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MIT BIOSTRATEGY SEMINAR SERIES. Trends in Venture Capital and the Biotechnology Industry Michael Lytton General Partner Oxford Bioscience Partners Boston, MA [email protected] December 12, 2001. The Biotechnology Industry in the mid-1990s.

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MIT BIOSTRATEGY SEMINAR SERIES

Trends in Venture Capital and the Biotechnology Industry

Michael Lytton

General Partner

Oxford Bioscience Partners

Boston, MA

[email protected]

December 12, 2001


The biotechnology industry in the mid 1990s l.jpg
The Biotechnology Industry in the mid-1990s

  • Investors wanted certainty in new drug discovery. . . So large pharmaceutical companies were prepared to spend significant funds to reduce their R&D and regulatory expenditures

  • The search for novelty and the downgrading of me-too research (McKinsey's 90% generic, 247 drug formula that met 95% of 1995 drug needs)

  • Message: only novel drugs are worth pursuing, and new biotech tools will increase productivity and novelty

  • The “omicization” of biotechnology (genomics, proteomics, metabalomics. . .) will transform drug discovery


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The Tool Company Business Model

  • The best product to sell is stock (never make a product, never make a profit – the price-to-dreams ratio)

  • The $33 billion raised in 2000 exceeded the amount invested in the previous five years combined

  • 1999 -- 55% of public biotechs have less than two years’ cash 35% have less than one year

  • 2000 -- 42% have more than three years’ cash 33% have more than five years’ cash

  • But, this success is over-shadowed by a persistent, nagging problem. . . .


Slide4 l.jpg

While Critical for Long-Term Value, Genomics Is Likely to Lead to Higher R&D Cost Pressure Short-Term

Complicating Factors in the R&D Process

Genomics Poorer “In 1990, there were 100 literature Increased

has led to an quality literature references/target - downstream

explosion of of Now we average 8. We are also attrition

new potential target exploring many more targets than

targets valida- before. What we don’t know

tion about the targets leads to more

problems downstream and

worse attrition.”

- Pharma R&D executive

Source: Lehman Brothers & McKinsey & Co. Report, January 2001


Slide5 l.jpg

While Critical for Long-Term Value, Genomics Is Likely to Lead to Higher R&D Cost Pressure Short-Term

Complicating Factors in the R&D Process

Companies Novel “New targets will require novel Increased

are pursuing Chem- chemistries and will create new R&D Costs

a much higher istry barriers in toxicology.”

proportion of

novel targets - Biotech executive

Source: Lehman Brothers & McKinsey & Co. Report, January 2001


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While Critical for Long-Term Value, Genomics Is Likely to Lead to Higher R&D Costs Pressure Short-Term

Complicating Factors in the R&D Process

Other Uncertain “The trial and error cost is Increased high clinical high when you have a new R&D Costs

impact develop- drug target without a well-known

tech- ment clinical protocol.”

nologies

are in

early

development

Source: Lehman Brothers & McKinsey & Co. Report, January 2001


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The New Discovery Tools Have Not Increased Output Lead to Higher R&D Costs Pressure Short-Term

  • Accenture survey:

    • in 1997, drug companies predicted new technologies would make them 50% faster and 300% more productive

    • in 2001, drug companies are no faster and no more productive

      Why?

  • Novelty is risky

    • New targets increase R&D risk 2X; compounds can fail and targets can fail (with older targets, developer runs only compound risk and chemistries are easier)

    • FDA cautious about new mechanisms; inclined to go slow (e.g., Xigris)

  • Pharma companies hit the wall of data overload, and biotechs fail to contribute improved processing capabilities

  • Tool companies must, annually, predict pharma’s bottleneck next year in the drug discovery process

  • Startup fratricide – 50+ proteomics companies


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The Sobering Statistic Lead to Higher R&D Costs Pressure Short-Term

Cost of Developing a New Drug: $100 million

Cost of Failures Associated

with Development: $300 million

$400 million


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Why do compounds fail to become successful drugs? Lead to Higher R&D Costs Pressure Short-Term

Toxicity Issues 22%

Biopharmaceutical Issues 41%

Efficacy Issues 31%

Marketing Considerations 6%


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Drug Discovery Technology – The Opportunity Lead to Higher R&D Costs Pressure Short-Term

Reducing the Failure Rate in Pre-Clinical and Clinical Development and Increasing the Efficiency of Drug Discovery

Failures occur on account of:

  • Lack of specificity

  • Poor absorption

  • Too rapid metabolism

  • Toxicity


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Drug Discovery Technology – The Opportunity Lead to Higher R&D Costs Pressure Short-Term

Efficiency is enhanced as a result of:

  • Target selection and validation

  • Assay development

  • High throughput screening

  • Lead optimization

  • Generation of suitable back-up compounds

  • Appropriate pre-clinical models


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Drug Discovery Technology – The Opportunity Lead to Higher R&D Costs Pressure Short-Term

  • The 1990s revolutionized the study of associations and created data overload

  • Hopefully we are now entering the decade of understanding the behavior of whole systems

    • Finding the right target(s)

    • Finding the right drug

    • Improving the productivity of clinical trials


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For the Time Being, the Only Long-Term Successful Business Model Is Still Developing a Successful Drug

  • 125 biotechnology products are on the market (50 to be approved this year)

  • 300 biotech products are in Phase III (80% chance of FDA approval)

  • Currently, there are 40 profitable biotech companies, with 60 anticipated by year-end, accounting for $25-30 billion in revenues

  • As pharma companies’ drug discovery efforts continue to fail to yield results, the value of late-stage products rises


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The Increasing Value of a Late-Stage Product Model Is Still Developing a Successful Drug

  • In 1996, Pfizer paid Warner-Lambert $25 million upfront for U.S. and Europe rights to Lipitor (Phase III)

  • In 1998, Pfizer paid Searle $85 million upfront for U.S. rights to Celebrex (Phase III) and Pharmacia paid Otsuka $80 million for North American rights to Pletal (filed for approval)

  • In 2001, Bristol-Myers Squibb pays Imclone in excess of $1 billion upfront for its Phase III epithelial growth factor for cancer


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The Future: More Big Value, Late-Stage Product Deals Model Is Still Developing a Successful Drug

  • In-licensing is cheaper than acquisition since it avoids dilution and provides the potential for off-P&L transactions (nearly half the cost of the Imclone deal is on BMS’s balance sheet)

  • The biotech industry responds by trying to create fully integrated research platforms through M&A (e.g., Vertex/Aurora, Lexicon/Coelecanth)

  • Alternatively, platform companies become product companies as well (e.g., Millennium’s acquisitions of Cor and Leukosite, Celera’s acquisition of AxyS)


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What Does All of This Mean for Venture Funding? Model Is Still Developing a Successful Drug

  • Funding devoted to life sciences increases from 9% (in 2000) to 15% in 2001 of all venture capital investing (approximately $5 billion)

  • New funds raised in 2000 and 2001 will push percentage to approximately 20% ($6 billion)

  • Fewer, bigger specialized funds

  • Multiple reasons to be optimistic

    • Doubling of NIH budget

    • More trained management

    • Gloomy investment climate leads to more reasonable valuations for early-stage investments

    • Less competition, due to the number of vc firms that exited the sector with the Internet boom


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What VCs are Looking For. . . Model Is Still Developing a Successful DrugProducts

  • A novel biological or chemical hypothesis

  • A well understood mechanism of action

  • Proof of principle

  • A broad intellectual property portfolio

  • A strategy for partnering so that the risks associated with the timing of FDA approval can be passed on to someone else

  • Multiple shots on goal


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What VCs are Looking For. . . Model Is Still Developing a Successful DrugTools

  • Provide new information which addresses an unmet need

  • Reduce the failure rate and/or increase the efficiency of drug discovery or development – eliminate a “bottleneck”

  • Commercialize via a business model that takes account of (i) lengthening sales cycle for platform technology deals due to pharma company confusion and information overload, (ii) commoditization and obsolescence, and (iii) the need to ultimately share in the upside of a successful drug


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Still, There Remains Unlimited Potential for Model Is Still Developing a Successful DrugMistakes. . .

  • Investing in a scientific hypothesis that has not achieved proof of principle

  • Investing in a technology that works, only to find out that no one cares


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Still, There Remains Unlimited Potential for Model Is Still Developing a Successful DrugMistakes. . .

  • Backing a company with weak management or board of directors

  • Investing as part of a weak syndicate of investors


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Still, There Remains Unlimited Potential for Model Is Still Developing a Successful DrugMistakes. . .

  • Valuing a company based on the valuation of comparable companies

    • A successful venture fund must earn a compounded, cash-on-cash gross return in excess of 30% over its ten-year term (at least a 22.5% net return)

    • The analysis is driven by multiples (10x or greater), not the time value of money

    • Valuation is determined by reference to (i) the ‘pre-money’ valuation of the next round, (ii) the number of financing rounds required until liquidity, and (iii) the amount of money needed in each round

      So, comparables are of limited utility—high tide in the Bay of Fundy is not a useful metric for Boston Harbor


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Still, There Remains Unlimited Potential for Model Is Still Developing a Successful DrugMistakes. . .

  • Betting on the timing of a clinical milestone, corporate partnering deal, or IPO

  • Investing in a company where success is dependent on accelerating the FDA’s review and approval process


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Still, There Remains Unlimited Potential for Model Is Still Developing a Successful DrugMistakes. . .

  • Investing in a company without doing careful intellectual property due diligence

  • Firing, then aiming or aiming, and not firing: waiting too long, or not long enough, to change management


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Still, There Remains Unlimited Potential for Model Is Still Developing a Successful DrugMistakes. . .

  • Bad Timing

    • Monoclonal antibodies

    • Antisense

    • Sepsis

    • Gene therapy

    • Diagnostics


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What’s Next? Model Is Still Developing a Successful Drug

  • Predicting disease at the molecular level through biomarkers, and developing a value proposition for new diagnostics

  • Going from gene to drug to develop new therapeutics

  • Miniaturizing drug discovery technology to enhance throughput (and maintain accuracy)

  • New antibiotics that overcome resistance

  • Finally, the Decade of the Brain?


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What’s Next? Model Is Still Developing a Successful Drug

  • Focusing on the right applications to benefit from biotech/IT convergence

  • Executing successful specialty pharma business models

  • Quality of life devices and drugs (from cholesterol to male pattern baldness, wrinkle removal, smoking cessation, weight loss, and arthritis pain relief)


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