Consolidation in the Pharmaceutical Industry Charles Baum, MD, MS, FACG Vice President and Head US Medical Affairs Takeda Pharmaceuticals USA Bio-Pharma M&A History • 30 y consolidation: ~110 companies >>> 30 • Early – national consolidation (e.g., Glaxo, Welcome and Smith/Kline) • Later – US market serves as nidus for small overseas companies – Multinational consolidation David Davidovic, http://www.pm360online.com/the-history-of-biopharma-industry-mas-lessons-learned-and-trends-to-watch/ The History of Bio-Pharma M&A's: Pfizer 10 companies >>>>> 1 David Davidovic, http://www.pm360online.com/the-history-of-biopharma-industry-mas-lessons-learned-and-trends-to-watch/ The History of Bio-Pharma M&A's: Sanofi 18 companies >>>>> 1 David Davidovic, http://www.pm360online.com/the-history-of-biopharma-industry-mas-lessons-learned-and-trends-to-watch/ Historical Drivers of M&A • 1980's (profit pressure) - Rising R+D costs - Passage of Waxman Hatch Act - Price competition from generics • 1990's (declining profits) - LOE and end of blockbuster era - Rise of buyer-side market power (MCOs/PBMs) • 2000's (single digit growth) - Shrinking Pipelines and Emergence of bio-techs - Overcapacity drives branded pharma M&A - Eliminating competition drives generics manufacturers M&A Annual Number of Pharmaceutical Mergers (2004-2014) Number of Deals over $1 Billion 25 20 15 10 5 0 2004 2005 2006 2007 https://www.levinassociates.com/dealsearch 2008 2009 2010 2011 2012 2013 2014 Overcapacity Drives M&As • M&As result in cost savings of 30-40% appeasing investors • Restructuring of Development and Commercial functions - Strategic shift from "me too" to novel specialty and orphan indications - New commercial models that leverage lower cost multi-channel/digital marketing - A shift from salesforce to value-based contracts with payers and health systems (IDNs) - Reduce research investment in favor of biotech partnerships and acquisitions. - Outsourcing William Pursche: The McKinsey Quarterly, 1996 M&As Drive Global Footprint: Example -Takeda and Nycomed Merger Low Interest Rates Favorable Exchange Rates Medicaid Spending and Prescriptions for Albendazole (Amedra Pharma) and Mebendazole (Terminated by Teva) High Cost Generic Drugs – Implications for patients and policymakers. Alpern et al., NEJM 371;20:1859-1862 Generics Manufacturers and Pricing • Turing Pharmaceuticals - Martin Shkreli raises price of generic Daraprim (pyramethamine) from $13.50 to $750 per tab – used to treat life threatening toxoplasmosis infections in HIV and cancer patients • Valeant has acquired 100 drugs and increased price of 56 drugs by average of 66% - The case of Isuprel and Nitropress (525% and 212% increases) - Ascension health has calculated cost impact for its system of ~$8 M. • PhRMA speaks out Despite Several Bad Actors Generic Drug Prices Continue to Fall http://www.aarp.org/content/d am/aarp/ppi/2015/trends-inretail-prices-of-genericprescription-drugs.pdf Impact of Consolidation for Innovators Financial • Reduction in competition drives bargaining power with payers • Tax implications Efficiency • Greater expertise, deal making agility, regulatory success Innovation • Focused pipelines – specialty pharma, oncology and orphan indications • Emphasis on Inorganic Growth - Increase in venture capital and fostering of biotech - Academic partnerships FDA Approvals Indicate M&As Have Positive Effect on Pharmaceutical Innovation http://www.fda.gov/drugs/developme ntapprovalprocess/druginnovation/uc m20025676.htm Number of US Biotech Companies is Growing 27% Increase since 2012 Public Co. Private Co. Total http://www.statista.com/statistics/197930/number-of-united-states-biotech-companies-by-type/ Looking Beyond M&A • Partnerships (basic and foundational research, co-promotion and codevelopment/commercialization arrangements) • Spinoffs and divestitures • Asset swap deals • ACA is helping drive alignment between payers, healthcare and pharmaceutical manufacturers • Moving "beyond the pill" is driving non-traditional business development