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2011 Annual Report

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2011 Annual Report streamlined. 2 0 1 1 / Annual Report Intercell AG page 2 company group management report financials 04 Shareholder Information 16 Products and Programs 40 Auditor‘s Report 05 Intercell at a Glance 22 Technology Platforms 42 Consolidated Financial Statements 06 Letter from the CEO 24 Partnerships, Collaborations 74 Declaration by the 07 Management Board and Stakeholders Management Board 07 Supervisory Board 26 Locations 74 Financial Calendar 2012 08 Corporate Governance Report 27 Social Responsibility at Intercell 75 Contact Information 31 Financial Review 2011 75 Imprint 33 Internal Controls 34 Risk Factors 36 Disclosures acc. to sec. 243a of the Austrian Commercial Code 37 Operational and Strategic Outlook 2012 37 Events after the Balance Sheet Date FORWard–lOOKING STATEMENTS or development are consistent with the forward-looking ments. In particular, the Company‘s expectations could be These materials contain certain forward-looking statements statements contained in this annual report, those results affected by, among other things, uncertainties involved relating to the business of Intercell AG (the „Company“), or developments may not be indicative of the Company‘s in the development and manufacture of vaccines, unex- including with respect to the progress, timing and comple- results or developments in the future. In some cases, you pected clinical trial results, unexpected regulatory actions tion of the Company‘s research, development and clinical can identify forward-looking statements by words such or delays, competition in general, the impact of the global trials for product candidates, the Company‘s ability to as „could,“ „should,“ „may,“ „expects,“ „anticipates,“ credit crisis, and the Company‘s ability to obtain or maintain manufacture, market, commercialize and achieve market „believes,“ „intends,“ „estimates,“ or similar words. These patent or other proprietary intellectual property protection. acceptance for product candidates, its ability to protect forward-looking statements are based largely on the Com- In light of these risks and uncertainties, there can be no its intellectual property and operate its business without pany‘s current expectations as of the date of this annual assurance that the forward-looking statements made dur- infringing on the intellectual property rights of others, report and are subject to a number of known and unknown ing this annual report will in fact be realized. The Company the Company‘s estimates for future performance and its risks and uncertainties and other factors that may cause is providing the information in these materials as of this estimates regarding anticipated operating losses, future actual results, performance or achievements to be material- date, and we disclaim any intention or obligation to publicly revenues, capital requirements and its needs for additional ly different from any future results, performance or achieve- update or revise any forward-looking statements, whether financing. In addition, even if the Company‘s actual results ment expressed or implied by these forward-looking state- as a result of new information, future events or otherwise. * Content Chapter company 01 thomas lingelbach, ceo / “Our strategy is based on our extraordinary capabilities, key assets and our strong ability to develop and commercialize novel vaccines with high unmet medical need. Moreover, we are a biotech company with several product candidates in clinical development and – notably – a first product on the market.” page 3 / Annual Report Intercell AG 2011 page 4 SHAREHOLDER INFORMATION share performance intercell ag (2011-01-01 – 2011-12-31) financial position Development of Intercell’s share price/ATX • IXIARO®/JESPECT® product sales growth of 100% EUR 8.8m, or 68.4%, from EUR 12.8m in 2010 to EUR 21.6m in 2011 10 • Total revenues of EUR 32.9m in 2011 compared 80% to EUR 34.2m in 2010, due to lower collaboration 8 revenues 60% • Reduction of R&D expenses by 60.0% to 6 EUR 29.9m and reduction of SG&A expenses by 20.1% to EUR 15.8m 40% 4 • Net loss of EUR 29.3m in the year 2011, compared to EUR 255.2m in 2010 20% 2 • Cash position of EUR 50.9m at year-end Develop- EUR ment 2011 Jan Feb Mär z April Mai Juni Juli Aug Sept Okt Nov Dez ATX Intercell share Source: Wiener Börse AG & Interactive Data shareholder structure GSK 1.9% Treasury Shares 0.6% Management 0.3% Novartis 14.9% Free float 82.3% For further information please contact Intercell Investor Relations, [email protected] Shareholder structure as of December 31, 2011 T +43-1-20620 Numbers of shares issued: 48,592,219 Chapter01 Shareholder Information Chapter 01 Intercell at a Glance INTERCELL AT A GLANCE Intercell is listed on the Vienna Stock Exchange under key strengths Intercell AG is a vaccine-biotechnology company with the the symbol "ICLL" and has a U.S. level 1 ADR program • Marketed product with growing revenues clear vision to develop and commercialize novel immu- (symbol "INRLY"). • Diversified pipeline with Pseudomonas Phase II/III nomodulatory biologicals to prevent disease and reduce project and multiple other product opportunities suffering across the world. The Company is focused on For further information, please visit our website: • Combination of proprietary technology platforms gen- research, development, manufacturing, and commercia- www.intercell.com erating novel product candidates lization of innovative vaccines and monoclonal antibo- • Strategic partnerships with leading global players dies. Our product portfolio contains a marketed product against Japanese Encephalitis, several product candida- tes in clinical development, and additional candidates in pre-clinical development. organizational chart – intercell group The Company's technology base includes novel platforms, Intercell AG such as the patch-based delivery system and the pro- prietary human monoclonal antibody discovery system eMAB®, in addition to well-established technologies upon which Intercell has entered into strategic partnerships with Intercell AG Intercell Biomedical Ltd. Intercell USA, Inc. a number of leading pharmaceutical companies, including Vienna, Austria Livingston, Scotland Gaithersburg, MD, USA GSK, Novartis, Merck & Co., Inc. (Whitehouse Station, USA), and Sanofi. General & General & General & A prophylactic vaccine to prevent Japanese Encephalitis Administration Administration Administration (JE) – IXIARO®/JESPECT® – is the Company's first product on the market. This is a next-generation vaccine against Research & Manufacturing Sales & Marketing the most common vaccine-preventable cause of Encepha- Development of JE vaccine* of JE vaccine* litis in Asia licensed in more than thirty countries. Intercell AG's corporate headquarters, research and deve- Technical lopment functions and multi-purpose laboratories are Operations based in Vienna, Austria. In addition, we have a manufac- turing site for our JE vaccine in Livingston, Scotland. Our Corporate offices in Gaithersburg, Maryland, U.S., together with our Headquarters distribution partner Novartis, focus on expanding direct * Japanese Encephalitis vaccine, IXIARO®/JESPECT® selling resources of IXIARO®/JESPECT® to increase penet- ration in key markets. Intercell AG also conducts research Research Intercell Biomedical Ltd. and Intercell USA, Inc. are wholly owned in Schlieren, Switzerland, in connection with the platform (eMAB®) subsidiaries of Intercell AG. technology for monoclonal antibody discovery. Schlieren, Switzerland In Schlieren, Switzerland, Intercell AG has branch activities. page 5 page 6 LETTER FROM THE CEO co-financing arrangement for our Pseudomonas Phase II/III I think it is also important to point out that Intercell has dear shareholder, trial with Novartis and received a milestone payment from progressed one of its fundamental public health com- The past year was a very challenging and demanding one Merck & Co., Inc. for the S. aureus vaccine development mitments as a vaccine manufacturer, that is to bring this for Intercell. We had to deal with major setbacks follow- program, despite the termination of the study. potentially life-saving vaccine at an affordable price to the ing the disappointing results of the Travelers’ Diarrhea people in the endemic markets in Asia through our con- Phase III trial and Merck & Co., Inc.’s decision to discon- The execution of Intercell’s renewal strategy also includes tinued collaboration with Biological E. Ltd. in India. Our tinue the Phase II/III S. aureus program. The consequences significant cost cutting and re-structuring measures. Within announcement in November 2011 regarding the approval were a negative share price development and an all-time the last six months we managed to implement and finalize in India for the Japanese Encephalitis vaccine based on low for Intercell’s share price. Having served the Company a rigorous consolidation path as well as cost reduction pro- Intercell’s modern, cell culture-derived technology can for more than five years, I took over as CEO at one of the cesses. As part of this reorganization, it was necessary to be considered to be one of the greatest milestones in the most difficult times in Intercell’s history. However, I would reduce our total workforce – mainly at the sites in Vienna and decade-long development of this vaccine. not have accepted the challenge of leading this Company in the U.S. – by approximately one third. This was the most without believing in its future and potential. Therefore, as difficult decision for me as the new CEO of Intercell, because
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