LEIDEN, NETHERLANDS--(Marketwire - March 18, 2010) -
OctoPlus N.V. (“OctoPlus” or the “Company”) (Euronext: OCTO), announces today its unaudited annual results for the year ended 31 December 2009, achieving its guidance on revenues of EUR 19 million.
At the end of 2008, OctoPlus announced its intention to make the transition into a drug delivery company building a portfolio of compounds in development for clients, utilising its proprietary controlled release technologies. Key to the success of this strategy are the following events:
* Locteron successfully progressing through Phase IIb studies: top-line results to be presented at EASL International Liver Congress in April 2010 * Growing adoption of OctoPlus’ controlled release technology by the biotech and pharmaceutical industries through the acquisition of multiple feasibility projects * Increasing demand for formulation development and contract manufacturing services from existing and new customers * Successful completion of reorganisation to align organisational structure with new strategy
These events have resulted in record revenues of EUR 19 million, with highest ever core business (non-Locteron) revenues, and a positive EBITDA for the full year 2009.
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) 45 631 6902. After the presentation, Simon Sturge, CEO of OctoPlus and Susan Swarte, CFO, will be available to answer questions. After the event, the webcast will be available for replay on the Company’s website.
Highlights 2009
Operational
* OctoPlus’ licensee Biolex completed patient recruitment in a Phase IIb study with Locteron in June 2009 * Promising results from two Phase IIb studies with Locteron will be presented at the EASL International Liver Congress which takes place from 14 to 18 April 2010 * Five feasibility projects won to develop controlled release formulations in which OctoPlus’ proprietary technology is combined with a client’s product * New manufacturing facility fully licensed and operational: manufacturing capacity now available from pre-clinical to commercial supplies * 25% reduction in work force resulting in a streamlined organisation for 2010.
Financial
* Full year revenue guidance achieved: revenues increased by 13% from EUR 16.9 million in 2008 to EUR 19.0 million in 2009 * Positive EBITDA achieved of EUR 1.0 million in 2009 compared to a negative EBITDA of EUR 2.7 million in 2008 * Core business (non-Locteron) revenues increased by 12% from EUR 7.0 million in 2008 to EUR 7.9 million in 2009 under difficult economic circumstances * Locteron revenues generated 59% of total revenues (2008: 58%), mainly resulting from development and manufacturing work for Phase IIb clinical studies * Net loss reduced by 52% from EUR 6.2 million in 2008 to EUR 3.0 million in 2009 despite significant one-off costs * One-off costs of EUR 1.5 million related to organisational restructuring and start-up of the new manufacturing facility * 2009 closing net cash position EUR 3.3 million, a EUR 4.2 million increase from a negative opening cash balance of EUR 0.9 million * Two successful equity raisings completed to expand investor base and strengthen cash position.
Outlook 2010
* Further adoption of OctoPlus’ proprietary drug delivery technology by the biotech and pharmaceutical industries to result in several new feasibility projects to be acquired this year * Cost reduction measures taken in 2009 reduced total cost base for 2010 significantly * Locteron’s Phase IIb study to be completed successfully in 2010 and top-line results to be presented at International Liver Congress in April 2010, which, if successful, would validate the clinical benefit of OctoPlus’ PolyActive® technology * Licensee Biolex expected to find commercialisation partner for Locteron before the end of the year.
Simon Sturge, CEO of OctoPlus comments: “2009 has been a year of transition for OctoPlus. We are delighted to report that our revenues are in line with the guidance we gave for the year and that we have accomplished a positive EBITDA for the full year. Our goal is to build a portfolio of products on behalf of our clients, led by Locteron, based on our proprietary drug delivery technology.
Financials 2009
The table below outlines the key unaudited financial figures of the Company for the six-month period ended 31 December 2009 and 2008 and the full year 2009 and 2008. The 2009 financial figures are as yet unaudited.
Key figures last six months and full year 2009 and 2008 (unaudited, in Euro x 1,000; except unaudited per share data) 2H 2009 2H 2008 % change Yr 2009 Yr 2008 % change Total revenues 9,043 13,185 -31% 19,046 16,923 13% EBITDA 777 2,443 -68% 970 (2,716) n.a. Net result for the (1,330) 205 n.a. (2,957) (6,209) -52% period Earnings per share (0.04) 0.02 n.a. (0.10) (0.38) -74% (basic and diluted) Cash flow 1,799 2,831 -36% 4,195 (3,397) n.a. Cash, cash 3,313 (882) n.a. equivalents and bank overdrafts
Full year ended 31 December 2009
For the full year 2009, total revenues increased by 13% to EUR 19.0 million (2008: EUR 16.9 million), with core business (non-Locteron) revenues increasing by 12% to EUR 7.9 million (2008: EUR 7.0 million) and revenues from Locteron increasing by 13% to EUR 11.2 million (2008: EUR 9.9 million). The EUR 9.9 million in 2008 included a EUR 7.9 million up-front fee related to the product rights acquisition agreement with Biolex. 2009 Locteron revenues mainly comprised process development and manufacturing work for Biolex’ Phase IIb studies. Most of these activities have now been concluded.
Total operating costs decreased modestly by 2% to EUR 20.8 million (2008: EUR 21.2 million). The operating costs in 2009 included a relatively high proportion of one-off costs such as the costs associated with streamlining the organisation from 150 to 106 FTE’s by 1 March 2010 (EUR 0.7 million), costs associated with the first year of operation for the new manufacturing facility (EUR 0.5 million) and impairment of some intangible assets (EUR 0.3 million).
Net loss for 2009 was EUR 3.0 million; a reduction of more than 50% compared to the net loss of EUR 6.2 million for the year 2008.
Last six months ended 31 December 2009
Over the last six months of 2009, revenues amounted to EUR 9.0 million (2008: EUR 13.2 million). The last six months of 2008 contained EUR 7.9 million revenues from the up-front fee related to the product rights acquisition agreement with Biolex. Excluding that one-off amount, revenues in the last six months of 2009 increased by 71% compared to the same period last year.
Total operating costs decreased by 15% to EUR 10.0 million (2008: EUR 11.7 million), resulting from a decrease of most operational cost items (raw materials, cost of contracted work, employee benefits and other costs) as a result of the change in strategy, offset by an increase in depreciation as a result of the expanded manufacturing facilities of EUR 0.5 million, impairment charges of some intangible assets as an effect of the change in strategy of EUR 0.3 million, and higher restructuring charges of EUR 0.1 million.
As a result, OctoPlus reports a net loss for the second half of 2009 of EUR 1.3 million, compared to a net profit of EUR 0.2 million in the second half of 2008, which was driven by the EUR 7.9 million up-front fee related to the product rights acquisition agreement for Locteron with Biolex.
Cash flow
The Company began 2009 with a net negative cash and cash equivalents balance of EUR 0.9 million. A total of EUR 2.8 million (2008: EUR 4.0 million) was used during the year for OctoPlus’ operating activities. A further EUR 1.5 million was used for capital expenditures (2008: EUR 6.7 million), predominantly investments related to the new production facility built at the Company’s headquarters. OctoPlus received EUR 9.4 million of cash in 2009 from the issuance of new shares. Finally, the Company had a EUR 0.9 million cash outflow from finance lease payments in 2009 (2008: EUR 0.3 million).
As a result, the Company’s cash and cash equivalents increased by EUR 4.2 million during 2009 to a positive EUR 3.3 million at year-end. In addition, OctoPlus currently has a credit line facility available of up to a maximum of EUR 2.0 million.
Outlook 2010
In 2010, OctoPlus will focus on the acquisition of additional feasibility projects utilising the Company’s controlled release drug delivery technology, and additional formulation development and contract manufacturing projects.
As part of the Company’s strategy to no longer invest in own risk product development, out-licensing the OP-145 product for ear infection to a commercial partner is also a goal for 2010. Partnering discussions for OP-145 are ongoing and will be progressed further.
With regard to Locteron, OctoPlus’ licensee Biolex will present the top- line results from two ongoing Phase IIb studies at the International Liver Congress in April 2010. In addition to that, the Company expects that Biolex will find a commercial partner for Locteron this year. If Biolex finds a commercial partner for Locteron that will increase the success rate for the market introduction of Locteron, which in turn represents a major value driver for OctoPlus.
Annual report and Annual General Meeting of Shareholders OctoPlus will publish its Annual Report on 12 April 2010. The report will also be available on the Company’s website www.octoplus.nl.
The Annual General Meeting of Shareholders will take place at the Company’s headquarters in Leiden on 12 May 2010 at 14:00 Central European Time (CET).
The consolidated statement of financial position of OctoPlus N.V. as of 31 December 2009, the related consolidated statements of comprehensive income and the consolidated statement of cash flows for the year ended 31 December 2009, as presented in this press release, are unaudited.
For further information, please contact: Rianne Roukema, Corporate Communications: telephone number +31 (71) 524 1071, or send an e-mail to Investor Relations atIR@octoplus.nl. About OctoPlus
OctoPlus is a drug delivery company committed to the creation of improved pharmaceutical products that are based on OctoPlus’ proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. OctoPlus focuses on the development of long-acting, controlled release versions of new and existing drugs, especially protein therapeutics, 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 is currently in Phase IIb clinical studies.
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 difficult-to-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.
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.
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