notes to Consolidated Financial Statements (Continued)
where appropriate. To date, there have been no provisions established for uncertain tax positions. The IASB issued IFRIC 23 Uncertainty over Income Tax
Treatments ("IFRIC 23") in May 2017. IFRIC 23 is effective on January 1, 2019 and clarifies the recognition and measurement requirements in IAS 12 Income
Taxes when there is uncertainty over income tax treatments. The future application of IFRIC 23 is not expected to have an effect on the Company's consolidated
financial statements.
Deferred tax
Deferred tax is provided based on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts for financial
reporting purposes at the reporting date. Deferred tax assets and liabilities are measured at the tax rates that are expected to apply in the year when the asset is
realized, or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted at the reporting date. Deferred tax assets are
recognized to the extent that it is probable that taxable profit will be available in the future against which the deductible temporary differences, unused tax credits
and unused tax losses can be utilized. Deferred tax assets and deferred tax liabilities of the same tax jurisdiction are offset if a legally enforceable right exists to
set off.
The carrying amount of deferred tax assets is reviewed at each reporting date and reduced to the extent that it is no longer probable that sufficient taxable
profit will be available to allow all or part of the deferred tax asset to be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are
recognized to the extent that it has become probable that future taxable profits will allow the deferred tax asset to be recovered. See Note 3.4.
Deferred tax relating to items recognized outside the profit or loss are recognized in correlation to the underlying transaction either in other comprehensive
income or directly in equity.
During the period from January 19, 2013 to December 31, 2015, the Company was part of a Danish joint taxation group with Tech Growth Invest ApS (see
Note 3.4) and entities under Tech Growth Invest ApS's control (collectively "Tech Growth"). Under the joint taxation, the Company received a refund equal to the
tax benefit realized by Tech Growth from Tech Growth's partial utilization of the Company's tax losses at the applicable corporate tax rate to the extent that the
tax losses reduced the taxable income of Tech Growth. An entity that was part of Tech Growth experienced a change in ownership on December 31, 2015. As a
result of the change in ownership, the year ended December 31, 2015 was the final year in which the Company received a refund equal to the tax benefit realized
by Tech Growth from Tech Growth's partial utilization of the Company's tax losses.
On January 1, 2016, the Parent became part of a new Danish joint taxation group ("2016 Tax Group") with NB FP Investment General Partner ApS and
Forward Pharma FA ApS. For the year ended December 31, 2017, Operations became member of the 2016 Tax Group on June 30, 2017 (inception) and FWP IP
became a member of the 2016 Tax Group on June 30, 2017 (inception) through the date of the Sale (November 22, 2017.) For the year ended December 31, 2018,
the Parent, Operations and Forward Pharma FA ApS were part of the 2016 Tax Group.
Equipment
Historically equipment included computers, office equipment, furniture and manufacturing equipment. Equipment is reflected in the accompanying financial
statements at cost net of accumulated
F-16
Table of Contents
Section 2—Basis of Preparation (Continued)
Notes to Consolidated Financial Statements (Continued)
depreciation. Manufacturing equipment owned by the Group was placed in service for the use of Group vendors that provided contract manufacturing services to
the Group.
Depreciation is calculated on a straight-line basis over the expected useful lives of the underlying assets of two to eight years. The residual values of
equipment are not material. Except as discussed in Note 4.1, there have been no impairment losses recognized by the Group since the inception of the Company.
The useful life of and method of depreciation of equipment are reviewed by management at least each annually or more often based on changes in facts or
circumstances that may result and are adjusted prospectively as changes in accounting estimates. For all periods presented herein, the effect of changes in
accounting estimates for equipment were immaterial.
Financial Instruments and the adoption of IFRS 9 Financial Instruments
Effective January 1, 2018, the Group adopted IFRS 9 Financial Instruments ("IFRS 9") retrospectively; however, IFRS 9 does not require restatement of
prior periods but allows for the cumulative effect of adopting IFRS 9 to be reflected as an adjustment to the Group's accumulated deficit at January 1, 2018. At the
adoption date, and subsequent thereto, the Group did not hold financial instruments where the accounting for such financial instruments changed as the result of
adopting IFRS 9. Accordingly, the adoption of IFRS 9 had no effect on the accompanying consolidated financial statements nor was an adjustment made to the
Group's accumulated deficit at January 1, 2018.
For all periods presented herein, the Group did not hold derivative financial instruments nor has there been a change in classification of a financial asset after
initial recognition and measurements. Financial instruments are not acquired for trading or speculative purposes.
The basis of presentation of financial assets prior to the adoption of IFRS 9 on January 1, 2018
Initial recognition and measurement
The Group's financial assets were recognized initially at fair value plus transaction costs that were attributable to the acquisition of the financial asset, if any.
Transaction costs were applicable only to the Company's available-for-sale financial assets.
Subsequent measurement
The Group held financial assets within the following measurement categories:
•
•
Loans and receivables comprising cash, cash equivalents and other receivables.
Available-for-sale financial assets comprising government issued debt instruments.
Loans and receivables were measured at amortised cost using the effective interest rate method. Available-for-sale financial assets were carried at fair value
with changes in fair value from period to period recognized in other comprehensive income. Interest income was reported using the effective interest rate method
with foreign exchange gains or losses recognized in the consolidated statement of profit and loss within foreign exchange rate gain (loss). Subsequent to
October 15, 2017, the Group did not hold available-for-sale financial assets.
F-17
Table of Contents
Section 2—Basis of Preparation (Continued)
Financial asset impairment
Notes to Consolidated Financial Statements (Continued)
The Group assessed at the end of each reporting period whether there had been objective evidence that a financial asset or group of financial assets was
impaired. Impairment losses would have been incurred if there was objective evidence of impairment and the evidence indicated that estimated future cash flows
would be negatively impacted. For each of the years ended December 31, 2017 and 2016, the Group did not experience an impairment of a financial asset.
The basis of presentation of financial assets subsequent to the adoption of IFRS 9 on January 1, 2018
Initial recognition and measurement
The Group's financial assets will be recognized initially at fair value. For financial assets acquired that will not be measured at fair value through profit and
loss, the initial measure of fair value will include transaction costs.
Subsequent measurement
Financial assets will be classified as either financial assets measured at amortized cost, measured at fair value through profit or loss or measured at fair value
through other comprehensive income. The classification will depend on the facts and circumstances at the measurement date and the technical requirements of
IFRS 9.
As of and for the year ended December 31, 2018, the only financial assets held by the Group were cash, cash equivalents and receivables. Cash and cash
equivalents represent funds available on demand that are measured at cost. Historically, the Group's receivables are due within a short period of time and Group
holds its receivables to collect contractual cash flows, accordingly, the fair value of receivables are based on the undiscounted amount due.
Financial asset impairment
IFRS 9 requires the use of the expected credit loss model (the "Model") to determine the amount of credit losses. Under the Model, the Group calculates the
allowance for losses on a discounted basis based on different default scenarios probability weighted. For the year ended December 31, 2018, credit losses incurred
by the Group were insignificant.
Financial Liabilities
The Group's financial liabilities for all periods presented herein include only trade payables. Trade payables relate to the Group's purchase of products and
services from various vendors in the normal course of business with payment terms generally not exceeding 30 days. Trade payables are initially recognized at
fair value and subsequently measured at amortized cost using the effective interest rate method in the event a vendor has provided extended payment terms to the
Group. Historically none of the Group's vendors have provided extended payment terms and therefore the effective interest method has not been used. The
adoption of IFRS 9 had no effect on the Group's accounting for financial liabilities.
F-18
Table of Contents
Section 2—Basis of Preparation (Continued)
Consolidated statement of cash flow
Notes to Consolidated Financial Statements (Continued)
The consolidated statement of cash flows is presented using the indirect method. The consolidated statement of cash flows shows cash flows resulting from
operating activities, investing activities and financing activities, and the Group's cash and cash equivalents at the beginning and end of the year.
Cash flows used in operating activities primarily comprise the operating results, before tax, for the year adjusted for non-cash items, such as share-based
compensation, foreign exchange gains and losses, depreciation, changes in working capital and cash flows for interest and taxes.
Cash flows from investing activities are comprised primarily of payments relating to equipment purchases and the maturity of available-for-sale financial
assets.
Cash flows from financing activities are comprised of proceeds from the repurchase of equity awards, share issuances and the Capital Reduction see
Notes 3.3 and 5.1.
2.2 Significant accounting judgments, estimates and assumptions
The preparation of the consolidated financial statements requires management to make judgments, estimates and assumptions that affect the reported
amounts of income, expenses, assets and liabilities, as well as the accompanying disclosures. Uncertainty about these assumptions and estimates could result in
outcomes that require a material adjustment to the carrying amount of the asset or liability affected in future periods.
Judgments made in applying accounting policies
In the process of applying the Group's accounting policies, management has made the following judgment that has the most significant effect on the amounts
recognized in the consolidated financial statements:
Revenue recognition of the Non-refundable Fee
Income taxes
Deferred tax assets
Note 2.1
Note 3.4
Note 3.4
There is a significant risk that the judgments used by management to prepare the accompanying consolidated financial statements could differ from actual
results causing a material adjustment to the carrying amounts of assets and liabilities in future years. The Group based its judgments on information available
when the consolidated financial statements were prepared.
Estimates and assumptions
The key assumptions concerning the future and other key sources of estimation uncertainty at the reporting date that have a significant risk of causing a
material adjustment to the carrying amounts of assets and liabilities within the next financial year are listed below. The Group based its assumptions and estimates
on information available when the consolidated financial statements were prepared.
Management has determined that the following items are subject to a high degree of estimation uncertainty and are significant to the financial statements:
Valuation of share-based payment
Note 3.3
F-19
Table of Contents
Notes to Consolidated Financial Statements (Continued)
Section 2—Basis of Preparation (Continued)
2.3 New and Amendments to Accounting Standards
Standards effective in 2018:
Excluding IFRS 9 and 15, which are discussed above, the IASB issued new standards and amendments to standards and interpretations that were effective in
2018 (collectively "2018 New Standards"). None of the 2018 New Standards had an impact on the Group's financial statements.
Standards issued but not yet effective:
The IASB issued new standards, amendments to standards and interpretations that become effective on or after January 1, 2019 (collectively "New
Standards"). None of the New Standards are currently expected to have a material effect on the Group's financial statements; including, as discussed below, the
future adoption of IFRS 16 Leases ("IFRS 16").
IFRS 16 introduces a single lessee accounting model and requires a lessee to recognize assets and liabilities for all leases with a term of more than twelve
months, unless the underlying asset is of low value. A lessee is required to recognize a right-of-use asset representing its right to use the underlying leased asset
and a lease liability representing its obligation to make lease payments. IFRS 16 has an effective date of January 1, 2019. The Group does not have long-term
leases that are material and therefore the future adoption of IFRS 16 will not have a material effect on the Group's consolidated financial statements.
Section 3—Results for the Year
3.1 Segment information
For management purposes, the Group is managed and operated as one business unit, which is reflected in the organizational structure and internal reporting.
No separate lines of business or separate business entities have been identified with respect to any product candidate or geographical market and no segment
information is currently disclosed in the Group's internal reporting. Accordingly, it has been concluded that it is not relevant to include segment disclosures in the
financial statements as the Group's business activities are not organized into business units, products or geographical areas.
F-20
Table of Contents
Section 3—Results for the Year (Continued)
3.2 Staff costs
Notes to Consolidated Financial Statements (Continued)
Wages and salaries
Social taxes and benefits
Share-based payments (Note 3.3)
Total
Staff costs are included in the statement of profit or loss as follows:
Research and development costs
General and administrative costs
Total
Compensation to senior management personnel of the Group(a)
Short-term employee benefits(b)
Severance benefits
Share-based payments(c)
Total compensation paid to senior management personnel
Year ended December 31
2017
2018
2016
USD '000
USD '000
USD '000
1,123
27
6,170
7,320
1,721
5,599
7,320
342
—
3,088
3,430
2,166
197
7,082
9,445
5,712
3,733
9,445
622
117
223
962
2,175
407
14,288
16,870
9,230
7,640
16,870
670
—
3,290
3,960
(a)
(b)
(c)
Senior management consisted of the Company's Chief Executive Officer, Chief Operating Officer, and Chief Financial Officer. The
Company's Chief Operating Officer, and Chief Financial Officer were terminated during 2017 and not replaced.
The amounts disclosed in the table above are the amounts recognized as an expense during the reporting periods related to senior
management personnel. As discussed in more detail in Note 3.3, during each of the years ended December 31, 2018 and 2017, certain
amounts were paid to warrant and option holders, including senior management, that were deemed to be a partial repurchase of equity
awards and accounted for as a reduction of shareholders' equity. The table above excludes $265,000 and $7.2 million, respectively, that
was paid to senior management and accounted for as a repurchase of equity awards.
The amount disclosed for the year ended December 31, 2017 includes the effect of the reversal of previously recognized share-based
compensation of $5.3 million in connection with the termination of certain members of senior management.
See Note 6.1 for compensation paid to the members of the board of directors.
3.3 Share-based payment
Unless otherwise stated, all amounts disclosed in this Note, including the quoted share prices, have been revised to reflect the Share Split as if it had
occurred at the beginning of the earliest period presented. In addition, per share amounts in DKK have been updated as the result of changes in exchange rates.
Accordingly, the information reported herein may differ from the amounts previously reported.
The Group has entered into various share-based payment arrangements through the granting of equity awards in the form of warrants, options or deferred
shares (collectively "equity awards") to employees, consultants (who provide services similar to employees), non-employee consultants and
F-21
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
members of the board of directors. Equity awards have been granted under either the Company's 2014 Omnibus Equity Incentive Compensation Plan (the "Equity
Plan") or outside the Equity Plan. Outstanding warrants and options have exercise prices stated in DKK or USD. Equity awards that have exercise prices in DKK
have been translated to USD.
Prior to the Share Split, each ADS represented one ordinary share. At the time of the Share Split and after the subsequent Capital Reduction, each ADS
represented ten ordinary shares and two ordinary shares respectively. The per share amounts disclosed herein are based on one ordinary share.
The terms of the Equity Plan provide for the board of directors, or a committee appointed by the board of directors, to grant equity awards to employees,
consultants and directors of the Group. Subsequent to the Share Split and the Capital Reduction, the Equity Plan currently provides for the granting of an
aggregate of 9.9 million ordinary shares. Awards can be in the form of ordinary shares, deferred shares, restricted shares or share options with terms and vesting
conditions determined by the board of directors. The Equity Plan contains antidilution provisions in the event of a stock split or certain other corporate
transactions. As of December 31, 2018, 3.1 million shares were available for future grant under the Equity Plan. In addition, at December 31, 2018, under Danish
Corporate Law, the board of directors has available for the future grant 2.1 million warrants and 17 million deferred shares (inclusive of the shares available for
future grant under the Equity Plan.)
During September 2018, 7,200 options (the "2018 Option") were granted to one employee at an exercise price per share price of $1.40. The 2018 Option
vests in increments as defined through September 1, 2021; however, the 2018 Option contains a provision whereby the holder cannot exercise prior to a defined
date. Vesting and the exercise period are accelerated in the event there is a change in control, as defined in the award agreement. The terms of the 2018 Option
include antidilution protection to the holder in the event there is a distribution to the shareholders as defined in the underlying award agreement. The 2018 Option
expires on August 31, 2024. At the date of grant, the aggregate fair value of the 2018 Option was not material.
During the second half of 2018, the Company's board of directors allowed two former employees to continue to hold 105,000 vested options (collectively the
"2018 Vested Options") that would have otherwise been forfeited shortly after each former employee's termination date if not exercised. The exercise prices of the
2018 Vested Options ranging from 0.01 DKK to $3.77 and the expiration dates, as stated in the underlying awards agreements, do not exceed June 19, 2023. For
financial reporting purposes, allowing the former employees to hold the 2018 Vested Options to their stated expiration dates was accounted for as a modification.
The financial statement impact of allowing the former employees to hold the 2018 Vested Options to their stated expiration date was not material.
During the year ended December 31, 2018, a total of 706,000 warrants were exercised yielding proceeds to the Company of $1,000. The quoted fair values
of an ordinary share of the Company on the dates of exercise were $1.36 with respect to 334,000 warrants and $1.49 for the remaining warrants.
During March 2017, the Company granted 60,000 options (600,000 after the Share Split) to the Company's Chief Executive Officer with an exercise price of
$27.49 ($2.75 after the Share Split.) Vesting is monthly over 48 months commencing on March 1, 2017; however, each award contains a provision whereby the
Chief Executive Officer cannot exercise prior to a defined date. Vesting and exercise periods are accelerated in the event there is a change in control, as defined in
the option award agreement. Stock options expire six years from the date of grant. At the date of grant, the aggregate fair value of options granted in March 2017
totaled $913,000.
F-22
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
During June 2017, the Company granted 825,000 options (8.3 million after the Share Split) (the "June 2017 Options"), including 300,000 (3 million after the
Share Split) that were granted to the Company's Chief Executive Officer and 75,000 (750,000 after the Share Split) that were granted to members of the
Company's Board of Directors, that have an exercise price of $20.35 ($2.04 after the Share Split.) Vesting is monthly over 36 months commencing on June 1,
2017; however, each award contains a provision whereby the option holder cannot exercise prior to a defined date. Vesting and/or exercise periods are accelerated
under certain defined situations, including a change in control. The terms of the June 2017 Options include antidilution protection to the holders in the event there
is a distribution to the shareholders as defined in the underlying award agreements. As a result of the Capital Reduction and the antidilution protection, the
exercise price of the June 2017 Options has been decreased to the nominal value of an ordinary share, the number of shares that may be subscribed for pursuant to
the June 2017 Options has been reduced by 80% (6.6 million options after the Share Split) (referred to as the "June 2017 Award Adjustment") and the holders
could be due a total cash payment of 1.9 million EUR ($2.2 million based on the December 31, 2017 exchange rate) if all of the June 2017 Options vest. For the
year ended December 31, 2018, 650,000 EUR ($761,000) was paid to the holders of the June 2017 Options in connection with June 2017 Options that vested
during the year and the corresponding amount for the year ended December 31, 2017, was 361,000 EUR ($430,000 based on the December 31, 2017 exchange
rate.) As of December 31, 2018, the remaining cash payment due the holders of the June 2017 Options, if vesting occurs in full, is 844,000 EUR ($967,000 based
on the December 31, 2018 exchange rate.) Such amount is payable semi-annually on a pro rata basis over the remaining vesting period that ends on May 31,
2020. Since the June 2017 Option award agreements contain antidilution terms, payments made to the holders as the result of such terms were treated as a
reduction to shareholder equity. The June 2017 Options expire six years from the date of grant. At the date of grant, the aggregate fair value of options granted in
June 2017 Options totaled $8.9 million.
During June 2017, the Company granted 90,000 deferred shares (900,000 after the Share Split) (the "June 2017 Deferred Shares"), including 45,000
(450,000 after the Share Split) granted to the Company's Chief Executive Officer. Subject to meeting defined employment provisions, 50,000 of the June 2017
Deferred Shares (500,000 after the Share Split), including 25,000 (250,000 after the Share Split) held by the Company's Chief Executive Officer, vest in the event
there would have been a successful outcome of the Interference Proceeding, as defined in the award agreements, and, subject to meeting defined employment
provisions, the balance vest in the event there is a successful outcome of the Opposition Proceeding as defined in the award agreements. The deferred shares that
vest in the event there is a successful outcome to the Interference Proceeding expire five years from the date of grant, or earlier, in the event of an unsuccessful
outcome in the Interference Proceeding, while the remaining deferred shares expire five years from date of grant, or earlier, in the event of an unsuccessful
outcome of the Opposition Proceeding. At the date of grant, the aggregate fair value of the deferred shares totaled $1.8 million. The fair value of the June 2017
Deferred Shares will be recognized as an expense within the statement of profit and loss only if such deferred shares vest. In addition, the award agreements
underlying the June 2017 Deferred Shares contain provisions similar to the antidilution provisions included in the June 2017 Options. Accordingly, the number of
shares that may be subscribed for pursuant to the June 2017 Deferred Shares awards agreements has been reduced by 80% (720,000 deferred shares after the
Share Split) (referred to as the "Deferred Share Adjustment") and the antidilution provisions would have obligated the Company to remit an aggregate of
1.7 million EUR ($2.0 million based on the December 31, 2018 exchange rate) to the holders, payable upon vesting, if all the June 2017 Deferred Shares had
vested. Subsequent to the Deferred Share Adjustment, there were 180,000 deferred shares outstanding of which 100,000 would have vested
F-23
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
upon a successful outcome of the Interference Proceeding and the balance vest in the event there is a successful outcome of the Opposition Proceeding as defined
in the award agreements. As a result of the unsuccessful outcome of the Interference Proceeding, as discussed in Note 1.2, 100,000 deferred shares expired on
January 9, 2019 when the Federal Circuit's decision became final. The potential antidilution payment due the holders of the June 2017 Deferred Shares should the
Company be successful in the Opposition Proceeding, as defined, totals 777,000 EUR ($890,000 based on the December 31, 2018 exchange rate.)
During the year ended December 31, 2017, a number of employees, including the Company's former Chief Executive and Operating Officer, Chief Financial
Officer, and two board members terminated roles with the Company (collectively "Former Employees"). At the time of termination, unvested equity awards held
by the Former Employees were forfeited resulting in the reversal of previously recognized share-based compensation of $7.6 million. The equity awards forfeited
included 284,000 deferred shares (2.8 million after the Share Split) and 564,000 options or warrants (5.6 million after the Share Split.) The Company's board of
directors allowed ("Allowance") the Former Employees to continue to hold 1.1 million vested options or warrants (11.1 million after the Share Split) that would
have otherwise been forfeited shortly after each Former Employee's termination date if not exercised. As the result of the Allowance, the Company, during the
year ended December 31, 2017, recognized share-based compensation of $2.7 million.
In November 2017, the shareholders of the Company approved an amendment to the Company's articles of association. The amendment modified the terms
of certain outstanding options and warrants granted by the Company before June 2017 to mitigate the dilution to such awards caused by the Capital Reduction. In
November 2017, a similar amendment was approved by the board of directors of the Company in respect of certain deferred share awards granted by the
Company before June 2017 (the amended options, warrants and deferred shares are collectively referred to as the "Awards" and the amendments of the Awards
are collectively referred to as the "Amendment"). For financial reporting purposes, the Amendment was accounted for as a modification whereby any increase in
the fair value of an Award resulting from the Amendment is deemed to be additional compensation to the Award holder and accounted for as discussed below.
The Amendment was designed to apply a set of principles (the "Principles") consistently across all Awards; however, since the Awards affected by the
Amendment had a wide range of different terms, the Amendment's effect on individual Awards varied resulting in certain Awards increasing in fair value while
others decreased in fair value. The Principles employed were modelled off the Capital Reduction including, but not limited to, the per share cash distributed to
shareholders and the 80% annulment of shares (see Note 5.1.) The overall effect of the Amendment provided for cash payments to Award holders of 36.2 million
EUR ($43.4 million based on the December 31, 2017 exchange rate) and a reduction in the number of outstanding Awards of 28.8 million. In situations where the
Amendment favourably affected the fair value of an Award, such effect was deemed to be additional compensation to the Award holder that will be expensed over
the remaining vesting period for unvested Awards and expensed immediately in connection with vested Awards. In situations where the fair value of an Award
was negatively affected by the Amendment, no expense will be recognized. Cash payments made to Award holders were deemed to be a partial repurchase of the
Award and accounted for as a reduction to shareholder equity except in situations where the cash payment to an Award holder increased the fair value of an
Award. In situations where the cash payment to an Award holder increased the fair value of an Award, such increase was deemed to be additional compensation
and expensed, as discussed above, based on the Award's vesting status. As a result of the Amendment, the Group recognized compensation of $11.7 million and a
reduction to
F-24
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
shareholder equity of $32.2 million. Subsequent to the Amendment, the exercise prices of options and warrants range from 0.01 DKK (or $0.0015 based on the
December 31, 2018 exchange rate) to $14.13 per share and the holders of deferred shares need to remit 0.01 DKK (or $0.0015 based on the December 31, 2018
exchange rate) per share upon the issuance.
During March 2017, 40,000 warrants (401,000 after the Share Split) were exercised yielding proceeds to the Company of $49,000. The quoted fair value of
an ordinary share of the Company on the date of exercise was $27.95 ($2.80 after the Share Split.)
During the year ended December 31, 2016, 664,000 stock options (6.6 million after the Share Split) were granted, including 178,000 (1.8 million after the
Share Split) that were granted to members of the Company's Board of Directors. The option exercise prices per share range from $12.75 to $21.95 ($1.28 to $2.20
after the Share Split.) Vesting terms are pro rata over either a three or four-year term, however, each award contains a provision whereby the option holder cannot
exercise prior to a defined date. Vesting and exercise periods are accelerated in the event there is a change in control, as defined in the option award agreements.
Stock options expire six years from the date of grant. At the date of grant, the aggregate fair value of options granted in 2016 totaled $8.2 million.
In June 2016, 89,000 warrants (891,000 after the Share Split) ("June 2016 Warrants") were granted to a consultant. The June 2016 Warrants replaced an
equal number of expiring warrants. The exercise price of the June 2016 Warrants is the same as the expiring warrants, or $0.56 ($0.06 after the Share Split.) The
June 2016 Warrants were fully vested upon grant and had an expiration date of July 1, 2018. For financial reporting purposes, the June 2016 Warrants were
accounted for as a modification of the expiring warrants to extend the expiration date. The financial statement impact of the modification of the June 2016
Warrants was not material.
During May 2016, 130,000 warrants (1.3 million after the Share Split) were exercised yielding proceeds to the Company of $112,000. The quoted fair value
of an ordinary share of the Company on the date of exercise was $18.60 ($1.86 after the Share Split.)
During October 2016, the Company entered into a four-year consulting agreement with a member of the board of directors. The consulting agreement
provides for the granting of 12,500 deferred shares (125,000 after the Share Split) shares as full compensation for services to be rendered. The deferred shares
vest in equal increments annually over four years. Unvested deferred shares vest immediately in the event there is a change in control as defined in the award
agreement. At the date of grant, the aggregate fair value of the deferred shares totaled $275,000.
During the year ended December 31, 2015 a total of 500,000 stock options (5 million after the Share Split) were granted to non-employee consultants of the
Group ("Consultant Options"). 250,000 Consultant Options (2.5 million after the Share Split) have an exercise price of $28.26 ($2.83 after the Share Split) and
the balance have an exercise price of $141.30 ($14.13 after the Share Split.) The Consultant Options expire on May 15, 2020 and vesting is over five years;
however, the Consultant Options can only be exercised during the period from April 2, 2020 to May 15, 2020. Vesting and exercise are accelerated in the event
there is a change in control as defined in the option award agreements. The Company's board of directors holds a unilateral right to terminate the Consultant
Options for any reason at any time prior to vesting. The fair value of the Consultant Options is measured using the Black Scholes model with inputs not materially
different from those discussed below. The fair value of the Consultant Options is determined as services are rendered. As of December 31, 2018 (after the Share
Split), 3 million of the Consultant Options have vested including
F-25
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
1.5 million with an exercise price of $2.83 (after the Share Split.) The fair value of the Consultant Options was computed using the Black Scholes method and not
based on the value of the services received. In reaching the decision to use the value of the Consultant Options and not the value of the services, management
considered the variability in the nature, timing and extent of services to be provided by the non-employee consultants that will be significantly affected by actions
taken by parties who are not under the control of the Group. Accordingly, the value and timing of the services to be received over the service period cannot be
estimated reliably and therefore the value of the Consultant Options was deemed to be a more accurate measure of the consideration paid to the non-employee
consultants for services rendered. The weighted average fair value per Consultant Options applied for recognition of an expense during each of the years ended
December 31, 2018, 2017 and 2016 was $0.16, $0.63 and $0.60 (after the Share Split) respectively. The total expense recognized during each of the years ended
December 31, 2018, 2017 and 2016 was $96,000, $615,000 and $892,000 respectively.
In order to provide the Company's former Chief Executive Officer with the ability to forgo exercising 89,000 warrants (891,000 million after the Share Split)
warrants that were set to expire on January 1, 2016 ("Expiring Awards"), the board of directors, during the year ended December 31, 2015, granting of 89,000
warrants (891,000 million after the Share Split) ("Replacement Awards") to replace the Expiring Awards. The Replacement Awards have substantially similar
terms as the Expiring Awards, except the expiration date was extended to March 31, 2021. The financial statement impact of the Extended Awards was not
material.
The table below summarizes the activity for each of the years ended December 31, 2018, 2017 and 2016 for equity awards in the form of options and
warrants and the weighted average exercise price ("WAEP"):
Outstanding at January 1, 2016
Granted
Expiring Awards
Exercised
Expired and forfeited
Outstanding at December 31, 2016
Granted
Exercised
Forfeited
Effect of the Amendment and the June 2017 Award
Adjustment
Outstanding at December 31, 2017
Granted
Exercised
Expired
Outstanding at December 31, 2018
Exercisable at December 31, 2018
Share Options and Warrants Adjusted for the Share Split
Key
Management
Personnel(*)
No. '000
Employees and
Consultants
No. '000
Non-Employee
Consultants
No. '000
Total
Awards
No. '000
WAEP
14,731
1,783
(891)
—
—
15,623
4,350
—
(2,976)
(12,801)
4,196
—
(123)
(333)
3,740
3,066
22,818
5,743
—
(1,300)
(985)
26,276
4,500
(401)
(2,773)
(22,603)
4,999
7
(583)
(179)
4,244
3,719
4,996
—
—
—
—
4,996
—
—
—
—
4,996
—
—
—
4,996
2,998
42,545 $ 2.04
7,526 $ 1.50
(891) $ 0.08
(1,300) $ 0.09
(985) $ 0.35
46,895 $ 2.08
8,850 $ 2.08
(401) $ 0.12
(5,749) $ 1.86
(35,404) $ 1.33
14,191 $ 3.45
7 $ 1.40
Nil
(706)
Nil
(512)
12,980 $ 3.77
9,783
(*)
Includes current and former senior management and current and former members of the board of directors.
F-26
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
The weighted average remaining contractual life of equity awards in the form of options and warrants outstanding as of December 31, 2018, 2017 and 2016
was 2.4 years, 3.2 years and 4.3 years respectively.
The table below summarizes the range of exercise prices, after converting, where applicable, exercise prices that are stated in DKK to USD, for outstanding
equity awards in the form of options and warrants as of December 31, 2018, 2017 and 2016.
Range of exercise prices (per share)
$0.0015 to $0.12
$0.75 to $0.95
$1.24 to $1.80
$2.09 to $2.83
$3.05 to $3.77
$4.51 to $6.92
$14.13
Total
Adjusted for the Share Split
2017
2016
2018
No. '000
No. '000
No. '000
6,407
—
186
2,618
674
597
2,498
12,980
7,625
—
179
2,618
674
597
2,498
14,191
17,878
2,139
4,635
13,037
6,708
—
2,498
46,895
The tables below summarize the inputs to the model used to value equity awards, including modifications of equity awards, as well as the average fair value
per option or warrant awarded or modified for each of the years ended December 31, 2018, 2017 and 2016:
Year ended December 31, 2018
Dividend yield (%)
Expected volatility (%)
Risk-free interest rate (%)
Expected life of the equity award (years)
Share price
Exercise price
Model used
Basis for determination of share price
Average fair value per option or warrant granted
Year ended December 31, 2017
Dividend yield (%)
Expected volatility (%)
Risk-free interest rate (%)
Expected life of the equity award (years)
Share price
Exercise price
Model used
Basis for determination of share price
Average fair value per option or warrant granted
F-27
Zero
73 - 86
2.8 to 2.9
2.3 to 3.3
0.53 USD to 1.30 USD
1.40 USD to 3.77 USD
Black Scholes
Quote on Nasdaq
0.21 USD
Zero
64 - 79
(0.7) to 2.1
0.5 to 7
2.04 USD to 2.74 USD
0.0016 USD to 6.92 USD
Black Scholes
Quote on Nasdaq
10.90 USD
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
Year ended December 31, 2016
Dividend yield (%)
Expected volatility (%)
Risk-free interest rate (%)
Expected life of the equity award (years)
Share price
Exercise price
Model used
Basis for determination of share price
Average fair value per option or warrant granted
Zero
73 - 79
(1.2) to 1.8
4.0 to 5.0
1.64 USD to 2.20 USD
0.06 USD to 2.20 USD
Black Scholes
Quote on Nasdaq
1.18 USD
The table below summarizes the deferred share activity for each of the years ended December 31, 2017 and 2016 (there were no deferred shares granted,
issued or forfeited during the year ended December 31, 2018):
Outstanding at January 1, 2016
Granted
Transfer(a)
Vested and issued(b)
Outstanding at December 31, 2016
Granted
Forfeited(b)
Effect of the Amendment and the Deferred Share Adjustment
Outstanding at December 31, 2017 and 2018(c)(d)
Vested and unissued at December 31, 2018
Deferred Shares Adjusted for
the Share Split
Key
Management
Personnel(*)
No. '000
Employees and
Consultants
No. '000
Total
Awards
No. '000
4,264
125
250
(1,422)
3,217
450
(2,842)
(419)
406
206
550
—
(250)
—
300
450
—
(456)
294
156
4,814
125
—
(1,422)
3,517
900
(2,842)
(875)
700
362
(*)
(a)
(b)
(c)
(d)
Includes current and former senior management and current and former members of the board of directors.
A consultant who was granted deferred shares in 2015 was a member of the Company's board of directors from May 6, 2016 to May 3,
2017. See Note 6.1.
During 2014, 5.7 million deferred shares were granted to the Company's Chief Financial Officer ("CFO"). The deferred shares vested
annually over four years. The CFO was terminated during 2017 and 2.8 million unvested deferred shares were forfeited.
At December 31, 2018, each deferred share has an exercise price of 0.01 DKK or $0.0015 based on the December 31, 2018 exchange rate.
On January 9, 2019, 100,000 deferred shares expired including 50,000 deferred shares held by the Company's Chief Executive Officer.
See above.
F-28
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
Share-based compensation expense included within operating results for each of the years ended December 31, 2018, 2017 and 2016 is as follows:
Year Ended December 31,
2017
2016
2018
Research and development costs
General and administrative costs
Total
USD '000
USD '000
USD '000
1,547
4,623
6,170
4,852
2,230
7,082
7,984
6,304
14,288
Significant estimation uncertainty regarding share-based payments
Determining the fair value, whether at grant date, modification date or the date of the Amendment, and the subsequent accounting for equity awards requires
significant judgment regarding expected life and volatility of an equity award; however, as a public listed company there is objective evidence of the fair value of
an ordinary share on the date an equity award is granted or modified. The expected life of an equity award is based on the assumption that the holder will not
exercise until after the equity award is fully vested and all restrictions on the holders' ability to dispose of the underlying ordinary shares expire. Actual exercise
patterns may differ from the assumption used herein. The volatility rate used to value equity awards has been based on either peer group volatility, where the
expected life of an equity award exceeds the Company's historical trading data, or the Company's volatility rate where historical trading activity of the Company
equals or exceeds the expected life of an equity award. Using historical volatility rates to project future trends is a highly subjective estimate that may not
necessarily be the actual outcome. The peer group consists of listed companies that management believes are similar to the Company in respect to industry and
stage of development. Even with objective evidence of the fair value of an ordinary share, small changes in any other individual assumption or in combination
with other assumptions could have yielded significantly different results.
3.4 Income tax
The major components of income tax benefit (expense) reported in the consolidated statement of profit and loss for the years ended December 31, 2018,
2017 and 2016 are as follows:
Current income tax benefit (expense)
Deferred income tax benefit (expense)
Total income tax benefit (expense)
Year Ended December 31,
2017
2016
2018
USD '000
USD '000
USD '000
161
43
204
(244,288)
(23,107)
(267,395)
(79)
21,282
21,203
The tax benefit recognized during the year ended December 31, 2018 of $204,000 is primarily due to a change in estimate relating to the prior year of
$161,000 and the balance relates to changes in deferred tax balances during the period.
The current income tax expense for the year ended December 31, 2016 primarily relates to a change in estimate of the benefit obtained by Tech Growth's
utilization of the Company's tax loss. The
F-29
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
deferred income tax benefit recognized in 2016 was the result of management concluding at December 31, 2016 that it was probable the Group would have
taxable profits in 2017, thereby enabling the Group to recognize certain deferred tax assets that historically did not meet the criteria for recognition. In reaching
the conclusion to recognize deferred tax assets at December 31, 2016, numerous judgments were made including the close proximity of the date the License
Agreement was executed to December 31, 2016 and the magnitude of the Non-refundable Fee compared to the projected total expenses for 2017. The deferred tax
benefit recognized during the year ended December 31, 2016 was primarily related to net operating loss carryforwards ("NOLs").
Taxable profits are not assured beyond the year ended December 31, 2017; therefore, temporary differences that will be available to offset taxable profits
after December 31, 2017 do not meet the criteria for financial statement recognition and therefore the related deferred tax assets have not been recognized.
The income tax benefit (expense) recorded for the years ended December 31, 2018, 2017 and 2016 is reconciled as follows:
(Loss) income before tax
Tax benefit (expense) at the Company's statutory income tax rate(1)
Adjustments:
Non-deductible expenses for tax purposes
Effect of higher tax rate in Germany(2)
(Unrecognized) recognized deferred tax assets
Adjustment related to prior year
Income tax benefit (expense) reported in the statement of profit and
loss
Effective tax rate
2018
USD '000
2017
USD '000
2016
USD '000
(8,926) 1,184,488
1,964
(260,587)
(54,539)
11,999
(2)
(7)
(1,912)
161
(1,780)
(4,980)
(48)
—
(3,100)
844
11,460
—
204
2.3%
(267,395)
22.6%
21,203
38.9%
(1)
(2)
The statutory Danish tax rate for each of the years presented is 22%.
The statutory German tax rate for each of the years presented is 31.9%.
For Danish and United States tax purposes, the Company's United States subsidiary does not conduct a trade or business and is therefore deemed to be a
disregarded entity ("Disregarded Entity"). Accordingly, the United States subsidiary is not subject to income taxes in the United States. Recently enacted tax
legislation in the United States had no impact on the Group.
F-30
Table of Contents
Section 3—Results for the Year (Continued)
Deferred tax
Notes to Consolidated Financial Statements (Continued)
The unrecognized deferred tax assets at December 31, 2018 and 2017 are as follows:
Tax effect of tax loss carry forwards
Share-based payment
Other
Unrecognized deferred tax assets, net
2018
2017
USD '000
USD '000
5,344
503
(39)
5,808
4,726
2,304
—
7,030
The Group has the following unrecognized deductible temporary differences as of December 31, 2018, 2017 and 2016 respectively:
Unused tax losses
Other temporary differences primarily share-based
2018
Denmark
2017
2016
2018
Germany
2017
2016
USD '000
USD '000
USD '000
USD '000
USD '000
USD '000
4,276
—
—
13,793
14,805
13,273
payment
2,107
10,474
22,163
—
—
—
The Danish and German tax loss carry forwards have no expiry date. For Danish tax purposes, the Company's ability to use tax loss carry forwards in any
one year is limited to 100% of the first 8.2 million DKK ($1.3 million based on the December 31, 2018 exchange rate) of taxable income plus 60% of taxable
income above 8.2 million DKK. For German tax purposes, the ability for FP GmbH to use tax loss carry forwards in any one year is also limited based on a
formula not materially different from the limit used in Denmark. Other deductible temporary differences are not subject to any restrictions.
During each of the years ended December 31, 2017 and 2016, the Company recognized tax benefits within the consolidated statement of changes in
shareholders' equity of $6.3 million and $2.8 million respectively. The tax benefits were related to equity awards where the Company's tax filing provided a
benefit in excess of the corresponding share-based compensation recognized within reported operating results.
Joint Taxation Groups
During the period from January 19, 2013 to December 31, 2015, the Company was part of the Tech Growth joint tax group. Under applicable provisions of
the Danish taxation law, the Company was entitled to obtain refunds at the prevailing tax rate from other entities within the Tech Growth joint taxation group who
utilized tax losses of the Company. A subsidiary of Tech Growth Invest ApS experienced a change in ownership on December 31, 2015. The effect of the change
in ownership resulted in the year ended December 31, 2015 being the final year in which the Company received a refund equal to the tax benefit realized by Tech
Growth Invest ApS and other entities within the joint taxation group who utilized the Company's tax losses. On January 1, 2016, the joint taxation group with
Tech Growth ceased and the Company became part of the 2016 Tax Group. The Company remains jointly and severally liable with other entities in the Tech
Growth joint taxation group for Tech Growth's Danish tax liabilities during each of the years ended December 31, 2015, 2014 and 2013. The
F-31
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
Company is jointly and severally liable under the 2016 Tax Group for Danish tax liabilities incurred by members of the 2016 Tax Group while being a member of
the 2016 Tax Group.
Significant accounting judgments, estimates and assumptions
The Group recognizes deferred tax assets, including the tax base of tax loss carry-forwards, if management assesses that these tax assets can be offset against
future positive taxable income. Significant management judgment is required to determine the amount of deferred tax assets that can be recognized, based upon
the likely timing and the level of future taxable profits together with future tax planning strategies. This judgment is made periodically after considering current
facts, circumstances, budgets and business plans as well as the risks and uncertainty associated with the operations of the Group. As facts and circumstances
change, adjustments to previously made estimates will be made that could result in volatility in reported operating results and the occurrence of unforeseen events
could have a material favorable or unfavorable effect on the financial statements of the Group.
The Group determined that previously unrecognized deferred tax assets should be recognized at December 31, 2016 as it was probable at that time that the
Group would have sufficient taxable income in the year ending December 31, 2017 to utilize deferred tax assets recognized at December 31, 2016. Accordingly,
this change in estimate had a material favorable effect on the consolidated financial statements as of and for the year ended December 31, 2016.
Tax uncertainties
The Group exercises judgment when determining the Group's tax position. As discussed in more detail below, significant judgments were made when
determining the tax treatment of Forward Pharma USA, LLC, transfer pricing and in determining tax deductibility of certain transactions.
The Company's Danish, German and United States tax returns are subject to periodic audit by the local tax authorities. Such audits could result in the tax
authorities disagreeing with the tax filing positions taken by the Group which would expose the Group to additional taxes being assessed, including interest and
penalties, that could be material. There are numerous transactions between the Company, Operations, FWP IP, FP GmbH and Forward Pharma USA, LLC where
the tax authorities could challenge whether pricing of such transactions were at arm's length. Management believes that appropriate tax filing provisions have
been taken by the Company and its subsidiaries; however, there is always a risk that the tax authorities could disagree with the tax filing positions taken resulting
in additional taxes, interest and penalty becoming due and such amount could be material.
The Company has taken the position that since Forward Pharma USA, LLC is deemed to be a Disregarded Entity, it is not subject to U.S. federal or state
income tax. In reaching this conclusion, significant judgment was used in evaluating the nature of the operations in the U.S., the interpretation of the U.S. and
Danish tax laws, and the income tax treaty between the U.S. and Denmark. Management believes that the tax filing provisions taken in the U.S. and Denmark
regarding Forward Pharma USA, LLC are correct; however, there is always a risk that the U.S. or Danish tax authorities could disagree with the tax filing
positions taken resulting in additional taxes, interest and penalty becoming due and such amount could be material.
As a result of the receipt of the Non-refundable Fee and the resulting taxable income in 2017, the Danish and German tax authorities have commenced tax
audits of the Group's Danish and German tax
F-32
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
returns covering the five-year period ending December 31, 2017. The tax audits are expected to focus on the intercompany recognition of revenue and expense to
ensure that such transactions were conducted at arm's length. There is a risk that the tax authorities could impose additional taxable income or disallow the
deductibility of expenses on intercompany cross-border transactions resulting in higher tax obligations in one or more tax jurisdictions. Management's experience
has been that the taxing authorities can be aggressive in taking positions that would increase taxable income and/or disallow deductible expenses reported. If the
tax authorities are successful in increasing taxable income and/or disallowing deductible expenses in one or more jurisdictions, it would result in the Group
experiencing a higher effective tax rate that could be material. Management believes that the tax positions taken with regards to intercompany transactions are in
accordance with tax regulations and that appropriate tax provisions have been made in the accompanying financial statements; however, there is always a risk that
the Danish and/or the German tax authorities could disagree with the tax filing positions taken resulting in additional taxes, interest and penalty becoming due and
such amount could be material. The Danish and German tax authorities are conducting a joint tax audit of the Group's Danish and German tax returns.
Conducting a joint tax audit is expected to reduce the burden and cost to the Group of undergoing two audits that address similar transactions and to accelerate the
resolution of disagreements through the mutual agreement procedure ("MAP") by early involvement of Competent Authorities, if necessary. The timing of the tax
authorities completing the joint audit is unknown and there is no assurance that the joint audit will achieve expected benefits.
During the year ended December 31, 2017, the Company made certain cash payments (the "Deduction") to equity award holders in accordance with
amendments to the Company's article of association that were approved by the Company's shareholders and board of directors (see Note 3.3). The Company
believes the Deduction, that totalled 36.2 million EUR ($43.4 million based on the December 31, 2017 exchange rate), represents, for tax reporting purposes,
compensation for services rendered to the Company and is tax deductible for Danish tax purposes for the year ended December 31, 2017. Management believes
that the tax positions taken with regards to the Deduction is in accordance with tax regulations and that appropriate tax provisions have been made in the
accompanying financial statements; however, there is always a risk that the Danish authorities could disagree with the tax filing positions taken resulting in
additional taxes, interest and penalty becoming due and such amount could be material. There were similar cash payments made to equity award holders during
the year ended December 31, 2018 that totalled 650,000 EUR ($761,000); however, such amounts are reflected herein as unrecognized deductible temporary
differences at December 31, 2018 and disclosed above as unused tax losses in Denmark.
As of December 31, 2018, the tax years that remain open for audit by the Danish, German, and United States tax authorities include 2013 through 2018.
3.5 Net (loss) income per share
Basis for preparing per share amounts
The amounts disclosed below have been prepared to reflect the Share Split as if it had occurred at the beginning of the earliest period presented. In addition,
the Capital Reduction was effected by the annulment of 80% of the ordinary shares outstanding and was deemed, for IFRS purposes, to have been at a 15%
premium (the "15% Premium") based on the trading price of an ADS immediately before the Capital Reduction was executed. The 15% Premium, as per IAS 33
Earnings per Share, is accounted for in a manner similar to the Share Split (as the outflow of resources was greater than the
F-33
Table of Contents
Section 3—Results for the Year (Continued)
Notes to Consolidated Financial Statements (Continued)
reduction in the number of shares outstanding) and reflected in the below amounts as if it had occurred at the beginning of the earliest period presented. The
combined effect of the Share Split and the 15% Premium is as if a 11.5 for 1 share split had occurred at the beginning of the earliest period presented.
Net (loss) income per share
The following reflects the net (loss) income attributable to ordinary shareholders and share data used in the basic and diluted net (loss) income per share
computations for each of the years ended December 31, 2018, 2017 and 2016:
2018
USD
2017
USD
2016
USD
Net (loss) income attributable to ordinary shareholders of the Parent used for computing
basic and diluted net (loss) income per share
Weighted average number of ordinary shares used for basic per share amounts
Dilutive effect of outstanding options, warrants and deferred shares
Weighted average number of ordinary shares used for diluted per share amounts
Net (loss) income per share basic
Net (loss) income per share diluted
Amounts within the table above are in thousands except per share amounts
94,671
—
94,671
(8,722) 917,093
380,133
18,810
398,943
2.41
2.30
(0.09)
(0.09)
(33,336)
540,650
—
540,650
(0.06)
(0.06)
Basic (loss) income per share amounts are calculated by dividing the net (loss) income for the year attributable to ordinary shareholders of the Parent by the
weighted average number of ordinary shares outstanding during the year. The diluted per share amounts are calculated by dividing the net income for the year
attributable to ordinary shareholders of the Parent by the weighted average number of ordinary shares outstanding during the period increased by the dilutive
effect of the assumed issuance of deferred shares and exercise of outstanding options and warrants. As the result of the Group incurring losses for each of the
years ended December 31, 2018 and 2016, the potential shares issuable related to outstanding deferred shares, options and warrants have been excluded from the
calculation of diluted per share amounts as the effect of such shares is anti-dilutive. As of December 31, 2018, 2017 and 2016, options, warrants and deferred
shares that could potentially dilute basic earnings per share in the future, but were not included in the calculation of diluted amounts per share because they are
anti-dilutive, were 13.7 million, 8.2 million and 50.4 million respectively. See Note 3.3.
F-34
Table of Contents
Section 4—Operating Assets and Liabilities
4.1 Equipment
Notes to Consolidated Financial Statements (Continued)
Depreciation expense included within operating results for each of the years ended December 31, 2018, 2017 and 2016 is as follows:
Year Ended December 31,
2017
2016
2018
Research and development costs
General and administrative costs
Total
USD '000
USD '000
USD '000
2
2
4
224
3
227
106
3
109
As discussed in Note 1.1, the Company announced on March 1, 2017 a plan to reduce costs and wind-down research and development efforts of FP187®. In
connection with winding down of research and development efforts, certain equipment that had been used in the development of FP187 ® was deemed impaired.
Accordingly, during the year ended December 31, 2017, the Group recognized an impairment expense of $208,000 that is included in the above table within
research and development costs.
At December 31, 2018 and 2017, the cost of the Group's equipment and the corresponding accumulated depreciation was not material.
4.2 Prepaid expenses
Insurance
Other
Total
4.3 Other receivables
Value added tax receivables ("VAT")
Other receivables
Total
F-35
December 31,
2018
2017
USD '000
USD '000
313
27
340
421
81
502
December 31,
2018
2017
USD '000
USD '000
265
1
266
513
5
518
Table of Contents
Notes to Consolidated Financial Statements (Continued)
Section 4—Operating Assets and Liabilities (Continued)
4.4 Accrued liabilities
Accrued amounts due equity award holders (Note 3.3)
Professional advisors
Other
Total
Section 5—Capital Structure and Financial Risk and Related Items
5.1 Equity and Capital Management
Share capital
December 31,
2018
2017
USD '000
USD '000
—
318
304
622
11,757
910
376
13,043
The following table summarizes the Parent's ordinary share activity for each of the years ended December 31, 2018, 2017 and 2016:
January 1, 2016
Issuance of deferred shares
Exercise of warrants for cash
December 31, 2016
Exercise of warrants for cash
Capital Reduction
December 31, 2017
Exercise of warrants for cash
December 31, 2018
Ordinary
shares(*)
No. '000
468,717
1,422
1,300
471,439
401
(377,472)
94,368
706
95,074
(*)
Amounts reflect the Share Split as if it had occurred at the beginning of the earliest period presented. Subsequent to the Share
Split, the nominal value of an ordinary share of the Parent is 0.01 DKK.
During the year ended December 31, 2018, a total of 706,000 warrants were exercised yielding proceeds to the Company of $1,000. See Note 3.3.
On August 2, 2017, the Company's shareholders approved the Capital Reduction of 917.7 million EUR ($1.1 billion). The funds for the Capital Reduction
were distributed to shareholders during September 2017. The Capital Reduction was executed through the annulment of 80% of the ordinary shares outstanding
post Share Split or 377.5 million ordinary shares. The Capital Reduction resulted in a payment of 2.43125 EUR per ordinary share ($2.92 per share based on the
December 31, 2017 exchange rate), which was annulled (post Share Split.)
During March 2017, 401,000 warrants (post Share Split) were exercised yielding proceeds to the Company of $49,000. See Note 3.3.
F-36
Table of Contents
Section 5—Capital Structure and Financial Risk and Related Items (Continued)
Notes to Consolidated Financial Statements (Continued)
During the year ended December 31, 2016, 1.4 million ordinary shares (post Share Split) were issued upon the vesting of deferred shares, and the receipt of
the per share nominal value of $2,000, and 1.3 million ordinary shares (post Share Split) were issued in connection with the exercise of warrants and the receipt of
$112,000. See Note 3.3.
Except for the Capital Reduction, the Company has never distributed funds to shareholders in any form, including dividends, and currently there are no plans
to distribute funds to shareholders in the future.
Capital Management
For the purpose of the Group's capital management, capital includes issued capital, share premium and all other equity reserves attributable to the equity
holders of the Company. The primary objective of the Group's capital management is to maximize shareholder value. The board of directors' policy is to maintain
an adequate capital base so as to maintain investor, creditor and market confidence that the Group will continue as a going concern. Cash, cash equivalents and
financial assets are monitored on a regular basis by management and the board of directors in assessing current and long-term capital needs of the Group. As of
December 31, 2018, the Group held cash and cash equivalents totaling $82.5 million that will be sufficient to provide adequate funding to allow the Group to
meet its planned operating activities in the normal course of business beyond the year ending December 31, 2019. Unforeseen events could negatively affect the
Group's ability to fund planned operations in the future. The Group currently has no significant planned capital expenditures nor are there plans to make cash
distributions to shareholders.
5.2 Financial risk factors
The Group's activities expose it to a number of financial risks whereby future events, which can be outside the control of the Group, could have a material
effect on the Group's financial position and operating results. The known risks include foreign currency and credit risk and there could be other risks currently
unknown to management. The Group historically has not hedged its financial risks and has no plans to do so in the future.
Foreign Currency
The Group maintains operations in Denmark, Germany and the United States that use the DKK, the EUR and the USD as their functional currencies,
respectively. The Group conducts cross border transactions where the functional currency is not always used, including purchases from vendors in the United
Kingdom where the British Pound ("GBP") is used. In addition, the Company, whose functional currency is the DKK, has in the past invested in debt instruments
issued by the governments of Germany, the United Kingdom and the United States. Accordingly, future changes in the exchange rates of the DKK, the EUR, the
USD and/or the GBP will expose the Group to currency gains or losses that will impact the reported amounts of assets, liabilities, income and expenses and the
impact could be material. For each of the years ended December 31, 2018, 2017 and 2016, the impact on the
F-37
Table of Contents
Section 5—Capital Structure and Financial Risk and Related Items (Continued)
Notes to Consolidated Financial Statements (Continued)
Group's statement of profit or loss of possible changes in the USD, GBP and EUR exchange rates against the Group's functional currencies, USD, DKK and EUR,
would be as follows.
Currency
USD
GBP
EUR
Credit Risk
Possible
change
2018
USD '000
+/–10%
+/–10%
+/–2%
+3,064/–3,064
+79/–79
+985/–985
2017
USD '000
+5,625/–5,625
+128/–128
+506/–506
2016
USD '000
+7,124/–7,124
+430/–430
+1,212/–1,212
The Group's management manages credit risk on a group basis. The Group's credit risk is associated with cash and cash equivalents held in banks. The
Group's investment policy is to collect contractual cash flows and preserve capital by investing in a diversified group of highly rated debt instruments. The Group
does not trade financial assets for speculative purposes.
As of December 31, 2018, the cash and cash equivalents of the Group are held primarily at two banks that have Moody's long-term debt ratings of Aa3 or
better.
5.3 Other finance income (costs)
Other finance income (costs) primarily include interest income on USD cash holdings offset by bank charges (negative interest) related to DKK and EUR
cash holdings.
5.4 Financial assets and liabilities
Recognized financial instruments
The Group has recognized the following categories of financial assets and liabilities.
Financial assets:
Financial assets at amortized cost as of December 31, 2018 and 2017
Other receivables
Total
2018
2017
Carrying
amount
USD '000
Fair
value
USD '000
Carrying
amount
USD '000
Fair
value
USD '000
266
266
266
266
518
518
518
518
Fair value of other receivables is deemed to be their carrying amount based on payment terms that are generally 30 days.
F-38
Table of Contents
Notes to Consolidated Financial Statements (Continued)
Section 5—Capital Structure and Financial Risk and Related Items (Continued)
Financial Liabilities:
Financial liabilities at amortized cost as of December 31, 2018 and 2017
Trade payables
Total
2018
2017
Carrying
amount
USD '000
Fair
value
USD '000
Carrying
amount
USD '000
Fair
value
USD '000
428
428
428
428
1,203
1,203
1,203
1,203
Fair value of trade payables is deemed to be their carrying amount based on payment terms that are generally 30 days.
Section 6—Other Disclosures
6.1 Related party disclosures
The Company is controlled by NB FP Investment K/S and its affiliates (collectively "NB"). The ultimate controlling party of the Company is Mr. Florian
Schönharting who controls NB. See Note 6.2 for additional related party transactions.
A director of the Company is a partner at the law firm that provides Danish legal services to the Group. Remuneration paid to the law firm is referred to
below as "Danish Legal Services". The director serves on the Company's board of directors in his individual capacity and not as a representative of the law firm.
Two directors of the Company, who were elected to the board of directors on May 6, 2016, each entered into a four-year consulting agreement with the
Company. One of the consulting agreements commenced in September 2015 and the second during October 2016. The consulting agreements provided for the
granting of 25,000 (250,000 after the Share Split) and 12,500 (125,000 after the Share Split) deferred shares, respectively, as full compensation for services to be
rendered. The deferred shares vest in equal increments annually over four years from the date of grant. Unvested deferred shares vest immediately in the event
there is a change in control as defined in the award agreement. The board member who holds 25,000 deferred shares did not stand for re-election and accordingly
the consultant's role as a board member terminated at the time of the Company's Annual Shareholder meeting on May 3, 2017. Subsequent to the Amendment, the
consultant who remains on the Company's board of directors holds 121,000 deferred shares and the consultant whose role as a board member terminated at the
time of the Company's Annual Shareholder meeting on May 3, 2017 holds 194,000 deferred shares. Share-based remuneration paid to the consultants while the
consultants were members of the Company's board of directors is referred to in the table below as "Consulting Services."
Beginning in 2013, the Company was part of a Danish joint tax group with Tech Growth Invest ApS and subsidiaries of Tech Growth Invest ApS. The
Company's participation in the Tech Growth Invest ApS Danish joint tax group ceased on January 1, 2016. On January 1, 2016, the Company became part of a
new Danish joint taxation group with NB FP Investment General Partner ApS, Forward Pharma FA ApS, Operations and FWP IP. See Note 3.4 for additional
information.
F-39
Table of Contents
Section 6—Other Disclosures (Continued)
Notes to Consolidated Financial Statements (Continued)
The following table provides the total amount of transactions that have been entered into with related parties for the relevant year or as of yearend. All
amounts disclosed in the table below exclude VAT:
Purchase of services from NB
Danish Legal Services
Consulting Services
Amounts owed to related parties
Amounts owed by related parties
Year ended or as of December 31,
2016
2017
2018
USD '000
USD '000
USD '000
76
396
71
113
—
68
1,454
188
283
—
68
1,377
202
723
—
The above table excludes the related party transactions disclosed in Note 1.1, regarding FWP IP, and Note 6.2, regarding Aditech Pharma AG.
Terms and conditions of transactions with related parties
Amounts due to related parties are uncollateralized and interest free. There have been no guarantees provided or received for any related party receivables or
payables.
Transactions with key management
The Group has not granted any loans, guarantees, or other commitments to or on behalf of any key management personnel.
Other than the remuneration including share-based payment relating to key management personnel described in Notes 3.2 and 3.3, no other transactions have
taken place with key management personnel during the period presented herein.
Compensation paid to the members of the board of directors
Compensation to members of the Company's board of directors, excluding non-cash share-based compensation, for each of the years ended December 31,
2018, 2017 and 2016 totaled $60,000, $373,000 and $87,000 respectively. Share-based compensation paid to members of the Company's board of directors for
each of the years ended December 31, 2018, 2017 and 2016 totaled $495,000, $1.3 million and $2.2 million respectively. As discussed in more detail in Note 3.3,
during the year ended December 31, 2017, certain amounts were paid to warrant and option holders, including members of the board of directors, that were
deemed to be a partial repurchase of equity awards and accounted for as a reduction to shareholders' equity. The amounts disclosed above exclude $65,000 and
$864,000 that was paid to members of the board of directors that were deemed to be a partial repurchase of equity awards for the year ended December 31, 2018
and 2017 respectively.
6.2 Commitments and contingent liabilities
Leasing activities
Lease contracts, where the lessor retains the significant risks and rewards associated with the ownership of the asset, are classified as operating leases. The
Group's operating leases are for office space.
F-40
Table of Contents
Section 6—Other Disclosures (Continued)
Notes to Consolidated Financial Statements (Continued)
Lease payments under operating leases for office space are recognized in the statement of profit and loss over the lease term. The total remaining non-
cancellable operating lease commitment as of December 31, 2018 is $54,000 of which $51,000 and $3,000 is payable during each of the years ending
December 31, 2019 and 2020 respectively. Operating lease payments recognized as an expense amounted to $102,000, $128,000 and $124,000 for each of the
years ended December 31, 2018, 2017 and 2016 respectively.
The Company has a non-cancellable service agreement that requires annual payments of $2,000 through May 2022.
As of December 31, 2018 and 2017, the other non-current asset is the rent security deposit on leased office space.
Contingent liabilities
Contingent liabilities are liabilities that arose from past events but whose existence will only be confirmed by the occurrence or non-occurrence of future
events that in some situations are beyond the Groups' control. See Note 3.4 for tax contingencies.
In 2004, a private company Aditech Pharma AB (together with its successor-in-interest Aditech Pharma AG, "Aditech"), controlled by NB, began
developing and filing patents for, among other things, formulations and dosing regimens of DMF. In 2005, the Company entered into a patent license agreement
with Aditech to license this patent family from Aditech. In 2010, the Company acquired this patent family from Aditech pursuant to a patent transfer agreement
(the "Transfer Agreement") that replaced the patent license agreement. Under the Transfer Agreement, the Company obtained, among other things, Aditech's
patents and associated know-how related to DMF formulations and delivery systems (the "Aditech IP"). In connection with the License Agreement, the Company
and Aditech executed an addendum to the Transfer Agreement (the "Addendum"). The Addendum clarified certain ambiguities with respect to the compensation
due to Aditech in the event the Company would enter into the License Agreement and also provided for Aditech to waive certain rights under the Transfer
Agreement. The Addendum specifies that Aditech receives 2% of the Non-refundable Fee (or $25 million) and is entitled to additional compensation should the
Company receive royalties from Biogen under the License Agreement. If royalties are paid to the Company in accordance with the License Agreement, Aditech
will be entitled to receive a cash payment equal to 2% of the same base amount with respect to which the Company's royalty percentage is calculated, accruing
from the same period of time as any royalty payment payable by Biogen to the Company (prior to taking into account taxes, duties and VAT, if any). Aditech is
considered to be a related party of the Company due to control over Aditech by NB. The $25 million due to Aditech in accordance with the Addendum and in
connection with the Company's receipt of the Non-refundable Fee was paid during May 2017.
As part of the project for the development of new or innovative products and procedures in the Free State of Saxony, Germany, the Sächsische Aufbaubank
—Förderbank ("SAB") awarded FP GmbH a grant ("Grant") of €3.8 million ($4.4 million based on the December 31, 2018 exchange rate) that subsidized certain
product development costs incurred by FP GmbH during the period from March 2007 to December 2008. In June 2012, the SAB concluded the proceeding of
proof of correct use of the Grant and determined that FP GmbH was in compliance with the terms of the Grant. In January 2017, the SAB informed the Company
that FP GmbH had no further obligation to perform under the Grant or to repay the Grant. The SAB maintains the right to revoke the Grant and demand
repayment
F-41
Table of Contents
Section 6—Other Disclosures (Continued)
Notes to Consolidated Financial Statements (Continued)
of the Grant plus interest in the event the SAB in the future determines that FP GmbH failed to comply with the terms of the Grant.
6.3 Events after the reporting period
Subsequent to December 31, 2018, there were no events that were required to be reported except for the matters discussed in Note 1.2 regarding the final
decision reached in the Interference Proceeding, Biogen's purchase of the intellectual property in the United States associated with the Company, and the
expiration of 100,000 deferred shares as discussed in Note 3.3.
F-42
QuickLinks -- Click here to rapidly navigate through this document
List of Subsidiaries of Forward Pharma A/S
Exhibit 8.1
Subsidiaries of the Registrant
Forward Pharma GmbH
Forward Pharma USA, LLC
Forward Pharma FA ApS
Forward Pharma Operations ApS
State or Other Jurisdiction
of Incorporation
Germany
Delaware
Denmark
Denmark
QuickLinks
Exhibit 8.1
List of Subsidiaries of Forward Pharma A/S
QuickLinks -- Click here to rapidly navigate through this document
Exhibit 12.1
I, Claus Bo Svendsen, certify that:
CERTIFICATION
(1)
(2)
(3)
(4)
I have reviewed this annual report on Form 20-F of Forward Pharma A/S;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
The company's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
company and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the company's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the company's internal control over financial reporting that occurred during the period covered by the annual
report that has materially affected, or is reasonably likely to materially affect, the company's internal control over financial reporting; and
(5)
The company's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
company's auditors and the audit committee of the company's board of directors (or persons performing the equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the company's ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company's internal control
over financial reporting.
Dated: April 4, 2019
/s/ CLAUS BO SVENDSEN
Claus Bo Svendsen
Principal Executive Officer
QuickLinks
Exhibit 12.1
CERTIFICATION
QuickLinks -- Click here to rapidly navigate through this document
Exhibit 12.2
I, Claus Bo Svendsen, certify that:
CERTIFICATION
(1)
(2)
(3)
(4)
I have reviewed this annual report on Form 20-F of Forward Pharma A/S;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
The company's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
company and have:
(a)
(b)
(c)
(d)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the company's disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the company's internal control over financial reporting that occurred during the period covered by the annual
report that has materially affected, or is reasonably likely to materially affect, the company's internal control over financial reporting; and
(5)
The company's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
company's auditors and the audit committee of the company's board of directors (or persons performing the equivalent functions):
(a)
(b)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the company's ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company's internal control
over financial reporting.
Dated: April 4, 2019
/s/ CLAUS BO SVENDSEN
Claus Bo Svendsen
Principal Financial Officer
QuickLinks
Exhibit 12.2
CERTIFICATION
QuickLinks -- Click here to rapidly navigate through this document
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 13.1
In connection with the Annual Report of Forward Pharma A/S (the "Company"), on Form 20-F for the fiscal year ended December 31, 2018 as filed with the
Securities and Exchange Commission (the "Report"), I, Claus Bo Svendsen, Chief Executive Officer, principal executive officer and principal financial officer,
hereby certify as of the date hereof, solely for purposes of 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to the best of my
knowledge:
(1)
(2)
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at
the dates and for the periods indicated.
Dated: April 4, 2019
/s/ CLAUS BO SVENDSEN
Claus Bo Svendsen
Principal Executive Officer and Principal Financial Officer
QuickLinks
Exhibit 13.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
QuickLinks -- Click here to rapidly navigate through this document
Consent of Independent Registered Public Accounting Firm
Exhibit 15.1
We consent to the incorporation by reference in the Registration Statement (Form S-8 No. 333-203313) pertaining to the Forward Pharma A/S 2014
Omnibus Equity Incentive Compensation Plan of our report dated April 4, 2019, with respect to the consolidated financial statements of Forward Pharma A/S
included in this Annual Report (Form 20-F) for the year ended December 31, 2018.
/s/ Ernst & Young P/S
Copenhagen, Denmark
April 4, 2019
QuickLinks
Exhibit 15.1
Consent of Independent Registered Public Accounting Firm