This document discusses key factors for entrepreneurs to consider. It identifies the top three factors for startup success as the team, intellectual property, and viability of product development. It recommends entrepreneurs seek assistance in developing business plans, regulatory strategies, and fundraising to present robust companies to investors. Having well-defined plans helps secure funding and position startups for successful negotiations with venture capitalists.

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Factores clave a tener en cuenta
Josep Lluís Falcó
Socio-Director
jfalco@antares-consulting.com
Barcelona, 7 de octubre de 2016

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1 2 3 4Activities to
perform
Context 10 Key
success factors
Conclusions

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1 2 3 4Activities to
perform
Context 10 Key
success factors
Conclusions

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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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However, this temporal window is a good thing

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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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2
3
4
5

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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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2
3
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5

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1 2 3 4Activities to
perform
Context 10 Key
success factors
Conclusions

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Our new consultancy business model
Based 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/Family
Offices/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 Roadmap
Clinical 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 pats
Ph III pats
12-18 mo 12-18 mo 24-36 mo
3-4 CTs Sequential
Ph II DC patsPh II POC pats
Ph III pats
8 mo 12-18 mo 12-18 mo 24-36 mo
4-5 CTs Sequential
Good proposals
to 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 Roadmap
Clinical outline Phase I + II or I/II?
Ph I h vol

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Regulatory Strategy Validation
Briefing Meeting at EMA
Activity 1
Briefing
Meeting at
EMA
Activity 2
Preclinical
regulatory
package
Activity 3
Scientific
Advice 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 asset
As 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 Capital
Some 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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3
4
5
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7

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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 early
Academic idea/result
The Deal is signed
Consolidated and Robust
Biotech Company

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1 2 3 4Activities to
perform
Context 10 Key
success factors
Conclusions

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Which are the 10 success factors to learn and implement?

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Which are the 10 success factors to learn and implement?

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Which are the 10 success factors to learn and implement?

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1 2 3 4Activities to
perform
Context 10 Key
success factors
Conclusions

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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
3
Finished
projects
8
Finished
projects
21
Finished
projects
18
Ongoing
projects…
1
Round 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.
1
It is mandatory for small biotechs to look for help at the very beginning.
Regulatory assistance is highly recommended, it clarifies the milestones
in the development and the associated costs. This information can be
exported in the financial and business plans.
2
Venture Capital investors need 100% comfort to take decisions on
where to invest and how. Robust companies have evident competitive
advantages in VC screening.
3
Consultants / Advisors / Mentors are in the middle between Start-ups
and VCs! We have to adapt to our clients and supply high-quality
deliverables to achieve good results.
4

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Josep Lluís Falcó
jfalco@antares-consulting.com
El Equipo, la IP y la Viabilidad del desarrollo del producto son los 3
factores clave para el éxito de un proyecto de emprendeduría