SOURCE: Pharming Group N.V.

April 20, 2007 01:08 ET


LEIDEN, NETHERLANDS -- (MARKET WIRE) -- April 20, 2007 --

Leiden, The Netherlands, April 20, 2007. Biotech company Pharming Group NV ("Pharming" or "the Company") (Euronext: PHARM) announced today its financial first quarter (Q1) results for the period ended March 31, 2007.

Key Developments in first quarter 2007


* Cash position of EUR 26.2 million (including marketable securities) at March 31, 2007 (EUR 31.1 million at December 31, 2006)

* Equity at March 31, 2007 of EUR 45.2 million (EUR 49.8 million at December 31, 2006)

* Net cash of EUR 4.7 million used in operating activities in Q1 2007 compared to EUR 5.9 million in Q1 2006

* Revenues of EUR 0.2 million (EUR 0.1 million in Q1 2006)

* Total costs and expenses EUR 4.8 million in Q1 2007 (EUR 3.7 million in Q1 2006)

* Total net loss of EUR 5.0 million in Q1 2007 (EUR 3.7 million in Q1 2006)


* Adjustment Board of Management (BOM)

* Focus on commercial development and strengthening of commercial development team

* Inclusion in Euronext Amsterdam Small Cap index as of March 2, 2007

* Pharming's Annual General Meeting of Shareholders (AGM) to be held on May 23, 2007

"In the first quarter of 2007, Pharming continued its preparations for market authorization of Rhucin® in Europe and strengthened its focus on commercial development," said Dr. Francis J. Pinto, CEO of Pharming. "We are working hard towards succesfull completion of the regulatory review process for our first products later this year. We are confident that our efforts will also form the basis for strengthening our product portfolio and expanding our research engine."


Pharming's cash position, including marketable securities, was EUR 26.2 million at March 31, 2007 in comparison to EUR 31.1 million at the end of 2006. The equity position of the Company was EUR 45.2 million compared to EUR 49.8 million at the end of 2006. Current liabilities were EUR 10.2 million compared to EUR 9.2 million at December 31, 2006. Total non-current assets were EUR 36.7 million, almost identical to December 31, 2006. Total cash used for operating activities in the first quarter amounted to EUR 4.7 million compared to EUR 5.9 million in Q1 2006.

The total costs and expenses in Q1 2007 were EUR 4.8 million compared to EUR 3.7 million in Q1 2006. The net loss in Q1 2007 was EUR 5.0 million compared to a net loss of EUR 3.7 million in Q1 2006. Total net loss for Q1 2007 was comparable to the quartely results in the second half of 2006. Costs for Research and Development increased due to expansion of the staff and full recognition of costs associated with DNage research. The remainder of the increase can mostly be attributed to charges made for clinical studies with Rhucin® in Europe and North America and the European filing for Rhucin®. Revenues increased to EUR 0.2 million compared to March 31, 2006, as a result of the partial recognition of grants from SenterNovem and the grant from the FDA's Office of Orphan Products Development.

Product Development

In the first quarter of 2007, Pharming focused its attention on answering the list of questions, received from the EMEA at the end of 2006, related to its Marketing Authorization Application of Rhucin®. Most of the necesssary information has now been collected and the Company expects to file its answers in the second quarter of 2007. Based on the standard schedule, Pharming anticipates EMEA's opinion concerning the MAA of Rhucin® in the second half of 2007. The Company continued to make progress in conducting its randomized placebo controlled clinical study with Rhucin® for HAE in the USA and still expects completion of this study in the course of 2007. A decision from regulatory authorities on compassionate (or named-patient) use of Rhucin® to provide Rhucin® for HAE patients in markets with limited treatment options, is also expected later this year.

Pharming was granted Orphan Drug designation by EMEA for recombinant human C1 inhibitor for prevention of Delayed Graft Function after solid organ transplantation. DGF is a serious medical condition, characterized by non-functioning of the transplanted organ or tissue during the first period after transplantation. Pharming's rhC1INH may provide additional benefits as it acts in a different way than existing treatments. The Company is currently preparing to start clinical studies in the relevant patient groups.

Pharming has submitted a dossier concerning use of hLF in certain foods to the FDA, to obtain its confirmation that such use is GRAS. Pharming is developing hLF for use as an ingredient in advanced nutritional products. Review by the FDA of the dossier has been substantially completed, but is still ongoing due to the fact that hLF is an advanced and innovative product made with a new technology and, therefore, a pioneer product which has not been reviewed to such an extent by the FDA before. The Company expects to receive a response from the FDA regarding its review in the near future.

Early 2007, SenterNovem, an agency of the Dutch Ministry of Economic Affairs, granted two subsidies to Pharming's subsidiary DNage for the development of products in the field of osteoporosis. The grants total just over EUR 1 million and are to be received over a period of three years. Osteoporosis is a skeletal disorder effecting an estimated every one in three women and one in eight men over the age of fifty. The disease is characterized by weakened bones leading to increased risk of fractures and disability.


In March 2007, Pharming announced an adjustment of its Board of Management. With the appointment of Mr. Samir Singh to his new position (President, US Operations) and the decision of Dr. Frank Pieper to leave Pharming as of October 1, 2007, the BOM now consists of Dr. Francis Pinto (Chief Executive Officer), Dr. Rein Strijker (Chief Commercial Officer) and Dr. Bruno Giannetti (Chief Operating Officer). Dr. Pinto is Chairman of the BOM and has the primary responsibility for the long-term strategy of the Company, Dr. Strijker is responsible for all commercial, financial, communication and investor relation activities and Dr. Giannetti is responsible for all operational activities, including clinical development, R&D, regulatory and manufacturing activities.

In the area of commercial development Pharming strengthened its team with the appointments of Mr. Richard Onyett (previous Commercial Director at KuDOS Pharmaceuticals Ltd) and Dr. Tolleiv Trimborn (former Director Commercial Development of DNage). Mr. Singh will be focusing specifically on business development and operational activities in the USA. The Company will continue its discussions with potential licensing partners, in particular in the USA, with the goal to conclude one or more licensing agreements in 2007.

As of March 2, 2007, Pharming was included in the Euronext Amsterdam Small Cap index and removed from the Midkap Index. Pharming's Annual General Meeting of Shareholders will be held at the Company's headquarters in Leiden on May 23, 2007 commencing at 15.00 pm CET. All documentation relating to the AGM, including Pharming's Annual Report 2007, will be available on Pharming's website as of of May 8, 2007.

Background on Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® (recombinant human C1 inhibitor) for hereditary angioedema (MAA under review by EMEA) and human lactoferrin for use in food products (GRAS notification under review by the FDA). The advanced technologies of the Company include innovative platforms for the production of protein therapeutics and technology and processes for the purification and formulation of these products, as well as technologies in the field of tissue repair (via its collaboration with NovaThera) and DNA repair (via its acquisition of DNage). Additional information is available on the Pharming website, and on

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. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.


Anne Louise van Lynden    Rein Strijker
Investor Voice            Pharming Group NV
T: +31 (0)6 543 155 49    T: +31 (0)71 52 47 400
T: +31 (0)71 52 47 400
The full report including tables can be downloaded from the following link:

Q1 Results 2007:

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