Perspectives on BioPharma Innovation

Transcription

1 Perspectives on BioPharma Innovation David Thomas, CFA Senior Director, Industry Research & Policy Analysis BIO Presented to members of the National Conference of State Legislatures June 2016 BIOTECHNOLOGY INDUSTRY ORGANIZATION PRESENTATION TITLE IN FOOTER MONTH XX,

2 New FDA Drug Approvals Small Molecule Biologic Source: FDA.gov, EvaluatePharma, BIO Industry Analysis, January 2016

3 Global BioPharma Pipeline 5,393 clinical programs 70% from small companies 38% Partnered Small Company N=1,219 companies Large Company N=68 companies Source: BIO Industry Analysis, BioMedTracker, June 2016

4 Perspective on R&D Spending 2014 Spending 4.7x Source: NIH.gov: Factset, EvaluatePharma, BIO Industry Analysis, January 2016

5 Drug Development Timeline Discovery Hypothesis BASIC RESEARCH years In vitro testing Company funded Preclinical Research In vivo testing IND Ph I Company funded Clinical DEVELOPMENT Ph II Ph III FDA Review 1 FDA Approval 3-5 years 6-9 years 1 2 years BIO Industry Analysis, January 2016

6 Drug Development Timeline Discovery In vitro testing 1000s molecules In vivo testing Hypothesis 100 Ph I BASIC RESEARCH 10% probability of approval from Phase I Success Rate: (63%) * (31%) * (58%) * (85%) = 9.6% Ph II Ph III Review FDA Approval 3-5 years 6-9 years 1 2 years Source: BIO Industry Analysis, Biomedtracker, January 2016

7 Drug Development Timeline Hypothesis BASIC RESEARCH Discovery In vitro testing In vivo testing 1000s 100 Ph I Direct Cost: ~$1-2 B Capitalized Cost: $2.6 B* Ph II Ph III Cost Post-Approval: $0.5B for Phase IV & monitoring FDA Review 1 FDA Approval 3-5 years 6-9 years 1 2 years *Tufts, Journal of Health Economics, 2016 BIO Industry Analysis, January 2016

8 Biotech R&D Funding Sources Angels, Incubators, Family Offices Foundations, Patient Groups US Funding 2015* Government SBIR/BARDA $1.1 B** Venture Capital/Corporate VC Series A Series B Series C etc. R&D Collaborations with Pharma/Biotech IPOs Follow-On Offerings $1.8 B $5.1 B $7.1 B*** $3.5 B $12.6 B Preclinical Phase I Phase II Phase III Market * US Emerging Therapeutic Companies only **2014: SBIR = $677M, BARDA = $415M ***Upfront Licensing Fees BIO Industry Analysis, January 2016

9 How Many Profitable Drug Companies in the US? Publically traded therapeutic biotechs N = 367 Privately held therapeutic biotechs N = 1,080 Source: Factset, BIO Industry Analysis, January 2016

10 How Profitable are Drug Companies? (Sorted by Top 10 US Companies, ROE) ROE = Return on Equity Top 10 BioPharma rank #23 Industry N ROE Financial Publishing/Services % Information Technology Services % Other Transportation % Restaurants % Automotive Aftermarket % Home Improvement Chains % Finance/Rental/Leasing % Apparel/Footwear Retail % Telecommunications Equipment % Beverages: Non-Alcoholic % Aerospace & Defense % Airlines % Air Freight/Couriers % Chemicals: Agricultural % Other Metals/Minerals % Office Equipment/Supplies % Trucks/Construction/Farm Machinery % Household/Personal Care % Packaged Software % Food Retail % Specialty Stores % Chemicals: Major Diversified % Top 10 Biopharma % Source: Factset, BIO Industry Analysis, November 2015

11 How Profitable are Drug Companies? (looking at the entire industry) ROE = Return on Equity BioPharma ranks #42 Source: Factset, BIO Industry Analysis, November 2015

12 Highest Rate of R&D Reinvestment of any Industry 353 US Public BioPharma Companies Rank #1 of 126 industries Source: Factset, BIO Industry Analysis, November 2015

13 On the Cusp of the Next Generation of Medical Breakthroughs Immuno-oncology Rare Disease Precision Medicine Gene Therapy & Cell Therapy Next Generation Biologics Source: BIO Industry Analysis, January 2016

14 New BIO Reports Available Online 1. Emerging Therapeutic Company Report: Investment and Deal Trends Clinical Development Success Rates Economic Development in the States: Legislation and job creation best practices Source: BIO Industry Analysis, June, 2015