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Pharming Group (PHGUF.PK) Reports On Financial Results First Half Year 2014

7/31/2014 9:12:58 AM

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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.


? 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.”

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 USA, Israel, all 27 EU countries plus Norway, Iceland and Liechtenstein. RUCONEST® is distributed in the EU by Swedish Orphan Biovitrum. RUCONEST® is partnered with Salix Pharmaceuticals Inc. (NASDAQ: SLXP) in North America. The product is also being evaluated for various 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. In July 2013, the platform was 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 rhFVIII for the treatment of Haemophilia A. Additional information is available on the Pharming website;

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.

Contact Sijmen de Vries, CEO: T: +31 71 524 7400

FTI Consulting
Julia Phillips/ John Dineen, T: +44 203 727 1136

Conference call information
Today, Chief Executive Officer Sijmen de Vries will discuss the first half 2014 results in a conference call for 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 7784 1036
From Belgium: +32(0)2 400 6864
From France: +33(0)1 76 77 22 30
From Germany: +49(0)69 2222 10620
From Switzerland: +41(0)22 567 5432

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