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How can biotechnology prosper?

The Financial Times Global Biotech Conference was held in London, November 12-13 2003. There was a healthy attendance, with representatives from the biotechnology industry itself, 'Big Pharma', consultants, investors, and many others with an interest in this dynamic sector.

In 2002, FT research suggests there were 4,300 biotech companies, 630 of them public, with $41 billion in revenues, up from $36 billion in 2001. But net losses doubled - to $12 billion. The trans-atlantic gap is also widening: US biotechs raised $8.7 billion in equity financing in 2002, up 10% from 2001, while the finance available to European firms dropped 40%. This dichotomy between the US and Europe was a recurring theme at the conference.

A lengthy, expensive business

One of the major problems for biotechs is surviving long enough to develop products and get them on the market. It has to be borne in mind that clinical development takes five to eight years, launching two to three years, and peak sales are unlikely to appear until five years post-launch. Each product needs an average investment of $800 million to develop, possibly up to $1.5 billion to fund its entire lifecycle. There are three main options:

  • Raising finance, either privately (venture capital firms) or publicly (initial public offerings etc.)
  • Consolidate or cut costs
  • Licensing deals (the subject of a separate article)
Jean-Paul Clozel, CEO of Actelion, stressed that it was a tough road to commercialisation. It did bring the most profits, but also high risks for small biotechs lacking the necessary infrastructure.

Like other speakers, Dr Clozel believed many companies made the basic mistake of trying to market the wrong drug. For example, Actelion would probably avoid the general practitioner market completely without a partner, whereas specialised areas were easier to deal with. Pre-marketing costs could be high, especially for very innovative products, and Dr Clozel pointed out that companies had to consider post-launch expenses, if they made it that far, such as pharmacovigilance costs, which could be high.

Merge or die?

Most speakers thought collaborations between biotechnology companies, geographical clustering, and especially consolidation within the industry were all necessary, particularly in Europe.

Peter Fellner, Chairman of both Celltech and Vernalis, believes that of the 1,870 biotechs in the European Union, only 20 have sustainable profitability. He pointed out that 25-30% of the EU's biotechs had less than one year's cash left, and identified a number of problems, including:

  • sub-critical R&D capabilities
  • high infrastructure costs and inefficiencies
  • poor business models and management
Dr Fellner is a strong believer in consolidation, having built up both Celltech and Vernalis this way. But he noted that management was often reluctant and valuation expectations were sometimes unreasonable. If successful, however, mergers and acquisitions could strengthen pipelines by keeping only the best from both companies, and create cost synergies (infrastructure and facilities represent 30-45% of the cost base of small-cap firms).

When asked if Celltech could buy the UK's Alizyme, as an example, Fellner said Celltech was more likely to look to the US. Any acquisition would have to have strategic value, and markets would probably penalise any buying of an early-stage company - pipeline products were key - although sentiment is improving. He also noted that many EU companies were being bought by US firms, which found it easier due to their higher valuations.

Major biotech M&A - 2003

Larger company/acquirer

Smaller company/target

Resulting entity

Versicor

Biosearch Italia

Vicuron

Protein Design Labs

Eos Biotech

PDL

British Biotech

RiboTargets

British Biotech

Celltech

Oxford GlycoSciences

Celltech

Genaissance

DNA Sciences

Genaissance

OSI

Cell Pathways

OSI

Chiron

PowderJect

Chiron

Genzyme

SangStat

Genzyme

British Biotech

Vernalis

Vernalis

Idec

Biogen

Biogen Idec

Source: IMS Companies Information

Questioned about pharmaceutical 'mega-mergers' and their impact on R&D, Fellner said 4-5,000 researchers wasn't an optimum level, even split into smaller units, but on the other hand, 50-70 wasn't enough. He pointed out that all companies, large or small, have the same 'client' - regulatory authorities.


When to go public? ...if you can

There was a range of opinions about when in their lifecycle companies should hold an IPO. Actelion's Clozel thought firms shouldn't go to the market too early - they could not survive if they only had one or two products and one failed - a decent pipeline was necessary and would help companies meet the ultimate goal of "more and more" profit.

Christopher Evans, Chairman of Merlin Biosciences and the UK's biotech investment expert, however, said there was a funding gap between venture capital and IPOs, and that criteria for the latter were often unreasonable (e.g. good Phase II data, strong management). Early-stage work needed to be funded, therefore companies should have an IPO fairly early in their existence. Sir Chris said a market capitalisation of £100 million was OK, it didn't need to be £500 million.

Patrick Lee, of Advent Venture Partners, noted that less than 25% of private biotechs meet the criteria for either an IPO or major deal, and that achieving this critical mass would be difficult for the remaining 75%; he therefore reiterated that it was essential that rationalisation and consolidation occurs. While only one recent IPO, for Genitope, was viewed as being successful, biotech market indices have risen 30% over the last 12 months, thanks to positive trial results for products such as Genentech's cancer drug Avastin, and efforts by the FDA to speed the approval process.

Ann Hanham from Burrill & Co also noted this improvement, stating that for the first time in seven years, in 2003 biotech overtook software as the number one industry for VC investment, with a total of $873 million. But one issue identified by several speakers was the lack of analyst coverage for small biotechs - in the US, largely stemming from changes to SEC regulations, and in the EU due to a lack of interest from exchanges. This was seen as problematical, even possibly leading to a "death spiral", and one of the reasons for huge fluctuations in share prices related to pipeline news.

Dr Hanham remarked that Burrill had only recently begun investing in the EU again after a two year hiatus, and that the biotech investment specialist expects the current IPO window to close again from the second half of 2004. Both Sir Chris and George Poste, Chair of the conference, thought Big Pharma should help, being more generous with licensing deals, and perhaps less timid about using, for example, off balance sheet financing. Given that $800 million was needed for each company to reach profitability, and only $300 million was available for the whole sector in London, relying on venture capital is clearly not sustainable. Dr Poste remarked that many VCs have become more risk averse, travelling in herds, which could lead to a hiatus in the innovation stream in 7-10 years' time.

Government support in the UK

Although Sir Chris had some concerns about the control of domestic companies from the US, the UK is nevertheless seen as having the strongest biotech industry within Europe, and the sector received a boost a few days later when Prime Minister Tony Blair pledged his government's support. Richard Sykes, former CEO of Glaxo Wellcome, will head the Bioscience Leadership Council, a new body charged with introducing measures to keep the UK's industry second only to the US in terms of its success in finding new drugs. A National Clinical Trials Agency has also been proposed, utilising the National Health Service, to help accelerate the approval process.

One of Dr Poste's closing remarks was that in the 1980s, every biotech was aiming to become a fully integrated company: of 1,824 firms in 1988, only 17 have achieved this status. But, there is a new realism that it takes up to $1.5 billion to get a drug on sale, and that critical mass was therefore needed, probably involving 300-800 R&D employees. Poste foresaw deconsolidation of the big, consolidation of the 'big enough', and crash and burn for the rest. Many of the speakers thought poor companies and products should be killed off, and a more Darwinian approach to investing in both taken - leading to survival of the fittest.

This article was written by Selena Class, Deputy Executive Editor of IMS Company Profiles.

External Links:
FT Conferences
Burrill & Co
Merlin Biosciences
Copyright IMS HEALTH, 1 December 2003













 

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