Ex-US imperative
For a majority of blockbuster candidates, ex-US markets represent opportunity as big as that of the US market.
Most of the blockbuster products are acquired by global pharmaceutical companies before commercial launch or full take-off.
Traction in ex-US development can materially increase exit value and investors expect it.
The upside
Investor credibility, better prospect for additional raise
Higher exit value: upto x 2
Option value for Plan B: out-license, partnering or in-house launch
CEO/CFO view and local experience required
Target product profile and positioning based on deep local insight – understand unique clinical practice and competitor dynamics in each of the key countries
Integrated regulatory label and market access strategy – identify high value claims that meet both regulatory and market access requirements
Strategic development plan - optimise trade-off between reward, risk and cashflow building on the US development plan. Opportunities are in the details. High-level strategies fail to capture them
CEO/ CFO perspective critical. Commercially-led planning will lead to over optimistic views.