LEIDEN, Netherlands, Nov. 3, 2005 (PRIMEZONE) -- Highlights: upcoming product filings, licensing progress and pipeline expansion. Pharming Group N.V. ("Pharming" or "the Company") (Euronext: PHARM) (PHARM.AS) announced today its financial results for the third quarter of 2005 and for the first nine months ended September 30, 2005. The Company highlighted upcoming product filings for recombinant human C1 inhibitor (rhC1INH) and its human lactoferrin product (rhLF), licensing progress and its pipeline expansion.
Key Developments First Nine Months of 2005 Financial
- Strong cash position of Eur 23.7 million (including marketable
securities) as of September 30, 2005
- Net loss of Eur 12.7 million in the first nine months of 2005
(including non-cash IFRS 2 share-based costs)
- Investments made in the filings for rhC1INH and rhLF, product
development and manufacturing
- Net cash of Eur 9.0 million used for operating activities in
the first nine months of 2005
- Eur 7.7 million cash raised from exercise of warrants
Product Development
- Finalizing the first filing of rhC1INH for hereditary
angioedema (HAE) in Europe by 2005
- Submission of orphan drug applications with rhC1INH for new
indications
- Preparing for Generally Recognized as Safe (GRAS) filing for its
human lactoferrin with the US Food and Drug Administration (FDA)
- Recombinant human fibrinogen (rhFIB) selected for US Army funded
project
- Collaboration on product pipeline with NovaThera Limited
("NovaThera")
Corporate
- Manufacturing partnership with Diosynth for rhC1INH completed
successfully
- Patent on rhLF granted from the Japanese Patent Office
- Partnership with AgResearch for rhLF and license agreement on
Protein Production Technology
- Milestone payment on rhC1INH clinical development from Laboratorios
del Dr. Esteve, S.A. ("Esteve")
- John Pieters appointed as Chief Operating Officer
Financial In the first nine months of 2005, total revenues were Eur 0.4 million compared to Eur 0.6 million during the same period in 2004. The total costs and expenses in the first nine months of 2005 (including Eur 1.6 million non-cash, share-based compensation) were Eur 13.6 million compared to Eur 11.3 million in the first nine months of 2004. The costs in the first nine months of 2005 reflect the investments made on the upcoming filings for rhC1INH and rhLF, clinical trials of rhC1INH in Europe as well as North America, commercial supply of rhC1INH with Diosynth Biotechnology, research and development of product pipeline and upgrading of its production facility for rhC1INH. Including interest income of Eur 0.5 million, the net loss of Pharming in the first nine months of 2005 was Eur 12.7 million compared to a net loss of Eur 10.3 million in the first nine months of 2004. Net cash used for operating activities in the first nine months of 2005 was Eur 9.0 million compared to Eur 7.3 million in 2004.
Pharming raised Eur 7.7 million in cash from the exercise of warrants in the first three quarters of 2005, including Eur 2 million from European Bioscience Investments, Ltd. The Company's cash position, including marketable securities, was Eur 23.7 million as of September 30, 2005 compared to Eur 25.8 million at the end of 2004. The equity position of the Company was Eur 33.5 million compared to Eur 36.2 million at the end of 2004. Total liabilities were Eur 2.6 million compared to Eur 1.6 million at December 31, 2004.
Product Development
Pharming is preparing to develop rhC1INH for new indications beyond hereditary angioedema. In addition, the Company will submit orphan drug applications with rhC1INH for specific indications. The use of rhC1INH could provide significant therapeutic benefit for cardiovascular and inflammatory diseases.
Pharming expects to submit its first European filing on rhC1INH for HAE in 2005. The Company aims to rapidly complete its Pan-European filing thereafter, including the filing with EMEA and in the second half of 2006 file with the FDA. Production of the three validation batches for commercial manufacturing has been completed and the manufacturing dossier is ready in anticipation of the upcoming filings on rhC1INH.
Pharming expects to submit its GRAS filing on rhLF to the US FDA by year end. The Company has completed a large panel of toxicology studies with rhLF required to obtain GRAS status. The results demonstrated that rhLF can be considered safe for its intended use.
Pharming's recombinant human fibrinogen has been selected for use in a US Army funded project focusing on the development of fibrin bandages. In addition, the Company is exploring additional opportunities for its product pipeline through its research collaboration with NovaThera.
"Pharming is at the threshold of a major advancement with its regulatory filings for rhC1INH and rhLF," said Dr. Francis J. Pinto, CEO of Pharming. "The Company is poised for the next phase of rapid growth, including through upcoming licensing transactions and strategic alliances."
Corporate Pharming expects to execute licensing agreements on rhC1INH as well as to strengthen its product pipeline. The outcome of these licensing agreements is expected soon and should strengthen the financial position of the Company.
Pharming previously received a milestone payment for the clinical development of rhC1INH from Esteve. 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 for other regional markets in a manner to maximize value for all stakeholders of Pharming.
Pharming was granted a patent on rhLF from the Japanese Patent Office, which covers the production and purification of the product as well as its use in food formulations. In addition, Pharming signed an agreement with AgResearch on the development and production of rhLF.
The organization has been strengthened to facilitate the growth of the Company in 2006, notably in product development and manufacturing. Pharming has strengthened its management team with the appointment of Mr. John Pieters to the position of Chief Operating Officer. Recently, the Company appointed Mr. Wim J. E. Burgemeestre as Head of Finance and Administration.
Future Outlook
- Partnerships for product pipeline, technology and rhC1INH licensing - Filing(s) on rhC1INH for hereditary angioedema - Clinical development for follow-on indications with rhC1INH - Product pipeline expansion - GRAS filing for rhLF with the US FDA
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 food 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: http://hugin.info/132866/R/1019431/160308.pdf