Pharming Announces First Half 2006 Results
Reports on solid cash position and progress on rhC1INH submissions
Leiden, The Netherlands, August 4, 2006. Biotech company Pharming Group NV (“Pharming” or “the Company”) (Euronext: PHARM) (PHARM.AS) announced today its results for the first half (HY1) of 2006 and second quarter ended June 30, 2006. The Company reports on its solid financial position and progress with regulatory submissions for recombinant human C1 inhibitor (rhC1INH).
# Cash position of € 41.6 million (including marketable securities) as of June 30, 2006
# € 17.1 million in equity to develop rhC1INH for new indications and other corporate purposes
# US $15 million in cash and US $5 million in equity raised from affiliates of Paul Royalty Fund II, LP (“Paul Royalty Fund”)
# Inventories increased to € 7.7 million from € 3.9 million in preparation for rhC1INH launch
# Total costs and expenses were € 8.1 million in HY1 2006 compared to € 8.8 million in HY1 2005
# Net loss of € 8.1 million in HY1 2006 compared to € 8.2 million in HY1 2005
# Marketing Authorization Application (MAA) for rhC1INH submitted to the European Medicines Agency (EMEA) for the treatment of acute attacks of hereditary angioedema (HAE)
# Discussion with regulatory authorities ongoing for the compassionate use of rhC1INH
# Fast Track designation on rhC1INH for the treatment of HAE from the US Food and Drug Administration (FDA)
# Orphan Drug designations for rhC1INH for treatment of two additional indications (Delayed Graft Function after solid organ transplantation and Capillary Leakage Syndrome) beyond HAE granted by the FDA
# Filing on human lactoferrin (hLF) for Generally Recognized as Safe (GRAS) notification under review with the FDA
# Strategic agreement with Paul Royalty Fund on the development of rhC1INH
# Acquisition of DNage BV (“DNage”) pending the outcome of the appeal at the Enterprise Section in Amsterdam
# Pharming added to the Euronext Amsterdam Midkap Index (AMX) as of March 2, 2006
“Pharming has achieved significant milestones with the submission of the MAA for rhC1INH with the EMEA, the Fast Track designation on rhC1INH for HAE and Orphan Drug designations on rhC1INH for new indications from the FDA,” said Dr. Francis J. Pinto, CEO of Pharming. “In the first half of 2006, Pharming attained a solid cash position through key transactions and well controlled costs and expenses.”
In the first half of 2006, total costs and expenses were € 8.1 million compared to € 8.8 million in HY1 2005. The costs of operations decreased by € 1.0 million compared to the first half of 2005 due to non-recurring costs of the agreement with Diosynth BV (“Diosynth”). Net cash used for operating activities in HY1 2006 was € 10.8 million, including investments made on rhC1INH inventories. In the first half of 2006, the Company also paid € 1.3 million for investments in property, plant and equipment. This amount primarily relates to investments in the new office building to which Pharming will move in the second half of the year. Including interest and foreign currency results, the net loss of Pharming in HY1 2006 was € 8.1 million compared to a net loss of € 8.2 million in HY1 2005.
Pharming raised over € 30 million through a share placement with institutional investors and an agreement with Paul Royalty Fund. The cash position, including marketable securities, was € 41.6 million as of June 30, 2006 in comparison to € 20.3 million at the end of 2005. Pharming has further built up its inventories by € 3.8 million, including commercial supply of rhC1INH in preparation for launch. The equity position of the Company improved to € 44.2 million from € 28.7 million at the end of 2005. Total liabilities were € 15.9 million compared to € 5.8 million at December 31, 2005, which include amounts to be paid to Paul Royalty Fund in the future.
Pharming submitted the Marketing Authorization Application for its lead product, recombinant human C1 inhibitor, for the treatment of acute attacks of HAE to the EMEA. The data from preclinical and clinical studies reinforce rhC1INH’s safety and effectiveness with rapid and sustained relief for patients with acute attacks of HAE - a rapid time to beginning of relief (typically less than 2 hrs) and time to minimal symptoms (typically less than 12 hrs). Recently, Pharming also received Fast Track designation on rhC1INH for the treatment of HAE from the FDA.
Pharming is committed to providing a highly effective therapy for patients living with the burden of hereditary angioedema. Several countries have specific legislation for compassionate use to make products available in a quick and efficient manner for patients with unmet medical needs. The discussion with regulatory authorities on the compassionate use of rhC1INH is ongoing and is expected to rapidly provide rhC1INH for HAE patients in markets with limited treatment options.
Pharming’s rhC1INH product has Orphan Medicinal Product designation for HAE in Europe and Orphan Drug designation in the US, which provides a certain period of market exclusivity for an approved product. Pharming also received Orphan Drug designation from the FDA for two other indications beyond HAE - the prevention and/or treatment of Delayed Graft Function after solid organ transplantation and the treatment of Capillary Leakage Syndrome.
Pharming’s position to commercialize rhC1INH for HAE and other indications was further strengthened with the issuance of a US patent covering the production of rhC1INH in milk of transgenic mammals as well as its use in the treatment of patients suffering from or susceptible to C1 inhibitor deficiency. With Pharming’s intellectual property position, its Orphan Drug designations, the agreement with Paul Royalty Fund and the secured large scale commercial production of rhC1INH through its collaboration with Diosynth, Pharming is in a strong position to complete the final stages towards commercialization of its lead product rhC1INH.
Pharming is developing its lactoferrin product for use as an ingredient in functional foods. The hLF dossier for GRAS notification, which was filed with the FDA at the end of 2005, is under review. The research on recombinant human fibrinogen with the US Army and the research on combination products with NovaThera is ongoing. The Company will provide an update on the progress being made with these products when specific milestones have been achieved.
Pharming formed a strategic financial partnership with Paul Royalty Fund for US $30 million on the development of rhC1INH and other corporate purposes. Under the terms of the agreement, Pharming has received an upfront payment of US $20 million. This amount consists of US $15 million for the Company’s development work on rhC1INH to date and the continued development and commercialization of rhC1INH products, as well as a US $5 million equity investment. Pharming is also eligible to receive up to US $10 million in milestone payments based on the achievement of FDA approval and the commercial launch of rhC1INH in the US.
Earlier this year, Pharming signed a heads of agreement to acquire DNage, a privately held biopharmaceutical company based in Rotterdam, the Netherlands, developing products for medical and health problems associated with ageing. The acquisition process was delayed based on the appeal of the Works Council of Pharming at the Enterprise Section. Pharming is awaiting the decision from the Enterprise Section and will provide an update on the acquisition at that time. The acquisition of DNage will give access to a highly innovative technology platform and products for several new markets such as metabolic diseases, like type II diabetes and genetic diseases, such as premature ageing.
Pharming was included in the Euronext Amsterdam Midkap Index as of March 2, 2006, based on turnover value of its shares for the full year 2005. The AMX Index is composed of the 25 most actively traded mid cap companies on Euronext Amsterdam.
Background on Pharming Group NV
Pharming Group NV is developing innovative protein products for the treatment of genetic disorders, specialty products for surgical indications, intermediates for various applications and food products. Pharming has two products in late stage development - recombinant human C1 inhibitor for hereditary angioedema (MAA submitted to EMEA) and human lactoferrin for use in functional foods (GRAS notification filed with FDA). The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, as well as technology and processes for the purification and formulation of these products. 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. The press release also appears in Dutch. In the event of any inconsistency, the English version will prevail over the Dutch version.
Click here to download the full press release: www.pharming.com/index.php?act=dl&file=060804_hy1_results_2006_eng.pdf
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- Samir Singh
- Pharming Group NV (US)
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