LEIDEN, Netherlands, Nov. 7, 2013 (GLOBE NEWSWIRE) --
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. FINANCIAL RESULTS In the nine months to 30 September 2013 the Company generated revenue and other income of €6.0 million (9M 2012: €2.4 million). This increase results from a license fee following achievement of the US$ 5 million milestone from our US partner Santarus for FDA acceptance for review of our BLA for Ruconest. Product sales in the nine months of 2013 amounted to €0.6 million, of which €0.4 million came in during the third quarter (€0.8 million 9M 2012). Costs of revenues amounted to € 0.4 million in the first nine months of 2013 compared to €0.8 million in the same period of 2012. In the first nine months of 2012, there was an inventory impairment of €2.3 million, while there were no impairments in 2013. Total operating costs in the first nine months of 2013 decreased to €9.3 million from €17.9 million in the same period in 2012. Research and development costs decreased by €6.7 million to €7.4 million in the first nine months of 2013 from €14.1 million in the same period of 2012, which reflects reduced human capital costs following the restructuring in 2012, as well as lower costs related to clinical study 1310 and other cost savings. General and administrative costs decreased by €0.7 million to €1.6 million in the first nine months of 2013 compared to the first nine months of 2012, mainly as a result of the restructuring in 2012. In the first nine months of 2013, there were no impairment charges while these amounted to €1.2 million in the same period of 2012. On 16 January 2013, the Company entered into a 8.5% convertible bond transaction of €16.35 million convertible bonds plus 16,349,999 warrants that was approved at the EGM of 28 February 2013. The bonds were repayable in cash and/or in shares in seven installments until 1 October 2013. In the first nine months of 2013, five installments were repaid in shares and one installment in cash. The seventh installment has been redeemed in cash subsequent to the reporting period, on 1 October 2013. With regards to these pay-backs in shares, the Company issued a total of 127,369,529 shares in the first nine months of 2013. Financial income in the first nine months of 2013 amounts to €0.6 million compared to €1.7 million in the same period of 2012. Financial income is non- cash in both periods and is exclusively related to decreases in the fair value of derivative financial liabilities. As a result of the above items, net loss for the first nine months of 2013 decreased to €11.1 million from €24.2 million in the same period of 2012. FINANCIAL POSITION Total cash and cash equivalents (including restricted cash) increased to €13.5 million at 30 September 2013 from €6.3 million at year end 2012. The increase follows from net cash outflows from operations of €7.1 million with net cash inflows from financing activities amounting to €14.2 million and net cash inflows from investing activities amounting to €0.2 million. Financing cash flows mainly result from the 2013 issue of convertible bonds which raised gross €16.0 million in cash. NEGATIVE EQUITY The Company has negative equity since December 2011. The negative equity position at 30 September 2013 amounts to €1.6 million, a decrease of €6.2 million compared to 31 December 2012. The decrease is a result of new equity issues related to the 2013 convertible bonds in the first nine months of 2013, partially offset by the net loss for the period. The negative equity position has in itself no immediate impact on the execution of Pharming's business plan, nor does it imply that the Company is legally required to issue new share capital. However, the Company is considering various options in order to reduce the negative equity and return to a positive equity position. About RUCONEST(®) and Hereditary Angioedema RUCONEST (INN conestat alfa) is a recombinant version of the human protein C1 esterase inhibitor, and is produced with Pharming's proprietary transgenic technology. RUCONEST is approved in Europe for the treatment of acute angioedema attacks in patients with HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 esterase inhibitor, resulting in unpredictable and debilitating episodes of intense swelling. The swelling may occur in one or more anatomical areas, including the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals. RUCONEST is an investigational drug in the U.S. and has been granted orphan drug designation by the FDA both for the treatment of acute attacks of HAE and for prophylactic treatment of HAE. About Pharming Group NV Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum. RUCONEST® is partnered with Santarus, Inc. (NASDAQ: SNTS) in North America and a Biologics License Application (BLA) for RUCONEST® is under review by the U.S. Food and Drug Administration. The product is also being evaluated for various follow-on indications. Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell based technologies. In July 2013, the Platform was partnered with Shanghai Institute for Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre- clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilise this platform for the development of rhFVIII for the treatment of Haemophilia A. Additional information is available on the Pharming website, 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. Contact Sijmen de Vries, CEO: T: +31 71 524 7400 FTI Consulting Julia Phillips/ John Dineen, T: +44 (0)207 269 7193 Click here to download the full press release [HUG#1741323] Source:Pharming Group N.V.