claves para emprender - josep lluís falcó antares

¿Quieres emprender? Factores clave a tener en cuenta

Josep Lluís Falcó[email protected]

Barcelona, 7 de octubre de 2016

Antares Consulting © 2016 2

1 2 3 4Activities to

performContext 10 Key

success factorsConclusions


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.


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


However, this temporal window is a good thing


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

1

2

3

4

5


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

1

2

3

4

5


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


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.


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


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


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


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.

1

2

3

4

5


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

1

2

3

4

5

6

7


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


Which are the 10 success factors to learn and implement?


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


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 milestonesin 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 onwhere to invest and how. Robust companies have evident competitiveadvantages 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-qualitydeliverables to achieve good results.

4


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

claves para emprender - josep lluís falcó antares

Small Business & Entrepreneurship