Allicense 2013 Agenda

April 29-30 | Palace Hotel | San Francisco, CA

Celebrating its 17th year in 2013, the ALLICENSE meetings have tracked the successes and setbacks of biotech business development and licensing. We’ve seen best practices evolve as new participants bring innovative approaches to the industry. This year’s forum will examine many facets of the evolving relationship among biotech, traditional pharma, corporate VCs, academia, and payers.

Monday, April 29

[8:00 – 8:15] - Day 1
Continental Breakfast
Introduction by: Eric Walczykowski, Managing Director, Deloitte Recap LLC

[8:15 – 9:15] - Day 1
Keynote:
Health Care Reform, Economic Recovery, and Innovation:
The Path to the New Normal for the Biopharma Industry
Keynote by: Paul H. Keckley, Ph.D. Executive Director, Deloitte Center for Health Solutions

• State of the U.S. health system
• The new normal: 2013 and beyond
• Four big fiscal issues that lie ahead
• Congressional action and key committees to watch
• Big issues and implications for biopharma

[9:15 – 9:45] - Day 1
What's the Deal in 2012?
Presenter: Jennifer Doyle, Senior Biopharma Deals Analyst, Deloitte Recap LLC

In 2012, Deloitte Recap analyzed 1,692 deals with a disclosed value of $115 billion. Licenses or joint ventures accounted for 584 of the deals with a total disclosed deal value of $27 billion. Jennifer Doyle, a senior analyst at Deloitte Recap will present insights from the 2012 deals including:

• Deal making by the numbers:
             - Heavy hitters - hot therapeutic areas, molecular moieties, and license structures
             - The best time to license - upfronts by stage at signing

• Impact of license structure – outlicense vs collaboration vs co-development
• Old dogs with new tricks – reformulated product deals
• Crafty exits – reverse mergers and call options

[9:45 – 10:00] - Day 1
Break

[10:00 – 10:45] - Day 1
Leading Dealmakers: Building Value through Doing Deals?
Moderator: Barbara Kosacz, Partner, Cooley LLP
Panelists: John McDonald, George Golumbeski, Ph.D., Mark Miller, Margi McLoughlin

In 2012, nearly 600 licenses and JVs were consummated with the goal of bringing more assets to market. As capital availability continues to be challenging, the market for all but the elite assets continues to be a buyer’s market. The lack of capital is due to the lack of returns for private company investors, yet – big pharma continues to struggle to fill its pipeline. As the biopharma ecosystem continues to struggle with the most efficient way to develop compounds – some companies are continuing to complete deals at a strong pace. Come see these leading dealmakers from 2012 discuss:

• Their own deal strategies
• Option deals
• The decline of co -development deals
• Improving the capital availability for early stage assets
• Emerging markets

[10:45 – 11:45] - Day 1
Breakthrough Alliance Deal of the Year
Presenter: Eric Walczykowski, Managing Director, Deloitte Recap LLC
Nominees: Merck/Endocyte: Jim Schaffer, Merck / Matthew Call, Endocyte
                  Merck/AiCuris: Jim Schaffer, Merck / Helga R‹BSAMEN-SCHAEFF, AiCuris
                  Abbvie/Galapagos: Barbara Carlisle, Galapagos
                  Menarini/Oxford: Christian Rohlff, Oxford / Andrew Slade, Menarini
                  Adamas/Forest Labs: Greg Went, Adamas

The Breakthrough Alliance Award honors the creative partnering efforts of business development licensing professionals. Deloitte Recap's Eric Walczykowski will discuss this year's award nominees and the new ideas each of these deals brought to biopharma deal making in 2012.

[11:45 – 12:45] - Day 1
Lunch &
The UCSF Model: Academia/Industry Partnerships
Presenter: Susan Desmond-Hellmann, MD, MPH., Chancellor, UCSF Medical School

UCSF's long and unique history of partnering with industry dates back to its critical role in the genesis of the biotechnology industry. UCSF is a leader in developing and fostering truly collaborative models, bringing together academia and industry to achieve common goals. Dr. Desmond-Hellmann will describe UCSF’s unique experience and approach to moving bench innovations to commercial application including achieving societal benefit. She will discuss specific examples and share how this work has accelerated UCSF’s mission of advancing health worldwide and fostered further innovations in the field of biomedical research and healthcare.

[12:45 – 1:15] - Day 1
VC Trends
Presenter: Jonathan Norris, Managing Director, SVB Capital

[1:15 – 2:00] - Day 1
Panel: A Fresh Perspective, The Versant Approach
Moderator: Jonathan Norris, Managing Director, SVB Capital
Panelists: Clare Ozawa, Jerel Davis, Steve Kaldor, Shafique Virani, George Golumbeski

Many people in the biotech and pharmaceutical industry feel that the venture capital system is broken and does not meet the needs of today’s licensing requirements. Over the last four quarters, there has been a consistent decline in traditional VC funding in life sciences. However, while traditional funding models seem to be in decline, new partnerships are forming. Versant Ventures has created a new path for funding. This panel will highlight two partnerships that have led to successful licensing campaigns- Quanticel and Celgene and Inception Sciences and Roche.

[2:00 – 2:45] - Day 1
Roundtable: Old vs. New, Venture Capital Model
Moderator: Jonathan Norris, Managing Director, SVB Capital
Panelists: David Collier, M.D., Brian Atwood, Patrick Heron

[2:45 – 3:00] - Day 1
Break

[3:00 – 3:45] - Day 1
The Rising Bar for Oncology Assets in 2013 and Beyond
Moderator: Lisa Natanson, Sr. Analyst Data Operations, Deloitte Recap LLC
Panelists: Alain Curaudeau, Jeffrey Bockman, Sunil Patel

Deloitte Recap LLC data indicate that oncology drug development remains a risky endeavor with high rates of Phase II and Phase III failures. But the data also show that industry’s appetite for cancer products and technologies, as measured by licensing activity, has not waned: About a third of all deals in 2012 were for oncology assets, a higher percentage than that recorded for any other single therapeutic area. Meanwhile, the bar for clinical performance is on the rise among the key decision-makers including regulators, clinicians and payers. This is driving greater demand for personalized healthcare (PHC), typically enabled by companion diagnostics, wherein patient populations most likely to respond to therapies are well defined. Against this backdrop, our distinguished panel will discuss the following:

• What are the key qualities buyers seek in an oncology asset in 2013?
• How do buyers (and sellers) evaluate the risk of oncology assets by:
             - Large versus small molecules?
             - Early- versus late-stage?
             - First-in-class versus best-in-class?
             - Mechanism of action?
             - Unmet need (i.e., pancreatic cancer) versus multiple treatment options
                (i.e., lymphoma)?

• How will the PHC/companion diagnostic trend of targeting well-defined patient populations change the return on investment (ROI) and oncology deal making?
• How important is the choice and order of indication pursuits to the success of an oncology partnership?
• What is the best stage to partner an oncology asset given the high risk of failure?
• And ultimately, how are the large and small players structuring deals to share the risk and maximize benefit to both parties?

[3:45 – 4:30] - Day 1
Panel: Corporate Venturing and Deals Coming Together
Moderator: Rod Ferguson, Managing Director, Panorama Capital
Panelists: Ilan Zipkin, Brian Piper, Samuel S Wu

Corporate venturing—where a firm takes an equity stake or enters into a joint venture arrangement with another company (e.g. investment of corporate funds directly in external start-up company), has emerged as an important component in advancing life science innovation. The deep pockets of capital, abundant advice and guidance from their R&D organizations, and market validation of downstream potential provide an especially high value add to early stage companies.

Companies that receive corporate venture funding are often more likely do an IPO, be acquired and do more licensing deals. For example, of the 11 therapeutic and diagnostic IPO’s in 2012, 6 had a corporate venture fund as a major pre-IPO funding source.

Our panelists will discuss the current trends and future outlook for Corporate Venture Capital (CVC) addressing the following topics:

• What defines success in the CVC model?
• How reliable are CVCs? Does Pharma change its venture strategy every few years?
• Is CVC just a temporary phenomenon or stop-gap measure in today’s tough environment? When the capital markets return will CVCs once again be shunned from the best syndicates?
• How does corporate venturing lead to innovation and development in high risk therapeutic areas?

[4:30 – 4:45] - Day 1
Wrap Up
Presenter: Eric Walczykowski, Managing Director, Deloitte Recap LLC

[5:00] - Day 1
Breakthrough Alliance Award Voting Closes

[5:30 - 6:30] - Day 1
Cocktail Reception

[6:30 - 9:30] - Day 1
Breakthrough Alliance Award of the Year Dinner

Tuesday, April 30

[8:00 – 8:15] - Day 2
Continental Breakfast
Introduction/Day 1 Recap by: Eric Walczykowski, Managing Director, Deloitte Recap LLC

[9:15 – 10:00] - Day 2
Stemline Therapeutics – First Biotech IPO of 2013
Presenter: Ivan Bergstein, CEO, Stemline Therapeutics

Stemline Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel oncology therapeutics that target both cancer stem cells (CSCs) as well as the tumor bulk. Among Stemline's drug candidates are SL-401 and SL-701, both of which have demonstrated clinical activity, including durable complete responses (CRs), and an overall survival (OS) benefit versus historical controls in Phase 1/2 studies of advanced cancer patients.

[10:00 – 10:45] - Day 2
Public Market: Serial Entrepreneur – Lessons Learned in Taking More than One Biotech Company Public
A Fireside Chat hosted by Matthew K. Hudes, U.S. Managing Principal, Biotechnology, Deloitte and Kleanthis G. Xanthopoulos, President and CEO, Regulus Therapeutics Inc.

Kleanthis G. Xanthopoulos, Ph.D., President and CEO of Regulus Therapeutics Inc. [NASDAQ: RGLS], is a serial entrepreneur who has successfully taken two life-sciences companies public within the last decade. Dr. Xanthopoulos founded Anadys Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of novel medicines for the treatment of Hepatitis C, in 2000 and took the company public in 2004. Anadys was acquired by Roche in late 2011 for $230M, a 256% premium over the closing price of ANDS stock on the acquisition date. Dr. Xanthopoulos joined Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, as President and CEO in 2007 and took the company public in October 2012. On paper, the processes of taking two companies public should appear to be quite similar. In reality, each experience was quite unique for Dr. Xanthopoulos and each company. Dr. Xanthopoulos will compare and contrast the external and internal factors that made each deal unique, such as the overall banking and financial environment, the desired capital structure of each company and institutional and strategic investment appetite

[10:45 – 11:00] - Day 2
Break

[11:00 – 11:45] - Day 2
Panel: Public Offerings
Moderator: Mark Simon, Advisor, Torreya Partners
Panelists: Spike Loy, Ivan Bergstein, M.D., Kleanthis G. Xanthopoulos, Ph.D.

After the financial crisis in 2008, there was a crippling decline in biotech IPOs. Investors were reluctant to wager on drug developers, and heavy insider support was needed for the few offerings that were seen. Drug developers began to see respite in 2010, and by 2011, over $4.8B was invested in the industry. 2012 was still a tough year for IPOs, but there has been what seems to be a steady increase in both offering and success. All but one biotech offering 2012 met IPO prices at the top of their range, and the first of 2013 are hopefully inspiring other companies to follow. Join a panel of top level executives and financial backers as they candidly discuss their views of the IPO process from both a corporate and a funding point of view as they discuss the following topics:

• The changing relationship between the finance and biotech industries.
• How are new Federal Regulations, such as the JOBS Act, helping boost the IPO market?
• Insider support- how could changing methods of funding affect trends in offerings?

[11:45 – 12:45] - Day 2
Lunch

[12:45 – 1:30] - Day 2
Biotech's Valuation Challenge: Predicting Payer Response
Presenter: Roger Longman, CEO, RealEndPoints

Deal values are increasingly reflecting payer values (such as preferentially adopting a particular therapy). Traditionally, most development executives at pharmas, let alone those at biotechs, have primarily focused on regulatory requirements and secondarily on what physicians or payers might see as differentiating. Compounding the problem, payers haven't, for a variety of reasons, been particularly forthcoming with specifics. In short, the basis of deal values is growing increasingly problematic. To be successful in optimizing deal values, companies will have determine the most important payer criteria, respond credibly, and clearly communicate their rationale to potential licensees and acquirers.

[1:30 – 2:15] - Day 2
The Impact of the Price (of the Product) – on the Price (of the Deal)
Moderator: John Cullity, Principal, Torreya Partners
Panelists: John McDonald, Garry Menzel, Ted Haack, Steve Rosen

Deal making increasingly requires us to take pricing and reimbursement (P&R) assumptions on product and portfolio forecasts into consideration. What do our panelists observe today and how do they believe this will evolve over the coming years? Animated and informed discussion is guaranteed based on the tenured perspectives of the selected panelists as they discuss the following questions:

• How is your company currently developing its P&R assumptions for sell-side and buy-side mandates?
• Are you commissioning primary market research to gain a tighter perspective? If so, why? If not, why not?
• How do you view the Affordable Care Act (ACA) impacting pricing power in the United States? How will this impact deal-making by therapeutic area and by stage of development?
• The European P&R situation is sobering. Are there islands of value-based pricing in Europe, and how should deal-makers evaluate and respond to these?
• It appears to be an inexorable downward spiral in Japan with respect to pricing. How do you see Japanese Pharma responding?

Questions from the audience are welcome. Please send yours to cullity@torreya.com.

[2:15 – 2:30] - Day 2
Break

[2:30 – 3:00] - Day 2
Option Deals and M&A Trends
Presenter: Christian Dokomajilar, Manager and Senior Biopharma Analyst, Deloitte Recap

Option Deals
Deals with option components are not new to the biopharmaceutical deal making space – the first major license option deal was signed in 1979, and a handful of such deals followed through the early 2000s. Yet the trend towards this deal structure has increased recently. Major option deals – those involving an exclusive option to license and those with the call option to acquire the target company – have become an integral part of deal making as buyers attempt to mitigate risk and as sellers attempt to secure upside to their programs.

This session will cover trends and current issues around license options and acquisition options, or call options. The following will be presented:

• Data and analyses around the trend in major option structures – license options and call options
• What happened to that deal? A case study following up on deals whose options were exercised
• What happens if the buyer passes on the option?
• Other frequently optioned contractual elements – territories and indications, co-development, and co-promotion

M&A Trends
2012 presented the lowest M&A activity in six years as recent buyers took inventory and recovered from their biopharma shopping spree. Some analysts predict that ‘mega deals’ will return in 2013 as there may be some potentially high-value deals to be done. The following will put recent M&A activity in perspective:

• Data and analyses around the trend in life science company M&A from 2008 through Q1 2013
• Market Segment Focus – M&A target companies developing therapeutic products
• Therapies and Technologies Focus – The areas that drew the most acquisitions in 2012
• Company Maturity at Acquisition – The clinical development and commercial stages reached prior to the sale
• Private Company Focus – The deals and the major investors behind the companies

[3:00 – 3:45] - Day 2
Panel: Mergers & Acquisitions
Moderator: Christian Dokomajilar, Manager and Senior Biopharma Analyst, Deloitte Recap
Panelists: Chris Ehrlich, Felix Karim, Stephen Brady, Mark Goldsmith

Industry leaders from both the buy-side and sell-side of biopharma discuss current topics shaping M&A deal structures. The data show prevalence in deals becoming more complex with contingent payments, earn outs, and put/call options. Panelists will share their insights on these structures as major components to deal making going forward and major issues shaping life science M&A:

• Are acquisition option deals the key to company roadmapping in a complex fundraising environment?
• Do prior partnerships matter?

[3:45 – 4:30] - Day 2
Panel: What the Future Holds
Moderator: Eric Walczykowski, Managing Director, Deloitte Recap LLC
Panelists: Jane Wasman, Roger Longman, Barbara Kosacz, Paul Hastings

[4:30 – 4:45] - Day 2
Conference Wrap Up
Presenter: Eric Walczykowski, Managing Director, Deloitte Recap LLC

Other agenda items include:
Biotech's Valuation Challenge: Predicting Payer Response
The Future of Pharma

Breakthrough Alliance Award Dinner
A special dinner announcing the award winner and celebrating the most innovative deals of 2012.