L18 Business Plans Flashcards
Licensing steps
- non-confidential disclosure
- face to face meeting under CDA
- due diligence
- negotiate Term Sheet
- sign contract
Spinout company to hold IP - steps
- raise funds with VCs or other investors
- add value with more development/trials
- exit - sell company or float IPO on stock exchange
License IP to industry pros and cons
see onenote table
Spinout company to hold and develop IP - pros and cons
see onenote table
Foundations of a biotech business
- passion and purpose
- product idea
- technology
- disease focus
- customer focus
Choosing a direction to build a business plan around
see onenote slides
- company mission
- resources
- capabilities
- unsolved clinical problems
- goals, measure of success
- strategy for growth
- how to make it happen
- leadership, communication and HR plans
Why do you need a business plan?
- internal document to show board of directors you know what you’re doing
- external document to show investors you know what you’re doing
- planning document to figure out what you’re doing
Typical business plan headings
see onenote
- The Business
- The Market
- The Future
- The Finances
Execution or Exploration
see onenote
Alternatives to traditional business plans
writing a full business plan with detailed projections can trap you into believing them and not looking for what’s really going to impact your business
more flexible, early planning tools have emerged:
- business canvas
- lean launch pad/startup methods
- pitch pack - VC
The business canvas
see onenote slides
Is there an unmet need?
see onenote slides
First, talk to doctors and patients to find out what are the big unsolved clinical problems?
a. check with clinicians whether what researchers think is an unmet need, really is an unmet need
b. does your solution meet the needs of clinicians and patients
c. would your solution offer a big improvement on how clinicians are dealing with the problem now
Market Research
To discover if they’ll buy your product
Primary research sources for unmet needs, user preferences, work practices
- interviews
- questionnaires
- focus groups
- observation
To discover the size and shape of your potential market
secondary research sources for demographics, pop growth, age, prevalence, incidence etc.
- gov’t agencies
- census
- industry associations
- company websites
Example - Opthamology market segment analysis
see onenote table
Your value proposition
see onenote
- based on understanding your key customer’s problems and desires
- what compelling benefit will your product/service product that they really care about?
Entrepreneur issues - a solution in search of a problem
see onenote
Startup methods for Life Sciences - dual pathway
Dual part
- Making technology, science better, efficacy in humans
- What are the commercial things we need to know
a. Is it commercially valuable
b. Regulatory issues
c. IP
d. Reimbursement - who pays for the drugs, therapeutics, diagnostics
e. Understanding clinical trials
Get the key scientist/principal investigator outside the lab, to understand the commercialisation
- To understand the second part, not just the science
Biotech customers
Who your customers are changes as you go
- clinicians
- patients
- patent offices
- investors
- industry
- regulators
- reimbursement agencies
with every customer, you need to test your hypotheses about your assumed “truths”
Target product profile
see onenote
To guide product development
- indication
- usage
- efficacy
- marker
- safety
- dose/delivery
- manufacture
- patent
Guiding lights for the business
see onenote slides
- vision
- mission
- core capabilities
- target customers
- objectives/goals
- strategy
- values
- culture
- leadership
- risk management
Vision
see onenote
- ambition of you you want to be in the end
Mission statements
see onenote slides
- can define the business you’re in
Goals
SMART goals: Specific Measurable Attainable Realistic Timely
Strategy and Tactics
strategy - game plan you develop to reach your goals
tactics - changes you make in the heat of the game
Business models
- FIPCO - fully integrated pharma company
- speciality pharma
- services, databases, tools
- biotech global value chain sausage, factory in-license, add value, then out license
- one shot biotech (favoured by VCs)
- virtual company - outsourcing everything but management
Values
see onenote
provides a reference for decisions and desired behaviours
Culture
how the group actually behaves
Risk management
see onenote slides
raise more money than you need every chance you get
don’t skimp on extensive preclinical trials to work out dose, efficacy and safety as much as possible before human trials
build relationships with more than one company
have insurance and build a team
Leadership needs can change
see onenote
- early - visionary, founder
- mid - investor facing
- mid to late - portfolio manager
- late - mergers and acquisitions expert
Pitch Pack in today’s Business Plan
- cover slide with tag line
- problem
- solution
- market opportunity
- team
- competitive analysis
- business model
- financial data and projections
- the ask
- closing slide
reasons companies fail
- no market need
- ran out of cash
- not the right team
- competition was better
- needed a better business model
- product mistimed
