Strategic Research Institute, Doubletree Paradise Valley Resort- Scottsdale, AZ
March 29-31, 2005
Tuesday, March 29, 2005 (Day 1)
7:15 - 8:30
Pre-Conference Workshop Registration & Networking
8:30 - 1:30
WORKSHOP #1: VALUING TECHNOLOGY & NEGOTIATING THE DEAL
Considerable demand has been expressed to provide a Valuation workshop that goes into considerable detail regarding the methodologies used to achieve a valuation analysis. This workshop will give examples of valuation analysis for early stage gene company, a value added drug delivery technology and a mid-stage (Phase II In the light of the recent wave of partnering or merger activity in the biotechnology/ pharmaceutical area), technology valuation continues to be a key area of interest and importance. In addition, valuation continues to impact business development negotiations is the key focus with a special emphasis on intellectual property and a licensing portfolio. Active discussions through panels address key issues that are important in the valuation and negotiation processes that are part of forming and maintaining strong strategic alliances. You learn: How small companies and big pharma recognize a Bio/Rx fit. How to deal with key issues in negotiations: risk, milestones, and control, deal structure. How to identify and research due diligence items of importance: legal, patent, financial, management, technology and products. The major methods used to value technologies and the pros and cons of each.
Putting Your Learning to Practice
The second segment of the workshop is a hands-on session in which participants are divided into interactive opposing teams. Each group is given a set of conditions with the objective to finalize a deal structure acceptable to all partners involved. Each team evaluates a specific licensing opportunity. Each group then presents their individual solutions to the entire group and in doing so, further highlight specific issues of importance in valuing technology for partnering. This workshop is designed with models and case studies to promote group participation and allow plenty of time to ensure that your most pressing questions are answered.
About your Distinguished Workshop Leaders: Howard Wachtler is a Managing Officer of QED Technologies Inc., a life science based strategic consulting and transactional group. Mr. Wachtler is a senior health care industry executive, who brings with him more than twenty-five years of broad-based and diversified experience in venture capital, business development, strategic planning, and sales and marketing management. Mr. Wachtler directed Business Planning and Development for Pfizer, Inc. Hospital Products Group with responsibility for business/strategic planning, acquisitions, strategic alliances, licensing and venture programs for the division and corporate management worldwide. Prior to his tenure at Pfizer, Mr. Wachtler directed Corporate Development for Organon, Inc., where his responsibilities included the identification, evaluation, and consummation of acquisitions, new ventures, and technologies opportunities for all divisions of the company. He is a frequent speaker at industry meetings and has lectured and taught undergraduate and graduate le vel courses. In addition, he currently serves on the Editorial Advisory Board of Drug Delivery Technology magazine and is a regular contributor. Dragan Cicic is a Project Director with QED Technologies Inc., a life science based strategic consulting and transactional group. Dr. Cicic has worked in a number of health care related roles, ranging from that of a Medical Doctor to strategy consultant to health care investment banker. Prior to joining QED Technologies, Dr. Cicic was an investment banker with SG Cowen Securities, a New York subsidiary of SocietË General, a Paris based multinational banking organization and one of the largest in the world. At SG Cowen, Dr. Cicic specialized in Health Care Mergers and Acquisitions.
12:30 - 1:30
Registration for Pre-Conference #2 and Networking
1:30 - 2:30
A Light Lunch Will Be Served to All Workshop Attendees in Workshop Area
2:30 - 5:30
WORKSHOP #2: LICENSE ENGINEERING: FINANCIAL EVALUATION AND OPTIMUM DEAL STRUCTURING FOR LICENSING OPPORTUNITIES
With an increasing numbers of biotech companies seeking to generate cash from their projects early and the need of big pharma to create well balanced portfolios, licensing activities become more and more important. Drafting favourable licensing agreements and the valuation of licensing terms requires an in depth understanding of the projects considered. The risk of failure in the development process as well as the commercial potential of licensing opportunities has to be assessed and integrated in the evaluation. Through lectures, case-studies and practical exercises this workshop will show you how evaluate licensing opportunities. The workshop will help you appreciate the advantages of financial modelling, will enable you to value highly uncertain cash flows, and will improve your ability to draft value maximizing term sheets. Valuation Principles Practice discounted cash flow analyses Calculate Net Present Values (NPVs) Exercise - Participants will calculate the NPV of a cash flow stream. Evaluating a Pharmaceutical Project Understand why traditional NPV does not properly value pharmaceutical projects Learn to apply augmented NPV Integrate R&D risk in your analysis Estimate outcome probabilities based on expert judgement and benchmarks Take advantage of continuous probability distributions to model commercial risk Learn how to build a market model Analyze competitors and estimate market shares Arrive at reasonable cash flow forecasts Use Monte Carlo simulations to assess feasible scenarios and sensitivities Identify the most significant value drivers Exercise - Delegates will create a probability tree and assess the value of an R&D project. Increasing the Value of a Pharmaceutical Project Explore alternative R&D and marketing strategies Improve risk analysis and risk management Make educated decisions based on the value analysis
Case Study
A value assessment for alternative R&D strategies will be demonstrated and discussed.
Maximizing Value from Licensing Agreements Create state of the art license models Identify and analyze comparable agreements Re-engineer deals and assess the value created for each partner Find the optimal structure for your licensing agreement Get the right balance between upfront payments royalties options equity milestone payments
Case Study
A term sheet will be analyzed during the workshop.
THE PARTICIPANTS ARE STRONGLY ENCOURAGED TO TAKE THEIR LAPTOPS TO THE WORKSHOP! Workshop Leader: Kirsten Bode-Greuel, MD is founding partner of Bioscience Valuation BSV GmbH, a consulting company that focuses on project, portfolio, license and company valuations, deal structuring, and market modeling. Joachim began his professional career as head of a research team at Bayer AG. Before founding Bioscience Valuation BSV GmbH, he was investment manager at a Swiss Venture Capital Fund. In this function, Joachim analysed projects of numerous biotech companies. Contact information: Tel: +49 8821 966979-0,email: contact@bioscience-valuation.com
5:30 - 7:00
WELCOMING NETWORKING RECEPTION
Wednesday, March 30, 2005 (Day 2)
7:15 - 8:20
Registration & Networking
8:20 - 8:30
Chairs' Opening Remarks
Phyllis Gardner, M.D.
Associate Professor of Medicine
STANFORD UNIVERSITY SCHOOL OF MEDICINE Carolyn Siegal
Executive Vice President, Corporate Partnering & Strategic Planning
CATALYST PHARMACEUTICAL RESEARCH LLC
8:30 - 9:05
Butchers, Jelly Beans, and Stocks: What Wall Street Can Teach Pharma About Improving Profitability
Despite slowing growth and new regulatory hurdles, exciting and sometimes unconventional new ways to improve corporate strategies to enhance profitability are emerging. These approaches can provide tools to better select compounds for development, choose and value partnerships to enter, and identify markets in which to expand. Market-based approaches and behavioral studies have not only been used successfully on Wall Street, but also to predict Hollywood box office hits and bombs, and have proven to be highly accurate predictors of elections results! A few companies are already using market-based approaches in an effort to gain an edge in the increasingly competitive, globalized, and changing pharmaceutical economy. This audience-interactive talk will address the new concepts and applications and will provide surprising revelations for the future of the industry. Stefan Loren, Ph.D.
Managing Director
LEGG MASON
9:05 - 9:40
Potential Implications of the Vioxx and Celebrex Fallout on Licensing Deals
The Vioxx situation is bound to have effects on our industry. While we will not have a complete understanding of these effects for some time, there are some that can be predicted. Certain of these effects, in turn, could have implications for licensing deals. What will be the fallout from Vioxx? What are the potential implications for licensing deals? Scott Foraker
Vice President, Licensing
AMGEN
9:40 - 10:10
Corporate Partnering in Life Sciences 2005– A Venture Capital Perspective
Learn how to structure your corporate collaborations to drive shareholder value and reduce the cost of capital. This leading venture capitalist will illuminate the key elements of various development deals that attract investors and improve your valuation. Tim Howe
Partner
CHL MEDICAL PARTNERS
10:10 - 10:55
Networking
10:55 - 11:25
Globalization of R&D Through Effective Partnerships
While R&D activities still predominantly occur in the West, there is increasing evidence that countries, especially in Asia, are building capability to conduct many of these activities. This talk presents the experiences of the Novartis Institute for Tropical Diseases (NITD) located in Singapore, focusing on globalization of R&D through effective partnerships. Mae Shieh
Head, Global Partnerships
NOVARTIS INSTITUTE FOR TROPICAL DISEASES
11:25 - 11:55
US Healthcare– A Pharmaceutical Perspective
In this talk, key trends in US healthcare and how they relate to pharmaceutical opportunities and threats will be addressed. Additionally, strategic options for pharmaceutical companies and how those trends might effect Business Development activities will be explored. Juergen Lasowski, Ph.D.
Head of Business Development and Strategy, North America
SANOFI-AVENTIS
11:55 - 12:25
Where Will the New Product Partnering Opportunities Come From and Who Will Pay for Them?
Independent Biotech/BioPharma companies are a primary source of innovation in drug development. At the same time, the cost to develop new drugs continues to expand, and the capital markets increasingly require companies to remove as much of the risk of drug development as possible prior to accessing public capital. This talk will examine how independent drug development companies obtain funding and how the process has evolved, including accessing private and public capital and how potential partners should view financing windows. George J. Milstein
Head of Investment Banking
PACIFIC GROWTH EQUITIES, LLC
12:30 - 1:45
Networking Luncheon
Cash-Free Licensing of University Technologies UTEK® Corporation enables publicly traded companies to rapidly acquire innovative technologies from universities and research laboratories. Our business model is both simple and elegant: First, we form a strategic alliance and learn about your business. We then find, acquire and finance new technologies for you from the best universities and research centers worldwide. Second, we enable your firm to acquire this technology from us for unregistered stock. The result is a world of new opportunities to grow and expand your company's intellectual capital. Jeff Bleil
Chief Technology Officer
UTEK CORP.
1:45 - 2:15
TRACK A: Blockbuster Multiple Product CNS Co-Development and Co-Promotion Deal
In the first quarter of 2004, Wyeth and Solvay Pharmaceuticals entered into a complex partnership involving five compounds in the areas of schizophrenia and depression. The deal involves the codevelopment and co-promotion of one phase lll and three phase ll compounds from Solvay, and the copromotion of Wyeth's blockbuster product drug for depression, Effexor in the U.S. The agreement was consummated with a $145mm signing fee. The rationale, goals, structure, and scope of this landmark partnership will be discussed. Theodore R. Koziol, Ph.D.
Vice President, Global Business Development
WYETH PHARMACEUTICALS Ed Schutter
Vice President, Business Development
SOLVAY PHARMACEUTICAL MARKETING AND LICENSING AG
1:45 - 2:15
TRACK B: Quantitative Deal Structuring for the Life Science Industry: Accurately Aligning Deal Value & Risk
The structure of collaborative business agreements is critical for all organizations in the life science industry. Yet, executives commonly structure these deals using comparable business deals as models. However, it is to the strong advantage of company shareholders that management understands the inherent value and risk of their products at various developmental stages. Most importantly, the structure of all collaborative agreements a company enters into should accurately embody these value and risk determinations. This is precisely what quantitative deal structuring allows and empirical deal making does not. Furthermore, agreements can be financially structured that align collaborative incentives resulting in a deal with the highest priority for each participant, a win-win business proposition. Charles T. Hardy, Ph.D., MBA
Principal
BIOVALUATION & ANALYSIS
2:15 - 3:30
TRACK A: Neuroscience Licensing: What's Different?
Neuroscience therapeutics, with $73 billion (WW, 2003) are second only to CV drugs in sales. Only oncology comes close to neuroscience, in terms of the number of new products in development. Given the potential rewards and R&D activity, neuroscience would seem to be a fertile area for deal making. But is it really different than other therapeutic areas, in this regard? What, if anything, is different about the world of neuroscience licensing? What are the trends, and where is neuroscience deal-making going? What's hot, and what's not? MODERATOR: Gary King, Ph.D.
Senior Director
BRISTOL-MYERS SQUIBB PANEL: Kevin Gorman
Sr. Vice President, Business Development
NEUROCRINE BIOSCIENCES, INC. Theodore R. Koziol, Ph.D.
Vice President, Global Business Development
WYETH PHARMACEUTICALS James Schaeffer, Ph.D.
Executive Director, Licensing and External Research San Diego
MERCK RESEARCH LABORATORIES Ed Schutter
Vice President, Business Development
SOLVAY PHARMACEUTICALS Mitchell Weinberger, Ph.D.
Scientific Director, Worldwide Business Development
ORGANON INTERNATIONAL, INC. Richard Weinshank, Ph.D., MBA
Vice President, U.S. Business Development & Licensing
LUNDBECK, INC. Jeffrey A. Witcher, Ph.D.
Evaluations Director, Licensing Neuroscience
ASTRAZENECA PHARMACEUTICALS LP
2:15 - 3:30
TRACK B: Oncology Licensing & Partnering; Where Are the Opportunities in 2005?
This therapeutic class is an R & D hotbed with lots of compounds and drugs coming from biotech, particularly in the monoclonal antibody area, here and abroad. Coupled with small molecules and a flurry of NDAs and approvals over the last year and many more molecules in trials, one can reasonably surmise that there will continue to be very active deal-making in this sector. What are the hot areas and what kinds of deals are being inked? MODERATOR: Robert Schwartz, Ph.D.
Director, Oncology Licensing
BRISTOL-MYERS SQUIBB PANEL: Andrew Iyer, Ph.D., Esq (invited)
Senior Director, Biopharma Licensing Global Business Development
WYETH PHARMACEUTICALS Gita Kumar D.V.M.
Associate Director, Business Development
BIOGEN IDEC INC. Manuel Litchman, M.D.
Executive Director, Business Development & Licensing
NOVARTIS ONCOLOGY Douglas E. Onsi
Vice President, Business Development
GENZYME CORPORATION
3:30 - 4:15
Networking
4:15 - 4:45
TRACK A: Partnering With the Japanese Healthcare Industry
Many foreign healthcare companies are interested in gaining access to Japan's huge healthcare market, and face significant challenges despite recent changes to make market entry and partnering with Japanese healthcare companies more accessible. Using case studies and observations drawn from over 25 years experience, this presentation will focus on key issues companies face in deals with Japanese healthcare companies and provide attendees with some valuable, practical strategies to assist companies wishing to enter this market. Strategies for identifying and engaging the best Japanese partners Techniques for evaluating various market entry mechanisms Insider's hints and tips to understanding cultural issues Kyle Murphy
Managing Director
KMG JAPAN K.K.
4:15 - 4:45
TRACK B: The Greater China Healthcare Market: It is Not Only About the Future
Greater China represents the future of the Healthcare market. Yet few MNCs have committed strategic decisions of aggressive investment. Many hurdles (eg, IPR and price) are cited. However, there are significant opportunities that require immediate actions not only to position for the future, but also to utilize the enormous resources to contribute to the bottom lines. This presentation will explore some of the promising areas, such as prescription drugs, API, R&D, and OTC/TCM. Wenjie Zhang
Business Development Manager, Asia Pacific
BAYER HEALTHCARE AG
4:45 - 6:00
Networking Reception
6:00 - 9:00
Casino Night, Reception & Networking Dinner
This evening we'll take a respite from sessions to have some fun. A networking dinner, buffet style, and casino games are planned for you and your fellow attendees and speakers to enjoy. Leave your cash at home, the money's fake. Three prizes will be awarded during the general session on the afternoon of March 24th. Come join your colleagues for the tables and networking!. No separate registration required.
Thursday, March 31, 2005 (Day 3)
7:30 - 8:30
Networking
8:30 - 9:00
TRACK A: Japan Insider's Experiences of Current In-Licensing into Japan
An overview of the top 10 and top 30 Japan biopharmaceutical companies as potential licensees. What drugs do they seek, at what development stage? How much will they pay in license fees/royalties? Other license term sheet terms and conditions? How long will it take to do the deal? What are other licenseout to Korea-Taiwan-China opportunities and players are there? Up-to-date intelligence from a speaker with 135 trips to Japan, 20 deals arranged in to Japan and Korea, and 3 more currently in negotiations. Ted T. Tanaka
President
TANAKA INTERNATIONAL LLC
8:30 - 9:00
TRACK B: The Medarex 2004 Antibody Deals: Details of the Strategic Partnerships
In 2004, Medarex completed several significant licensing transactions with major pharmaceutical companies (Bristol-Myers Squibb, MedImmune and Pfizer). These transactions spanned the range from research to later stage antibody products. Taken together, these deals represented hundreds of millions of dollars including upfront, equity, funded research and potential milestone and royalty payments. In two of these, Medarex retained the option to co-develop and co-promote products. These transactions will be described to give the audience a sense of how they are structured and how this newer model of licensing affects Medarex. Ronald A. Pepin, PhD
Senior Vice President, Business Development
MEDAREX, INC.
9:00 - 10:15
TRACK A: Japan - USA Partnering in 2005: Which Compounds and Drugs Will be Licensed in 2005, and by Which Companies?
Japan and USA are fertile grounds for R & D and large numbers of pre-clinical and clinical compounds plus drugs hence in/out-licensing activities are intense on both sides of the Pacific. The panel will explore the prospects for 2005 amongst itself with audience participation during its entirety. How will 2005 shape up, who will be the players, how early will the deals be made, and what therapeutic areas are of particular interest? MODERATORS: Kyle Murphy
Managing Director
KMG JAPAN K.K. Ted T. Tanaka
President
TANAKA INTERNATIONAL LLC PANEL: James Foley, Ph.D.
Vice President Business Development, Japan
BRISTOL-MYERS SQUIBB COMPANY Gary A. Gabrielsen
Director, Business Development
FUJISAWA HEALTHCARE, INC. Hiroyoshi Horikoshi, DVM, Ph.D.
President
SANKYO PHARMA RESEARCH INSTITUTE Paul Park
International Licensing
AMGEN, INC. Peter Tsao, Ph.D., M.B.A.
Director, Corporate Licensing
TANABE HOLDING AMERICA, INC.
(A WHOLLY OWNED SUBSIDIARY OF TANABE SEIYAKU CO., LTD.) John R. Tupman, Jr.
Director, Corporate Business Development
ELI LILLY AND COMPANY
9:00 - 10:15
TRACK B: The Role of Venture Capital in Biotechnology and Pharmaceutical Innovation
In the past 25 years, hundreds of new biotechnology and pharmaceutical companies have been formed and financed by venture capitalists. What is their role in bringing new drugs to market? Have they been more effective innovators than larger, more traditional companies? We will explore this controversy and talk about the best business models for driving value with a distinguished panel of VCs and executives from VC-backed companies. MODERATOR: Myles Greenberg, M.D.
Partner
CHL MEDICAL PARTNERS PANEL: John Crowley
Chairman and CEO
AMICUS THERAPEUTICS, INC Arthur Pappas
Managing Partner
A. M. PAPPAS & ASSOCIATES Seth Rudnick
MD, General Partner
CANAAN PARTNERS Pratik Shah
Venture Partner
THOMAS, MCNERNEY AND PARTNERS
10:15 - 11:00
Networking
11:00 - 12:00
TRACK A: Medical Devices Partnering Roundup: What's Likely to Happen in 2005
The devices space has seen a lot of recent action and this panel, comprised of some of the industry's largest players, will discuss future developments as they forsee them unfolding. The discussion will focus on the cardiovascular, opthopedic, and CNS areas, but address others as well. Be they partnerships or other types of alliances, acquisitions, or joint ventures, this panel will discuss the options prospectively, retrospectively, and speculatively. Find out how the 2005 deals are likely to unfold. INVITED PANEL: John Onopchenko
Vice President
JOHNSON & JOHNSON DEVELOPMENT CORPORATION Sami Hamade
Vice President, Business Development
GUIDANT CORPORATION Richard Dakers
Vice President Business development & Strategic Planning, Medical Devices & Diagnostics Group
JOHNSON & JOHNSON Additional Panelists TBA
11:00 - 11:30
TRACK B: The 2005 Licensing Landscape: The Novartis Perspective
This talk will review the current deal-making climate and how Novartis has established itself as a collaborator of choice. Like all other Novartis functions, the Global Business Development and Licensing group is guided by a disease area strategy that identifies pipeline needs across different therapeutic areas, including cardiovascular & metabolism, CNS, oncology, transplantation, arthritis, dermatology, respiratory and anti-infectives. William Mann, MBA, Ph.D.
Director, Search & Evaluation, Global Business Development & Licensing
NOVARTIS PHARMACEUTICALS CORPORATION
11:30 - 12:00
TRACK B: China's Pharmaceutical Market and Industry: Current Trends And A Look Towards the Future
In this talk, the fast-evolving Chinese pharmaceutical and biotechnology industries and markets will be described, and key issues that will guide the future of both will be discussed. Partnering opportunities and how those of the future may develop will be addressed in areas such as drug discovery & development and direct investment in China, and the sorts of alliances the Chinese companies are forging in the United States and other countries. This talk will also include current regulatory and IP issues. Hong Xu, M.D., Ph.D.
Director, Licensing and Development
PFIZER INC.
12:00 - 1:00
Networking Luncheon: Ribonucleases: New Horizons in the Development of Targeted Therapeutics
Ribonucleases (RNases) are primordial enzymes that play important roles in nature. RNases are known to mediate several essential biological activities, including regulation of cell proliferation, maturation, and differentiation. Clinical studies have also shown that RNases have an affinity for malignant cells, while sparing healthy cells. The supporting science, demonstrated activity and potential of RNases as novel therapies for cancer and other life-threatening diseases will be presented. Andrew P. Aromando
Senior Vice President, Commercial Development and Operations
ALFACELL CORPORATION
1:00 - 1:30
Maximizing Shareholder Value by Better Resource Allocation and Licensing Transactions
To maximize value, biosciences companies need to deploy their limited resources across a portfolio of the highest return assets as well as extract maximum value for their intellectual property in licensing transactions. Because of the high level of uncertainty and decision flexibility that exist in this industry, traditional financial techniques have not been useful to make these decisions. Over the last decade, methodologies and tools have advanced to better capture the value of biosciences assets and use it in important decisions inside companies and in external transactions. This talk provides a brief introduction into these techniques and three real case studies where they were applied successfully. Gill Eapen
Principal
DECISION OPTIONS, LLC
1:30 - 2:15
Fluxuating Valuations in the Small Cap Biotech, Diagnostic, and Device Market - 2005 Forecast
This panel will address the often volatile increases and decreases in mid-cap life science stocks due to a variety of variables and the outlook for 2005 based on many years of combined experience in dealmaking in this sphere amongst the many uncertainties. The purpose of the panel is to employ past experiences as a look to the future - 2005. Bring questions and commentary to the panel to enliven the debate and resolve common doubts. MODERATOR: Stan Yakatan
Chairman
KATAN ASSOCIATES PANEL: Bill Abajian
CEO
THE ABAIJIAN GROUP Gill Eapen
Principal
DECISION OPTIONS, LLC Harold Gubnitsky
Vice President, Relations
AGCERT AND THE XLTG GROUP Charles T. Hardy, Ph.D.
MBA, Principal
BIOVALUATION & ANALYSIS Linda Masterson
Consultant, (FORMER CEO LIFEPOINT, INC.)
2:15 - 3:15
Pharma & Biotech Deal-Making 2005: How The Year Could Shape Up
After 3 days of sessions and discussion, what are some of the key ideas that will shape the partnering landscape in 2005? Where will the compounds behind the biggest deals come from and how will they be valued? Will the Vioxx fallout or new federal regulations affect licensing? How early will deals go and how will companies gain access to lucrative foreign markets, including the USA? Will there be further M & A activity? We'll summarize some of the more cogent points made during the meeting and introduce new ideas to the mix. MODERATOR: Herbert Ormsbee, Ph.D.
Senior Director, Licensing & Development
PFIZER, INC. PANEL: Michael Aberman, M.D.
Equity Research, Biotech
MORGAN STANLEY Ren Benjamin
Senior Biotechnology Analyst
RODMAN & RENSHAW, LLC Kevin Gorman
Vice President, Business Development
NEUROCRINE BIOSCIENCES, INC. Theodore R. Koziol, Ph.D.
Vice President, Global Business Development
WYETH PHARMACEUTICALS Bob Maggiacomo
Managing Partner
SYNERGY ADVISORS, LLC William Mann, MBA, Ph.D.
Director, Search & Evaluation
GLOBAL BUSINESS DEVELOPMENT & LICENSING NOVARTIS PHARMACEUTICALS CORPORATION Vik Seoni
Senior Director, Business Development
ENDO PHARMACEUTICALS Phillip L. Smith, Ph.D.
General Partner
S.R.ONE, LTD, A WHOLLY OWNED SUBSIDIARY OF GLAXOSMITHKLINE
3:15 - 3:20
Conference Concludes
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