LEIDEN, The Netherlands,
March 5, 2015 /PRNewswire/ --
Biotech company Pharming Group N.V. ("Pharming" or "the
Company") (NYSE Euronext: PHARM) today published its preliminary
(unaudited) financial results for the year ended 31 December 2014.
FINANCIAL HIGHLIGHTS
- Revenues from operations increased to €21.2 million (2013: €6.8
million) as a result of higher license fees, including the receipt
of a US$20.0 million (€16.0 million)
milestone from US partner Salix Pharmaceuticals, Inc. (NASDAQ:SLXP)
(2013: €3.8 million) and increased product sales to €3.0 million
(2013: €0.9 million) as a result of increased sales in the EU and
initial sales in the US of €0.3 million.
- Operating result improved to an operating profit of €2.9
million in 2014 from a loss of €6.9 million in 2013.
- Financial expenses amounted to €8.8 million (2013: €8.2
million). The increase is due to the (non-cash) revaluation of our
warrants resulting from the strong increase of our share price in
2014.
- Net loss decreased to €5.8 million in 2014 (2013: €15.1
million).
- The equity position increased to €29.8 million (2013: €5.0
million), mainly as a result of the receipt of a US$20.0 million milestone, a private equity
placement of net €14.0 million and the exercise of
warrants.
- In preparation of further commercialisation of Ruconest®, the
inventories of Ruconest increased to €13.4 million (2013: €4.8
million).
- The cash position significantly improved to €34.4 million
(2013: €19.2 million), mainly as a result of the receipt of the
€16.0 million milestone payment from Salix, the private equity
placement of net €14.0 million and the exercise of warrants of €4.6
million.
OPERATIONAL HIGHLIGHTS
- Following the FDA approval for the treatment of acute attacks
of angioedema in patients with Hereditary Angioedema (HAE) in
July 2014, Ruconest was launched by
partner Salix in the US in November
2014.
- Receipt of US$20.0 million
milestone payment in November 2014
from Salix for first commercial sale of Ruconest in the US.
- Announced the initiation of direct commercialisation activities
for Ruconest in Austria,
Germany and the Netherlands; hired a small team of HAE
commercialisation and medical affairs experts.
- Acquired certain assets from TRM SASU, for €0.5 million in
cash, including product leads for the development of new Enzyme
Replacement Therapies (ERT) for Pompe, Fabry's and Gaucher's
disease and rhFactor VIII for the treatment of Haemophilia A.
- Initiated a randomised double blind placebo controlled Phase II
clinical trial to investigate Ruconest for the prophylaxis of HAE.
The first patient was enrolled in early January 2015, patient enrollment for the study
continues.
Sijmen de Vries, Pharming's CEO commented: "In 2014, Pharming
achieved an important and long-awaited milestone, with the FDA
approval of Ruconest for acute attacks of angioedema in patients
with Hereditary Angioedema in July. In November, Ruconest was
launched by our US commercialisation partner, Salix. The Company
also furthered the clinical development of Ruconest in the
additional indication of Prophylaxis of HAE by initiating a Phase
II study in September. This study is the first step in a
50/50 shared cost development programme with our US partner Salix.
During the period, we also made good progress in Europe, where we prepared for direct
commercialisation of Ruconest in Austria, Germany and the
Netherlands.
To facilitate broadening the pipeline through new product
development and leverage of our technology platform, we acquired
certain assets from TRM SASU for €0.5 million in cash, including
product leads for the development of Enzyme Replacement Therapies
for rare diseases such Pompe, Fabry's and Gaucher's disease.
I would like to thank Pharming's employees for their commitment
and dedication in establishing a platform from which we can
confidently build a financially sustainable enterprise with a
pipeline beyond the Ruconest franchise."
FINANCIAL RESULTS
Gross profit
Gross profit increased from €5.7 million in 2013 to €17.8
million in 2014, mainly as a result of a milestone payment from
Salix and increased product sales in the EU.
Revenues increased to €21.2 million, from €6.8 million in 2013.
The increase is mainly a result of the receipt of a US$20.0 million (€16.0 million) milestone payment
from US partner Salix in 2014, following the launch of Ruconest in
the US, while the Company received a US$5.0
million (€3.8 million) milestone payment in 2013.
Revenue from product sales increased to €3.0 million (2013: €0.9
million) due to higher sales in the EU and first sales (€0.3
million) in the US. Other license fee income increased to €2.2
million from €2.1 million in 2013. This license fee income reflects
the release of accrued deferred license fees following receipt of
in total €21.0 million upfront and milestone payments in 2010 and
2013 from Sobi, Salix and SIPI.
Cost of product sales in 2014 amounted to €2.8 million (2013:
€0.5 million). In 2014 the Company incurred €0.6 million (2013:
€0.6 million) of inventory impairments related to cost of goods
exceeding the anticipated sales revenue for the product.
Operating costs
Operating costs increased to €15.0 million from €12.8 million in
2013. The increase is a result of the combined effect of the start
of a Phase II clinical study of Ruconest as prophylaxis for HAE,
increased human capital costs as result of new hirings and the
expenses related to the (non-cash) accrual for share-based
compensation.
Research and Development costs increased to €11.7 million from
€10.2 million in 2013 and General and Administrative costs
increased to €3.3 million in 2014 from €2.5 million in 2013.
Operating result
Mainly as result of the receipt of a US$20 million milestone in November, the
operating result improved from a loss of €6.9 million in 2013 to an
operating profit of €2.9 million in 2014.
Financial income and expenses
The 2014 net loss on financial income and expenses was €8.6
million, compared to a €8.1 million net loss on financial income
and expenses in 2013. The 2014 financial expenses included losses
due to the increase of the fair value of outstanding and exercised
warrants of €9.1 million.
The 2013 financial income and expenses included settlement
losses of the convertible bonds in the amount of €4.6 million and
effective interest of the convertible bond of €3.2 million.
Net result
As a result of the above items, the net loss decreased by €9.3
million to €5.8 million in 2014 (2013: €15.1 million). The net loss
per share for 2014 decreased to €0.014 (2013: €0.071).
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash)
increased by €15.2 million from €19.2 million at year-end 2013 to
€34.4 million at the end of 2014. The increase follows from net
cash outflows from operations of €2.6 million and investing
activities of €0.7 million with net cash inflows from financing
activities amounting to €18.0 million and exchange rate effects
amounting to €0.5 million. Net cash flows from financing activities
mainly follow from the April 2014
equity issue of net €14.0 million and the exercise of warrants of
€4.6 million.
EQUITY POSITION
Since the private placement in October
2013, the Company's equity position is positive and amounted
to €29.8 million at year-end 2014 (2013: €5.0 million). In
addition, it should be noted that the Company has a significant
amount of deferred license fee income (year-end 2014: €12.2
million) regarding non-refundable license fees received in 2010 and
2013 which fees, will be recognised in the statement of income over
the term of the license agreements involved.
The number of outstanding shares as of 31
December 2014 is 407.7 million and the fully diluted number
of shares is 475.6 million.
OUTLOOK
For 2015, the Company expects:
- Increasing sales of Ruconest from US partner Salix, 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.
- 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.
About Pharming Group NV
Pharming Group NV 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 27 EU countries plus Norway, Iceland and Liechtenstein. Ruconest is commercialized 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, Inc. (NASDAQ: SLXP) in North America.
Ruconest® is also being investigated in a randomized Phase II
clinical trial for prophylaxis of HAE 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 in Pompe's, Fabry's and Gaucher's
diseases are under early evaluation.The platform is partnered with
Shanghai Institute for 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 utilize this
platform for the development of rh-FVIII for the treatment of
Haemophilia-A. Additional information is available on the Pharming
website; http://www.pharming.com.
This press release contains forward looking statements that
involve known and unknown risks, uncertainties and other factors,
which may cause the actual results, performance or achievements of
the Company to be materially different from the
results, performance or achievements expressed or implied by these
forward looking statements.
Conference call information
Today, Chief Executive Officer Sijmen de Vries will discuss the
full year 2014 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 3427 1902
From Belgium:
+32(0)2 400 6864
From France:
+33(0)1 70 99 42 76
From Germany:
+49(0)69 2222 10628
From Switzerland:
+41(0)22 592 7953
Conference ID: 6008681
PHARMING GROUP N.V.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
FOR THE YEAR ENDED 31 DECEMBER
2014
Consolidated Statement of Income
Consolidated Statement of Comprehensive Income
Consolidated Balance Sheet
Consolidated Statement of Cash Flows
CONSOLIDATED STATEMENT OF INCOME
For the year ended 31 December (amounts in €'000, except per
share data)
2014 2013
License fees 18,190 5,903
Product sales 2,996 941
Revenues 21,186 6,844
Costs of product sales (2,853) (533)
Inventory impairments (574) (579)
Costs of sales (3,427) (1,112)
Gross profit 17,759 5,732
Other income 105 106
Research and development (11,663) (10,232)
General and administrative (3,324) (2,518)
Costs (14,987) (12,750)
Operating result 2,877 (6,912)
Interest income cash and cash equivalents 180 91
Financial income 180 91
Effective interest convertible bonds - (3,178)
Settlement convertible bonds - (4,555)
Other interest expenses, net (175) (198)
Foreign currency results 457 (214)
Fair value loss derivatives (9,106) (12)
Other financial expenses - (82)
Financial expenses (8,824) (8,239)
Result before income tax (5,767) (15,060)
Income tax expense - -
Net result for the year from continuing
operations (5,767) (15,060)
Net result for the year from discontinued
operations - -
Net result for the year (5,767) (15,060)
Attributable to:
Owners of the parent (5,767) (15,060)
Non-controlling interests - -
Total net result (5,767) (15,060)
Basic earnings per share (EUR) from
continuing operations (0.014) (0.071)
CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
For the year ended 31 December (amounts in
€'000)
2014 2013
Net result for the year (5,767) (15,060)
Currency translation differences 45 -
Items that may be subsequently reclassified to
profit or loss 45 -
Other comprehensive income, net of tax 45 -
Total comprehensive income for the year (5,722) (15,060)
Attributable to:
(15,060)
Owners of the parent (5,722)
-
Non-controlling interests -
CONSOLIDATED BALANCE SHEET
As at 31 December (amounts in €'000)
2014 2013
Intangible assets 777 405
Property, plant and equipment 5,598 6,228
Restricted cash 200 176
Non-current assets 6,575 6,809
Inventories 13,404 4,763
Trade and other receivables 1,554 860
Restricted cash - 2,008
Cash and cash equivalents 34,185 16,968
Current assets 49,143 24,599
Total assets 55,718 31,408
Share capital 4,077 3,346
Share premium 282,260 254,901
Other reserves 36 -
Accumulated deficit (256,530) (253,237)
Shareholders' equity 29,843 5,010
Deferred license fees income 10,022 12,222
Finance lease liabilities 965 1,207
Other liabilities 15 44
Non-current liabilities 11,002 13,473
Deferred license fees income 2,200 2,200
Derivative financial liabilities 4,266 4,147
Trade and other payables 7,781 5,812
Finance lease liabilities 626 766
Current liabilities 14,873 12,925
Total equity and liabilities 55,718 31,408
CONSOLIDATED STATEMENT OF CASH FLOWS
For the year ended 31 December (amounts in
€'000)
2014 2013
Receipts from license partners, including
product sales 18,544 5,626
Receipt of Value Added Tax 971 882
Interest received 185 49
Receipt of grants - 145
Other receipts 283 300
Payments of third party fees and expenses,
including Value Added Tax (7,851) (8,492)
Payments of manufacturing expenses (10,124) (1,456)
Net compensation paid to (former) board members
and (former) employees (2,472) (3,136)
Payments of pension premiums, payroll taxes and
social securities, net of grants settled (2,109) (2,211)
Other payments - -
Net cash flows from operating activities (2,573) (8,293)
Proceeds of sale of assets - 262
Purchases of property, plant and equipment (185) (21)
Purchases of intangible assets (469) -
Net cash flows from investing activities (654) 241
Proceeds of equity and warrants issued 19,375 12,178
Proceeds of convertible bonds issued - 16,023
Repayments of convertible bonds - (4,746)
Payments of transaction fees and expenses (697) (1,485)
Payments of finance lease liabilities (682) (881)
Net cash flows from financing activities 17,996 21,089
Increase/(decrease) of cash 14,769 13,037
Exchange rate effects 464 (199)
Cash and cash equivalents at 1 January 19,152 6,314
Total cash at 31 December 34,385 19,152
Of which restricted cash 200 2,184
Cash and cash equivalents at 31 December 34,185 16,968
Contact
Sijmen de Vries, CEO: T: +31-71-524-7400
FTI Consulting
Julia Phillips/ Victoria Foster Mitchell, T:
+44-203-727-1136
PRN NLD