Summary published in connection to the admission to trading of shares in - Algeta ASA on NASDAQ OMX Stockholm

Transcription

1 Summary published in connection to the admission to trading of shares in - Algeta ASA on NASDAQ OMX Stockholm This summary is entirely based on information available in Algeta ASA (also referred to as the Company or Algeta ) annual reports, interim reports, the Company s website, press releases from the Company or information given by the Company s primary exchange. If nothing else is stated website indicates the Company s corporate website and annual report indicates the Company s annual report. The Swedish FSA has not approved this summary. General Admission to trading of listed shares OMX Treasury AB has applied for admission to trading of shares in The Company on NASDAQ OMX Stockholm. The Company is listed on the regulated market at Oslo Stock Exchange. The Company s latest published prospectus was published on the 4th of March 2009 and is available at the Company s webpage: Information regarding this Summary This summary is not part of a prospectus and is issued by OMX Treasury AB solely due to the fact that the Company s shares are being admitted to trading on NASDAQ OMX Stockholm s regulated market, in accordance with the Swedish Securities Market Act (2007:528) chapter 15, section 4, sub-section 1. The Company has not been involved in preparing this summary. In accordance with the Swedish Financial Instruments Trading Act (1991:980) chapter 2, section 7, the Company will be notified by NASDAQ OMX Stockholm of the decision to admit the shares to trading on the regulated market. All information in this summary is based on information published by the issuer. The purpose of this summary is to provide the market with information on the Company in accordance with the Swedish Financial Instruments Trading Act (1991:980) chapter 2, section 7. The purpose is not to provide sufficient information for making investment decisions regarding the Company share. Investors shall not base investment decisions on the information in this summary. On the contrary, investment decisions shall be based on information issued by the Company as a whole. The preparation of this summary shall not in any circumstances mean that the contents of the information on the Company would not have changed after the issuing date of the summary. This summary is not a guarantee, neither by the Company nor OMX Treasury AB, regarding future events and shall not be considered as such. Note to the investors The purpose of this summary is not to be an encouragement or advice to invest in the Company. The summary shall not be distributed outside Sweden, except as such circumstances where this information does not breach any local legislation. Neither the Company nor OMX Treasury AB

2 nor their representatives have any kind of legal liability on any breaches referred to above, irrespective of whether such limitations are known or unknown by the investor. Algeta ASA Information and history [Website 25 th of June 2012, Q4-11 report] Algeta was founded in 1997 and the headquarters and R&D facilities are located in Oslo, Norway and manufacturing is based nearby in Kjeller, Norway. Ageta s clinical operations are global. Algeta has also established a subsidiary in the US ("Algeta US") to carry out the copromotion of Alpharadin, pursuant to its 2009 agreement with Bayer. The headquarters of this operation will be located in Cambridge, MA. Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. Algeta's lead product is Alpharadin (radium-223 chloride) which has the potential to be a firstin-class, highly targeted alpha-pharmaceutical and is under clinical evaluation to improve survival in patients with advanced forms of cancer and bone metastases. It is partnered with Bayer Pharma AG, a major pharmaceutical company, and met its primary endpoint in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from prostate cancer. Algeta reported revenues for the full-year 2011, of NOK 250m (of which NOK 97m deferred signing fee, NOK 4m milestone payments and NOK 149m cost sharing) versus NOK 271m for 2010 (NOK 82m deferred signing fee and NOK 40m milestone payments and NOK 148m cost sharing). Algeta s income statement shows a net loss of NOK 13m for 2011, compared to a net profit of NOK 13m in The Algeta share was listed on the Oslo Stock Exchange in 27 th of March 2007 (Ticker: ALGETA). The Algeta website is Long-term Vision and strategy [Annual Report 2011] Vision Algeta s vision is to be a world class oncology company bringing novel targeted medicines to patients through leadership in alpha-pharmaceuticals. R&D will continue to be based in Oslo, Norway, and commercial operations are planned in the USA. Strategy The success of Alpharadin in the phase III ALSYMPCA clinical trial has advanced Algeta s leading position in this new field of alpha-pharmaceuticals, which have the potential to be highly effective cancer therapeutics. Algeta s corporate strategy aims to build value for our shareholders and other stakeholders based on the following key elements: I. Bring ALPHARADIN to the market for the treatment of bone metastases in cancer patients. II. Establish successful commercial operations in the USA. 2(10)

3 III. IV. Accelerate and validate commercial Manufacturing facility for ALPHARADIN Build a future pipeline of novel targeted cancer product candidates. For details regarding corporate strategy, please refer to page 10 Annual Report Outlook According to the Company, year 2012 promises to be an exciting year for Algeta, during which the Company will focus on continuing to deliver multiple strategic milestones aimed at creating further value for shareholders. For details regarding goals set up by the Company, please refer to page 4 in the Q1-12 report. Recent Developments [Annual Report 2011] Product developments Algeta with the positive phase III ALSYMCA clinical trial for our lead alpha-pharmaceutical, Alpharadin, dominating the headlines. These and other clinical results announced throughout the year have reinforced the Company s belief in Alpharadin s potential to become an important treatment for cancer patients whose disease has spread to the bones. Algeta is now moving into a new phase of development as we prepare the regulatory dossiers for Alpharadin, the filing of which are anticipated in mid-2012, and its subsequent launch, upon regulatory approval, in the major markets will be a busy and exciting year as Algeta gets closer to achieving its strategic goal of becoming a world class oncology company with a US commercial presence and specialized R&D capability. Distribution and collaboration with Bayer [Q-1 Report 2012] In February 2012, Algeta announced that Bayer, with authorization from the US FDA, initiated an Expanded Access Program (EAP) to provide Alpharadin to CRPC patients with symptomatic bone metastases through qualified clinical sites in the US. Expanded access refers to the use of an investigational drug, under certain circumstances, to treat patients with a serious disease or condition who cannot participate in a controlled clinical trial. Through the EAP, Alpharadin is being made available to patients who fit the inclusion criteria of the ALSYMPCA phase III trial. A similar program is expected to begin in Europe later this year. A phase I trial of Alpharadin in CRPC patients in Japan has already been initiated by Bayer, and Bayer is also evaluating clinical development and filing strategies for Japan and China. Bayer has also stated that it expects to announce an update on details of the plans for further clinical trials for Alpharadin in mid Algeta and Bayer have been focused on regulatory and other pre-commercialization activities for Alpharadin following the positive results from ALSYMPCA, which led to the trial being stopped early in June Bayer, which is responsible for regulatory submissions under the co-promotion agreement, has stated that it expects to make its first regulatory filings for marketing approval in the US and Europe in mid Thorium Extension to Sanofi Agreement [Q-1 Report 2012] In April, Algeta announced that its research collaboration with Sanofi (previously Genzyme) has been extended for a further year. This collaboration, which was announced in April 2011, is 3(10)

4 focused on evaluating the potential of linking the alpha-emitter thorium-227 to a novel and proprietary antibody from Sanofi to create a potential tumor-targeting alpha-pharmaceutical (also known as a Targeted Thorium Conjugate, or TTC). Successful Equity Offering [Q-1 Report 2012] In February, Algeta raised NOK 271m (approximately USD 47m) in net proceeds in a private placement and subsequent repair offering totaling 2.1 million new shares. Algeta intends to use the proceeds in part to establish what the Company believes would be an optimal level of commercial operations in the US in connection with the launch of Alpharadin, pending approval. In addition, Algeta intends to use a substantial proportion of the proceeds to advance the research and development of the TTC platform. Board [website] Stein Holst Annexstad (Born 1944), Non-executive Chairman John Edward Berriman (Born 1948), Deputy Chairman Joseph Anderson (Born 1959), Director Kapil Dhingra (Born 1959), Director Judith Hemberger (Born 1947), Director Per Anders Göte Samuelsson (Born 1961), Director Hilde Hermansen Steineger (Born 1966), Director Ingrid Wiik (Born 1945), Director Group Executive Board [website] Andrew Kay, (Born 1955), B. Pharm., President and Chief Executive Officer (CEO) Thomas Ramdahl, (Born 1956), Ph.D., EVP and Chief Technology Officer (CTO) Lars Abrahmsén, (Born 1957) Ph.D., Senior VP, Protein Therapeutics Jeffrey W. Albers, (Born 1971) JD/MBA, President, Algeta US Mike Booth, (Born 1971), D.Phil., Senior VP, Communications & Corporate Affairs Kari Grønås Dyvik, (Born 1964), M.Sc.Pharm., Senior VP, Operations Roger Harrison, (Born 1954), Ph.D., Chief Business Officer (CBO) Ragnhild Marie Løberg, (Born 1953), M.Sc.Pharm., Senior VP, Quality and Regulatory Affairs Gillies O'Bryan-Tear, (Born 1955), MD, MBA, Chief Medical Officer (CMO) Øystein Soug, (Born 1969), M.Sc., Chief Financial Officer (CFO) The Shares There were 42,525,142 shares outstanding as of 25 of June [website] The Company's common stock is listed on the Oslo Stock Exchange (OSE) under the symbol/ticker: ALGETA. Largest shareholders [website/investor relations/shareholders/ ] The largest shareholder in Algeta is SHB Stockholm Clients Account and the 20 largest shareholders represent some 63% of the total shares. 4(10)

5 Investor Number of % of top % of total shares 20 Type Country SHB STOCKHOLM CLIENTS ACCOUNT 6,160, % 14.49% Nom. SWE BANK OF NEW YORK MELLON SA/NV 5,205, % 12.24% Nom. GBR FOLKETRYGDFONDET 2,440, % 5.74% Comp. NOR PICTET-GENERICS 2,118, % 4.98% Comp. LUX STATE STREET BANK AND TRUST CO. 1,489, % 3.50% Nom. USA STATE STREET BANK AND TRUST CO. 1,185, % 2.79% Nom. USA GOLDMAN SACHS & CO - EQUITY 937, % 2.20% Nom. USA VERDIPAPIRFONDET DNB NORGE SELEKTI 896, % 2.11% Comp. NOR TREDJE AP-FONDEN 887, % 2.09% Comp. SWE STATE STREET BANK & TRUST CO. 754, % 1.77% Nom. USA SELVAAG INVEST A/S 683, % 1.61% Comp. NOR ADVENT PRIVATE EQUITY FUND IV 634, % 1.49% Comp. GBR VANGUARD LENDING ACCOUNT 565, % 1.33% Comp. USA STATOIL PENSJON 462, % 1.09% Comp. NOR VPF NORDEA KAPITAL 459, % 1.08% Comp. NOR VERDIPAPIRFONDET DNB NORGE (IV) 415, % 0.98% Comp. NOR JEFFERIES & CO., INC. 395, % 0.93% Nom. USA DNB LIVSFORSIKRING ASA 368, % 0.87% Comp. NOR JPMORGAN LUXEMBOURG 357,9 1.34% 0.84% Nom. LUX DNB NOR MARKETS, AKSJEHAND/ANALYSE 341, % 0.80% Comp. NOR Total number owned by top 20 26,757, % 62.92% Total number of shares 42,525, % Remuneration and Share-based remuneration [Annual report 2011] The Board has prepared guidelines for the remuneration of the executive management which are included in note 25 to the consolidated financial statements. The Board s remuneration committee presents a recommendation concerning the terms and conditions for the CEO to the Board of directors and monitors the general terms and conditions for other senior employees. The Board assesses the CEO and his terms and conditions once a year. Members of the management team receive an annual bonus and in addition, management participates in a share option plan. See note 11 and note 25 in the consolidated financial statements for details. In order to ensure competitive remuneration and align incentives and compensation with shareholders objectives, the Company may implement a restricted share program as a part of the Company s incentive program. Information on the financial figures [Annual Report 2011] The revenue for Algeta 2011 was NOK thousands. Extracts of Consolidated Income Statements and Balance Sheets for Algeta for the year ended 31 December and 1st quarter of 2012 are presented below. All figures in NOK thousands. 5(10)

6 Extract - Income Statement Revenue Net profit (loss) before income taxes (170098) (12889) Net Profit (Loss) (170098) (12889) Extract - Balance Sheet Non-current Assets Current Assets Equity Balance sheet Total Q report Income Statement Revenue for the first quarter 2012 amounted to NOK 73m of which NOK 27m was recognition of the upfront signing fee, NOK 26m was cost sharing and NOK 20m (EUR 2.6m) was the recognition of a milestone related to progress in the upgrade of the commercial production facility. In the first quarter last year, revenues amounted to NOK 56m, of which NOK 20m was recognition of the upfront signing fee and NOK 35m was cost sharing. Algeta s operating expenses, which exclude currency effects and interest income, for the first quarter 2012 amounted to NOK 64m compared with NOK 63m in the first quarter The largest cost element has historically been External R&D expenses but with diminishing activity in the ALSYMPCA trial, External R&D was down to NOK 22m (from NOK 35m in the same period a year ago). Payroll and related expenses were the largest cost element at NOK 30m as compared to NOK 20m in the same quarter last year. In connection with a potential launch of Alpharadin in the US, pending approval, Algeta has commenced operations but the current level of investment is currently not significant. Algeta s income statement shows a net loss of NOK 2m for the quarter compared with a net loss of NOK 6m for the same period last year. Balance Sheet and Cash Flow Algeta issued 2.1 million shares in a public offering in February and raised NOK 271m. As a consequence, cash and cash equivalents rose sharply from NOK 317m at the end of 2011 to NOK 527m at the end of the first quarter Cash and cash equivalents are all invested in bank deposits and money market funds. Property, plant and equipment rose from NOK 161m at the end of 2011 to NOK 180m at the end of the first quarter 2012, reflecting the ongoing upgrade of the IFE (Institute for Energy Technology, Norway) facility. Algeta had no interestbearing debt in first quarter As of 31 March 2012 liabilities totaled NOK 289m, of which NOK 144m represented deferred income from the agreement with Bayer, compared to NOK 352m year-end Net cash flow used in operating activities totaled NOK 28m in the first quarter 2012 versus NOK 58m in the first quarter The total number of outstanding shares as of 31 March 2012 was 42.5 million. The total number of outstanding share options as of 31 March was 2.1 million (vested and unvested). Below, extracts of Consolidated Income Statements and Balance Sheets for Algeta Q1-12 are presented. 6(10)

7 Extract - Income Statement Q1-12 Revenue Net profit (loss) before income taxes (2375) Net Profit (Loss) (2375) Extract - Balance Sheet Q1-12 Non-current Assets Current Assets Equity Balance sheet Total Important notice For further financial information about the Company, please refer to the Company s financial reports. Comments regarding recent development and forward looking statements please refer to the Annual and Quarterly reports and press releases as well as the Company s webpage. The accounting Policies [Q1-12 report] General information Algeta is focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform. These financial statements of the Company have been approved for issue by the Board of Directors on 2 May Basis of preparation This condensed consolidated interim financial information for the three months ended 31 March 2012 has been prepared in accordance with International Financial Reporting Standards as adopted by the European Union (IFRS). This condensed consolidated interim financial information should be read in conjunction with the annual financial statements for the year ended 31 December 2011, which have been prepared in accordance with IFRS. The interim financial statements are unaudited. For details regarding the accounting Policies during 2011, please refer to the Company s Annual Report of The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in the process of applying Algeta s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the consolidated financial statements are disclosed in Note 2. in the Q1-12 report. Going concern As a result of the co-promotion agreement with Bayer Pharma AG and the Algeta s current liquidity situation, the Directors have a reasonable expectation that Algeta has adequate resources to continue in operational existence for the foreseeable future. Algeta therefore continues to adopt the going concern basis in preparing its consolidated financial statements. 7(10)

8 Changes in accounting policy and disclosures (a) New and amended standards adopted by Algeta There are no IFRSs or IFRIC interpretations that are effective for the first time for the financial year beginning on or after 1 January 2012 that would be expected to have material impact on Algeta. (b) New standards, amendments and interpretations issued but not effective for the financial year beginning 1 January 2012 and not early adopted IFRS 9, Financial instruments, addresses the classification, measurement and recognition of financial assets and financial liabilities. IFRS 9 was issued in November 2009 and October It replaces the parts of IAS 39 that relate to the classification and measurement of financial instruments. IFRS 9 requires financial assets to be classified into two measurement categories: those measured as at fair value and those measured at amortized cost. The determination is made at initial recognition. The classification depends on the entity s business model for managing its financial instruments and the contractual cash flow characteristics of the instrument. For financial liabilities, the standard retains most of the IAS 39 requirements. The main change is that, in cases where the fair value option is taken for financial liabilities, the part of a fair value change due to an entity s own credit risk is recorded in other comprehensive income rather than the income statement, unless this creates an accounting mismatch. Algeta is yet to assess IFRS 9 s full impact and intends to adopt IFRS 9 no later than the accounting period beginning on or after 1 January IFRS 10, Consolidated financial statements builds on existing principles by identifying the concept of control as the determining factor in whether an entity should be included within the consolidated financial statements of the parent company. The standard provides additional guidance to assist in the determination of control where this is difficult to assess. Algeta has yet to assess IFRS 10 s full impact and intends to adopt IFRS 10 no later than the accounting period beginning on or after 1 January IFRS 12, Disclosures of interests in other entities includes the disclosure requirements for all forms of interests in other entities, including joint arrangements, associates, special purpose vehicles and other off balance sheet vehicles. Algeta has yet to assess IFRS 12 s full impact and intends to adopt IFRS 12 no later than the accounting period beginning on or after 1 January IFRS 13, Fair value measurement, aims to improve consistency and reduce complexity by providing a precise definition of fair value and a single source of fair value measurement and disclosure requirements for use across IFRSs. The requirements, which are largely aligned between IFRSs and US GAAP, do not extend the use of fair value accounting but provide guidance on how it should be applied where its use is already required or permitted by other standards within IFRSs or US GAAP. Algeta has yet to assess IFRS13 s full impact and intends to adopt IFRS 13 no later than the accounting period beginning on or after 1 January There are no other IFRSs or IFRIC interpretations that are not yet effective that would be expected to have a material impact on Algeta. For more details regarding accounting policies please refer to the Company s financial reports. Risks [Q report] Risk management and Internal Control 8(10)

9 The development of pharmaceuticals carries significant risk. Failure may occur at any stage during development due to safety or clinical efficacy issues. it cannot be predicted with certainty if or when Algeta will be able to submit an application to the regulatory authorities in the relevant markets. It can further not be assured that Algeta will receive marketing and regulatory approvals necessary to commercialize the final products, nor that Algeta and/or its partners will be successful in commercializing the product once on the market. Regulatory approvals may be denied, delayed or limited. In addition to clinical and regulatory risk, the major risk factors for Algeta during the next few years include timely upgrade of the commercial production facility, timely preparation of raw materials for production, the loss of various intellectual property rights and commercialization and eventually launch of Alpharadin together with Bayer. Currency risks in the development phase are managed by matching the main currencies with expected payments. To manage the Company specific risks and risk inherent in the industry, and to comply with international and national regulations, Algeta has implemented a regular process to identify, analyse and handle the main risk factors facing the Company. Three times per year, the audit committee receives a written report, highlighting the main risks and proposed actions to address these risks. Once a year the Board reviews and discusses the Company s risks. Risk management is further described under directors report and a discussion of Algeta s financial risk factors can be found in the Note 21 to the consolidated financial statements. For more detailed information on risks, please refer to the Company s latest Prospectus and also study the Company s other financial reports, and relevant sources. Liquidity It is not sure whether there at all times will be a high liquidity for the Company on NASDAQ OMX Stockholm s regulated market. The market price of the Company may fluctuate significantly depending on different factors. The market process of the Company s shares may fluctuate significantly which does not necessarily depend on the Company s success of its business operations or future forecasts. Lack of liquidity may partly depend on the fact that the market prices of securities may fluctuate more on NASDAQ OMX Stockholm in this case than on those exchanges where these securities are traded more actively. NASDAQ OMX Stockholm has the ambition to have several Liquidity Providers to mitigate this risk. Exchange rate The Company share s exchange rate on Oslo Stock Exchange is NOK. The trading on NASDAQ OMX Stockholm will take place in NOK. The Company s information obligation The Company has no information obligation regarding the current admission to trading of the shares at NASDAQ OMX Stockholm, neither based on the Swedish Securities Markets Act nor on NASDAQ OMX Stockholm s rules. However, by being continuously primarily listed on Oslo Stock Exchange s regulated market, the Company complies with the Norwegian legislation on information obligation and its home exchange s disclosure rules. The Company has no further obligation to disclose price sensitive information in Swedish language but the Company normally uses Norwegian and English language with regard to its disclosure practices. The Company s press releases and financial reports are generally available in Norwegian and English language. By having Norway as home member state, the Company is under obligation to meet Norwegian requirements on publication and storage of information in Norway s national information database for issuers (OAM) which is handled by Oslo Stock Exchange 9(10)

10 The availability of information on The Company The Company s website in English and Norwegian: Norwegian national storage regarding all price sensitive information published by companies whose shares are admitted to trading on a regulated market in Norway: The availability of this summary This summary is supplied by NASDAQ OMX on Information obtained from the external information sources and declaration on this summary The information on the Company originates from financial reports, press releases on financial accounts published by the Company as well as from the Company s investor web page. OMX Treasury AB has issued this summary which is based on information published by the Company. In accordance with the Swedish Financial Instruments Trading Act, chapter 2, section 15, OMX Treasury AB declares that it has accurately ensured, to such extend as appropriate, that the information in this summary is repeated appropriately and that no facts are omitted from the information in the summary that could result in that the repeated information in this summary would be misleading or inaccurate. According to the Swedish Financial Instruments Trading Act, chapter 2, section 14, sub-section 3, please note that any investor who commences judicial proceedings as a result of information in this summary may be compelled to pay for a translation of the document. 10(10)