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As it readies submission for a once-weekly diabetes injectable, Amylin announces that it will trim 35 percent of its sales force and put focus on specialty physicians.

Amylin Drops 200 Sales Reps

New prescriptions for antiviral treatments get huge boost due to H1N1 epidemic. Numbers exceed those seen during this year's influenza season, and the numbers are climbing.

Rx Scripts Spike in Wake of Swine Flu

Ernst & Young, on Tuesday, released its massive biotech report detailing changes in the industry over the past 12 months.

Alliance deals were the big news of 2008, with numerous transactions worth billions in "biobucks." More recently, though, the global economic crisis has hit home, with venture capital dollars slipping away and smaller cap companies forced to sell or go under.

 Biotech revenues increased 12 percent to $89.7 billion in 2008.
    

Net loss dove 53%, from $3 billion in 2007 to $1.4 billion in 2008.
    

Companies raised only $16 billion in capital in 2008, down 46 percent from 2007. 
    

Venture financing dropped 19 percent from $6 billion in 2008.
    

United States biotech M&As reached more than $28.5 billion.
    
    As in every other industry this year, the big story for biotech is the impact from the global financial crisis. The bio industry, in particular,  depends on capital funding and equity investors to fuel its R&D.

"This has been one of the tougher years we've seen in biotech," said Glen Giovannetti, Ernst & Young’s global biotechnology leader. "Which raises the bigger question about the financing model for biotech and its sustainability. If you think about that $14 billion decrease in funding year over year, the industry has depended on a number that big to keep the 300-plus public companies cranking along doing R&D, but if you don't see that rapid return, we are going to have to see adaptation and companies cease operation because there isn't enough capital."

Venture capital fell 19 percent, a sizable decrease compared to the prior year, but still one of the biggest years for biotech investment. That said, 2008 was a record year for venture capital dollars flowing into biotech.

"On a relative basis, venture capital held in there fairly well. We've seen some softness in 2009, so it's not clear that we are out of the woods yet, but as compared to the public market, it wasn't as [much] of a drop off," Giovannetti told Pharm Exec on Tuesday.

Overall revenue was up 12 percent, which is consistent with the double-digit growth of prior years and the net loss improved by half (53 percent globally). In the US, for the first time in 35 years, the biotech industry was profitable—up $0.4 billion for the year.

"That is symbolic because it is driven by the fortunes of a couple of handfuls of larger, more profitable companies, while the vast majority of companies are losing money as they do R&D," Giovannetti said. Also, Genentech, which is still in the 2008 report and will disappear in 2009 when it becomes part of Roche, makes up a very large chunk of the industry's overall profitability.

"The overall goal is to create value for shareholders and patients, and if at some point the best reward is to sell out to a larger company, be it a larger biotech or pharma company, that is up for the individual boards to decide," Giovannetti said. "Its very hard to create a company with the prospect that it will only get sold. You can't know that someone will come around and just buy your company at the right price."

As the economy continues to retract, fewer biotech companies are finding the funding they need to survive, driving more firms to sell or close shop.

Bio Companies Low on Venture Capital Cash

The concept of risk is in the very DNA of the life science industry—consider the following terms: risk assessment, risk adjustment, risk benefit, risk factors, risk management, risk perception, risk profile, risk ratios, risk scores, risk stratification, etc... For good measure, Ernst & Young, has added a new term—‘risk radar’— in a report published this month (The 2009 Ernst & Young business risk report, April 2009). The report surveyed over 100 industry specialists and asked them to identify and rank the top ten business risks affecting life science firms today, including both biotech and Big Pharma. Andrew Jones, a senior analyst in the pharmaceutical practice at Ernst & Young, outlines the context in which the report was commissioned: “Historically, pharma has been highly regulated, and the risk landscape can change dramatically—one change can have widespread consequences. We are seeing a number of changes at the corporate level: business models are changing, there is geographical expansion, life science companies are more reliant on third parties, patient groups are more empowered, and the customer environment is changing. Tomorrow’s businesses will look materially different from today’s. 

 
One of the tools used to assess risks affecting tomorrow’s business model is the ‘risk radar,’ which can be customised and used as a basis for ongoing dialogue in one’s organisation. The risk radar (see left) is a circular map which places the top ten risks into quadrants—financial, compliance, strategic, and operations risks—and signifies the relative importance of a risk by its proximity to the centre. For life science firms in general, financial and compliance quadrants include just two of the business risks in the top ten—‘capital access/allocation’ and ‘ensuring safeproducts,’ respectively. Of the remaining eight leading risks, four are strategic and three are in operations; ‘sustaining a culture of innovation’ as a risk sits on the border of strategy and operations. 


For industry analysts and specialists alike, the top risk was demonstrating value amid pricing pressures, with capital access/allocation and boosting R&D productivity claiming silver and bronze positions respectively. Andrew explains to whom demonstrating value was most important: "The commercial model of pharma has to address a wider group of stakeholders than ever before, including patients, physicians, nurses, care-givers, payers, insurers and pricing and reimbursement specialists—and the customer mix changes by product and by geography. A patient cares about getting better; for a physician it’s about improving health outcomes. A payer may also value that, but will consider the financial dimensions too.”

This is a view shared by Andrew Hobbs, managing director of PopeWoodhead Consulting, who tells me: “Payers are a big—but neglected—group, segmented at the local, regional, and national levels. Now there is a big shift towards embracing payers as a customer group—not just as a technical hurdle.”

However, demonstrating and articulating value throughout the company is seen as particularly important now, firstly because of the global financial crisis and concomitant shrinking tax base, and secondly in the light of patent expiries and the need to justify premia placed on drugs in the light of generic alternatives.

To the question of how an entire company could demonstrate value externally, Andrew responds: “Companies have deep knowledge about their product, but to compete, they need to leverage that knowledge and add value in all their interactions. For example, at the doctor level, training can be about product as well as about tools to increase patient compliance. It is just as important not to destroy value, for example, through illegitimate promotional practices, which can cause direct financial damage and brand reputation.” The reference to interactions will be familiar to AstraZeneca employees; CEO, David Brennan, is famous for his personal motto: “make every interaction count.”


The Ernst & Young report, quite rightly, is highly focused on life sciences; however, there is little discussion of risks from the macro-environment, which can severely affect business. PEST is a wellknown tool, used to assess the political, economic, social and technological trends in any given business context. Consider that Swiss pharmaceutical firm Hoffman-La Roche, founded in 1896, rapidly established nine international operations across Europe, Japan, and the US within twenty years. The Russian affiliate, established in St Petersburg in 1910, grew into Roche’s biggest market by 1916. However, the Russian Revolution in October 1917 abruptly ended Roche’s operations in Russia and almost bankrupted the firm.

So why were political risks were not considered in the report? Andrew comments: “The report focuses on wellcharacterised, industry-specific risks; in practice, companies should also look to the horizon at the periphery to pick up emerging risks. However, it can only go so far. You can’t plan for ‘black swans’—some risks can come out of nowhere. Management should therefore strive to improve the resilience of their businesses to the impact of such events.”and almost bankrupted the firm. So why were political risks were not considered in the report? Andrew comments: “The report focuses on wellcharacterised, industry-specific risks; in practice, companies should also look to the horizon at the periphery to pick up emerging risks. However, it can only go so far. You can’t plan for ‘black swans’ —some risks can come out of nowhere. Management should therefore strive to improve the resilience of their businesses to the impact of such events.”

Pharm Exec Europe's Gerhard Symons speaks to Andrew Jones, a senior pharmaceutical analyst with the firm, about the value of introducing a "risk radar" to your organization.

Pharmaceutical Executive-05-07-2009

Amylin Drops 200 Sales Reps

Rx Scripts Spike in Wake of Swine Flu

Bio Companies Low on Venture Capital Cash

Reading the "Risk Radar"