BIOTECHNOLOGY INDUSTRY ORGANIZATION PRESENTATION TITLE IN FOOTER MONTH XX, 2012 1
Perspectives on BioPharma Innovation
David Thomas, CFASenior Director, Industry Research & Policy Analysis
BIO
Presented to members of the National Conference of State Legislatures
June 2016
New FDA Drug Approvals
Source: FDA.gov, EvaluatePharma, BIO Industry Analysis, January 2016
Biologic Small Molecule
Source: BIO Industry Analysis, BioMedTracker, June 2016
Global BioPharma Pipeline• 5,393 clinical programs• 70% from small companies
SmallCompany
LargeCompanyN=68 companiesN=1,219 companies
38% Partnered
Perspective on R&D Spending
Source: NIH.gov: https://report.nih.gov/fundingfacts/fundingfacts.aspx ,
Factset, EvaluatePharma, BIO Industry Analysis, January 2016
2014 Spending
4.7x
Drug Development Timeline
1–2 years6-9 years
10–15 years
1 FDA Approval
3-5 years
Ph II Ph IIIFDA
ReviewPh I
Discovery
Hypothesis
In vitro testing
In vivo testing
IND
BIO Industry Analysis, January 2016
Company fundedClinical DEVELOPMENT
Company fundedPreclinical Research
BASIC RESEARCH
Drug Development Timeline
1–2 years6-9 years
10% probability of approval from Phase I
1 FDA Approval
3-5 years
Ph II Ph III ReviewPh I
100
1000s molecules
10 6 2 1
Discovery
Hypothesis
In vitro testing
In vivo testing
Source: BIO Industry Analysis, Biomedtracker, January 2016
Success Rate: (63%) * (31%) * (58%) * (85%) = 9.6%
BASIC RESEARCH
Drug Development Timeline
1–2 years6-9 years
1 FDA Approval
3-5 years
Ph II Ph IIIFDA
ReviewPh I
Discovery
Hypothesis
In vitro testing
In vivo testing
*Tufts, Journal of Health Economics, 2016
BIO Industry Analysis, January 2016
Direct Cost: ~$1-2 B Capitalized Cost: $2.6 B*
Cost Post-Approval: $0.5B for Phase IV & monitoring
100
1000s
10 6 2 1
BASIC RESEARCH
Preclinical Phase I Phase II Phase III Market
Angels, Incubators,Family Offices
Foundations, Patient Groups
R&D Collaborations with Pharma/Biotech
IPOs
Government SBIR/BARDA
Venture Capital/Corporate VCSeries A ----
- Series B Series C etc.
Follow-On Offerings
Biotech R&D Funding Sources
$1.8 B$5.1 B
$7.1 B***
$12.6 B
$3.5 B
US Funding 2015*
$1.1 B**
* US Emerging Therapeutic Companies only**2014: SBIR = $677M, BARDA = $415M***Upfront Licensing Fees
BIO Industry Analysis, January 2016
How Many ProfitableDrug Companies in the US ?
Source: Factset, BIO Industry Analysis, January 2016
Publically tradedtherapeutic biotechs
N = 367
Privately heldtherapeutic biotechs
N = 1,080
Industry N ROE
Financial Publishing/Services 10 44.8%
Information Technology Services 10 44.2%
Other Transportation 4 33.2%
Restaurants 10 32.9%
Automotive Aftermarket 10 32.9%
Home Improvement Chains 3 31.3%
Finance/Rental/Leasing 10 30.0%
Apparel/Footwear Retail 10 29.5%
Telecommunications Equipment 10 29.2%
Beverages: Non-Alcoholic 10 29.1%
Aerospace & Defense 10 27.5%
Airl ines 10 25.3%
Air Freight/Couriers 10 24.6%
Chemicals: Agricultural 10 23.0%
Other Metals/Minerals 10 22.6%
Office Equipment/Supplies 9 22.3%
Trucks/Construction/Farm Machinery 10 22.3%
Household/Personal Care 10 22.0%
Packaged Software 10 21.0%
Food Retail 10 20.9%
Specialty Stores 10 20.8%
Chemicals: Major Diversified 8 20.8%
Top 10 Biopharma 10 20.5%
How Profitable are Drug Companies? (Sorted by Top 10 US Companies, ROE)
ROE = “Return on Equity”Top 10 BioPharma rank #23
Source: Factset, BIO Industry Analysis, November 2015
How Profitable are Drug Companies? (looking at the entire industry)
ROE = “Return on Equity” BioPharma ranks #42
Source: Factset, BIO Industry Analysis, November 2015
353 US Public BioPharma CompaniesRank #1 of 126 industries
Highest Rate of R&DReinvestment of any Industry
Source: Factset, BIO Industry Analysis, November 2015
On the Cusp of the Next Generation of Medical Breakthroughs
Source: BIO Industry Analysis, January 2016
Immuno-oncologyRare Disease
Gene Therapy & Cell TherapyNext Generation Biologics
Precision Medicine
New BIO Reports Available Online
Source: BIO Industry Analysis, June , 2015
www.bio.org/iareports1. Emerging Therapeutic Company Report:
Investment and Deal Trends 2006-20152. Clinical Development Success Rates 2006-2015
www.bio.org/bestpracticesEconomic Development in the States:Legislation and job creation best practices
