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Ablynx [Euronext Brussels: ABLX] today announced its results for the six-month period ending 30 June 2011, which have been prepared in accordance with the IAS 34 Interim Financial Reporting as adopted by the European Union, and highlighted the developments in its product pipeline and partnerships.
In the six-month period ending 30 June 2011, revenues increased by 27% to €12.8 million (2010: €10.1 million), primarily driven by milestones from existing collaborations and recognised income from new collaborations. Total research and development costs increased to €28.9 million (2010: €21.4 million), in line with the increasing number of pre-clinical and clinical development candidates. General and administrative expenses amounted to €4.9 million (2010: €4.6 million). The loss from continuing operations before tax and net finance income, increased to €21.0 million (2010: €15.8 million). The net loss for the period was €20.2 million (2010: €15.3 million). The Company ended the six-month period with €92.6 million in cash, cash equivalents, restricted cash and short-term investments.
During the past six months, Ablynx continued to make progress in developing its product pipeline with both its proprietary and collaborative programmes. The first clinical-proof-of concept with a Nanobody in a patient population was achieved by Pfizer in May with the lead anti-TNF-alpha Nanobody, ATN-103. Two new Nanobody programmes entered the clinic, and the Phase II study recruitment for the anti-vWF Nanobody, ALX-0081, in ACS was successfully completed. At 30 June 2011, Ablynx had over 25 programmes in its R&D pipeline, including partnered programmes, and there were seven Nanobodies in clinical development.
Commenting on the half year 2011 results, Dr Edwin Moses, Chairman and CEO of Ablynx, said: “We are very pleased with the progress the Company has made during the past six months. In May, for the first time, clinical-proof-of-concept with a Nanobody was achieved. This was a major milestone for Ablynx as it is a clear validation of our Nanobody platform. As planned, we have initiated two additional clinical trials during 2011, bringing the total number of Nanobodies in the clinic to seven with a further Phase I programme due to start in the next months.”He added: “Our financial position remains strong and gives us the confidence and the means to invest further in our rich and maturing product pipeline while collaborating with partners, when appropriate, in a balanced approach designed to potentially create maximum value for all our stakeholders. We are looking forward to the remainder of the year.”
Ablynx led programmes
Total revenues increased by 27% to €12.8 million during the first six months of 2011 (2010: €10.1 million) primarily driven by milestones and FTE funding from existing collaborations and recognised income from new collaborations.
During the first half of 2011, research and development expenses increased by €7.5 million to €28.9 million (2010: €21.4 million). This increase was mainly attributable to increased personnel costs and a €5.6 million increase in external development costs largely related to clinical trials.
General and administrative expenses amounted to €4.9 million for the period ending June 30th 2011 (2010: €4.6 million).
As a result of the foregoing, the loss from continuing operations, before tax and net finance income, increased to €21.0 million during the first half of 2011 (2010: €15.8 million).
Net finance income primarily comprises interests from deposits which increased by €0.2 million to €0.8 million in the first six months of 2011 (2010: €0.5 million) as a result of the higher cash position arising from the Secondary Public Offering in March 2010.
As a result of the foregoing, the net loss before taxes increased to €20.2 million during the first six months ending June 30th 2011 (2010: €15.3 million).
As the Company incurred losses in the period, the Company had no taxable income.
The Company’s intangible assets include a portfolio of acquired patents which are being amortised over approximately 12 years, and technology licenses that are being amortised over 5 and 18 years. The Company has not capitalised any other patents and it expenses all its research and development activities. The intangible assets also include software licenses.
The Company’s non-current tangible assets include the Company’s laboratory and office equipment, the investments in its facilities and €3 million restricted cash, which is related to a cash pledge that the Company has provided. The Company does not own any real estate and continues to invest in equipment for its research activities.
The Company’s current assets consist mainly of trade receivables, other short-term investments, and cash and cash equivalents. The €21.6 million decrease during the first six months of 2011 is primarily related to the decrease in cash and cash equivalents used to fund the Company’s operations.
The Company’s equity decreased from €100.8 million to €81.5 million mainly as a result of the incorporation of the loss for the period (€20.2 million).
The Company’s non-current liabilities relate to the financing of additional investments in its building.
The Company’s current liabilities primarily relate to deferred income from collaborative agreements and trade payables.
Cash flow statement
Cash flow from operating activities represented a net outflow of €21.7 million during the first six months ending June 30th 2011, as compared to a net outflow of €16.6 million during the first six months ending June 30th 2010.
Cash flow from investing activities represented a net inflow of €0.4 million as compared to a net outflow of €18.6 million in 2010. The variance relates to the net movements in short-term investments and “available-for-sale”financial assets.
Cash flow from financing activities represented a net outflow of €0.007 million as compared to a net inflow of €47.3 million during the first six months of 2010. The net inflow in 2010 was mainly a result of the net proceeds arising from the Secondary Public Offering in March 2010.
Initial observations, presented at the ISTH meeting in Kyoto, Japan, from the ongoing Phase II trial with ALX-0081/ALX-0681 in patients with TTP, confirmed the biological activity of the Nanobody as measured through a reduction of the RICO biomarker, an important biomarker for vWF-mediated platelet aggregation. The observed safety signals were in line with what would have been expected given the severity of the disease and the hospitalised condition of the patients.
The European Patent Office informed Ablynx of its intention to grant three Ablynx patents around its half-life extension technologies.
The single ascending dose part of the Phase I/II study in RA patients with ALX-0061, the anti-IL-6R Nanobody, successfully finished recruitment with interim data expected to be available during the third quarter and the start of the multiple ascending dose part anticipated before year-end.
Ablynx was granted a certificate for Good Laboratory Practice (GLP) from the Belgian Scientific Institute of Public Health (IPH) for its new GLP unit at its headquarters in Ghent, Belgium. Having received this GLP certificate, Ablynx’s GLP unit will be able to carry out pre-clinical analytical testing and pharmacokinetics studies in-house, to the required regulatory standard.
Ablynx’s lead internal programme, ALX-0081, the anti-vWF Nanobody that is in Phase II clinical development in high risk ACS patients undergoing a PCI, is on track to generate data before the end of the year.
Final Phase I data, including immunogenicity data, for ALX-0141, the anti-RANKL Nanobody, is expected during the third quarter. The start of a Phase II study in bone metastasis is in preparation.
The single ascending dose part of the Phase I/II study in RA patients with ALX-0061, the anti-IL-6R Nanobody, is on track with interim data expected during the third quarter and the start of the multiple ascending dose part is anticipated before year-end.
Ablynx is on track to start a Phase I study with ALX-0171, the first Nanobody to be administered by inhalation.
During the remainder of the year, Pfizer is expected to make a decision with regard to whether and how to proceed with its lead anti-TNF-alpha Nanobody, ATN-103, in RA.
For the full year, we maintain our guidance of net cash burn in the range €25-35 million. Due to a change in the anticipated mix of milestones, up-front payments etc., we now believe that recognised revenues for 2011 will be in the range €20-25 million.
Ablynx will organise its annual R&D days on Wednesday, 5 October in New York, and Thursday, 13 October at its headquarters in Ghent.
Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease. Today, the Company has over 25 projects in the pipeline and there are seven Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer. The Company is headquartered in Ghent, Belgium and currently employs over 280 people. More information can be found on www.ablynx.com.