Building value – is the pipeline all that matters?

pharmafile | December 1, 2009 | Feature | Research and Development |  Les Rose, biotech, venture capital 

Venture capital is a curious business and the global financial crisis in which we find ourselves has exposed some rather surprising practices, which you can read about in more erudite sources than here.

However, most readers will be aware of the repackaging of `toxic’ debts to make them look solid, which is just one of the games played by bankers to hoodwink each other. It is all a matter of perceived value; the value doesn’t seem to be based on reality, but on what you can get the purchaser to believe.

Thinking about this led me how we add value during drug development. Let me first of all set the scene with my personal take on how investors operate. Once a potential investor has had their interest piqued by a proposal, among their first questions will be: “What’s the exit route?” By this they mean, how and when do I get my investment back, with my profits? At the level of buying a whole company, via the so-called private equity takeover, the exit route lies in selling the company, usually back to the stock market (from which it was usually bought in the first place). For a pharma company, there may be a choice of routes. The drug itself could be sold to someone who is able to complete development (if it’s not ready for market), it could be licensed to another developer or marketer, or the whole company could be sold. In this last case the company might be of interest for example to a major multinational, or to a bigger venture capital group, or quite commonly it will be offered on one of the stock markets.

When the guesses are wrong

Of course whatever deal is chosen, a value has to be attached. Years ago a client of mine had a promising drug that was first in class. It became clear that the clinical data package had a lot of quality problems, which late in the day could only be mitigated in a limited way. Nevertheless the sponsor managed to sell the licence to a major multinational, the proceeds of which enabled the seller to expand their development arm. As it happened the drug had toxicity problems requiring constant biochemical monitoring, and was very quickly overtaken by much safer analogues, so it probably didn’t represent a good deal for the purchaser. Now I wasn’t privy to all the negotiations, so maybe the purchaser saw it as high risk with possible high return, and was prepared to write it off, but my impression was that this was not a win-win deal, and the value perceived by the purchaser was obviously incorrect.

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Getting the guessing game right

So what are the determinants of perceived value in drug development? There are some well-accepted norms in this area. Companies usually agree with investors a time plan including key milestones, for example a regulatory submission for marketing authorisation. This is normally seen as adding a lot of value, leading to investors warming to the proposition. I am not sure though whether they really have a good grasp of the quality of the submission, for example whether it fits with the known preferences of the regulatory authority for particular types of study.

I can relate rather better to more directly science-based milestones, such as pivotal study results. I know I have discussed this previously, but I do see serious dangers in rushing into print without proper peer review. Yet the norm seems to be to badger the clinical research team for headline results and to hand these over to a PR agency, which then massages the numbers into a form which pleases the investors and impresses the markets. I don’t know of such a news release which turned out to be completely wrong, but I do know of non-critical problems with clinical data which emerged afterwards. It was pure luck that the main message wasn’t changed.

So there clearly are pitfalls attached to the perception of value of a medical product. Investors can’t be expected to be expert enough in drug development to assess value effectively, and I would expect them to hire independent experts to do it for them. But if such experts were really good at their jobs, we would not be seeing the problems I have outlined here.

Defining value anew

But let me expand my definition of value. The most expensive resource in a company is people. In the highly regulated field of drug development, that adage has particular force, as there are huge overheads in recruiting the right people, training them and controlling what they do. I recently read an interesting online discussion about the worth of standard operating procedures (SOPs). I believe they’re worth a great deal, because without them no credible scientific data can be produced. I say ‘credible` because the regulators won’t believe it in the absence of SOPs, and they are the people we have to convince. Yet I wonder whether top managers in some companies see SOPs as any more than a necessary evil – a kind of straitjacket. This is unfortunately, because if properly developed they enable people to meet the demanding standards of modern drug development, helping them to do their jobs.

Of course SOPs are tangibles – a clear demonstration of ability to do the work. But if they were enough on their own, we would not need to train people. Good Clinical Practice (GCP) requires that everyone is qualified by education, training and experience to be entrusted with the work. Of these, the first two are relatively easy. We can hire people with the right university degrees, and we can put them on training courses. Experience is harder to obtain, and takes time while we are paying their salaries. The short cut is to hire people with the right experience, but at higher cost.

Value overlooked

So far I have shown that value in drug development is not confined to the drug itself. The people doing the work, and the practices and procedures that they follow, also have clearly demonstrable value. My question is whether this is fully taken into account when assessing an investment or disposal opportunity. It relates to the dilemma faced by a service company such as a contract research organisation. At least on the eastern side of the Atlantic, investors are reluctant to put cash into what they see as intangibles – the old ‘bricks and mortar’ attitude. I have first hand experience of this, when shareholders were unwilling to support a service business, albeit one based on new technology. They saw it as a software company, and wanted to sell the technology on CDs. This despite market research data showing that in IT the service sector was growing faster than its software counterpart.

A microcosm of value

So let us reflect for a moment on the challenges faced by a small company with one flagship product and maybe a few minor drugs under development. It is in danger of being a one-trick pony, unless its owners can get investors to see a broader picture of value. What do they do to build up credibility as a professional R&D organisation? Ideally they should have a highly experienced core staff, but shareholders don’t like financial commitment and would prefer them to hire contract staff. But while people may come and go, policies, practices and procedures endure, as does the company’s ethos for doing things well. These need to be seen as less intangible and more concrete.

There is one further, curious, type of value, which must be intangible but is seen as solid enough to have a monetary value attached to it. Balance sheets commonly contain an item entitled ‘goodwill’, which is a measure of the company’s reputation in the marketplace. I suppose it is possible to estimate the likelihood of income continuing for an established business, compared with a new entry, but it still seems to me to be a remarkably vague concept. It seems less easy to quantify than are highly skilled staff and the structured environment within which they work.

I suppose I am fighting the corner of drug development professionals such as myself, and trying to talk up their value, but it’s certainly true that they are undervalued. For example, clinical project managers on contract rates usually get paid less than their peers in engineering and construction, and you don’t come across many PhDs on building sites. Efficient teams of people, well managed and with effective systems and processes, are the life blood of a company. Without them the most promising products will wither and die, and company owners overlook them at their peril.

Les Rose is a freelance clinical science consultant and medical writer. www.pharmavision-consulting.co.uk

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