LEIDEN, The Netherlands,
July 30, 2015 /PRNewswire/ --
Substantially increasing revenues
from sales
Biotech company Pharming Group N.V. ("Pharming" or "the
Company") (Euronext Amsterdam: PHARM) today published its
(unaudited) financial report for the six months ended 30 June 2015.
FINANCIAL HIGHLIGHTS
- Revenues from operations increased to €5.2 million (H1 2014:
€2.5 million) as a result of substantially increased revenues from
product sales of €4.1 million (€2.9 million for Q2), compared to
€1.4 million for H1 2014. Revenues from Ruconest® sales in the US
amounted to €3.0 million (€2.4 million for Q2) and in the EU
amounted to €1.1 million (€0.5 million for Q2).
- Gross profit increased to €2.9 million (€2.1 million for Q2)
from €0.7 million in H1 2014 as a result of sales in the US and a
gain on inventory impairments, reflecting the improving yields from
sales in the US and direct commercialisation in the EU.
- As result of increasing costs of operations (R&D, General
and Administrative and Marketing and Sales), operating result
decreased by €0.7 million, to a loss of €6.1 million compared
to a €5.4 million loss for H1 2014. The increase is mostly a result
of the (non-cash) share-based compensation.
- Financial income and expenses improved by €14.9 million to a
gain of €2.6 million (H1 2014: €12.3 million loss). The loss in
2014 was a result of a (non-cash) revaluation of warrants due to
the strong increase in Pharming's share price during H1
2014.
- Net loss amounted to €3.5 million (H1 2014: €17.7
million).
- The equity position decreased to €27.9 million compared to
31 December 2014, as a result of the
net loss in H1 2015.
- The inventories of Ruconest increased to €14.6 million from
€13.4 million as per 31 December 2014
in preparation of growing sales.
- The cash position decreased during H1 2015 by €9.4 million to
€25.0 million, due to negative cash flows from operating
activities.
OPERATIONAL HIGHLIGHTS
- Following the completed acquisition of our US partner, Salix
Pharmaceuticals by Valeant Pharmaceuticals (VRX), the Ruconest US
commercial infrastructure remains intact and commercialisation
continues to be unaffected.
- A steady inflow of new patients into Ruconest Solutions (the US
total care program under which Ruconest is made available to
Hereditary Angioedema (HAE) patients in the US) continued during H1
2015, creating the basis for continued revenue growth from sales in
the US.
- Patient enrollment for the randomised double blind placebo
controlled Phase II clinical trial to investigate Ruconest for the
prophylaxis of HAE was initiated in January and continued during
the period.
- In February, Dr. Perry Calias
was appointed as Chief Scientific Officer. Dr. Calias has
overall responsibility for the Company's new Enzyme Replacement
Therapy (ERT) programs, achieving the scientific milestones set in
the business plan, enhancing the IP portfolio, overseeing new
product development and contributing to the overall strategic
direction of the Company.
- In May, Pharming and Clinigen Group (CLIN) entered into an
international global access collaboration for HAEi, the
International Patient Organisation for C1-Inhibitor Deficiencies.
The "HAEi GAP" program will provide access to Ruconest to eligible
patients with HAE, who currently do not have access to effective
medication, to treat acute attacks of the disease.
- The Company entered into an exclusive distribution agreement
with Cytobioteck S.A.S. ("Cytobioteck"), a privately owned
Bogota, Colombia based specialty
healthcare company, for the distribution of Ruconest for the
treatment of acute attacks of HAE in Colombia and Venezuela.
Sijmen de Vries, Pharming's CEO, commented: "Pharming's
performance during the first half of 2015 continued to reflect the
transformational changes made in 2014. In particular, on a quarter
by quarter basis, we have seen substantially increasing Ruconest
sales in the US. We have also established new agreements that
will widen the availability of Ruconest to HAE patients across the
world, such as the HAEi GAP programme and the distribution
agreement for Colombia and
Venezuela with Cytobioteck.
Outside of this reporting period, we were pleased to report, on 20
July, that we have attracted non-dilutive growth capital financing
from Oxford Finance and Silicon Valley Bank, which represents
an important validation of our business model, growth plans and
financial stability. The funding enables us to accelerate the
growth of the business by simultaneously financing the working
capital required to support manufacturing for increasing Ruconest
sales and our investments in additional indications for Ruconest,
as well as the development of new products, utilising the strengths
of our platform."
FINANCIAL RESULTS
Key figures HY HY
Amounts in EUR'000 2015 2014
Revenues 5,235 2,539
Gross profit 2,884 739
Other income 34 66
Operating costs (8,980) (6,223)
Operating result (6,062) (5,418)
Financial income/expenses 2,575 (12,270)
Net result (3,487) (17,688)
Revenues
Revenues increased to €5.2 million (H1 2014: €2.5 million),
mainly as a result of product sales in the US.
Other license fee income amounted to €1.1 million (H1 2014: €1.1
million). This license fee income reflects the release of accrued
deferred license fees following receipt of €21.0 million upfront
and milestone payments in 2010 and 2013 from Sobi, Salix and
SIPI.
Cost of product sales in the first half year of 2015 amounted to
€2.6 million (H1 2014: €1.4 million).
In the first half year of 2015 the Company incurred a gain of
€0.2 million for release of inventory impairments (H1 2014: €0.4
million loss), related to reallocation of inventories to the
different markets with different prices, based on sales forecasts
by management and commercial partners, and clinical programmes.
Actual sales can differ from these forecasts.
Gross profit
Gross profit increased by €2.2 million, from €0.7 million in the
first half year of 2014 to €2.9 million in the first half year of
2015, mainly as a result of an improving "product mix", from sales
in the US by our partner Salix, direct commercialisation by
Pharming in Austria, Germany and Netherlands and a gain due to release of
impairments of inventories.
Operating costs
Operating costs increased to €9.0 million from €6.2 million in
the first half year of 2014. The increase is a result of the
increased (non-cash) share-based compensation, marketing &
sales expenses for direct commercialisation activities in the EU
and costs for the new R&D sites in Schaijk and France.
R&D costs increased by €1.3 million compared to H1 2014 and
amounted to €6.6 million in the first half year of 2015. General
and Administrative costs increased to €1.8 million from €1.0
million in 2014 and Marketing and Sales costs amounted to €0.6
million. In 2014 no direct commercialisation of Ruconest took
place.
Operating result
As a result of a higher increase of the operating costs compared
to the increase in gross profit, the operating loss increased to
€6.1 million in the first half year (H1 2014: €5.4 million
loss).
Financial income and expenses
The 2015 net gain on financial income and expenses was €2.6
million, compared to a €12.3 million net loss on financial income
and expenses in the first half year of 2014. The financial income
and expenses reflected the (non-cash) revaluation of warrants and
exchange rate effects on foreign currencies.
Net result
As a result of the above items, the net loss decreased by €14.2
million to €3.5 million in the first half year of 2015 (H1 2014:
€17.7 million). The net loss per share for the first half year of
2015 decreased to €0.009 (H1 2014: €0.047).
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash)
decreased by €9.4 million from €34.4 million at the end of 2014 to
€25.0 million at the end of the first half year 2015. The decrease
follows from net cash outflows from operations of €8.7 million and
investing activities of €0.5 million, with net cash outflows from
financing activities amounting to €0.5 million and positive
exchange rate effects amounting to €0.3 million.
EQUITY POSITION
The Company's equity position amounted to €27.9 million at the
end of the first half year 2015 (31 December
2014: €29.8 million). In addition, it should be noted that
the Company has a significant amount of deferred license fee income
(30 June 2015: €11.1 million)
regarding non-refundable license fees received in 2010 and 2013,
which will be recognised in the statement of income over the term
of the license agreements involved.
The number of outstanding shares as of 30
June 2015 is 408.2 million and the fully diluted number of
shares is 477.8 million.
OUTLOOK
For 2015, the Company anticipates :
- Increasing sales of Ruconest from US partner Salix (Valeant),
EU partner Sobi, Israel partner
Megapharm and the direct commercialisation of Ruconest in
Austria, Germany and the
Netherlands.
- Continued significant investments in purification of sufficient
quantities of Ruconest.
- Investments in the continuing Phase II clinical trial for
Prophylaxis of HAE; a 50/50 cost sharing project with US partner
Salix (Valeant).
- Investments in (early) development of new pipeline projects
driven by the French Research Group and the Boston-based New Product Development
group.
No financial guidance for 2015 is provided.
Risks and uncertainties
Pharming's Board of Management is responsible for designing,
implementing and operating the Company's internal risk management
and control systems. The purpose of these systems is to manage in
an effective and efficient manner the significant risks to which
the Company is exposed and that provide reasonable assurance that
the financial reporting does not contain any errors of material
importance. The Company's internal risk management and control
systems are designed to provide reasonable assurance that strategic
objectives can be met. The Company has developed an internal risk
management and control system that is tailored to the risk factors
that are relevant to the Company, allowing for its small size. Such
systems can never provide absolute assurance regarding achievement
of Company objectives, nor can they provide an absolute assurance
that material errors, losses, fraud, and the violation of laws or
regulations will not occur.
A summary of the risks that could prevent Pharming from
realising its objectives is included in the section 'Risk Factors'
in the Annual Report 2014 (pages 21-25). Management reviewed these
risks and concluded that the most important risks and
risk-mitigation actions reported in this Annual Report 2014 are
still applicable.
Auditor's involvement
These interim financial statements have not been audited or
reviewed by an external auditor.
Statement of the Board of Management
The Board of Management declares that to the best of its
knowledge and in accordance with applicable reporting principles,
the half-year consolidated financial statements give a true and
fair view of the assets, liabilities, financial position and profit
or loss of Pharming, and the half-year report incorporated in this
press release includes a fair review of the development and
performance of the business and the position of the Company,
together with a description of certain risks associated with the
expected development of the Company.
Leiden, 30 July 2015
The Board of Management
Sijmen de Vries, CEO
Bruno Giannetti, COO
ABOUT PHARMING GROUP
N.V.
Pharming Group N.V. is developing innovative products for the
treatment of unmet medical needs. Ruconest® (conestat alfa) is a
recombinant human C1 esterase inhibitor approved for the treatment
of angioedema attacks in patients with HAE in the US, Israel, all 28 EU countries plus Norway, Iceland and Liechtenstein.
Ruconest is commercialised by Pharming in Austria, Germany and the
Netherlands.
Ruconest is distributed by Swedish Orphan Biovitrum AB (publ)
(SS: SOBI) in the other EU countries and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine.
Ruconest is partnered with Salix Pharmaceuticals, Ltd. ("Salix")
in North America. Salix is part of
Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX:
VRX).
RUCONEST is also being investigated in a randomised Phase II
clinical trial for prophylaxis of HAE, in a Phase II clinical trial
for the treatment of HAE in young children (2-13 years of age) and
evaluated for various additional follow-on indications.
Pharming has a unique GMP compliant, validated platform for the
production of recombinant human proteins that has proven capable of
producing industrial volumes of high quality recombinant human
protein in a more economical way compared to current cell-based
technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe,
Fabry's and Gaucher's diseases are under early evaluation. The
platform is partnered with Shanghai Institute of Pharmaceutical
Industry (SIPI), a Sinopharm Company, for joint global development
of new products. Pre-clinical development and manufacturing will
take place at SIPI and are funded by SIPI. Pharming and SIPI
initially plan to utilise this platform for the development of
recombinant human Factor VIII for the treatment of Haemophilia A.
Additional information is available on the Pharming website:
http://www.pharming.com.
Conference call information
Today, Chief Executive Officer Sijmen de Vries will discuss the
half year 2015 results in a conference call at 10:00 am (CET). To participate, please call one
of the following numbers 10 minutes prior to the call:
From the Netherlands:
+31(0)20 713 2998
From the UK: +44(0)20 7136 2051
From Belgium:
+32(0)2 404 0662
From France:
+33(0)1 76 77 22 28
From Germany:
+49(0)69 2222 10626
From Switzerland:
+41(0)22 592 7953
Conference ID: 2660051
Forward-looking statements
This press release may contain forward-looking statements
including without limitation those regarding
Pharming's (the
"Company") financial projections, market
expectations, developments, partnerships, plans, strategies and
capital expenditures.
The Company cautions that such forward-looking statements may
involve certain risks and uncertainties, and actual results may
differ. Risks and uncertainties include without limitation the
effect of competitive, political and (macro) economic factors,
legal claims, the Company's ability to protect
intellectual property, fluctuations in exchange and interest rates,
changes in tax rates, changes in legislation and the
Company's ability to identify, develop and
successfully commercialise new products, markets or
technologies.
As a result, the Company's actual performance,
position and financial results may differ materially from the
plans, goals and expectations set forth in such forward-looking
statements. The Company assumes no obligation to update any
forward-looking statements or information, which speak as of their
respective dates, unless required by law or
regulations.
PHARMING GROUP N.V.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
For the first half year ended 30
June 2015
Condensed consolidated statement of income
Condensed consolidated statement of comprehensive income
Condensed consolidated balance sheet
Condensed consolidated statement of cash flows
Condensed consolidated statement of changes in equity
Notes to the condensed consolidated interim financial
statements
CONDENSED CONSOLIDATED STATEMENT OF
INCOME
For the first half year ended 30 June
HY HY
Amounts in EUR'000, except per share data Notes 2015 2014 [1]
Product sales 4,131 1,439
License fees 1,104 1,100
Revenues 7 5,235 2,539
Costs of product sales (2,551) (1,436)
Inventory impairments 200 (364)
Costs of sales 8 (2,351) (1,800)
Gross profit 2,884 739
Other income 34 66
Research and development (6,565) (5,256)
General and administrative (1,794) (967)
Marketing and sales (621) -
Costs 8 (8,980) (6,223)
Operating result (6,062) (5,418)
Financial income and expenses 2,575 (12,270)
Result before income tax (3,487) (17,688)
Income tax expense - -
Net result for the year from continuing
operations (3,487) (17,688)
Net result for the year from discontinued
operations - -
Net result for the year (3,487) (17,688)
Attributable to:
Owners of the parent (3,487) (17,688)
Non-controlling interests - -
Total net result (3,487) (17,688)
Basic earnings per share (EUR) from
continuing operations (0.009) (0.047)
The notes are an integral part of these condensed
interim financial statements
[1] As
disclosed under Note 6, the prior
year's interim financial statements have been
restated.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE
INCOME
For the first half year ended 30 June
HY HY
Amounts in EUR'000 2015 2014 [1]
Net result for the year (3,487) (17,688)
Currency translation differences 3 -
Items that may be subsequently reclassified
to profit or loss 3 -
Other comprehensive income, net of tax 3 -
Total comprehensive income for the year (3,484) (17,688)
Attributable to:
Owners of the parent (3,484) (17,688)
Non-controlling interests
- -
The notes are an integral part of these condensed
interim financial statements
[1] As
disclosed under Note 6, the prior
year's interim financial statements have been
restated.
CONDENSED CONSOLIDATED BALANCE SHEET
As at 30 June
Amounts in EUR'000 Notes 30 June 31 December
2015 2014
Intangible assets 751 777
Property, plant and equipment 5,619 5,598
Restricted cash 200 200
Non-current assets 6,570 6,575
Inventories 9 14,557 13,404
Trade and other receivables 4,256 1,554
Cash and cash equivalents 24,777 34,185
Current assets 43,590 49,143
Total assets 50,160 55,718
Share capital 4,082 4,077
Share premium 282,428 282,260
Other reserves 39 36
Accumulated deficit (258,656) (256,530)
Shareholders' equity 10 27,893 29,843
Deferred license fees income 8,911 10,022
Finance lease liabilities 895 965
Other liabilities - 15
Non-current liabilities 9,806 11,002
Deferred license fees income 2,207 2,200
Derivative financial liabilities 11 1,964 4,266
Trade and other payables 8,079 7,781
Finance lease liabilities 211 626
Current liabilities 12,461 14,873
Total equity and liabilities 50,160 55,718
The notes are an integral part of these condensed
interim financial statements
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
For the first half year ended 30 June
HY HY
Amounts in EUR'000 2015 2014
Receipts from license partners, including
product sales 2,458 1,080
Receipt of Value Added Tax 577 480
Interest received 80 81
Other receipts - 283
Payments of third party fees and expenses,
including Value Added Tax (4,083) (3,310)
Payments of manufacturing expenses (4,477) (7,364)
Net compensation paid to (former) board members
and (former) employees (1,854) (1,110)
Payments of pension premiums, payroll taxes and
social securities, net of grants settled (1,399) (1,150)
Net cash flows from operating activities (8,698) (11,010)
Purchases of property, plant and equipment (476) -
Purchases of intangible assets - -
Net cash flows from investing activities (476) -
Proceeds of equity and warrants issued - 19,125
Payments of transaction fees and expenses - (697)
Payments of finance lease liabilities (562) (139)
Net cash flows from financing activities (562) 18,289
Increase/(decrease) of cash (9,736) 7,279
Exchange rate effects 328 -
Cash and cash equivalents at 1 January 34,385 19,152
Total cash at 30 June 24,977 26,431
Of which restricted cash 200 176
Cash and cash equivalents at 30 June 24,777 26,255
The notes are an integral part of these condensed
interim financial statements
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN
EQUITY
For the first half year ended 30 June
Attributable to owners of the parent
Number
of
shares
Amounts in EUR'000 Share
Share-
Share Other Accu-mulated holders'
(*1,000) capital premium reserves deficit equity
Balance at 1 January 2014 334,655 3,346 254,901 - (253,237) 5,010
Loss for the period - - - (17,688) (17,688)
Other comprehensive
income - - - - -
Total comprehensive
income - - - - (17,688) (17,688)
Share-based compensation - - - - 299 299
Bonuses settled in shares 367 4 186 - - 190
Shares issued for cash 30,000 300 13,704 - - 14,004
Warrants exercised 40,313 404 12,425 - - 12,829
Options exercised 19 - - - - -
Total transactions with
owners, recognised
directly in equity 70,699 708 26,315 299 27,322
Balance at 30 June 2014
[1] 405,354 4,054 281,216 (270,626) 14,644
Balance at 1 January 2015 407,687 4,077 282,260 36 (256,530) 29,843
Loss for the period - - - (3,487) (3,487)
Other comprehensive
income - - 3 - 3
Total comprehensive
income - - 3 (3,487) (3,484)
Share-based compensation - - - 1,361 1,361
Bonuses settled in shares 523 5 168 - - 173
Shares issued for cash - - - - -
Warrants exercised/
issued - - - - -
Options exercised - - - - -
-
Total transactions with
owners, recognised
directly in equity 523 5 168 1,361 1,534
Balance at 30 June 2015 408,210 4,082 282,428 39 (258,656) 27,893
The notes are an integral part of these condensed
interim financial statements
[1] As
disclosed under Note 6, the prior
year's interim financial statements have been
restated.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM
FINANCIAL STATEMENTS
For the first half year ended 30 June
1. Company information
Pharming Group N.V. is a limited liability public company which
is listed on Euronext Amsterdam (PHARM), with its headquarters and
registered office located at:
Darwinweg 24
2333 CR Leiden
The Netherlands
2. Basis of preparation
These condensed interim financial statements for the six month
ended 30 June 2015 have been prepared
in accordance with IAS 34, 'Interim financial reporting'.The
condensed interim financial statements should be read in
conjunction with the annual financial statements for the year ended
31 December 2014, which have been
prepared in accordance with with International Financial Reporting
Standards (IFRS) and IFRS Interpretations Committtee (IFRS IC)
interpretations applicable to companies reporting under IFRS as
adopted by the European Union and valid as of the balance sheet
date.
3. Accounting
policies
The accounting policies adopted are consistent with those of the
financial statements for the year ended 31
December 2014.
4. Estimates and
judgements
The preparation of interim financial statements in conformity
with IFRS requires the use of certain critical accounting
estimates. It also requires management to exercise its judgement in
the process of applying the Company's accounting policies. In
preparing these condensed interim financial statements, the
significant judgements made by management in applying the Company's
accounting policies were the same as those apllied to the
consolidated financial statements for the ended 31 December 2014.
5. Seasonality of
operations
Seasonality has no material impact on Company's interim
financial statements.
6. Restatement of prior
year
As reported in the Financial results for the first nine months
of 2014, the Company restated the prior year's interim financial
statements due to a correction in calculating the fair value of
warrants. The fair values of warrant rights are based on
calculation models using assumptions with respect to, amongst
others, the exercise price of warrants, the maturity date, the risk
free rates well as (historical) volatility. Changes in the fair
value are recognised in the statement of income, under financial
expenses, as they arise.
As a consequence the reported financial expenses were €2.4
million too high. The resulting adjustment has no impact on
reported cash flows and also no impact on the reported financial
statements for the full year 2014.
The restatement to the Company's 2014 comparative amounts is as
follows:
HY HY
2014 2014
Amounts in EUR'000, except per share data as reported Restatement restated
Operating result (5,418) (5,418)
Financial income and expenses (14,724) 2,454 (12,270)
Result before income tax (20,142) 2,454 (17,688)
Basic earnings per share (EUR) from
continuing operations (0.053) 0.006 (0,047)
Attributable to owners of the parent
Amounts in EUR'000 Share
Share-
Share Other Accu-mulated holders'
capital premium reserves deficit equity
Balance at 30 June 2014 as
reported 4,054 281,216 (273,080) 12,190
Restatement 2,454 2,454
Balance at 30 June 2014
restated 4,054 281,216 (270,626) 14,644
7. Segment
information
The Board of Management is the chief operating decision-maker.
The Board of Management considers the business from both a
geographic and product perspective. From a product perspective the
Company's business was almost exclusively related to the
recombinant human C1 esterase inhibitor business. From a geographic
perspective the Company is operating in three main segments: The
US, Europe and Rest of the world.
These segments are only related to revenues. Management and thus
costs and assets are almost exclusively based at the central office
in Leiden, the Netherlands. Costs
and assets are not allocated to the geographic segments.
Total revenues per geographic segment:
HY HY
Amounts in EUR'000 2015 2014
US 3,570 568
Europe 1,393 1,839
Rest of the world 272 132
5,235 2,539
8. Expenses by nature
Cost of product sales in the first half year of 2015 amounted to
€2.6 million (H1 2014: €1.4 million). In the first half year of
2015 the Company incurred a gain of €0.2 million for release of
inventory impairments (H1 2014: €0.4 million loss), related to
reallocation of inventories to the different markets with different
prices, based on sales forecasts by management and commercial
partners, and clinical programmes. Actual sales can differ from
these forecasts.
The loss of €0.4 million in the first half year of 2014 is
related to cost of goods exceeding the anticipated sales revenue
for the product.
Operating costs increased to €9.0 million from €6.2 million in
the first half year of 2014. The increase is a result of the
increased (non-cash) share-based compensation, marketing &
sales expenses for direct commercialization activities in the EU
and costs for the new R&D sites in Schaijk and in France.
Research and Development costs increased with €1.3 million
compared to H1 2014 and amounted to €6.6 million in the first half
year of 2015, General and Administrative costs increased to €1.8
million from €1.0 million in 2014 and Marketing and Sales costs
amounted to €0.6 million. In 2014 no direct commercialisation of
Ruconest took place.
Employee benefits
Employee benefits are charged to Research and development costs
or General and administrative costs or Sales and Marketing costs
based on the nature of the services provided.
Depreciation and amortisation charges
HY HY
Amounts in EUR'000 2015 2014
Property, plant and
equipment (231) (209)
Intangible assets (26) (65)
(257) (274)
The increase of depreciation charges of property, plant and
equipment in the first half year of 2015 as compared to 2014 stems
from investments.
Amortisation charges of intangible assets have been fully
allocated to research and development costs in the statement of
income; for property, plant and equipment, in the first half year
of 2015 an amount of €179,000 was charged to research and
development costs (H1 2014: €162,000) and €52,000 to general and
administrative expenses (H1 2014: €47,000).
9. Inventories
Inventories include batches Ruconest and skimmed milk available
for production of Ruconest.
30 June 31 December
Amounts in EUR'000 2015 2014
Finished goods 10,913 7,023
Work in progress 2,188 5,044
Raw materials 1,456 1,337
14,557 13,404
The inventory valuation at 30 June
2015 is stated net of a provision of €1.0 million
(December 2014: €1.7 million) to
write inventories down to their net realisable value. In the first
half year of 2015 the Company released €0.2 million out of this
provision to the cost of sales due to the improved expected product
mix.
Amounts in EUR'000 2015
Balance at 1 January (1,691)
Release impairment 200
Used in cost of product sales 282
Used in clinical trials 239
Balance at 30 June (970)
The cost of inventories included in the costs of product sales
in the first half year 2015 was €2.6 million (HY 2014: €1.4
million).
The major portion of inventories at 30
June 2015 has expiration dates starting beyond 2017 and is
expected to be sold or used before expiration.
10. Equity
Main developments total equity in the first half year of
2015
The Company transferred an aggregate number of 523,813 shares to
members of the Board of Management and employees in lieu of bonus
rights for the year 2014.
11. Derivative financial
liabilities
Derivative financial liabilities relate to financial instruments
and include warrants issued in relation to the issue of equity.
Derivative financial liabilities include the initial fair value of
the 26,392,736 warrants issued in connection with the private
placements in October 2013 and
April 2014, as well as changes in the
fair value of the warrants resulting from adjustments of their
exercise prices. All outstanding warrants were revalued for
accounting purposes at 30 June
2015.
Movement of derivative financial liabilities for the first half
year of 2015 can be summarised as follows:
Amounts in EUR'000 2015
Balance at 1 January 4,266
Initial recognition upon issue -
Fair value losses (gains) derivatives (2,302)
Exercise of warrants -
Balance at 30 June 1,964
Fair value gains on derivatives have been presented within
financial income.
11. Commitments and
contingencies
In the first half year of 2015, there were no material changes
to the commitments and contingent liabilities from those disclosed
in Note 30 of the 2014 Annual Report.
12. Number of shares
The total number of outstanding shares at 30 July 2015 amounts to 408,210,412.
The composition of the number of shares and share rights
outstanding as well as authorised share capital as per the date of
these financial statements is provided in the following tables.
30 July 2015
Shares 408,210,412
Warrants 28,708,253
Options 37,959,027
LTIP 5,260,596
Issued 480,138,288
Available for issue 69,861,712
Authorised share
capital 550,000,000
13. Events after the end
of the reporting period
On 17 July 2015, the Company
entered into a straight debt financing of €15.6 million (€15.0
million net proceeds after subtraction of transaction fees and
costs) with Oxford Finance LLC and Silicon Valley Bank ("The
Lenders").
Contact
Sijmen de Vries, CEO: T: +31-71-524-7400
FTI Consulting
Julia Phillips/ Victoria Foster Mitchell: T:
+44-203-727-1136
PRN NLD