Earnings Release • Mar 6, 2014
Earnings Release
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Leiden, The Netherlands, 6 March 2014. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its preliminary (unaudited) financial results for the year ended 31 December 2013.
The European Medicines Agency (EMA) provided approval for Sanofi Chimie, Pharming's Contract Manufacturing Organization partner, to manufacture drug substance for Pharming's product Ruconest® at their Aramon (France) site. This has allowed Pharming to leverage the manufacturing process for Ruconest, completing an important upscaling of the production capacity that will allow for future significant economies of scale. This represents a significant competitive advantage over the manufacturers of plasma- (blood) derived products, which are dependent on blood donations.
A significant downsizing of the Dutch operations was implemented, following from a strategic re-emphasis on collaborative development efforts and out- sourcing of non- core activities, leading to significant reductions in operating expenses. At year- end 2013, the organization consisted of 40 FTE's (69 at YE 2012).
Sijmen De Vries, Chief Executive of Pharming commented: "2013 was a year of considerable progress for Pharming during which great strides forward were made on a number of important fronts, particularly the submission and subsequent receipt of acceptance for review of the Ruconest BLA by the FDA, and the receipt of EMA approval for the up-scaled downstream manufacturing process at Sanofi Chimie. Both achievements are important steps towards the future profitable commercialization of Ruconest, as well as the stabilization and strengthening of the balance sheet. Once achieved, the stabilized balance sheet, in combination with our signifantly reduced costs base will form the platform from which Pharming can achieve self sustaining profitability and develop a new pipeline through collaborative product development with partners.
In the year 2013 the Company generated revenue from continuing operations of €7.0 million (2012: €10.6 million). 2012 included receipt of a €7.9 million milestone from our US partner Santarus for successful completion of study 1310 while 2013 included a €3.8 milestone from Santarus for acceptance for review of the BLA for Ruconest by the US FDA. Costs of revenues amounted to €1.1 million (2012: €4.3 million) with impairments on inventories amounting to €0.5 million (2012: €3.1 million). Other income related to grants exclusively and decreased to €0.1 million in 2013 from €0.3 million in 2012.
Total operating costs decreased by €11.3 million from €24.1 million in 2012 to €12.8 million in the same period of 2013. The decrease is a result of the combined effect of reduced costs for clinical studies, cost reductions following the reorganization that was completed in the first half of 2013, reduced inventory impairments and implementation of stringent cost control measures.
In January 2013 the Company issued €16.35 million convertible bonds plus 16,349,999 warrants. The bonds had to be repaid in seven monthly installments and could be settled in cash and/or in shares. The bonds have been fully repaid in 2013; five installments plus interest were repaid in shares with the number of shares based on volume weighted average price during a reference period minus a discount and two installments plus interest in cash. With regard to these payments, the Company issued a total of 127,369,529 shares. Total costs associated with these bonds amounted to €7.7 million.
The 2013 net loss on financial income and expenses of €7.9 million compared to a €6.6 million net loss on financial income and expenses in 2012. The 2013 financial expenses included settlement losses of the convertible bonds in the amount of €4.6 million, 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 €14.8 million in 2013 (2012: €24.1 million). The net loss per share for 2013 amounted to €0.070 (2012: €0.330).
Total cash and cash equivalents (including restricted cash) increased by €12.9 million from €6.3 million at year end 2012 to €19.2 million at the end of 2013. The increase follows from net cash outflows from operations of €8.3 million with net cash inflows from financing activities amounting to €21.1 million and net cash inflows from investing activities amounting to €0.2 million. Net cash flows from financing activities mainly follow from the €16.35 million convertible bond transaction of January 2013 and the October 2013 equity issue of €12.0 million.
The equity position amounted to €5.0 million positive at year-end 2013, the first time the Company reports a positive equity since the end of 2011. At year-end 2012, the negative equity position amounted to €7.7 million.
Pharming continues to review its financial and liquidity position with the aim to further improve its equity standing under International Financial Reporting Standards (IFRS). Notably, the Company reports that the negative equity position at the end of 2011 was mainly caused by the inability to recognize the €19.7 million upfront payments and milestones received from Sobi and Santarus as equity (at 31 December 2013 the deferred license fees income amounted to €14.4 million).
On 28 February 2013, a 10:1 reverse split was approved by Pharming's AGM. All share numbers have been adjusted retro-actively to reflect this reverse split. The number of outstanding shares as of today, 6 March 2014, is 373,499,285 and the fully diluted number of shares is 390,785,449. This increase results from exercises of warrants which has provided the Company with an additional €4.2 million of cash in 2014. The number of remaining warrants outstanding as of 6 March 2014 is 8,460,733.
Today, Chief Executive Officer, Sijmen de Vries, will discuss the full year 2013 results in a conference call at 09:30am (CET). To participate, please call one of the following numbers 10 minutes prior to the call:
| From the Netherlands: | +31 (0) 45 631 6902 |
|---|---|
| From the UK: | +44 (0) 207 153 2027 |
| From Belgium: | +32 (0) 2 290 1401 |
| From France: | +33 (0) 1 70 99 3515 |
| From Germany: | +49 (0) 61 03 485 3001 |
| From Switzerland: | +41 (0) 22 5927312 |
Conference ID: 4673419
For the year ended 31 December
| Amounts in €'000 | 2013 | 2012 |
|---|---|---|
| Intangible assets | 405 | 535 |
| Property, plant and equipment | 6,228 | 7,128 |
| Restricted cash | 176 | 732 |
| Non-current assets | 6,809 | 8,395 |
| Inventories | 4,763 | 2,101 |
| Assets held for sale | - | 242 |
| Trade and other receivables | 860 | 524 |
| Restricted cash | 2,008 | 309 |
| Cash and cash equivalents | 16,968 | 5,273 |
| Current assets | 24,599 | 8,449 |
| Total assets | 31,408 | 16,844 |
| Share capital | 3,347 | 10,092 |
| Share premium | 254,684 | 231,866 |
| Other reserves | 14,873 | 14,144 |
| Accumulated deficit | (267,891) | (263,754) |
| Shareholders' equity | 5,013 | (7,652) |
| Deferred license fees income | 12,222 | 13,495 |
| Finance leases liabilities | 1,207 | 1,961 |
| Other liabilities | 44 | 72 |
| Non-current liabilities | 13,473 | 15,528 |
| Deferred license fees income | 2,200 | 1,936 |
| Derivative financial liabilities | 4,144 | 1,215 |
| Restructuring provision | - | 1,232 |
| Trade and other payables | 5,812 | 3,690 |
| Finance lease liabilities | 766 | 895 |
| Current liabilities | 12,922 | 8,968 |
| Total equity and liabilities | 31,408 | 16,844 |
| Amounts in €'000 | 2013 | 2012 |
|---|---|---|
| Continuing operations: | ||
| License fees Product sales Revenues Costs of product sales Inventory impairments Gross profit/(loss) |
5,903 941 6,844 (533) (579) 5,732 |
9,815 798 10,613 (1,126) (3,141) 6,346 |
| Income from grants Other income |
106 106 |
250 250 |
| Research and development General and administrative Impairment charges Share-based compensation Costs |
(9,849) (2,171) - (730) (12,750) |
(19,350) (3,080) (1,257) (370) (24,057) |
| Loss from operating activities | (6,912) | (17,461) |
| Fair value gain derivatives Financial income |
208 208 |
1,283 1,283 |
| Effective interest convertible bonds Settlement convertible bonds |
(3,178) (4,555) |
(2,353) (2,757) |
| Result equity working capital facility Recycling equity translation reserve Other interest expenses, net Foreign currency results Other financial expenses Financial expenses |
- - (107) (214) (82) (8,136) |
(673) (1,384) (242) (218) (288) (7,915) |
| Net loss from continuing operations | (14,840) | (24,093) |
| Net profit from discontinued operations | - | - |
| Net loss | (14,840) | (24,093) |
| Attributable to: Net loss from continuing operations Net profit from discontinued operations Owners of the parent |
(14,840) - (14,840) |
(24,093) - (24,093) |
| Share information: Weighted average shares outstanding |
213,007,959 | 72,977,269 |
| Basis loss per share (€), of which: From continuing operations (€) |
(0.070) (0.070) |
(0.330) (0.330) |
| Amounts in €'000 | 2013 | 2012 |
|---|---|---|
| Receipts from license partners | 5,626 | 9,069 |
| Receipt of Value Added Tax | 882 | 1,163 |
| Interest received | 49 | 18 |
| Receipt of grants | 145 | 72 |
| Other receipts | 300 | 829 |
| Payments of third party fees and expenses, including Value Added Tax Net compensation paid to (former) board members and (former) |
(9,948) | (14,941) |
| employees | (3,136) | (3,285) |
| Payments of pension premiums, payroll taxes and social | ||
| securities, net of grants settled | (2,211) | (2,983) |
| Other payments | - | (212) |
| Net cash flows used in operating activities | (8,293) | (10,270) |
| Proceeds of sale of assets | 262 | 722 |
| Purchase of property, plant and equipment | (21) | (614) |
| Deconsolidation of DNage | - | - |
| Net cash flows from/(used in) investing activities | 241 | 108 |
| Proceeds of equity and warrants issued | 12,178 | 5,340 |
| Proceeds of convertible bonds issued | 16,023 | 8,000 |
| Repayments of convertible bonds | (4,746) | - |
| Payments of transaction fees and expenses | (1,485) | (931) |
| Payments of finance lease liabilities | (881) | (838) |
| Net cash flows from financing activities | 21,089 | 11,571 |
| Increase/(decrease) of cash | 13,037 | 1,409 |
| Exchange rate effects | (199) | (160) |
| Cash and cash equivalents at 1 January |
6,314 | 5,065 |
| Cash and cash equivalents at 31 December | 19,152 | 6,314 |
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