艾昆玮-转折点：临床试验结果如何影响生物制药估值（英）

White PaperInflection Point: How Clinical Trial Results Impact Biopharma ValuationsUnderstanding the drivers of value creation to navigate an optimal development pathMARKUS GORES, Vice President, EMEA Thought Leadership, IQVIAWILLIAM HARRIES, Senior Consultant, EMEA Thought Leadership, IQVIAFRANCESCO CAPUZZI, Senior Consultant, EMEA Integrated Research, IQVIATable of contentsDisclaimerThe analyses, their interpretation, and related information contained herein are made and provided subject to the assumptions, methodologies, caveats, and variables described in this report and are based on third party sources and data reasonably believed to be reliable. No warranty is made as to the completeness or accuracy of such third party sources or data. No investment advice is given.Introduction 2Methodology: brief overview 3The asymmetry of market response 3Drivers of valuation impact: therapy areas, trial designs, company size 6Considerations for management teams 11Closing thoughts 13Appendix: additional methodology details 14References 16About the authors 18 iqvia.com | 2Developing novel therapies to address unmet patient need is the lifeblood of the biopharmaceutical industry. It is also a capital-intensive and high-stakes endeavour, requiring an estimated $3.1 billion to bring a new therapy to market,1 with a composite success rate of 11% from phase 1 through regulatory submission.2 Clinical trial readouts, therefore, represent major inflection points in this journey, as moments of truth, that resolve uncertainty around an asset’s future prospects, including its ultimate potential for revenue generation. Consequently, company valuations respond to clinical trial results — positive and negative — as investors re-calibrate their expectations based on the new information becoming available.3-6In this white paper, we will systematically investigate how clinical trial outcomes impact company valuations and explore the underlying drivers, such as how trial results compare to investors’ prior expectations, development phase at readout, therapy area or trial design. We focus on emerging biopharma companies (EBPs), in particular those with <$1 billion market capitalisation, because their valuations are highly responsive to trial results, as most of their value is concentrated in their pipeline which often comprises just a single asset. Unsurprisingly, we found that EBP valuations are much more sensitive to clinical trial readouts, by up to two orders of magnitude, compared to big pharma companies.Furthermore, we will elaborate on the practical implications of understanding those drivers of value inflection. For example, how such insight may inform strategic decisions and help management teams navigate a company’s optimal path that balances value upside vs. incremental clinical risk, such as the optimal timing for exploring partnerships or when to pursue an exit via the M&A route.Introduction3 | Inflection Point: How Clinical Trial Results Impact Biopharma Va