The premier commercial partner for late-stage specialty, rare/orphan - - PowerPoint PPT Presentation

the premier commercial partner for late stage specialty
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The premier commercial partner for late-stage specialty, rare/orphan - - PowerPoint PPT Presentation

The premier commercial partner for late-stage specialty, rare/orphan and hospital products in Europe May 2019 Faster value creation while maintaining strategic flexibility Two sequential service offerings to prepare for and execute launch in


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The premier commercial partner for late-stage specialty, rare/orphan and hospital products in Europe

May 2019

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May 2019 Corporate Presentation

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Faster value creation while maintaining strategic flexibility

Go-To-market Preparation: Vicarius carries out all pre-submission and pre-approval activities on a fee-for-service basis, through to decision point on direct entry or partnering Commercialization: Vicarius launches and commercializes partner asset on flexible terms Two sequential service offerings to prepare for and execute launch in Europe

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May 2019 Corporate Presentation

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We provide excellence in launch preparation and execution

Leadership team consists of senior executives with an average of 27 years

  • f experience in Life Sciences industry

Expertise and know-how gathered with over 40 product launches

  • n a pan-European level

Achieved multiple successful pan-European and national regulatory approvals Successfully negotiated P&R submissions, incl. HTA submissions, in all European markets Registered dozens of legal entities in Europe and built robust, tax-efficient inter-company structures Hired over 2000 employees for direct EU operations and successfully managed extensive third party distributor networks in and outside the EU

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May 2019 Corporate Presentation

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We are experienced in a wide range of disease areas

Neurology (Alzheimer’s disease, MS, Parkinson’s disease) Cardio-vascular diseases Auto-immune (Crohn’s disease, Lupus, rheumatoid arthritis) Infectious diseases Psychiatric disorders (depression, anxiety, schizophrenia) Dermatology (psoriasis) Oncology Pain management Metabolic diseases (diabetes, GH deficiency, hemophilia) Ophthalmology Respiratory diseases (asthma) Rheumatology Neuromuscular disorders Several rare and ultra rare diseases

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May 2019 Corporate Presentation

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Go-To-Market Preparation

A single point of contact for all pre-approval activities

Highly experienced European team with expertise in all key areas manages Go-To-Market process through to decision point on direct market entry

  • r partnering

Crucial preparatory activities are executed in timely fashion without stretching partner’s global management bandwidth or focus Single point of contact for partner reduces complexity of multiple consultants Services on an as-needed basis, saving the cost of a full but under-utilized Partner European management team Flexible in the event of changes in anticipated regulatory timelines Option to enter into full commercial agreement with Vicarius after the preparatory consulting phase, when organization build-up has to commence

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May 2019 Corporate Presentation

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Commercialization

Comprehensive European Commercialization Options

Tailored Contract Sales Organization

Dedicated commercial organizations for our partners on flexible service terms, with option to switch to Dedicated or Portfolio relationship

Dedicated Company Dedicated commercial organizations for assets with exp. peak sales of > €100m and partners interested in building footprint in Europe Multiple, non-competing assets in aligned therapeutic area with exp. peak sales < €100m that do not justify dedicated organization Portfolio Company

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May 2019 Corporate Presentation

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Commercializing a first product in Europe by building and managing a Dedicated Company

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Partner’s European commercial organization

Vicarius Pharma HQ Dedicated customer-facing Operations (OpCo)

> General management > HR > Regulatory > Market Access > Medical > Supply Chain > Legal > Pharmacovigilance > Compliance > Infrastructure > General management > Business Unit Head > Marketing > MSLs > KAMs > MAMs

Expertise and resources

Dedicated Company

We build dedicated customer-facing operations

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May 2019 Corporate Presentation

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Dedicated Company

Increased value capture compared to traditional out-licensing

Vicarius Pharma builds branded European footprint that can be taken over by the partner Partners enjoy goodwill creation and increased brand equity Improved economics through generous royalty stream and profit share Minimum target partner share of ca. 50% of NPV, more on early recovery Strategic options remain open for innovator company as asset can be recovered at any time Valuation of innovator company does not suffer from “poison pill” effect

  • f typical out-licensing agreements
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May 2019 Corporate Presentation

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Commercializing innovative small/medium size assets through a Portfolio Company

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May 2019 Corporate Presentation

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Typical out-license arrangements are not suited for all types of assets:

Some partners (e.g. single asset companies) don’t intend to build a dedicated organization in Europe but want improved economics vs out-licensing and wish to preserve strategic control following launch Assets in highly specialized disease areas may not provide sufficient business opportunity to justify a dedicated organization

Costly executive management and senior expert functions (e.g. VP Medical) Relatively small customer facing organization (KAMs, MSLs) compared to management and expert function overhead

Portfolio Company

Improved economics through leverage

Vicarius Pharma offers an alternative – the Portfolio Company

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May 2019 Corporate Presentation

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Portfolio Company

Features and benefits

Portfolio Company commercializes several non-competing assets in same therapeutic area which would be too small to justify single-asset Dedicated Company, or where partner is not interested in building an European Organization Vicarius offers partners opportunity to obtain attractive economic terms plus strategic flexibility to recover asset at any time, e.g. on change of control Recovery right removes poison pill effect of standard out-licenses Minimum target partner share of ca. 50% of NPV, more on early recovery

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Why entering Europe with Vicarius is a highly attractive option:

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Key benefits of a partnership with Vicarius Pharma

Expert launch preparation and execution Pan-European, right-sized commercial coverage Attractive economics Assured compliance Strategic and structural flexibility

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Faster value creation while maintaining strategic flexibility

benefit from our unmatched experience & focused execution reduce the risks of entering Europe and achieve increased value capture retain the highest strategic flexibility Preparing to register and commercialize a first product in Europe with Vicarius Pharma, our partners

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Thank you