SOURCE: OctoPlus N.V.

February 15, 2007 02:30 ET

OctoPlus Announces 2006 Annual Results

LEIDEN, THE NETHERLANDS -- (MARKET WIRE) -- February 15, 2007 -- OctoPlus N.V. ("OctoPlus" or "the Company") (Euronext: OCTO), the drug delivery and development company, announces today its annual results for the year ended 31 December 2006.

Highlights 2006

--  2 development-stage products progressed to Phase II clinical studies:
    Locteron, for the treatment of chronic hepatitis C, and OP-145 for the
    treatment of chronic middle ear infection
    
--  Contract Development revenues increased 25%
    
--  IPO on Euronext Amsterdam generated EUR  20 million (gross) in new
    capital
    

In the period, OctoPlus' two lead development compounds were progressed into Phase II clinical studies. OP-145 Phase II patient recruitment was initiated in the second quarter, while approval to start Phase IIa for Locteron was gained in November and patient dosing commenced in January 2007. Both products have reported positive Phase I results in 2006. For OP- 145, a commercial license agreement was signed with Green Cross, for the commercialisation of the product in the Republic of Korea.

OctoPlus' Contract Development total gross revenues from formulation development and clinical trial material manufacturing increased by 25% to EUR 8,504k. This is the second consecutive year that OctoPlus' Contract Development activities have grown more than 20%. 80% of external service revenues came from repeat-orders and long-term contracts, showing the loyalty in OctoPlus' customer base. In order to better service the North- American market, a business development office was opened in the Boston area.

"This has been an excellent year for OctoPlus with significant progress across all of our key areas," says Joost Holthuis, CEO. "Two mid-stage clinical trials have been initiated with our lead products and revenues from our Contract Development business have again shown strong growth. Our successful lPO demonstrated the strength of our business model. We are looking forward to building further value in 2007."

Financials 2006

The table below outlines the key financial figures of the Company for the six-month period ended 31 December 2006 and 2005 and the full year 2006 and 2005. These financial figures, unaudited, are in accordance with International Financial Reporting Standards. A distinction has been made in this table between gross revenues, inter-segment revenues and consolidated (net) revenues. Gross revenues include inter-segment revenues for Contract Development supporting our Products & Drug Delivery division in the development of our own product pipeline, mainly for Locteron and OP-145. Contract Development generates most of the Company's revenues, with additional revenues from license fees and subsidies generated by our Products & Drug Delivery division. Contract Development worked at full capacity in order to facilitate as much as possible requests from third parties as well as demands for our products under development.

Key figures last six months and full year 2006
(In Euro x 1,000; except per share data)

                              2H      2H      %       Yr      Yr      %
                             2006    2005   change   2006    2005   change
                            ------  ------  ------  ------  ------  ------

Gross revenues               4,762   3,613      32%  8,996   7,383      22%
Inter-segment revenues      (1,990)   (162)   1128% (2,945)   (366)    705%
Consolidated revenues        2,772   3,451     (20%) 6,051   7,017
(14%)

Result for the period       (4,564) (3,070)     49% (8,665) (4,209)    106%

Earnings per share
        (basic and diluted)  (0.33)  (0.27)     22%  (0.68)  (0.38)     79%

                            ======  ======  ======  ======  ======  ======


Cash, cash equivalents,
 deposits and bank
 overdrafts                                         19,553   9,230     112%
                            ======  ======  ======  ======  ======  ======
Last six months ended 31 December 2006

Over the last six months of 2006, gross revenues showed an increase of 32% to EUR 4,762k (2005: EUR 3,613k). In preparation of our two Phase II clinical trials (Locteron and OP-145), the Company's Products & Drug Delivery division received services (including formulation development and manufacturing of clinical trial material) from Contract Development for an amount of EUR 1,990k (2005: EUR 162k), resulting in a decrease of consolidated (net) revenues by 20% to EUR 2,772k (2005: EUR 3,451k).

Total operating costs increased by 13% to EUR 7,295k (2005: EUR 6,430k), mainly as a result of the growth of the Company.

Net loss for the period increased by 49% to EUR 4,564k (2005: net loss of EUR 3,070k).

Full year ended 31 December 2006

For the full year 2006, total gross revenues increased by 22% to EUR 8,996k (2005: EUR 7,383k), with inter-segment revenues growing from EUR 366k in 2005 to EUR 2,945k in 2006 as a result of Contract Development supporting our Products & Drug Delivery division in the preparation of our two Phase II clinical trials (Locteron and OP-145), which have both started in 2006. As a result, consolidated (net) revenues decreased by 14% to EUR 6,051k (2005: EUR 7,017k).

Total operating costs increased by 27% to EUR 14,571k (2005: EUR 11,461k) as a result of the growth of the Company from 110 employees per 31 December 2005 to 139 employees per 31 December 2006 as well as an increase in expenditures for our pre-clinical and clinical studies.

Net loss for 2006 was EUR 8,665k, an increase of 106% compared to the net loss of EUR 4,209k for the year 2005.

Equity and cash flow

The Company raised EUR 20 million (gross) through its IPO on 4 October 2006. 4,301,076 new shares were issued at a price of EUR 4.65 per share. Earlier in the year, new shares were issued for an additional EUR 750k related to a second tranche of the January 2005 investment agreement and an additional EUR 104k was received as part of employees exercising options. In total, equity increased with EUR 17,966k in 2006 as a result of newly issued shares.

The Company started the year 2006 with a cash and cash equivalents balance (net of bank overdrafts) of EUR 9,230k. A total of EUR 6,410k was used during the year for OctoPlus' operating activities and (as described above) EUR 17,966k was received as a result of new shares issued during the year. EUR 1,233k was used for the Company's remaining investing and financing activities in 2006 resulting in a 112% increase of our cash and cash equivalents (including deposits and net of bank overdrafts) from EUR 9,230k per 31 December 2005 to EUR 19,553k per 31 December 2006.


Outlook 2007

The Contract Development order book is higher than at the same stage in 2006 and supports our revenue targets for 2007. The Company expects to generate more Contract Development revenues but expenditures will also increase as investments in the product pipeline continue. Major milestones to be expected in 2007 are the results from the ongoing Locteron Phase IIa trial, expected mid-2007, and the data for the ongoing OP-145 Phase II study, expected late 2007.

Annual report and Annual General Meeting of Shareholders

OctoPlus will publish its Annual Report 2006 on 30 March 2007. The report will also be available on the Company's website www.octoplus.nl. The Annual General Meeting of Shareholders will take place at Naturalis in Leiden on 24 April 2007 at 14:00 Central European Time (CET).

Conference call and webcast presentation

On February 15, OctoPlus will hold a conference call at 09:30 CET. This event can also be followed during a live audio webcast via OctoPlus' website www.octoplus.nl. If you would like to participate in the conference call, please dial in on telephone number +31 45 631 6903. After the presentation of the results, Joost Holthuis, CEO of OctoPlus and Hans Pauli, CFO, will be available to answer questions. After the event, the webcast will be available for replay on the Company's website.

For further information, please contact:

Rianne Roukema, Corporate Communications, +31 71 524 4044.

About OctoPlus

OctoPlus N.V. is a product-oriented biopharmaceutical company committed to the development of improved pharmaceutical products that are based on its proprietary drug delivery technologies and have fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. Rather than seeking to discover novel drug candidates through early stage research activities, OctoPlus focuses on the development of long-acting, controlled release versions of known protein therapeutics and other drugs.

OctoPlus is also a leading provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industry, with a focus on difficult to formulate active pharmaceutical ingredients in injectable formulations. The earnings and expertise that OctoPlus derives from rendering formulation and manufacturing services help to support its own drug development programs.

OctoPlus is listed on Euronext Amsterdam 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 N.V. and the industry in which it operates. These statements are based on OctoPlus N.V.'s 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.

The press release including tables can be downloaded from the following link:

OctoPlus announces 2006 annual results

http://hugin.info/137076/R/1105270/198674.pdf

Contact Information

  • For further information, please contact:

    Rianne Roukema
    Corporate Communications
    +31 71 524 4044.