Pharmaceutical Products Liability. Michael C. Dubin Stephen Knobloch

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1 Pharmaceutical Products Liability Michael C. Dubin Stephen Knobloch

2 Objectives Objective 1 Get Actuaries Thinking About Adding Value to New Areas Objective 2 Provide example using pharmaceutical industry

3 Agenda Tuesday, June 12, 2007 Adding Actuarial Value Stephen Knobloch, Mike Dubin Q & A

4 Actuaries Adding Value to New Areas Become one of them Apply actuarial thinking Show them how to use it

5 I don t want to be a product of my environment...i want my environment to be a product of me Jack Nicholson, The Departed

6 Objectives Objective 1 Get Actuaries Thinking About Adding Value to New Areas Objective 2 Provide example using pharmaceutical industry

7 Background on Pharmaceutical Industry Economics Product Withdrawals Why So Much Liability?

8 Economics Market dominated by dozen multinational firms $Quarter trillion US market $Half trillion global Consecutive years of double digit growth $90 billion from 40 blockbuster drugs

9 Product Withdrawals 15 product withdrawals between 1997 and Prescription Drugs -1 Vaccine -$13 billion annual revenue lost 8 product withdrawals between 1971 and 1997.

10 Why So Much Liability? Rampant litigiousness Blockbuster Business Model Constant threat of Patent Expiration and Push for New Drugs

11 Rampant Litigiousness More product liability lawsuits than any other industry since ,000+ lawsuits filed Plaintiff lawyers are becoming increasingly skilled in finding consumers suffering adverse reactions The Effect... Litigation costs eat into research funds and change consumer behaviors Harris Poll found 4 out of 10 doctors stop prescribing medications after hearing they are involved in a PL lawsuit

12 Blockbuster business model Currently pursued $1 billion annual peak worldwide consumption Assume single compound can treat most patients (actually 40%-60%) Physicians use trial and error Severe adverse events are costly High risk - high reward Significant barriers to entry for new drugs Trials must be larger 8 to 12 years to advance drug to market Great Innovation and R/D expense Greater marketing expense

13 Drug Sales by Major Pharmaceutical Companies, Neurontin Avandia? Ortho Evra Vioxx Seroquel Zyprexa Leading Companies (Bil $ US) Pfizer GlaxoSmithKline J&J Merck & Co. AstraZeneca Novartis Amgen Sanofi-Aventis Lilly Bristol-Myers Squibb

14 Blockbuster US Drug Sales Blockbuster Sales ($B) Zocor Prevacid Zoloft Effexor XR Norvasc Risperdal Fosamax Pravachol Ambien Zyrtec Zofran

15 Patent Expirations Branded drugs with a market value of $21.3 billion face imminent patent expiration. 70 more innovative drugs face expiration by 2010, 19 of which are blockbusters The effect of losing revenue to generic drug makers is substantial: Less income for development of new products and research More pressure to do more with less Fuels Blockbuster Business Model Increased Competition

16 How pharma industry has dealt with products liability Traditional insurance lack of availability Self-insurance Large deductibles, retentions Finite deals Lack of understanding of coverage Remote coverage triggers Integrated occurrences Major exclusions, inadequate limits

17 Bad Reasons Pharma Companies Don t Use Actuaries Cannot be reasonably estimated Not a probable event Great uncertainty Estimate loss but not expense Management s best estimate Reliance on legal experts When is loss incurred Lack of company data

18 How pharma industry has dealt with self-insurance Each company has its own strategy Policy to not book IBNR claims made Policy to not book legal expense reserves Use of we expect to prevail Limit scope of actuarial involvement Pure IBNR only No data or actuarial involvement

19 Importance of Actuarial Involvement Huge and growing industry with growing liability High risk industry cost may shift to society Historically industry has not predicted liability Actuaries not fully utilized Public would benefit from best risk analysis techniques

20 Showing Them How to Use Actuaries Benchmarking Loss Development Factors Severity Distributions Claim Reporting Patterns Creating Models Based on Expert Assumptions Simulation Estimating Exposure from Sold Drugs

21 Summary Adding Actuarial Value Became pharma expert to converse in industry lingo Applied actuarial thinking Showed them how to use it to gain insight into their own business Can apply principles to any industry

22 Objectives Objective 1 Get Actuaries Thinking About Adding Value to New Areas Objective 2 Provide example using pharmaceutical industry

23 Questions and Answers P w C

24 P w C 2004 LLP. All rights reserved. "" refers to LLP (a Delaware limited liability partnership) or, as the context requires, other member firms of International Ltd., each of which is a separate and independent legal entity. *connectedthinking is a trademark of LLP. P w C

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