LEIDEN, The Netherlands, March 5, 2015
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.
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."
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 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.
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.
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).
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.
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.
For 2015, the Company expects:
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
Sijmen de Vries, CEO: T: +31-71-524-7400
Julia Phillips/ Victoria Foster Mitchell, T: +44-203-727-1136
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