Halfjaarcijfers 2014.
Pharming Reports On Financial Results First Half Year 2014
Leiden, The Netherlands, 31 July 2014. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the six months ended 30 June 2014.
FINANCIAL HIGHLIGHTS
•Revenues and other income decreased to €2.5 million (1H 2013: €4.9 million). This reflects last year’s receipt of a one-off US$5 million payment by our US partner Santarus (now Salix Pharmaceuticals: NASDAQ: SLXP “Salix”). Revenues from product sales increased to €1.4 million (1H 2013: €0.2 million).
•Operating costs remained constant at €6.2 million (1H 2013: €6.3 million).
•Loss from operating activities increased by €4.0 million to €5.4 million, predominantly as a result of the receipt of the US$5 million milestone in 2013.
•Net financial (non-cash) expenses amounted to €14.8 million (1H 2013: €6.8 million). The increase is a result of the revaluation of our warrants caused by the strong increase of our share price during 1H 2014. For more details on this, please refer to Note 10 on page 15 of the (attached) condensed consolidated interim financial statements for 1H 2014.
•Total net loss (financial expenses and loss from operating expenses) increased by €12.9 million to €20.1 million (1H 2013: €7.2 million), mainly as result of the increased (non-cash) financial expenses.
•Cash at the end of the first half of 2014 increased to €26.4 million (2013 FY: €19.2 million).
•The equity position increased from €5.0 million at year end 2013 to €12.2 million, mainly as a result of the private equity placement of net €14.0 million in April 2014 and the exercise of warrants.
•The total number of shares as of today, 31 July 2014 is 407,053,249.
OPERATIONS
•Our Israeli commercialization partner, MegaPharm Ltd (MegaPharm), received marketing approval for Ruconest® (recombinant human C1 inhibitor) for the treatment of angioedema attacks in patients with hereditary angioedema (HAE) in Israel.
•The US Food and Drug Administration (FDA) extended the Ruconest® BLA Prescription Drug User Fee Act (PDUFA) Action Date by three months to July 16, 2014
POST-PERIOD HIGHLIGHT
•On July 16, 2014, the US FDA approved Ruconest® for the treatment of angioedema attacks in patients with hereditary angioedema (HAE). A US$20 million milestone payment from Salix will become payable upon the first commercial sale of Ruconest® in the US.
Sijmen de Vries, Chief Executive Officer of Pharming commented: “Earlier this month we announced the US FDA approval for Ruconest®, the first and only recombinant protein replacement therapy for the treatment of acute attacks of angioedema in patient with HAE. Inhibition of C1 esterase is the gold standard for HAE treatment and our US pivotal phase III study has confirmed that Ruconest® demonstrates best-in-class efficacy and the cleanest safety profile of all other treatment options. The approval represents an important addition to the available treatment options for the US HAE patient population and the most significant achievement to date for Pharming. We are now working intensively with our US partner Salix to make Ruconest® available to US HAE patients as soon as feasible. Ahead of that, during the first six months of 2014 we focused on preparing for US market entry by investing in building up inventories of Ruconest®, such that we can now benefit from receiving 30% of net sales of Salix for the supply of Ruconest® in the US. In addition, in April, we strengthened the balance sheet with a “sub-10%” private placement to institutional investors that yielded €14.7 million which ensured that we can now also co-invest to develop our main asset Ruconest® for additional indications, such as Prophylaxis of HAE and, in addition, evaluate options to get directly involved in commercialization activities in certain markets.”.
FINANCIAL RESULTS
In the first half year of 2014, the Company generated revenue from sales of Ruconest® of €1.4 million and deferred licensing fees of €1.1 million, totaling to €2.5 million (1H 2013: €4.9 million). The increase in revenue from sales reflects the underlying increased demands for Ruconest® in the EU markets, compared to 1H 2013. Costs of revenues amounted to €1.4 million (2013: €nil). Impairments of inventories amounted to €0.4 million, reflecting the low yield from EU sales in combination with the current cost of manufacturing, absent economies of scale.
Loss from operating activities increased to €5.4 million (1H 2013 €1.4 million), predominantly as result of the receipt of the one-off milestone payment of US$5 million in 2013.
Financial income and expenses increased to €14.7 million (1H 2013: €5.9 million), as a result of the (non-cash) increase of the fair value of our outstanding warrants, reflecting the increase of our share price in 1H 2014; while the 1H 2013 costs were related to the €16.35 million convertible bond.
As a result of the above items, the net loss for the first half year of 2014 increased to €20.1 million from €7.2 million in the same period of 2013.
Cash outflows from operations increased by €3.5 million to €11.0 million in 1H 2014 (1H 2013: €7.5 million), mainly as result of the increase in manufacturing activities for Ruconest®, ahead of the anticipated US launch in 2H 2014.
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased to €26.4 million at 30 June 2014 from €19.2 million at year end 2013. The increase follows from net cash outflows from operations of €11.0 million with net cash inflows from financing activities amounting to €19.1 million and net cash outflows from financing activities amounting to €0.8 million. Financing cash inflows mainly result from the proceeds of the private equity placement of €14.7 million and the 2013 exercise of warrants which yielded €4.4 million in cash.
EQUITY POSITION
The equity position increased by €7.2 million versus year-end 2013 (€5.0 million) to €12.2 million (1H 2013: €0.6 million negative).
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 30 June 2014 the deferred license fees income amounted to €13.3 million).
The number of outstanding shares as of today, 31 July 2014, is 407,053,249 and the fully diluted number of shares is 465.6 million
FINANCIAL GUIDANCE 2014
Following the recent FDA approval for Ruconest®, Pharming expects the receipt of a US$20 million milestone from Salix on first commercial sale of Ruconest® in the USA during 2H 2014.
Pharming expects revenues from Ruconest® (not including US sales) of €3.0 million.
No additional financial guidance is provided.