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Strong clinical results for Locteron and growing second half-year revenues
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO), announces today its unaudited annual results for the year ended 31 December 2010.
During 2010, successful clinical Phase IIb results for Locteron® were presented, which further validated the potential of our PolyActive® technology. Jan Egberts joined OctoPlus in November 2010 and formally started as CEO on 1 January 2011. Non-Locteron revenues grew by 18% in the second half-year compared to the first half-year of 2010. In addition, OctoPlus realised a significantly reduced cost base and a successful financing enhanced our cash position.
OctoPlus builds value in three key areas:
1. Product pipeline: strong clinical results for Locteron
The clinically most advanced product incorporating our PolyActive technology is Locteron, a controlled release formulation of interferon alpha, which we manufacture for our licensee Biolex. Interferon alpha is considered one of the cornerstones of hepatitis C treatment and currently has annual revenues in excess of US$ 2.5 billion.
- Positive interim clinical Phase IIb data on Locteron including a superior side effect profile were presented at the EASL conference in April 2010 and at the AASLD conference in October 2010. These results further validate the clinical benefits of OctoPlus' PolyActive drug delivery technology
- Revenues from Locteron were in line with expectations and substantially lower than in 2009 as the development and manufacturing for Phase IIb has been completed
- Locteron is a major value driver for OctoPlus: we are eligible to future milestone payments up to $138 million. In addition to these milestone payments, we are eligible to royalties on net sales of Locteron and we continue to be involved in the process development and manufacturing of Locteron.
2. Increased adoption of our proprietary drug delivery technologies: four new contracts
- Four technology evaluation contracts were signed in 2010 with three new companies (Novartis and two US-based companies) and one existing customer
- Increased number of request for proposals shows the growing adoption of our proprietary technology by our clients.
3. Stabilising formulation and manufacturing business in a difficult economic climate
- Contracts with ten additional new customers were signed in 2010
- Non-Locteron revenues for the second half-year were 18% higher than in the first half-year.
Our financial performance has improved in the second half of 2010: the successful financing strengthened our cash position, non-Locteron revenues increased by 18% and costs and loss in the second half-year have been reduced compared to the first half-year. The net result is negative, but we are realising a steady progression towards a sustainable positive operational cash flow.
- Following the restructuring in 2009, the total cost base (including interest) for the full year was reduced by 34% or € 7.5 million to € 14.5 million (2009: € 22.0 million)
- Total 2010 revenues decreased by 56% to € 8.3 million (2009: € 19.0 million) due to reduced work for Biolex in 2010 (€ 0.8 million revenues, 2009: € 11.2 million). Non-Locteron revenues for the full year decreased by 5% to € 7.5 million (2009: € 7.9 million)
- Net loss for the year amounted to € 6.2 million (2009: net loss of € 3.0 million)
- The cash outflow for the year, excluding equity issues, was reduced to € 4.0 million (2009: € 5.2 million)
- The cash position was € 2.7 million on 31 December 2010 (31 December 2009: € 3.3 million)
- Further adoption of our proprietary drug delivery technology by the biotech and pharmaceutical industries will result in further growth of our customer base in this area
- We are on schedule to progress another product utilising our technology into the next phase of development this year
- The proceeds of the private placement that was completed in December will allow us to co-invest in promising customer-funded projects in which we want to retain more of the economic upside of our proprietary technologies
- Consequently, with the current cash position and available credit facility, the reduced cost base, current order portfolio and acquisition pipeline, we expect to be able to continue OctoPlus' development towards a sustainable positive cash flow
- Partnering discussions for OP-145 are taking longer than expected but we aim to bring these to conclusion in 2011.
Jan H. Egberts, M.D., CEO of OctoPlus comments: "We have achieved an encouraging second half-year in a difficult economic climate. We are committed to continue our focus on cost control and revenue growth and continue our path towards sustainable positive cash flow. We are delighted how the Locteron Phase IIb results have confirmed the clinical benefits of our technology in patients and look forward to Locteron moving into the next phase of clinical development. This would generate revenue for us, but even excluding Locteron business we anticipate a successful year."
Conference call and webcast presentation
OctoPlus will hold a conference call and webcast presentation today at 10:00 AM CET. This event can also be followed live via OctoPlus' website www.octoplus.nl. If you would like to participate in the conference call, please dial in on telephone number +31 (0) 45 6316901. After the presentation, Jan Egberts, CEO of OctoPlus and Susan Swarte, CFO of OctoPlus, will be available to answer questions. After the event, the webcast will be available for replay on the Company's website.
View financial tables here hugin.info/137076/R/1490323/425950.pdf
This document may contain certain forward-looking statements relating to the business, financial performance and results of OctoPlus and the industry in which it operates. These statements are based on OctoPlus' current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.
About OctoPlus N.V.
OctoPlus is a specialty pharmaceutical company committed to the creation of improved pharmaceutical products that are based on OctoPlus’ proprietary formulation technologies and have fewer side effects, improved patient convenience and improved efficacy/safety balance over existing therapies.
OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics, other drugs, and vaccines on behalf of its clients.
The clinically most advanced product incorporating our technology is Biolex Therapeutics’ lead product Locteron®, a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008. Locteron is being manufactured for Biolex by OctoPlus and has recently completed Phase IIb clinical studies with superior clinical data versus current treatment.
In addition, OctoPlus is a leading European provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficultto- formulate active pharmaceutical ingredients.
OctoPlus is listed on Euronext Amsterdam by NYSE Euronext under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.
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