¿Quieres emprender? Factores clave a tener en cuenta
Josep Lluís Falcó[email protected]
Barcelona, 7 de octubre de 2016
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The Company and the unmet needs
• Recently founded companies or even in pre-foundation period.
• A team of 2-4 people.
• In many cases the researcher is the alma mater.
• Sometimes a Tech Transfer Office is in the loop.
• Entrepreneurial team without business skills.
• In some cases, there is no real CEO for the company.
• Companies with lack of economic resources to pay for consultancy.
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The Economic scenario vs the investors
• Companies founded with the minimum capital.
• A small capital increase with friends/family round.
• Lack of economic resources.
• Excellent teams of investment analysts.
• Well established Scientific Advisory Board.
• Initial reluctancy to invest – need to comfort.
• Comfort given by projects defined very well from the beginning.
Economic scenario
The investors
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Some important points to bear in mind at the very beginning (1/2)
When projects are born, there are some important points to consider.
From the point of view of the entrepreneurial team:
Bad Partners
No CEO full-time
Bad Business Plan
No acceptance of % dilution
No separation between spinoff and research group
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Some important points to bear in mind at the very beginning (2/2)
When projects are born, there are some important points to consider.
From the point of view of the investors:
Excellent proof-of-concept results
Technology transfer and License
Intellectual property and strategy
Regulatory strategy and development plan
Definition of the Business model
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Our new consultancy business modelBased on a risk-sharing approach
Month 1 Month 3 Month 6 to 9
Main activity:• Strategy and Shaping• Regulatory/Development• Intellectual Property• Financials• Business Plan
Main activity:• Selection of VCs/Business
Angels/FamilyOffices/Pharma Companies
• Initial meeting• Negociation with most
advanced ones
When round is closed: Success Fee depending
on size raised
Key success factor: good selection of
projects to counsel
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Activities Antares Consulting can provide
Provide interim support to the Executive Management of the company.
Work with the entrepreneurial team to undertake basic level management objectives, including:
• Business Plan.
• Financial Plan.
• Regulatory and Development strategy.
• Industrial Property.
Prepare and support the team in the fundraising strategy:
• Raise public funding.
• Negotiate with Venture Capital for the first round of private financing.
Identify the future team that will be leading the company and plan the transfer.
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Ph III pats
Regulatory RoadmapClinical outline Phase I + II or I/II?
Ph I/II pats Ph II / III DC pats
Ph III pats
12-18 mo 24-36 mo
2-3 CTs Sequential / Parallel
Ph I/II pats Ph III patsPh II DC patsPh III pats
12-18 mo 12-18 mo 24-36 mo
3-4 CTs Sequential
Ph II DC patsPh II POC patsPh III pats
8 mo 12-18 mo 12-18 mo 24-36 mo
4-5 CTs Sequential
Good proposalsto VCs
Ph I h vol
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8 mo 12-18 mo 12-18 mo 24-36 mo
0.5 mio € 3-4 mio € 4-5 mio € 12-24 mio €
Low valueLow value High value
Ph II DC pats Ph III patsPh II POC patsPreclinical
VC’s point of view
Regulatory RoadmapClinical outline Phase I + II or I/II?
Ph I h vol
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Regulatory Strategy ValidationBriefing Meeting at EMA
Activity 1
BriefingMeeting at EMA
Activity 2
Preclinicalregulatorypackage
Activity 3
ScientificAdvice at EMA
Activity 4
CTA and clinical phase I
It is recommended to request a Briefing Meeting at the EMA. The application form must be accompanied by a scientific briefing document and questions. It is important to prepare relevant questions in order to get useful responses
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IP status of the Company: the unique assetAs strong and robust as possible
Nature of the patent: product, use, process…
OEPM or EPO? And USTPO?
Adding new matter before PCT.
ISR: to be included in the due diligence.
Have in mind national extensions and costs.
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Negotiation with Venture CapitalSome take-home messages
Lifecycle of the current fund
Portfolio of invested companies
Stage of development of the current project
Good Business Plan
Nice valuation but in the second meeting
Existing CEO full-time
Viable exit scenario
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Impact in the negotiation and Results
• Regulatory strategy defined• Development Plan established• Financial projections• Robust Business Plan
• Negociation and Due Diligence• Image of Robust company• Known size of the VC round to negociate• Regulatory Validation via Scientific Advice
Very earlyAcademic idea/result
The Deal is signed
Consolidated and RobustBiotech Company
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2013 2014 2015 2016
Our main milestones with spin-off companies in the last 4 years
Round 150k€Transplant Biomedicals
Out license 5,5 M€Oxolife – Kern Pharma
Round 100k€Leukos Biotech
Round 2,4 M€Peptomyc
3Finishedprojects
8Finishedprojects
21Finishedprojects
18Ongoing
projects…
1Round finishing
due diligence
Nature of the projects: Fundraising, Preparation of Business plan,Regulatory and development Roadmap, Strategic Plan, Business development program.
Now
Round 3,5 M€Leukos Biotech
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Conclusions
Small start-up companies are special clients: they need 100% knowledge supply and flexibility.
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It is mandatory for small biotechs to look for help at the very beginning. Regulatory assistance is highly recommended, it clarifies the milestonesin the development and the associated costs. This information can be exported in the financial and business plans.
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Venture Capital investors need 100% comfort to take decisions onwhere to invest and how. Robust companies have evident competitiveadvantages in VC screening.
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Consultants / Advisors / Mentors are in the middle between Start-ups and VCs! We have to adapt to our clients and supply high-qualitydeliverables to achieve good results.
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Josep Lluís Falcó[email protected]
El Equipo, la IP y la Viabilidad del desarrollo del producto son los 3 factores clave para el éxito de un proyecto de emprendeduría