Tomorrow’s Vaccines Today.

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TOMORROW’S VACCINES TODAY. METALLSTRASSE 4, 6300 ZUG, SWITZERLAND OFFICE PHONE: +41 (41) 7253230 OFFICE FAX: +41 (41) 7253239 www.amvac.eu [email protected] AMVAC: TOMORROW’S VACCINES TODAY Since its inception in 2005, AmVac has developed into a serious player in the vaccine sector combining powerful vaccine development platforms with one of the most innovative and advanced pipelines in this business. AmVac has: • exclusively acquired three unique technology platforms (Gynevac, Sendai Vector, MALP2) for the development of innovative vaccines. • built an advanced portfolio of six vaccine candidates, each of which is uniquely positioned in commercially attractive growth markets. • built a highly effective drug development organization with access to a dedicated manufacturing facility for the lead compound and a strong network of experts and service partners in the relevant disciplines of drug development and approval. • a well-managed IP portfolio with a strong IP position. • straightforward development plans with defined milestones. AmVac AG can be considered as a model case for the successful and efficient transfer of basic research results into the industrial development of a completely novel type of safe vaccine for a broad range of applications. Continued investment in vaccines is important to promote the public health contribution of these life-saving products and also represents an excellent opportunity to maximize return on investment The projections and predictions contained in this document relate to future facts. Such projections and predictions are subject to risks which cannot be foreseen and which are beyond the control of AmVac. Among other things, AmVac can offer no assurance that it will develop effective vaccines or therapeutics, obtain regulatory approval for its products, market or sell products based on its technologies, obtain or maintain patent protection for its technologies and product candidates or that technologies used by AmVac will not be subject to third party intellectual property rights. AmVac is, therefore, not in a position to make any representation as to the accuracy of economic projections and forward-looking statements or their respective impact on the financial situation of AmVac or the value of its shares, and is not under any obligation to update such information. In addition, information regarding market and industry statistics contained in this presentation is based on information available to AmVac and which AmVac believes is accurate. It is generally based on academic and other publications that are not produced for the purposes of securities offerings or economic analysis. AmVac has not independently verified this information, nor has it reviewed or included data from all sources, and it cannot give any assurance regarding the accuracy of the data it has included. Prospective investors should not rely on such data and information and AmVac cannot assume any responsibility for the accuracy of the market information and industry data contained herein. This presentation including all complementary documents are confidential and only for your personal information and analysis. You are not allowed to distribute them to third parties. Vaccines have emerged as one of the most profitable business segments in the healthcare industry. The global vaccines industry was valued at $24 billion in 2009, and is expected to reach $52 billion in 2016 at a Compounded Annual Growth Rate (CAGR) of 11,5% and is one of the fastest growing industries worldwide. 1 VACCINE DEVELOPMENT Gynevac Platform Product VACCINE DEVELOPMENT IS A LONG AND COMPLEX PROCESS. Vaccine development consists of three parts: basic research, a preclinical and a clinical phase. Clinical trials involve three steps: Phase I trials, usually on healthy volunteers, determine safety and dosing; Phase II trials are used to get an initial reading of efficacy and further explore safety in small numbers of patients; Phase III trials are large, pivotal trials to determine safety and efficacy in sufficiently large numbers of patients. • Produce an immune response? • Protect after viral challenge? Goals BASIC RESEARCH TO FIND A LEAD CANDIDATE PRECLINICAL • Safe? • Immune response? • Best dose? • Safe? • How much of an immune response? PHASE I PHASE II 20-50 People 100-300 People Status Target market Advantages AMV100 Gynecological infections mainly bacterial vaginosis (BV) and trichomonads: treatment and prevention of recurrence Phase III for EU Women AMV100 Secondary complications due to BV: Prevention of preterm birth/HPV/HIV/etc. Preparation of phase III Women No significant side effects. Infection rate recurrence only for 5% of the patients against 80% with competitive products. Full recovery bacterial flora No risk for antibiotics resistance AMV110 Chronic prostatitis/BPH: treatment Preparation of phase III Men over 50 and potential watchful waiting patients No siginificant side effects. Long term effect and highly effective (positive results for 91% patients in a pilot study) Superb safety levels • Sendai Vector Platform: a generation of prophylactic and therapeutic vaccines that combine ultimate safety with excellent efficacy. • Does it work? PHASE III The platform enables the generation of a new class of semi-live vaccines. The Sendai Vector system uniquely combines the efficacy of live vaccines with the ultimate safety of inactivated vaccines. Unique opportunity for effective protection of children, elderly or patients with impaired immune system who are not eligible for traditional treatment methods. The technology has been exclusively licensed in from Max Planck Innovation in Munich, Germany. It offers almost infinite opportunities as the Sendai Vector system can be combined with almost any antigen of choice to target a broad range of diseases. Sendai Vector Platform Product Participants Indication 2,000-10,000 People Indication Status Target market Advantages AMV602 Respiratory syncytial virus (RSV): Preparation of prophylaxe Phase I High risk population segments (e.g. children, elderly) Highly safe and efficient Potential market pioneer AMV611 Human parainfluenza virus type 3 Preclinical (PIV3) and RSV: prophylaxis Children Highly safe and efficient Potential market pioneer 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 YEAR OVER THE PAST 8 YEARS AMVAC HAS BUILT UP A BROAD PLATFORM AND PRODUCT PORTFOLIO. AmVac has established three powerful product development platforms: • Gynevac Platform: development of therapeutic vaccines against the most frequent urogenital diseases. The platform offers a new exceptionally safe and effective treatment modality to a broad range of urogenital conditions. It is based on a perfect blend of inactivated lactobacillus strains with the unique capability to stimulate the immune system against invading pathogens. The platform has already led to the successful launch of a marketed product in Hungary with overall experience from over 200,000 patients. • MALP2 Platform: a generation of adjuvants that can be combined with almost any vaccine to improve its efficacy and reduce its cost. Adjuvants are substances that are mixed with vaccines in order to enhance immune reaction of the body against the antigen (vaccine). An adjuvant increases vaccine efficacy and efficiency leading to significant cost savings and helping to prevent supply shortfalls, e.g. in flu seasons. With this adjuvant, Amvac meets a strong demand from vaccine developers around the world for new and better adjuvants. MALP2 is easy to produce, particularly effective and a versatile chemical compound. It is exclusively licensed in from the Helmholtz Center for Infection Research in Braunschweig, Germany. MALP2 Platform Product Indication Status Target market Advantages AMV411 Pandemic flu Preclinical High risk population Improved efficiency with decreased antigen segments (e.g. Potential, vaccine rate can be increased children, elderly) Needle free application AMV401 Seasonal flu Preclinical High risk population segments (e.g. children, elderly) Under analysis 3 AMV110 MARKET POTENTIAL FOR AMVAC’S MOST ADVANCED PRODUCTS AMV110 is a lactobacillus-based vaccine candidate designed for the treatment of chronic prostatitis/ benign prostate hyperplasia (BPH). The product successfully completed a clinical phase II trial in Hungary involving 100 patients with chronic prostatitis/benign prostate hyperplasia (BPH). Results were highly encouraging: 91% of patients reported decreased symptoms and increased quality of life. Remarkably, no undesired side-effects such as decreased libido or hypotension occurred. Benign prostate hyperplasia (BPH) is manifested by tissue hyperplasia, which is caused by a loss of regulatory control of prostate cells. BPH affects ~50 million men aged over 50, and more than 33 million of these men suffer from moderate to severe Symptoms. BPH is currently treated with either alpha-blockers and/or 5-alpha reductase inhibitors, each with significant side effects. Approximately 20% of patients receiving treatment suffer from side effects that lead patients to discontinue therapy. Chronic prostatitis is an extremely painful condition, which afflicts over 50% of adult men during their lifetime. Men suffering from prostatitis often experience intense pelvic pain with frequent, urgent and painful urination and sexual dysfunction. The underlying cause of the disease is not well understood. Current therapies are deemed inadequate. Urologists have identified chronic prostatitis as an area of high unmet need, resulting in a significant opportunity for an effective new treatment. The Benign Prostatic Hyperplasia Market, 2004-2014: Key Statistics United States Prevalent population Market ($MM) 2004 2014 18.9 m 22.7m 974.9 1,650.9 Europe Prevalent population Market ($MM) When men have the symptoms of BPH or enlarged prostate such as frequent urination, they are interrupting their life constantly, - whether they are at a football game, on the golf course or out fishing - because they have to use the bathroom. AmVac can help them with product candidate AMV110, so these men can get back to their lives with no interruption. Almost infinite market opportunities 2004 2014 28.5 m 32.2m 991.4 1,296.9 Japan 2004 2014 Prevalent population 8.4 m 9.2m Market ($MM) 645.4 768.8 Note: Estimates for Europe cover France, Germany, Italy, Spain and United Kingdom Source: Decision Resources, Inc. 5 AMV100 – THERAPEUTIC LACTOBACILLUS VACCINE FOR GYNECOLOGICAL INDICATIONS AMV602 - RSV The product gained regulatory approval in Hungary in 2006 meeting EU requirements for the treatment of acute, subacute and chronic gynecological inflammations caused by bacteria and trichomonads. It has since been applied successfully to over 200,000 patients, with long-term positive clinical outcome and not a single case of severe side-effects. AmVac is currently preparing dossiers for market authorization in the EU, US and other countries, based on the Hungarian approval. Additional observatory studies show efficacy for further indications. An EMA compatible phase III trial with AMV 100, related to pre-treatment of patients undergoing in vitro fertilization, is on-going. The global market for topical BV treatments alone is estimated at approximately US$350M. AmVac’s modeling suggests, the addressable global market for prevention of recurrence of BV is potentially in excess of $1 billion, due to the long-term usage associated with such a product. AMV602 is AmVac’s first vaccine based on the Sendai Vector platform. This platform allows the development of different vaccines that are safe and very efficacious at the same time. RSV is the most important cause of viral lower respiratory tract illness in infants and children worldwide, being responsible for a large number of hospitalizations due to pneumonia or bronchiolitis every year. In the USA approx. 25% of hospitalized pneumonia cases in children and approx. 70% of hospitalized bronchiolitis cases in children are attributable to RSV infections. In the USA alone it is estimated that RSV infections are responsible for approx. 126,000 hospitalizations of infants per year. The global RSV disease burden is estimated at 64 million cases and approx. 160,000 deaths every year (source: WHO, Acute Respiratory Infections (Update February 2009)). The size of the target population for prophylactic RSV vaccination is about 81.3 million people in the USA, about 87.1 million people in the 5 major European markets (Germany, France, Italy, Spain, U.K.), and about 38.1 million people in Japan (Source: Datamonitor Stakeholder Opinions: Respiratory Syncytial Virus (RSV) Infection. 2006). For details see the table below Elderly Incidence: 94 million pa in the five major EU countries, US and Japan Secondary infection/ complication Risk increase HIV* 25% thereof candidiasis 25% thereof trichomoniasis Gynecological complications Pelvic inflammatory disease* Post abortion infection* 50% thereof Post hysterectomy infection* Cervicitis bacterial vaginosis Obstetrical complications Amniotic fluid infection* Chorioamnionitis* Postpartum endometritis ** Preterm birth ** 2-4 fold * Proven relation to bacterial vaginosis ** Strong epidemiological relation to bacterial vaginosis Risks: Vaginal infections are door-openers to serious secondary infections such as HIV and are the main cause of preterm birth. Secondary infections and complications open additional potential markets for AmVac: Overall, approximately 10%-15% of all births are pre-term births. In approximately 70% of all cases of pre-term birth vaginal infections have been diagnosed. Pre-term birth is a major economic, emotional and social burden leading to high lifetime costs. The direct costs during initial hospitalization in Germany alone are estimated to be 1.6 billion Euros per year. Premature infants Total 37’196 22’929 20’639 527 81’291 Japan 25’534 6’463 6’055 96 38’148 Germany 16’018 4’546 3’542 68 24’174 9’998 3’329 3’740 73 17’104 11’450 3’236 2’632 51 17’370 Spain 7’170 2’205 2’023 39 11’437 U.K. 9’564 4’031 3’280 65 16’940 116’930 46’739 41’911 919 206’464 Italy Total 2-7 fold 2-7 fold 3-16 fold 2-7 fold Children < 4 years of age USA France 9 fold 2 fold 3-4 fold in 50% Adults with cardiopulmonary disease Size of the target population for a prophylactic RSV vaccine in thousands The target population in only the seven major markets is 206 million people. At a vaccination rate of 25% this could result in annual peak sales for a RSV vaccine of CHF 1.85 Billion. 7 AmVac has a balanced portfolio of proprietary technologies and innovative vaccine candidates, with one candidate already approved for specific markets. AmVac received the following prestigious grants in recognition of its on-going vaccine research efforts: AmVac is well backed by 1st tier private investors, who have so far provided total funding of CHF 28.7M in various financing rounds during 2005-2011. AmVac is now ready to initiate the next development steps that will trigger an upsurge in commercial value: • Obtaining market approval for its lead products in EU core markets (and subsequent partnering) • Start of EMA compatible phase III trial with AMV110 (chronic prostatitis) • Start of EMA compatible phase III trial with AMV 100 related to pre-treatment of patients undergoing in vitro fertilization • Execution of clinical phase I/IIA in humans for the RSV vaccine • Preclinical test of MALP2 combined with an influenza vaccine and subsequent clinical phase I Research grant for AmVac Research GmbH Start of the approval process for Gynevac Foundation of AmVac Kft. Start building-up a dedicated, modern, state-of-the-art production facility for Gynevac Preclinical proof-of-concept for first Sendai Vector-based product candidate Renewal of exclusive licence agreement for the MALP2 platform With these proceeds, AmVac expects to reach a crucial value inflection point by attaining significant product development milestones anticipated up from 2014. Foundation of AmVac AG Frost & Sullivan’s Enabling-Technologyof-the-Year-Award Foundation of AmVac Research GmbH Acquisition of Gynevac rights Renowned experts join AmVac’s board: Prof. Dr. Carlos Guzmann, Foudation of FranVax Srl Prof. Dr. Wolfgang Neubert, EPO approval of MALP2 Prof. Dr. Reinhard Glück related patents Acquisition Sendai Vector rights Acquisition of MALP2 rights Regulatory approval for the laboratories of AmVac Research GmbH (class S1 and S2) Foundress AmVac AG, entrepreneur; a long experience in start-up and development companies (medtech, biotech and IT industry). Current role at AmVac: overall responsible & general management. Thomas Schletter Chief Operations Officer, Dipl. Ing. Chemie, MBA, langjährige Erfahrung in Pharma-Rx & Biopharma-Industrie für General & Commercial/M&S/Market Access Management inkl. Impfstoffe bei u.a. bei Wyeth/Pfizer, Daiichi-Sankyo, Sanofi Pasteur MSD Dr. George Kavkasidze Head of Marketing and Business Development; Medical doctor, with academic degree of PhD. Almost 20 years operational experience in multicultural environment, including 16 years in marketing and sale of biotechnology products (Serono and Merck-Serono). Developer of several marketing and promotional projects, contributing to double digit sales growth. Ferenc Zimonyi Former CEO of Omninvest (No. 1 Hungarian flu vaccine producer). Under his direction a H5N1 pandemic mock-up vaccine was developed, which ensures safe and effective protection with a single vaccination, and with low antigen content. During the 2009 flu pandemic, the company’s swine-flu vaccine was among the very first ones which were granted marketing authorization in Europe and was used for mass-vaccination of the Hungarian population. Prof. Dr. Reinhard Glück International vaccine expert, former president of Swiss Biotech Association, currently CSO at Zydus Cadila Prof. Dr. Carlos A. Guzmán Head Vaccinology, Helmholtz Centre for Infectious Diseases, Braunschweig/ Germany Prof. Dr. Wolfgang J. Neubert Head Research Molecular Virology, Max Planck Institute of Biochemistry, Martinsried/Germany Dr. med. Ladislav Prikler Direction Uroviva, Centre of Urology in Bulach and Clinic Hirslanden, Switzerland AMVAC IS WELL PREPARED TO TAKE THE NEXT KEY STEPS AmVac Research GmbH*, Martinsried / Munich, Germany • 550 m2 R&D facility • BSL1 & BSL2 laboratories • Research and development of Sendai and MALP platforms and related projects AmVac AG, Zug, Switzerland (headquaters) • General management, finance, project coordination and administration *100% subsidiary of AmVac AG AmVac Kft*, Budapest, Hungary • Coordination of production, clinical development and regulatory approval of Gynevac • Supporting the approval and management of Gynevac production facility in Hungary, which is operated by Vakcina Kft and financed by AmVac AG FranVax Srl*, Catania, Italy • 240 m2 R&D facility • BSL1 standard laboratories, animal facilities • Immunological research and preclinical services for Sendai, MALP and Gynevac EU – Leishmania vaccine (consortium) EU – Universal Flu vaccine (consortium) Bayerischen Forschungsstiftung – Sendai/RSV Recruitment of three experts with long-standing experience in the production, quality assurance and licensing of vaccines. Recruitment of an internationally experienced marketing and business development manager to lead commercialization activities. Melinda-Kinga Kárpáti CEO EPO approval of Sendai Vector related patents AmVac has an established infrastructure and organisation while maintaining lean cost structure Continued progress with the development of the Gynevac platform. 9 EXIT STRATEGIES 1. Generating Revenues Product 3. IPO Indication Partnering status Commercial strategy Market opportunity At the moment there is no urge for AmVac to go to the stock market, but it has to be considered in the future if there is a possibility on the market. Such a potential IPO could take place at the SIX Swiss Exchange in Zurich (SIX). AMV100 for bacterial vaginosis (BV) Treatment Prevention of recurrence Internal Internal Sales income to BPh Sales income to BPh US $ 300-350 Million Estimated >US $ 1 Billion AMV100 for secondary infections/ complications due to BV Prevention of preterm birth/ Internal HPV/HIV/etc. Sales income to BPh US $ 3-6 Billion AMV110 for chronic prostatitis/BPH Treatment Sales income to BPh > US $ 10 Billion Internal Even with conservative projected market penetration rates AmVac should be capable to create revenues of 400 Mio CHF in 2019. The advantages of having a listing at the SIX are: • Zurich is a strong international financial centre with global leading banks. • Investment banks are locally positioned with well established research and a strong placement power. • Every IPO gains high attention. 2. Out-License Deals 4. Trade Sale Sendai Vector, RSV vaccine Another alternative is a Trade Sale. Many experts estimate that the next 24 months are the best time for a Trade Sale with Big Pharma. Product Indication Partnering status Commercial strategy Market opportunity AMV602 for respiratory syncytial Prophylaxis Internal virus (RSV) License out after Phase I/Iia US $ 1,9 Billion Further vaccines on the base of the Prophylaxis Internal Sendai Vector plattform License out after Phase I/Iia US $ > 10 Billion If the vaccine is safe and has an effect in humans it will represent a potential multi-billion $ market. Therefore there is a high possibility that Big Pharma will pay for a license, at least CHF 30,- million to CHF 50,- million in upfront cash, plus CHF 400,- million to CHF 500,- million in milestone payments based on future success in development. A trade sale can offer successful private biotech companies a higher return on investment in a shorter time than an IPO. Therefore trade sales have become an established alternative for the biotech sector. Trade sales have been growing, in terms of both deal frequency and the size of private biotech acquisitions. EXCELLENT OPPORTUNITY TO MAXIMIZE RETURN ON INVESTMENT But if AmVac can strike one of these straightforward licensing deals, investors who take the risk of backing AmVac will only have to wait two to three years, and could then be rewarded with a significant return on their investment from the upfront cash payment alone. Beyond that, the investors still have room for greater upside returns if the drug continues to progress. 11 This fits in with the idea that if you have chronic inflammation someplace, you’re at greater risk for negative health outcomes, in this case preterm birth. Raymond White President & Chief Executive Officer United Validation & Compliance Services, Inc Watseka, IL This is consistent with previous epidemiologic and genetic research that has suggested that prostate cancer may result from chronic inflammation, perhaps as a response to infection. Eric A. Klein MD, a thought leader in the biology and management of prostate cancer, has been appointed chairman of the Glickman Urological & Kidney Institute If we can use one-fifth of the vaccine along with an adjuvant, then the vaccine will go five times farther allowing that many more people to be vaccinated. Kathryn Edwards M.D., professor of Pediatrics, vice chair of Pediatric Research The rapid development and enormous potential of biotechnology and life science have greatly contributed to the fight against diseases and safeguard of health by mankind. Hu Xiaodi Ambassador of the Republic of China