Pharming Reports On Financial Results For The First Nine Months Of 2013
Leiden, The Netherlands, 7 November 2013. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the first nine months of 2013.
FINANCIAL HIGHLIGHTS
•Revenues and other income increased to €6.0 million (9M 2012: €2.4 million), mainly as a result of a US$ 5 million (€3.8 million) milestone payment by our US partner Santarus on the receipt of FDA acceptance for review of the BLA for Ruconest;
•Operating costs from continuing operations decreased to €9.3 million (9M 2012: €17.9 million), driven by reductions following the 2012 restructuring and lowering of project costs regarding Ruconest®;
•Financial income and expenses increased to €7.4 million (9M 2012: €5.5 million), primarily as a result of non-cash financial costs relating to the January 2013 €16.35 million convertible bond (2012 costs mainly related to the €8.0 million 2012 convertible bond);
•The net loss decreased to €11.1 million (9M 2012 €24.2 million), including the €7.4 million (9M 2012: €5.5 million) of net financing loss;
•Net cash outflows from operations decreased to €7.1 million (9M 2012: €11.6 million) while net cash inflows from financing activities amounted to €14.2 million (including €16.0 million from the issue of convertible bonds) and net cash inflows from investing activities amounted to €0.2 million received upon transfer of an intangible fixed asset;
•Cash at the end of the third quarter of 2013 amounted to €13.5 million (2012 FY: €6.3 million). The negative equity position decreased to €1.6 million from €7.7 million at year end 2012;
•Post events: On 1 October, the Company re-deeemed the final tranche (€2.35 million) of the January 2013 Convertible Bond in cash. On 9 October the Company announced a €12.0 million private placement with institutional investors. As a result of this private placement, Pharming’s equity position has become positive again for the first time since December 2011;
•A reverse share split 10:1 was approved at the EGM of 28 February 2013. The total number of shares as of today, 7 November 2013 is 332,434,319.
OPERATIONAL HIGHLIGHTS
•Biologics License Application (BLA) for RUCONEST® was filed and subsequently accepted by the US Food and Drug Administration (FDA)
?Pharming and Santarus are seeking U.S. marketing approval of RUCONEST® for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE);
?Pharming and Santarus were recently informed by the FDA that an Advisory Committee is not likely to be required as part of the RUCONEST review;
?Pharming and Santarus expect the FDA will complete its review or otherwise respond to the RUCONEST® BLA by 16 April 2014.
•European Medicines Agency (EMA) provided approval for Sanofi Chimie, Pharming’s Contract Manufacturing Organization partner, to manufacture drug substance for Pharming’s product RUCONEST® at their Aramon (France) site, completing an important up-scaling of the production capacity that will allow for future significant economies of scale.
•New data from a pivotal Phase III clinical study (Study 1310) of RUCONEST® for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE) featured in a poster presentation at the European Academy of Allergy and Clinical Immunology (EAACI) & World Allergy Organization (WAO) World Allergy & Asthma Congress in Milan, Italy.
•Results of a study demonstrating that RUCONEST® has been shown to have a beneficial effect as a donor pre-treatment therapy in an animal model of kidney transplantation was presented at the American Transplant Congress in Seattle, Washington.
•The Company entered into a strategic collaboration in China with Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for the development, manufacture and commercialisation of new products at SIPI, funded by SIPI upto IND stage, based on the Pharming technology platform. In addition, Pharming has also granted SIPI an exclusive license to commercialise RUCONEST® (conestat alfa) in China.
•For HAE prophylaxis, we submitted, under our investigational new drug application, a protocol to the FDA with a request for a special protocol assessment, or SPA. The FDA has indicated that modifications to the protocol are needed before proceeding with the study and further discussions will be required in order for the protocol to be approved pursuant to the SPA process. We and Santarus are evaluating next steps to move the program forward.
Sijmen De Vries, Chief Executive of Pharming commented: “During the third quarter we have continued to build on the positive momentum experienced in the first six months of 2013; momentum which allowed us to further strengthen our balance sheet through a successful €12.0 million private placement with institutional investors, completed directly after closing of the third quarter. This was an important event for Pharming: as well as strengthening of our balance sheet, the placement demonstrated the continued support of our existing institutional shareholders as well providing new institutional shareholders with the opportunity to take a position in Pharming. Significantly, the private placing occurred after we fully redeemed the January 2013 Convertible Bond. Together with our US partner Santarus, our team continues to work on the ongoing FDA review of RUCONEST® and in this context we are pleased to note today that the FDA has recently informed us that an Advisory Committee is not likely to be required as part of the RUCONEST® review.