Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today published its financial report for the three month period ended March 31, 2011.
FINANCIAL HIGHLIGHTS FIRST THREE MONTHS
-- Revenues of EUR0.6 million for the three month period (Ruconest first sales recorded in December 2010) -- Significant reduction in operating cash outflows to EUR4.5 million (Q1 2010: EUR6.3 million) -- Decrease in operating loss from continuing operations to EUR4.3 million (Q1 2010: EUR5.0 million) -- Significant decrease in net loss to EUR3.6 million (Q1 2010: EUR7.7 million) -- Cash at March 31, 2011 of EUR15.6 million compared to EUR10.5 million at year end 2010
OPERATIONAL HIGHLIGHTS IN FIRST QUARTER
-- Rollout of Ruconest in Europe progressing -- Clarity from the FDA on requirements for the US development of Rhucin@ -- Protocol for Phase III study 1310 amended in accordance with FDA requests and submitted -- Continuing focus on limiting cash burn -- Lease financing of production equipment completed, internal cost saving exercise ongoing -- Business development process initiated to leverage Pharming's technology platform
Sijmen de Vries, CEO, commented: "The first three months of 2011 have been an intense period for Pharming, as we focused on addressing the FDA's refusal to file letter for Rhucin. Pharming is now implementing the agreed changes in the Protocol for Study 1310. We are also continuing to seek and evaluate new sources of value creation and financing for the Company, including additional partnerships for our C1 inhibitor franchise and potential deals which utilise our validated proprietary, low cost production platform. We look forward to updating on further progress throughout the year."
Pharming's revenues from license fees and product sales were EUR0.6 million in the three months to March 31, 2011, compared to nil in the same period of 2010, resulting in the operating loss from continuing operations decreasing to EUR4.3 million (Q1 2010: EUR5.0 million). General and administrative costs and research and development expenses remained broadly constant during the three month period, compared to the corresponding period in 2010.
In the three months to March 31, 2011, the shareholders of DNage, in which Pharming had 51% ownership, decided to voluntary liquidate DNage and accordingly the DNage entity has been deconsolidated. This has resulted in a one- time net profit of EUR0.6 million compared to losses from the DNage operations of EUR1.0 million incurred during the corresponding period in 2010. Both results have been presented as discontinued operations in the statement of income.
In the three months to March 31, 2011, Pharming recorded a net loss of EUR3.6 million (Q1 2010: EUR7.7 million). The net loss per share was EUR0.01 (Q1 2010: EUR0.05). At the end of the period, the number of shares outstanding was 461,116,470 compared to 154,501,037 at the end of the corresponding period in 2010 and 436,261,010 shares at December 31, 2010.
In Q1 2011 the Company received an aggregate amount of EUR10.0 million from Socius in relation to a year end 2010 receivable of EUR9.0 million plus EUR1.0 million following the exercise of all 24,339,623 warrants. Mainly due to these receipts and net operating cash outflows of EUR4.5 million, the total cash position increased from EUR10.5 million at December 31, 2010 to EUR15.6 million at the end of Q1 2011 (Q1 2011: EUR3.3 million).
The rollout of Ruconest in Europe continues and both we and our partner, SOBI, remain confident that the launch is on track. Progress on reimbursement has been made across Europe both at national and regional levels.
We have received clarity from the FDA on the US development requirements for Rhucin. The issues raised by the FDA have been discussed and we have submitted the amended protocol for Study 1310 to the FDA.
We continue to focus on limiting our cash burn and to date a number of cost saving initiatives have been implemented. In Q3 2010 Pharming signed a manufacturing agreement with Sanofi Chimie to increase the production capacity of the drug substance of Ruconest. This will improve the cost of goods and competitiveness of Ruconest. We recently completed the lease financing of production equipment for this process. In order to leverage our proprietary technology platform, a business development process on potential new platform collaborations has been initiated.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest (Rhucin@ in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein. The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. Additional information is available on the Pharming website, www.pharming.com (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 full report including tables can be downloaded from the following link:
Q1 Report 2011:
This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE