LEIDEN, Netherlands, Aug. 19, 2005 (PRIMEZONE) -- Biotech company Pharming Group N.V. ("Pharming" or "the Company") (Euronext:PHARM) (PHARM.AS) (Other OTC:PHGUF) announced today its results for the first half (H1) of 2005 and second quarter ended June 30, 2005.
Key Developments First Half of 2005
Financial
-- Strong cash position of 24.7 million (including marketable
securities) as of June 30, 2005
-- Net loss of 9.1 million in H1 2005 (including 1.4 million
non-cash IFRS 2 share-based costs)
-- Net cash of 6.5 million used for operating activities in H1
2005
-- 5.7 million raised from exercise of warrants
-- Beneficiary return of over 800,000 shares from the Stichting
Pharming Trust Beheer (Pharming Trust Foundation or SPTB)
Product Development
-- Clinical Trial Application (CTA) approval from Health Canada
for recombinant human C1 inhibitor (rhC1INH)
-- Favorable interim results from Phase II/III clinical trial
with rhC1INH
-- Preparation for Generally Recognized as Safe (GRAS) filing
for recombinant human lactoferrin (rhLF) with the U.S. Food
and Drug Administration (FDA)
-- Investments in product pipeline increased
-- Collaboration on product pipeline with NovaThera Limited
("NovaThera")
Corporate
-- Manufacturing partnership with Diosynth for rhC1INH
-- Milestone payment on rhC1INH clinical development from
Laboratorios del Dr. Esteve, S.A. ("Esteve")
-- Partnership with AgResearch for rhLF and license agreement
(Protein Production Technology)
-- John Pieters appointed as Chief Operating Officer
-- Financial Dynamics and Investor Voice hired to further
strengthen Investor Relations
Financial
In the first half of 2005, total revenues of 0.3 million were in line with revenues during the same period in 2004. Revenues in H1 2005 have been generated mainly from a milestone payment from Esteve, and include a smaller amount of government grants and subsidies. The total costs and expenses in H1 2005 (including 1.4 million non-cash IFRS 2 share-based costs) were 9.7 million compared to 6.8 million in H1 2004. (For a description of IFRS 2, please refer to page 7). The costs in the first half of 2005 reflect the investments made on clinical trials of rhC1INH in Europe as well as North America, commercial supply of rhC1INH with Diosynth Biotechnology, GRAS filing for rhLF, and research and development on product pipeline. Including interest income of 0.3 million, the net loss of Pharming in H1 2005 was 9.1 million compared to a net loss of 6.3 million in H1 2004. Net cash used for operating activities in H1 2005 was 6.5 million.
Pharming raised 5.7 million in cash from the exercise of warrants in the first half of 2005. The Company's cash position, including marketable securities, was 24.7 million as of June 30, 2005 compared to 25.8 million at the end of 2004. The equity position of the Company was 34.8 million compared to 36.2 million at the end of 2004. Total liabilities were 2.4 million compared to 1.6 million at December 31, 2004.
Product Development
In the first half of 2005, Pharming reported favorable results from the open-label Phase II/III clinical trials with rhC1INH to treat hereditary angioedema (HAE). HAE patients treated with rhC1INH showed rapid relief, no adverse events and no relapse of their initial HAE attack.
Pharming has recruited over 150 patients with hereditary angioedema to participate in its clinical trials at over 20 centers. In Europe, the Company is actively working towards completing its multi-center, randomized, double blind, placebo controlled Phase III clinical trials as well as preparing its filing with the European Agency for the Evaluation of Medicinal Products (EMEA) for rhC1INH.
In addition, Pharming will submit treatment results with rhC1INH to specific European markets for a 'compassionate use' designation in order to ensure the rapid availability of rhC1INH for HAE patients. In North America, Pharming has randomized clinical trials with rhC1INH ongoing and has recruited HAE patients at multiple centers.
Pharming has submitted the study results with rhLF for publication and is convening an expert committee in preparation for a GRAS filing with the U.S. FDA. Pharming completed a key study with recombinant human lactoferrin which demonstrates that the oral application of rhLF is safe.
The Company has increased investments for the further development of its product pipeline, including recombinant human fibrinogen and recombinant human collagen. Pharming is also exploring additional opportunities for its product pipeline through its research collaboration with NovaThera. The collaboration takes advantage of the complementary capabilities of products from Pharming and NovaThera and could provide Pharming with several new products. Pharming retains commercial rights to the new products and ownership of the intellectual property developed in the collaboration.
Corporate
Pharming and Akzo Nobel's business unit, Diosynth Biotechnology, signed a commercial supply agreement for the production of rhC1INH. Working together on technology transfer and scale-up, the companies have produced consistency batches of rhC1INH required for commercial production. These developments could enable Pharming to prepare for the market introduction of rhC1INH for the treatment of HAE.
Pharming received a milestone payment from Esteve for the clinical development of rhC1INH. Pharming and Esteve have a partnership on the development, marketing and sales of rhC1INH in Spain, Portugal and Greece. The Company intends to execute similar agreements on rhC1INH, based on profit sharing and equitable partnership, for other regional markets and will complete these agreements in such a manner as to maximize value for all stakeholders of Pharming.
Pharming signed an agreement with AgResearch on the development and production of recombinant human lactoferrin. In addition, Pharming granted AgResearch a research license to its protein production technology. AgResearch will be responsible for the production of rhLF. AgResearch shall bear costs associated with the initial production of rhLF and will support the commercialization of the product in the South Pacific and Asia.
Pharming has appointed Mr. John Pieters to the position of Chief Operating Officer. Mr. Pieters has a strong operational track record in biotechnology, medical device and pharmaceutical businesses. He previously served at Amgen, Inc., Sterling Winthrop Europe, and ConvaTec Europe (a subsidiary of Bristol Myers Squibb) and on the Board of Supervisory Directors at Pharming Group N.V. In addition, Financial Dynamics and Investor Voice were hired to further strengthen the investor relations activities of the Company.
Future Outlook
-- Partnerships for product pipeline and technology -- Regulatory filing(s) on rhC1INH for hereditary angioedema -- Clinical development for follow-on indication with rhC1INH -- Product pipeline expansion -- GRAS filing for rhLF
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 has two products in late stage development -- recombinant human C1 inhibitor for hereditary angioedema (Phase III) and recombinant human lactoferrin for nutritional use. 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.
The full report including tables can be downloaded from the following link: