LEIDEN, Netherlands, May 6, 2005 (PRIMEZONE) -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext:PHARM) (PHAR.AS) announced today its first quarter (Q1) results for the period ended March 31, 2005. The Company reported on its strong financial position and progress with its product pipeline development.
Financial
-- 5.7 million raised from exercise of warrants
-- Strong cash position of 27.9 million (including marketable
securities)
-- Total liabilities of less than 2 million
Corporate
-- Manufacturing partnership with Diosynth for recombinant
human C1 inhibitor (rhC1INH)
-- Appointments of key executives and agreement for new office
building
-- Pharming included in the Next 150 Index and Euronext
Amsterdam Small Cap Index
-- Research coverage initiated on Pharming by various
institutions
Products
-- Pharming received CTA approval from Health Canada for rhC1INH
-- Favourable interim results of rhC1INH from Phase II/III open
label clinical trial reported
Financial
In Q1 2005, total revenues of 0.1 million were in line with revenues during the same period in 2004. Revenues in Q1 2005 have been generated from government grants and subsidies. The total costs and expenses in Q1 2005 (including 1.2 million IFRS 2 based costs) were 5.1 million compared to 3.2 million in Q1 2004. The costs incurred in the first quarter of 2005 were mainly related to the clinical trials of rhC1INH and expenses related to commercial supply of rhC1INH with Diosynth Biotechnology. As a result of implementing IFRS 2, Pharming reports (non-cash) costs for share based compensation of 1.2 million for Q1 2005. Including interest income, the net loss of Pharming in Q1 2005 was 4.9 million compared to a net loss of 3.1 million in Q1 2004. Excluding IFRS 2, the net loss would be 3.8 million compared to 3.1 in Q1 2004. Net cash used for operating activities in Q1 2005 was 3.6 million.
Pharming raised an additional 5.7 million in cash from exercise of warrants in early 2005. The cash position, including marketable securities, was 27.9 million as of March 31, 2005 in comparison to 25.8 million at the end of 2004. With the successful completion of key financial transactions, the equity position of the Company improved to 38.4 million from 36.2 million at the end of 2004. Total liabilities were 1.9 million compared to 1.6 million at December 31, 2004.
Corporate
Pharming and Akzo Nobel's biopharmaceutical CMO business, Diosynth Biotechnology, signed a supply agreement for the production of rhC1INH for commercial use. The agreement enables Pharming to prepare for the market launch of rhC1INH for the treatment of hereditary angioedema (HAE). Diosynth Biotechnology's large-scale facility is well suited to supply commercial quantities of rhC1INH. The facility has been FDA inspected and currently produces commercial products.
Pharming strengthened its management team with the addition of key executives in the areas of clinical development and quality assurance. The Company also signed a lease agreement for a new state-of-the-art office and laboratory building in Leiden to allow for the future growth of the Company. Pharming expects the building to be completed and to move during the second half of 2006.
In Q1 2005, research coverage on Pharming has been initiated by several financial institutions, including KBC Securities and Rabo Securities. In addition, Pharming was included in the Euronext Amsterdam small cap index as of March 2, 2005 and the Next 150 Index on Euronext as of April 1, 2005. Products Pharming reported favourable developments from the Phase II/III clinical trials with rhC1INH. The results of treatment with rhC1INH for hereditary angioedema are consistent with those previously reported by the Company. The patients treated with rhC1INH showed rapid time to beginning of relief (typically 15 mins) and time to complete resolution (typically within 24 hrs) as well as favourable evaluation of treatment by both patients and physicians. Treatments with rhC1INH did not elicit any allergic or clinically relevant immune responses. None of the patients treated with rhC1INH in the clinical trials experienced a relapse of the initial HAE attack.
Pharming is conducting a multi-center randomized, double blind, placebo controlled Phase III clinical trial across Europe and North America for rhC1INH to treat hereditary angioedema. The Company was granted an IND by the U.S. FDA to commence clinical trials in the United States in December 2004. In addition, Pharming has initiated pre-clinical studies with rhC1INH for specific cardiovascular and inflammatory diseases to explore follow-on indications beyond HAE. "Pharming aims to increase its revenues through licensing agreements on rhC1INH and its product pipeline," said Dr. Francis J. Pinto, CEO of Pharming. "We are pleased by the progress on the development of rhC1INH, recombinant human lactoferrin and other recombinant products in our pipeline."
Future Outlook
-- Present interim results from Phase II/III clinical trials of
rhC1INH at upcoming meetings
-- Clinical development of rhC1INH in the United States and Canada
-- Publish results of key study with rhLF required for GRAS
approval
-- Partnerships for rhC1INH, pipeline products and production
technology
-- File for rhC1INH approval in Europe
-- File for GRAS approval for rhLF in the USA
The full report including tables can be downloaded from the following link: http://hugin.info/132866/R/993112/150080.pdf
Background on Pharming Group N.V.
Pharming Group N.V. is developing innovative protein therapeutics for unmet medical needs. The Company's products include potential treatments for genetic disorders, medical and specialty products for surgical indications, and intermediates for various applications. Pharming's lead product (recombinant human C1 inhibitor) for hereditary angioedema is in Phase III of clinical development. 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.