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Avoiding Pitfalls of U.S. Biotech Companies Coming to Europe

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Avoiding Pitfalls of U.S. Biotech Companies Coming to Europe GREATER ZURICH AREA Avoiding Pitfalls of U.S. Biotech Companies Coming to Europe Whitepaper based on a virtual roundtable held on January 27, 2021 About the virtual roundtable On Wednesday, January 27, The speakers of the event offered 2021, Heidrick & Struggles and four unique perspectives: Greater Zurich Area Ltd (GZA) 1. Head of Europe represented by Michelle Lock, co-hosted a virtual roundtable Head of Europe/International, for a select group of leaders Acceleron Pharmaceutical from biopharmaceutical com- 2. Government represented by Beat Bachmann, panies interested in expanding Head of Economic Promotion, their operations to Europe. Canton of Zug The one-hour panel addressed (part of the Greater Zurich Area) some of the key decisions in 3. Talent & People represented by Oliver Schiltz, hiring and finding talent, tax Managing Partner Switzerland, and IP considerations as well as Global Co-Lead Biotechnology, accessibility and attractiveness Heidrick & Struggles 4. Tax & IP of a location. represented by Samuel Bussmann, Partner, MME Legal Tax Compliance, Co-Founder BioXpansion GmbH This summary of the roundtable is presented in a simple outline format. It is intended to capture the key points made by the speakers and has been edited for brevity. Imprint Editor: Greater Zurich Area Ltd (GZA) © Greater Zurich Area Ltd (GZA), February 2021 Michelle Lock Head of Europe/International, Acceleron Pharmaceutical Europe represents the second largest market in the world for pharmaceuticals. Therefore, it is highly attractive to companies with products that offer a compelling and differentiated value proposition. However, expanding to Europe can be daunting due to Europe’s multiple geographies and languages, different regulatory needs, as well as multiple EU payer requirements and reference pricing systems. Some of the critical questions when expanding to Europe are Go alone or not? Can the product Can the organization succeed in Europe/ empower ex-U.S. Maintain control over commercialization in internationally? decision making? mayor markets Regulatory, pricing, Enable appropriate and commercial model local decision making and flexibility Guiding principles for successful international builds Build early Invest for success Calibrate & pulse Over-invest build-out in talent – International build – Invest early to avoid to commence 2-3 yrs under-resourcing and – Recruit in ‘gated’ – Invest early, pre-launch potential slow uptake waves; 1st wave prioritize experience – Clarify global/ – Build with efficient, based on opportunity and mindset and pricing regional/local effective infrastructure – Empower hiring – Sequence country decisions and provide launches and define autonomy to make market specific decisions strategies – Engage payers early Timing & clarity are important The EU general manager (GM) role is a critical position and should be the first hire (24-30 months pre-approval). The sequencing of hiring is important as mistakes can be costly and time consuming. Roles to be appointed 18-24 months pre-approval include: Market Access, Medical Affairs, Regulatory and Commercial (MMRC) leader- ship. Allow ample time for recruitment as EU has significantly longer onboarding times than the U.S. Clarity should be built early for each leadership team member’s line function and leadership team accountabilities and communicated transparently. Align early on what decisions will be made from corporate HQ then empower EU leadership team to successfully run Europe. First hire: months pre-approval (selected companies in the Greater Zurich Area) Alnylam Blueprint Medicines Onix Apellis Ariad Agios Intermune 48 24 12 0 Prothena Sage Insights provided June 2020 by Paul Beresford - Blueprint Medicines Michelle Lock - Sage Therapeutics Cubist Tesaro Oliver Schiltz - Heidrick & Struggles Orlando Oliveira - Agios Theresa Heggie - Alnylam Thomas Lackner - Apellis and Prothena Mark Altmeyer - Arvelle Key milestones - 30 Month - 24 Month - 18 Month - 12 Month - 9 Month - 6 Month Launch – Secure cor- – EU HQ site – Country launch – Legal/compli- – Finalize distri- – Commer- – Product launch porate legal location sequencing ance strategy bution model cial launch strategy readiness – Recruit Heads – Site selection – Access and – Build ‘Wave II’ – Hire of General of Medical, and country commercial countries – Build ‘Wave II’ Manager and Market Access, builds execution countries – General Ma- Office Manager Regulatory & – Access & com- – Onboard sales nagers ‘Wave – Head of IT Commercial – Market access mercial plans organization II’ countries and pricing – Build of Euro- built – General Mana- and reimburse- pean opera- – Tax strategy gers of ‘Wave I’ ment study ting model countries – Legal, Compli- ance and Ge- – Head of Fi- neral Manager nance, HR and distribution Strategy Execution and build Infrastructure build is the engine of the company Build infrastructure in a scaled – Manufacturing The set-up and maintenance manner and according to the – Distribution to Europe of the infrastructure of different purpose. Infrastructure is needed – Warehousing in Europe business units including finance for a variety of business processes: – Analytical testing & & tax, commercial, legal & packaging compliance, regulatory & quality, – Distribution through wholesalers information systems, and supply – Product to patients chain. Beat Bachmann Head of Economic Promotion, Canton of Zug The Greater Zurich Area and the canton of Zug More than 300 companies focus on pharma, bio- have evolved into a dynamically expanding life tech or medtech. The canton is home to a mix of sciences hotspot. Academic excellence, business- small to large companies with a high influx of job friendly regulations, IP protection, a large interna- growth of U.S. biotech companies in the last 20 years. tional talent pool and R&D collaborations between Companies in the canton include: J&J (1,000+ universities and start-ups as well as large multina- employees), Biogen (500+ employees), Amgen tional corporations (like Roche, Johnson & Johnson, (300 employees), Astra (200 employees), BMS Biogen or Stryker) serve as an engine motor for (200 employees), Bluebird Bio (60 employees), innovation. Seagen (60 employees), Alnylam (40 employees). The canton of Zug is the preferred HQ location in New European headquarters from U.S. based the Greater Zurich Area and in all of Switzerland. biopharma companies include (2019/2020) The canton of Zug has ranked #1 for over 20 years in location attractiveness across all Swiss cantons. – Apellis It’s the preferred headquarters location in Europe – Arvelle Therapeutics with a presence of several hundred of European –Deciphera and international headquarters. – Global Blood Therapeutics – Kiniksa Pharmaceuticals Life sciences companies are of critical importance to –Reata Pharmaceuticals Zug and vice versa. 8 % of all jobs (or 9,000 jobs) are – Stemline in life sciences in the canton of Zug. – Viela Bio Oliver Schiltz Managing Partner Switzerland, Global Co-Lead Biotechnology, Heidrick & Struggles Branding matters Biotech companies headquartered in U.S. life sciences You need a strong brand hubs (i.e., Greater Boston area, San Francisco, San ambassador in Europe Diego, New York/Tri-State area), may have a strong This starts with partnering with a well-researched, brand awareness in the local market. However, they well-networked, credentialed search firm team are relatively unknown in Europe. Increasing over- to attract the best talent. You need a partner as seas publicity prior to and during recruitment is a your brand ambassador, differentiating you from necessary yet often underestimated effort by U.S. other competitors in the market. This brand lea- companies undergoing expansion and seeking to dership during the European build-out continues source the best talent from established biotech with a strong Head of Europe/International in or big pharma companies in Europe. place and with the EU leadership team. You need unique selling points as Why expand to Europe? a biotech beyond being ‘innovative’ It is not enough nowadays to stand behind a very Strengthen your U.S. HQ innovative product pipeline. There are approximately U.S. biotech companies that build a hub outside of 30+ U.S. biotech companies building a European the U.S. can differentiate themselves from compe- hub during any given financial year, each com- titors since they are now an international versus a peting with similar tag lines about innovation and national company. focus. Further differentiation is key to attract the top leaders, especially as it relates to the culture of Build a diverse culture your organization. Some U.S. biotech companies hesitate to build in Europe as they feel that their unique entrepreneurial Hiring process: key takeaways culture could be compromised as the organization grows larger and takes on an international cultural Levelling of the positions element. In discussions with several U.S. biotechs Appropriate and competitive levelling of the cri- such as Alnylam, Seattle Genetics, and Tesaro, tical hires during a European build-out will allow several leaders attested to the contrary: that the your biotech to attract top talent in a competitive international footprint only enriched the company European market. For example, it is ideal if the culture. Head of Europe/Head of International is hired at SVP level in order to recruit functional talent Become an attractive target at VP level. for acquisition When you build and launch successfully in Europe, Advantage of an experienced you
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