Leiden, The Netherlands, April 26, 2006. Biotech company Pharming Group NV ("Pharming" or "the Company") (Euronext: PHARM) (PHARM.AS) announced today its first quarter (Q1) results for the period ended March 31, 2006. The Company reports on its solid financial position and broadening of its product pipeline.
Key Developments Financial
* EUR 17.1 million raised to develop recombinant human C1 inhibitor (rhC1INH) for new indications * Total costs lower at ¤ 3.7 million compared to ¤ 4.2 million in Q1 2005 * Net loss of ¤ 3.7 million in Q1 2006 * Cash position of ¤ 48.3 million (including marketable securities)
* Clinical development of recombinant human C1 inhibitor (rhC1INH) for hereditary angioedema (HAE) expanded to 25 centers with over 150 patients enrolled * Orphan drug applications for new indications of rhC1INH under review * Filing on human lactoferrin (hLF) for Generally Recognized as Safe (GRAS) notification being reviewed by the Food and Drug Administration (FDA)
* Heads of Agreement to acquire DNage BV ("DNage"), a private company based in the Netherlands * Agreement with affiliates of Paul Royalty Fund II, LP ("Paul Royalty Fund) with a payment of US $15 million and US $5 million in equity * Pharming added to the Euronext Amsterdam Midkap Index (AMX) as of March 2, 2006
"In the first quarter 2006, Pharming attained a solid cash position with well controlled costs and expenses," said Dr. Francis J. Pinto, CEO of Pharming. "The Company is on the way to achieving its growth targets through the broadening of its technology platforms and product pipeline."
Financial In Q1 2006, total revenues of ¤ 0.1 million were in line with revenues during the same period in 2005. Revenues in Q1 2006 have been generated from government grants and subsidies. The total costs and expenses were lower in Q1 2006 (including ¤ 0.3 million IFRS 2 based costs) at ¤ 3.7 million compared to ¤ 4.2 million in Q1 2005. The costs incurred in the first quarter of 2006 were mainly related to operations, research and development and SG&A. Including interest and foreign currency results, the net loss of Pharming in Q1 2006 was ¤ 3.7 million compared to a net loss of ¤ 3.9 million in Q1 2005. Net cash used for operating activities in Q1 2006 was ¤ 6.0 million, reflecting investments made in rhC1INH inventories. Further information on IFRS 2 share based compensation and other financial items are presented in the notes to the financial statements.
Pharming raised over ¤ 30 million through a share placement with institutional investors and an agreement with Paul Royalty Fund. Pharming received an additional ¤ 2.1 million in cash from exercise of warrants and employee options in early 2006. The cash position, including marketable securities, was ¤ 48.3 million as of March 31, 2006 in comparison to ¤ 20.3 million at the end of 2005. With the successful completion of key financial transactions, the equity position of the Company improved to ¤ 48.8 million from ¤ 28.7 million at the end of 2005. Total liabilities were ¤ 15.3 million compared to ¤ 5.8 million at December 31, 2005, which include amounts to be paid to Paul Royalty Fund in the future.
Product Development Pharming confirmed the positive outlook for its lead product, recombinant human C1 inhibitor in Phase III clinical trials for the treatment of HAE. The clinical results of rhC1INH were presented at an international investigators meeting in Paris with participation of over 25 clinical centers from Europe, the USA, and Canada.
The Company has enrolled 150 patients in its randomized double-blind placebo controlled Phase III trials for HAE. Under various clinical studies, Pharming has administered more than 90 infusions of rhC1INH and over 25 patients have been infused with rhC1INH multiple times. HAE patients treated with rhC1INH in clinical studies showed rapid time to beginning of relief between fifteen minutes to two hours and time to minimal symptoms typically within twelve hours.
Pharming has submitted orphan drug applications with rhC1INH for new indications beyond HAE. The Company is initiating studies with rhC1INH on specific inflammatory and cardiovascular indications. In addition, Pharming has filed the hLF dossier for GRAS notification with the FDA at the end of 2005. The Company expects to provide further information on these developments in the first half of 2006.
Corporate Pharming signed a Heads of Agreement to acquire DNage BV, a privately held company based in Rotterdam, the Netherlands, focused on discovery and development of products for ageing diseases and cancer. The acquisition of DNage will enable Pharming to broaden its product pipeline and patent portfolio through new innovative programs in the areas of osteoporosis, neurodegeneration (brain diseases), metabolic diseases (type II diabetes) and genetic diseases (premature ageing).
Pharming formed a strategic financial partnership with Paul Royalty Fund valued at US $30 million on rhC1INH for the treatment of HAE. 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 USA.
Pharming was included in the Euronext Amsterdam Midkap Index as of March 2, 2006. The AMX Index is composed of the top 25 actively traded mid cap companies on Euronext Amsterdam. The companies in the AMX Index are selected based on turnover value of shares for the full year 2005.
Background on Pharming Group N.V. Pharming Group N.V. is developing innovative protein products for unmet needs. The Company's products include potential treatments for 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 (Phase III) and recombinant human lactoferrin for use in functional foods. 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.
Carina Hamaker Sarah MacLeod Samir Singh Investor Voice Financial Dynamics Pharming Group N.V. T: +31 (0)6 537 49959 T: +44 (0)20 7269 7148 T: +1 908 720 6224 T: +31 (0)71 524 7431 T: +44 (0)7747 602 739 T: +1 800 333 1476
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