•Annual Report 2018 is available for download on the Pharming website today at www.pharming.com/investors/financial-documents
•Printed copies will be available from mid-April upon application to email@example.com
•Pharming also announces a provisional commitment to invest in a minority stake in its fill & finish partner BioConnection BV
Leiden, the Netherlands – 29 March 2019
Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) announces publication of its Annual Report for the financial year ended 31 December 2018. The Company also announces that it has made a provisional commitment to invest up to €1.6 million in cash and convert €2.5 million of prepayments into equity in its fill & finish partner BioConnection BV, which manufactures the final sealed vials of Pharming’s product RUCONEST® from the purified drug substance.
BioConnection BV is a fast-growing profitable private company with a global customer base. To match a growing demand of GMP fill & finish services in the biopharmaceutical market, BioConnection is seeking to expand its manufacturing and production capacity. As one of its largest customers and one which will benefit strongly from the increased capacity in due course, Pharming has agreed to take a minority stake in the company.
Other current shareholders of BioConnection are also supporting the company with additional investments. The investment, which is still subject to agreement on final documentation, is expected to close next week.
Chief Executive Officer Sijmen de Vries said:
“BioConnection has been an excellent partner for Pharming for many years, and is an important part of our future plans. While we do not intend to take an active operational role in the company, its successful expansion will directly benefit Pharming as we look to increase capacity to support growing demand for RUCONEST® and as we expand our pipeline.”
About BioConnection B.V.
BioConnection B.V. (www.bioconnection.eu) is a Dutch contract manufacturing organization which offers flexible state-of-the-art development and GMP-compliant manufacturing services for sterile drug products. BioConnection is specialized in Fill and Finish including freeze-drying, technology transfers, scale-up and validations. BioConnection offers complete drug product manufacture service packages based on tailor-made solutions and customer-oriented flexibility from its own FDA and EMA accredited facility in Oss in the Netherlands.
About Pharming Group N.V.
Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. Pharming’s lead product, RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of acute Hereditary Angioedema (“HAE”) attacks in patients in Europe, the US, Israel and South Korea. The product is available on a named-patient basis in other territories where it has not yet obtained marketing authorization.
RUCONEST® is commercialized by Pharming in Algeria, Andorra, Austria, Bahrain, Belgium, France, Germany, Ireland, Jordan, Kuwait, Lebanon, Luxembourg, Morocco, the Netherlands, Oman, Portugal, Qatar, Syria, Spain, Switzerland, Tunisia, the United Arab Emirates, the United Kingdom, the United States of America and Yemen.
RUCONEST® is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine.
RUCONEST® is distributed in Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Megapharm.
RUCONEST® has recently completed a clinical trial for the treatment of HAE in young children (2-13 years of age) and is also evaluated for various additional follow-on indications.
Pharming’s technology platform includes a unique, GMP-compliant, validated process for the production of pure recombinant human proteins that has proven capable of producing industrial quantities of high quality recombinant human proteins in a more economical and less immunogenetic way compared with current cell-line based methods. Leads for enzyme replacement therapy (“ERT”) for Pompe and Fabry’s diseases are being optimized at present, with additional programs not involving ERT also being explored at an early stage at present.
Pharming has a long-term partnership with the China State Institute of Pharmaceutical Industry (“CSIPI”), a Sinopharm company, for joint global development of new products, starting with recombinant human Factor VIII for the treatment of Haemophilia A. Pre-clinical development and manufacturing will take place to global standards at CSIPI and are funded by CSIPI. Clinical development will be shared between the partners with each partner taking the costs for their territories under the partnership.
Additional information is available on the Pharming website: www.pharming.com
This press release of Pharming Group N.V. and its subsidiaries (“Pharming”, the “Company” or the “Group”) may contain forward-looking statements including without limitation those regarding Pharming’s financial projections, market expectations, developments, partnerships, plans, strategies and capital expenditures.
The Company cautions that such forward-looking statements may involve certain risks and uncertainties, and actual results may differ. Risks and uncertainties include without limitation the effect of competitive, political and economic factors, legal claims, the Company’s ability to protect intellectual property, fluctuations in exchange and interest rates, changes in taxation laws or rates, changes in legislation or accountancy practices and the Company’s ability to identify, develop and successfully commercialize new products, markets or technologies.
As a result, the Company’s actual performance, position and financial results and statements may differ materially from the plans, goals and expectations set forth in such forward-looking statements. The Company assumes no obligation to update any forward-looking statements or information, which should be taken as of their respective dates of issue, unless required by laws or regulations.