The document provides an overview of trends in the healthcare sector and a roadmap for investing in healthcare in 2016. Some of the key points summarized are:
1. The healthcare sector is experiencing several secular trends that are positive, including durable demand driven by aging demographics, growing affluence globally, and a shift from acute to chronic diseases.
2. Innovation is also fueling growth in the sector, including advances in genomics, immuno-oncology, and new therapies for various diseases.
3. Both regulatory and public policy trends have also become more positive recently for healthcare companies and products. The regulatory environment has sped up approval times while expanding pathways for approval.
Existing pharmacovigilance post-market surveillance system is based on reporting of adverse drug reactions to national databases in real-time and post-marketing safety studies.
Quantitative evaluation of incidence, prevalence trends, and patterns of use from reporting data is problematic due to under-reporting and missing data on exposure. This is especially true if drugs are used off-label, in populations they were not intended for, or in combination with other medications.
While the case study below emphasizes post-market surveillance of marketed drugs, the same principles apply to other areas within clinical research and drug development, outcomes research, monitoring, and evaluation of the quality of provided care and pharmaco-economic applications.
Virtual Workshop Innovative Approaches to Drug Safety 2019Arete-Zoe, LLC
The current practice of pharmacovigilance is fraught with challenges and limitations. Still, new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance. We offer you an opportunity to participate in a robust, informative, and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment
into automation and AI tools, the monetary value of safety information, patient privacy issues, and innovative approaches toward generating evidence.
Big Data in Drug Safety: Making post-marketing surveillance in pharmacovigila...Arete-Zoe, LLC
The paper makes a case for change in the way data on the safety of medicines is collected, structured, analyzed, visualized, and shared. Post-market surveillance shall move away from active reporting of individual case reports into national and international databases toward the collection and analysis of anonymous structured summary data from health care providers. The objective is to enable an analysis of total numbers of treated patients and treatment outcomes, including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. In the following modules we will introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.
Existing pharmacovigilance post-market surveillance system is based on reporting of adverse drug reactions to national databases in real-time and post-marketing safety studies.
Quantitative evaluation of incidence, prevalence trends, and patterns of use from reporting data is problematic due to under-reporting and missing data on exposure. This is especially true if drugs are used off-label, in populations they were not intended for, or in combination with other medications.
While the case study below emphasizes post-market surveillance of marketed drugs, the same principles apply to other areas within clinical research and drug development, outcomes research, monitoring, and evaluation of the quality of provided care and pharmaco-economic applications.
Virtual Workshop Innovative Approaches to Drug Safety 2019Arete-Zoe, LLC
The current practice of pharmacovigilance is fraught with challenges and limitations. Still, new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance. We offer you an opportunity to participate in a robust, informative, and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment
into automation and AI tools, the monetary value of safety information, patient privacy issues, and innovative approaches toward generating evidence.
Big Data in Drug Safety: Making post-marketing surveillance in pharmacovigila...Arete-Zoe, LLC
The paper makes a case for change in the way data on the safety of medicines is collected, structured, analyzed, visualized, and shared. Post-market surveillance shall move away from active reporting of individual case reports into national and international databases toward the collection and analysis of anonymous structured summary data from health care providers. The objective is to enable an analysis of total numbers of treated patients and treatment outcomes, including adverse drug reactions and off-label drug use, to provide meaningful, population-based, statistically valid, bias-free, real-time information on safety and efficacy of products on the market without endangering patients' privacy. Such approach would significantly reduce privacy concerns and add value for stakeholders who are interested in timely and accurate information on benefit:risk profile of medicinal products.
The debate on critical issues in science, health, and security encompasses many controversies and ethical challenges. The difference between a naturally occurring outbreak and criminal act of bioterrorism is often challenging to establish, and emergencies have to be handled as they come, regardless of the origin of the incident. The post-incident forensic analysis may or may not offer satisfactory answers in regards to attribution, liability, and the responsibility for compensation. The underlying issue for all ethical concerns examined in this work is the balance between individual rights and the needs of public health systems to protect others.
The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. In the following modules we will introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.
Patient confidentiality: Ethical and legal ramificationsArete-Zoe, LLC
Patient confidentiality is a complex ethical and legal area that is subject to detailed regulation in all developed countries. The general principles are shared across all jurisdictions.
Pharmaceutical Supply Chain Integrity and Security (2016)Arete-Zoe, LLC
The course material serves many interests by facilitating understanding of environment, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and safety of pharmaceutical products. In the first four chapters, we will introduce and describe the regulatory environment in the United States, European Union, in major Asian economies such as Japan, India and China, regulatory policies in Russia, and international standards. Holistic understanding of regulatory environment in global context is essential for understanding of the challenges in pharmaceutical supply chain in the current globalized, inter-connected and inter-dependent economy. In chapter “Enforcement”, we will introduce national enforcement systems in the context of globally operating pharmaceutical industry, and present major initiatives and events. Industry trends such as consolidation, outsourcing of key operations, and shift of manufacturing to Asia determine operational environment. Limited sourcing options, and increasing complexity and distance, affect vulnerability to disruption. Track and trace requirements introduced new vulnerabilities especially in the information management domain.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Healthcare Contract Research Organization (CRO) MarketTom Clark
Global Healthcare Contract Research Organization (CRO) Market is expected to reach USD 51.3 billion by 2024 with CAGR of 6.5% over the future period as the scope and its applications are rising enormously across the globe.
Reforming GxP for Today and Tomorrow- Philadelphia, PA meetingDemet G. Sag
Reforming GxP for today and tomorrow
The general issues
Imports vs Safety
Driving market & business
II. Global Impact Factors
Regulation Strategies
III. Development of Education Program &Training
Medicines outlook through_2016_report
source of info:
http://www.imshealth.com/deployedfiles/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/Global%20Use%20of%20Meds%202011/Medicines_Outlook_Through_2016_Report.pdf
When: June 10, 2021
Only 5% of rare diseases have an approved drug therapy. Only 60% of orphan medicines approved by the US FDA or EU EMA are approved in Canada, and often many months or years later. Only 34% of approved orphan medicines are funded by Canadian public drug plans. Under the BEST of circumstances, only 10% of eligible patients get access to an approved medicine. And worldwide, only 1% of rare disease patients will receive an approved drug. Most without treatment are children. How can Canada’s Rare Disease Drug Strategy assure all eligible Canadian patients get access to the most appropriate medicine for their individual needs?
Two panels will be tasked to consider a “Canada Leading the Way” strategic pharmaceutic framework that (1) attracts early investment in R&D; (2) reduces and manages risk for early adoption of innovative therapies; and (3) leads to a sustained culture of collaboration and trust among all stakeholders, including regulators, industry, payers, and patients. In particular, what has Canada learned from addressing COVID, for example, in terms of screening, diagnosis, drug repurposing, vaccine procurement, timely intervention, and monitoring, that can apply directly to rare disease therapies?
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
How to Use Data to Improve Patient Safety: Part 2Health Catalyst
Stan and Valere will discuss how using an automated trigger tool for all-cause harm reviews will provide timely, real-time patient safety data useful to drive down harm rates with earlier interventions. Additional benefits of this approach include having a more accurate and robust source of data for identifying harm trends to then be able to integrate the findings into existing quality improvement processes for further quality improvement efforts.
Attendees will learn how to:
Understand the importance of dedicating resources to impact downstream costs
Identify their key sources of Patient Safety data
Integrate Patient Safety data in to existing Quality Improvement Processes
Learn and improve from real-time safety analytics combined with a Culture of Safety
Patient confidentiality: Ethical and legal ramificationsArete-Zoe, LLC
Patient confidentiality is a complex ethical and legal area that is subject to detailed regulation in all developed countries. The general principles are shared across all jurisdictions.
Pharmaceutical Supply Chain Integrity and Security (2016)Arete-Zoe, LLC
The course material serves many interests by facilitating understanding of environment, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and safety of pharmaceutical products. In the first four chapters, we will introduce and describe the regulatory environment in the United States, European Union, in major Asian economies such as Japan, India and China, regulatory policies in Russia, and international standards. Holistic understanding of regulatory environment in global context is essential for understanding of the challenges in pharmaceutical supply chain in the current globalized, inter-connected and inter-dependent economy. In chapter “Enforcement”, we will introduce national enforcement systems in the context of globally operating pharmaceutical industry, and present major initiatives and events. Industry trends such as consolidation, outsourcing of key operations, and shift of manufacturing to Asia determine operational environment. Limited sourcing options, and increasing complexity and distance, affect vulnerability to disruption. Track and trace requirements introduced new vulnerabilities especially in the information management domain.
Drug manufacturers are looking to emerging markets like Latin America to fuel long-term success.
View this PAREXEL Consulting presentation to learn more.
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
Healthcare Contract Research Organization (CRO) MarketTom Clark
Global Healthcare Contract Research Organization (CRO) Market is expected to reach USD 51.3 billion by 2024 with CAGR of 6.5% over the future period as the scope and its applications are rising enormously across the globe.
Reforming GxP for Today and Tomorrow- Philadelphia, PA meetingDemet G. Sag
Reforming GxP for today and tomorrow
The general issues
Imports vs Safety
Driving market & business
II. Global Impact Factors
Regulation Strategies
III. Development of Education Program &Training
Medicines outlook through_2016_report
source of info:
http://www.imshealth.com/deployedfiles/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/Global%20Use%20of%20Meds%202011/Medicines_Outlook_Through_2016_Report.pdf
When: June 10, 2021
Only 5% of rare diseases have an approved drug therapy. Only 60% of orphan medicines approved by the US FDA or EU EMA are approved in Canada, and often many months or years later. Only 34% of approved orphan medicines are funded by Canadian public drug plans. Under the BEST of circumstances, only 10% of eligible patients get access to an approved medicine. And worldwide, only 1% of rare disease patients will receive an approved drug. Most without treatment are children. How can Canada’s Rare Disease Drug Strategy assure all eligible Canadian patients get access to the most appropriate medicine for their individual needs?
Two panels will be tasked to consider a “Canada Leading the Way” strategic pharmaceutic framework that (1) attracts early investment in R&D; (2) reduces and manages risk for early adoption of innovative therapies; and (3) leads to a sustained culture of collaboration and trust among all stakeholders, including regulators, industry, payers, and patients. In particular, what has Canada learned from addressing COVID, for example, in terms of screening, diagnosis, drug repurposing, vaccine procurement, timely intervention, and monitoring, that can apply directly to rare disease therapies?
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
How to Use Data to Improve Patient Safety: Part 2Health Catalyst
Stan and Valere will discuss how using an automated trigger tool for all-cause harm reviews will provide timely, real-time patient safety data useful to drive down harm rates with earlier interventions. Additional benefits of this approach include having a more accurate and robust source of data for identifying harm trends to then be able to integrate the findings into existing quality improvement processes for further quality improvement efforts.
Attendees will learn how to:
Understand the importance of dedicating resources to impact downstream costs
Identify their key sources of Patient Safety data
Integrate Patient Safety data in to existing Quality Improvement Processes
Learn and improve from real-time safety analytics combined with a Culture of Safety
Crossing the Valley of Death in Drug Discoveryszecola
The benefits of "Big Data" in health care will be undermined by the Valley of Death resulting from the FDA's drug approval process. The drug approval process should be changed as recommended herein.
StartUp Health - Private Market Perspectives - Digital Healthcare Innovation ...Healthegy
Presentation by StartUp Health at Digital Healthcare Innovation Summit 2016.
Participant:
Katya Hancock, Director of Strategic Partnerships – StartUp Health
Introduced By:
Tom Salemi, Content Director – Healthegy
Powered by:
Healthegy
For more healthcare innovation
Visit us at Healthegy.com
Presentation: Leading the Change In Healthcare Education and Delivery: how to surmount the barriers.
Presented by: Dalal Haldeman, Senior Vice President, Marketing and Communications, John Hopkins Medicine
What does the triple aim really mean and how do we get there? How can strong brands in healthcare influence outcomes, research and patient wellbeing for a healthier future in America and in the world.
An industry-wide survey of the health ecosystem. By looking at leading operating models that are representative of the future health ecosystem, the viewer can get a handle on how the future will look.
Medicine: A State of CRISIS, a State of CHANGELouis Cady, MD
Dr. Cady returns this year to repeat and update one of the most talked about presentations of the 2015 IMMH conference. In this presentation, Dr. Cady deconstructs the pressures and challenges facing patients, physicians, and all health care practitioners in today's practice environment. The role of integrated practice and functional medicine as a "differentiating factor" in one's practice is reviewed. The need for patients to adapt a healthy life style and take responsibility for their health for their own economic self-preservation is also touched on.
3º FÓRUM DA SAÚDE SUPLEMENTAR - CARMELLA BOCCHINOCNseg
Palestra de Carmella Bocchino no 3º Fórum Nacional da Saúde Suplementar, realizado pela Federação Nacional de Saúde Suplementar (FenaSaúde), no Sheraton WTC São Paulo Hotel, no dia 5 de outubro de 2017.
Preparing for the Future: How one ACO is Using Analytics to Drive Clinical & ...Health Catalyst
Crystal Run Healthcare — a physician-led Accountable Care Organization (ACO) and one of the first ACOs to participate in the Medicare Shared Savings Program — is experiencing the long-anticipated shift toward more value-based reimbursement.
To ensure financial stability as they assume more risk, Crystal Run is implementing a strategy focused on rapid growth and aligning physician reimbursement with favorable patient outcomes. To effectively execute on this strategy they knew they needed to become more data-driven. Webinar attendees will learn how this ACO is using advanced analytics to execute on their population management and growth strategies with a focus on continuous improvement in the following areas:
Ensuring patient care aligns with evidence based practices
Reducing inappropriate clinical variation
Enhancing operational efficiency
Analyzing data from a “single source of truth” integrated from their EMR, billing, costing, patient satisfaction and other operational systems
Making “self-service analytics” available to decision-makers to decrease time to decision
Please join Greg Spencer, MD, Chief Medical & Chief Medical Information Officer and Scott Hines, MD, Chief Quality Officer and Medical Specialties Medical Director, Crystal Run, as they discuss how advanced analytics is helping position the ACO for continued success in an increasingly value-based reimbursement environment.
Health Services Tax Conference May 18-19, 2015, Presentations included: Mega Trends and the Impact on Healthcare, The Healthcare Industry: A View from Washington and The New Health Economy.
Architecture Before Experience - EuroIA Amsterdam 2016 Bogdan Stanciu
Spending $9.715 per capita (The World Bank, 2013), the United States sits on top of the world of total health expenditures, but ranks only 33rd in population health. With 165.169 mHealth applications available for download to more than two-thirds of Americans who own a smartphone, one might think the digital revolution is going to cure everyone. However, the healthcare industry is failing the care model. Facing disruption in an open, competitive marketplace, the big insurance and big pharma, along with the hospital-based medical systems are trying to ride the wave of digital transformation in the most archaic way: adding a digital silo to their organisational chart. Battling conflicting workflows, poor integrations of a wide range of applications, and legacy policies and infrastructure, digital is as challenged as its peers in the marketing, patient experience, physician relationships, and consumer product departments to produce a comprehensive strategy for transformation. The good news is that medical systems are just that: systems. And like every other systems in the world, they can be designed.
Health Catalyst Launches COVID-19 Patient Data Repository to Speed Vaccine De...Health Catalyst
With a lack of historical population-based information to steer COVID-19 research, pharmaceutical companies are struggling to understand the everchanging virus as they work tirelessly to develop a vaccine in less than one year. Research teams can access near real-time COVID-19 patient data with Touchstone® for COVID-19 National Data Sets and Registry from over 80 million patients across the United States and three national data sources: John Hopkins University, The New York Times, and The COVID Tracking Project.
The Registry offers up-to-date, comprehensive data with outcome analysis and clinical trial analysis so research teams can stay up to date through every stage of the vaccine development process.
IT Solutions for Fee for Value Reimbursment and Population Health ManagementJohn Squeo
This presentation highlights some key considerations when building or integrating IT solutions for the emergent payment models evolving in Health Care. Population risk stratification, identifying patients to target for high success rate interventions, and tracking physicians adherence to evidence based medicine using key performance indicators are covered at a high level.
Top 7 Financial Healthcare Trends and Challenges for 2016Health Catalyst
Healthcare financial leaders will encounter a myriad of challenges and improvement opportunities in 2016. This year will force health system financial leadership to focus and prioritize, with challenges including increased healthcare spending, continued momentum toward value-based care, and the need to reexamine the revenue cycle after years of focusing so intently on ICD-10. But 2016’s financial healthcare trends include more than just challenges; exciting opportunities abound, from using technology to engage patients to a national focus on population health.
For the past several years, Bobbi Brown, our Vice President of Financial Engagement, has shared her predictions on trends and challenges that face the industry. We are happy to give the opportunity once again this year with a new webinar highlighting her top seven financial healthcare trends of 2016. Bobbi will also share the attributes necessary for healthcare leaders—particularly the characteristics of effective change leaders (resilient, collaborative, and inspirational)—to overcome challenges and make improvements to stay ahead of the curve in 2016.
Attendees will understand
The impact of these top seven trends to their organization.
Where to focus their quality improvement and efforts
How these 2016 trends will increase the need for healthcare data analytics.
It's always interesting to look ahead and try to predict what might or might not happen. Come prepared to share your opinions, vote on Bobbi’s predictions, and join in for a candid and lively conversation.
Patient organizations are an increasingly powerful voice in helping shape health policy. However, a new analysis found that there’s often minimal transparency among these groups - and many have a great deal of industry backing.
A systematic review published in BMJ showed that although up to 83% of patient advocacy groups received industry funding, only about a quarter disclosed that fact on their websites.
Dearth of funding transparency among patient advocacy groups
BEC2016_AAvanian_3_9_16
1. FOR INSTITUTIONAL USE ONLY
A Roadmap for Investing in Healthcare
Alice Avanian, CFA, Managing Director, Leerink Partners
March 9, 2016
Please refer to the Disclosure Appendix for Analyst Certification. To access Price Charts and Disclosures specific to Covered Companies,
please refer to https://leerink.bluematrix.com/bluematrix/Disclosure2 or send a request to Leerink Partners Editorial Department, One
Federal Street, 37th Floor, Boston, MA 02110.
The description of Leerink Partners benchmarks is available by contacting the Leerink Partners Editorial Department.
Rx trends derived from IMS Health.
2. FOR INSTITUTIONAL USE ONLY
• Alice Avanian, CFA, Managing Director
- Associate Director of Equity Research
- Past Chair and current Board member, Boston Security Analysts Society
- Executive Committee member, Boston Economic Club
• Leerink Partners LLC
- Leading investment bank specializing in healthcare
- Focus on companies which are developing and commercializing innovative
products and services, defining the future of healthcare
Source: Leerink Partners Equity Research, unless otherwise specified
INTRODUCTION
2
3. FOR INSTITUTIONAL USE ONLY
• Secular Trends: Positive
- Durable Demand, Innovation
• Regulatory, Public Policy: Positive
• Cyclical View: Improving
- Recent Performance
- Financings
- Valuation
• What to watch:
- Reimbursement/ Price
- Binary Events
- Competition
- Cash Runway
• Outlook for each Sub-sector
2016 HEALTHCARE ROADMAP: AGENDA
3
4. FOR INSTITUTIONAL USE ONLY
• Secular Trend #1 – Durable Demand: Demographics
- Aging population globally
- In a century (1960-2060), the number of senior citizens will grow over 5x, with
a higher growth rate 2020-2040
• Older folks spend more on healthcare
- The most rapidly aging countries are wealthier
- Three leading killers involve long periods of decline - heart, cancer, dementia
Dementia has the highest cost with the most uncovered costs (not including
opportunity cost to caregivers)
SECULAR TRENDS POSITIVE FOR HEALTHCARE
4
Source: U.S. Census Bureau, Population Estimates and Projections, 2014; NY Times 10/26/2015
5. FOR INSTITUTIONAL USE ONLY
Source: U.S. Census Bureau, Population Estimates and Projections, 2014
SECULAR TREND #1 – DURABLE DEMAND: DEMOGRAPHICS
5
3.1 4.9
9
16.6
25.5
35
44.7
56.4
82.3
98.2
0
20
40
60
80
100
120
1900 1920 1940 1960 1980 2000 2013 2020 2040 2060
Year (as of July 1, 2014)
Number of Persons 65+, 1900 to 2060
(numbers in millions)
6. FOR INSTITUTIONAL USE ONLY
• Secular Trend #1 – Durable Demand: Growing Affluence
- Healthcare becomes a right not a privilege
Many countries in Latin America have written a right to healthcare into their
constitutions
- Healthcare spending as a percentage of GDP for OECD countries now in the
9-10% range
- U.S. the outlier at 17.5% of 2014 GDP (although more is not necessarily
better!) and rising
SECULAR TREND #1 – DURABLE DEMAND: GROWING AFFLUENCE
6
Source: Leerink Partners Equity Research, The Economist 2/13/2016
7. FOR INSTITUTIONAL USE ONLY
SECULAR TREND #1 – DURABLE DEMAND: GROWING AFFLUENCE
7
Source: OECD Health Data, 2013
8. FOR INSTITUTIONAL USE ONLY
• Secular Trend #1 – Durable Demand: Export of Western Diet and Diseases
- Looking at rates of obesity among children points to a ticking time bomb
- As formerly poor countries become richer, children may be stunted in height
from poor nutrition and yet obese (BMI)
Examples: Brazil, Vietnam, S. Africa, India, Mexico
SECULAR TREND #1 – DURABLE DEMAND: EXPORTING OUR DIET
8
Source: “Child and adolescent obesity: part of a bigger picture,” The Lancet 2015
9. FOR INSTITUTIONAL USE ONLY
Source: The Lancet, World Obesity Federation 2015
SECULAR TREND #1 – DURABLE DEMAND: EXPORTING OUR DIET
Prevalence trends for child overweight and obesity in the USA and with
low-income and middle-income countries.
9
10. FOR INSTITUTIONAL USE ONLY
Source: Immunological complications of obesity. TD Kanneganti, VD Dixit - Nature Immunology, 2012 - nature.com
SECULAR TREND #1 – DURABLE DEMAND: EXPORTING OUR DIET
10
11. FOR INSTITUTIONAL USE ONLY
• Secular Trend #1 – Durable Demand: Shift from Acute to Chronic Diseases
- Acute/infectious diseases (viruses, malaria) have shorter durations of therapy
- Chronic diseases (diabetes, cancer) are treated for years
- Already 75% of annual deaths globally are in low & middle income countries
SECULAR TREND #1 – DURABLE DEMAND: SHIFT TO CHRONIC
11
Source: Novartis, 2/24/16, https://www.novartis.com/news/news-archive
12. FOR INSTITUTIONAL USE ONLY
SECULAR TREND #1 – DURABLE DEMAND: SHIFT TO CHRONIC
Source: cms.gov
12
13. FOR INSTITUTIONAL USE ONLY
• Genomic Revolution
- Personalized medicine is revolutionizing drug development and treatment
• Drug Development cycle shortening for Targeted Therapeutics – Higher
likelihood of regulatory success
- Cos. can enrich their studies to better select patients who will benefit
- Orphan is “the golden child of biotech”
• Immuno-oncology vs. Cancer, “The Emperor of All Maladies”
- Policy including the new, national “Moonshot” initiative
• More Innovation to come – Combo therapies, Anemia, Neurology, Microbiome,
and Retinal Disease, and more
• Big Data providing new insights through patient records (EHR, wearable
sensors, and even smartphones)
SECULAR TREND #2 – INNOVATION ABOUNDS
13
Source: Leerink Partners Equity Research, The Economist 2/27/16, Siddhartha Mukherjee
14. FOR INSTITUTIONAL USE ONLY
TIDAL WAVE FOR IMMUNO-ONCOLOGY – EST. $34B MARKET BY 2025
14
-
10,000
20,000
30,000
40,000
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Sales(milUSD)
WW Total Immuno-Oncology Market - By Tumor
(Discounted based on probability of success)
Myeloma
Leukemia
Hodgkins
FL
DLBCL
TNBC
ER+/ HER2- BC
HER2+ BC
Prostate
Colorectal
Cervical
Liver
Gastroesophageal
Pancreatic
Ovarian
Bladder
Glioblastoma
Head/Neck
Small Cell Lung Cancer
Renal Cancer
Squamous NSCLC
Non-Squamous NSCLC
Melanoma
Source: Leerink Partners Equity Research
15. FOR INSTITUTIONAL USE ONLY
• More visible Regulation
- Greater transparency, communication.
- More receptive to patient advocacy groups.
- FDA approvals have speeded up.
First cycle approvals at CDER at an all-time high of 95% vs. 50% in ’07-08
- Four mechanisms:
Accelerated Approval
Priority Review
Fast Track
Breakthrough Therapy Designation (began 7/9/12)
- Rare Is Better – Regulators and payers remain accommodating to orphans
Source: Leerink Partners Equity Research, CDER=Center for Drug Evaluation & Research
REGULATORY TRENDS – POSITIVE FOR HEALTHCARE PRODUCTS
15
16. FOR INSTITUTIONAL USE ONLY
REGULATORY TREND IMPROVING
16
Source: BloombergView 3/16/2015, 45 Approved New Drugs in 2015 (www.fda.gov)
17. FOR INSTITUTIONAL USE ONLY
Sources: 2016, EvaluatePharma®, Evaluate Ltd.
REGULATORY TREND REWARDING INNOVATION
17
18. FOR INSTITUTIONAL USE ONLY
• Affordable Care Act (ACA, Obamacare) and Medicaid expansion increased
coverage
- 10M adults on Public Exchanges
- 31 states expanded Medicaid, 3 more under discussion
• Most likely election outcome is Clinton = status quo
• What to watch:
- Cadillac tax delayed and Medical Device and MCO tax holidays for 2 years &
1 yr., respectively
- Major losses on Public Exchanges indicate rates will rise sharply in 2017,
economic model remains unstable
- The Election! If Republicans win White House & Congress, more efforts to
repeal Obamacare
PUBLIC POLICY TRENDS – POSITIVE FOR HEALTHCARE
18
Source: Leerink Partners Equity Research
19. FOR INSTITUTIONAL USE ONLY
PUBLIC POLICY TRENDS – POSITIVE FOR HEALTHCARE
19
Source: “Status of State Action on the Medicaid Expansion Decision,” KFF State Health Facts, updated 1/12/2016
20. FOR INSTITUTIONAL USE ONLY
CYCLICAL VIEW – OUTPERFORMANCE MAY BE POISED TO RESUME
20
Source: FactSet, S&P Indices, Percentage point outperformance versus indicated index, 3/4/16
-15%
-10%
-5%
0%
5%
10%
15%
20%
25%
30%
2011 2012 2013 2014 2015 2016 YTD
Outperformance of Healthcare
Large Caps
(v S&P 500)
Mid Caps
(v S&P 400)
Small Caps
(v S&P 600)
21. FOR INSTITUTIONAL USE ONLY
Source: FactSet, S&P Indices, Percentage point outperformance versus indicated index, 3/4/16
21
POSSIBLY EVEN FOR BIOTECH…
-30%
-20%
-10%
0%
10%
20%
30%
40%
2011 2012 2013 2014 2015 2016 YTD
Outperformance of Biotech (NBI)
Large Caps
(v S&P 500)
Mid Caps
(v S&P 400)
Small Caps
(v S&P 600)
22. FOR INSTITUTIONAL USE ONLY
BIOTECH UNDERPERFORMED BY A WIDE MARGIN SINCE MID-2015
22
Source: FactSet, 2/27/16, Leerink Partners Equity Research
23. FOR INSTITUTIONAL USE ONLY
CYCLICAL VIEW – RECORD CAPITAL INFLOWS
Source: FactSet, Leerink Partners Equity Research, FO=Follow-ons, IPO=Initial Public Offerings, P=Peak, T=Trough
23
• The trailing 12-month capital inflow peaked at more than $40B in late 2015,
almost double the peak of late 2000
24. FOR INSTITUTIONAL USE ONLY
CYCLICAL VIEW – RETURNS NEGATIVELY CORRELATED TO FINANCINGS
24
Source: FactSet, Leerink Partners Equity Research; NBI represents $698B in Total Mkt. Cap, 190 Stocks, mkt. cap weighted; BTK represents $2B in Total Mkt.
Cap, 30 Stocks, equal weighted
25. FOR INSTITUTIONAL USE ONLY
CYCLICAL VIEW – VALUATIONS BACK TO AN ATTRACTIVE RANGE
Source: FactSet, 3/4/16
25
26. FOR INSTITUTIONAL USE ONLY
• HC as % of GDP expected to continue rising
• Market forces driving Price Pressure throughout the industry
• At the margin, we expect reimbursement hurdles to rise
- Switch to value-based pricing vs. volume-based
- Ongoing privatization of Medicare/ Medicaid (60% of Medicaid spending is still
fee-for-service)
- MCO/PBM bargaining power rising, including MCO mega-mergers
• Headline Risk at least through the election
• But we see little appetite for cost containment legislation
WHAT TO WATCH: REIMBURSEMENT/ PRICE
26
Source: Leerink Partners Equity Research; MCO=Managed Care Organizations, PBM=Pharmacy Benefit Managers
27. FOR INSTITUTIONAL USE ONLY
HEADLINE RISK
27
Source: Leerink Partners Equity Research
28. FOR INSTITUTIONAL USE ONLY
WHAT TO WATCH: REIMBURSEMENT/ PRICE MORE THAN HEADLINE RISK
• Relentless focus on price of products and services growing
• Increasing sophistication & cost management by payers
- Payers working faster and cooperating with drs.
- Accelerating shift to closed formulary, tiers, controlling access, cost-shifting,
pricing models may be indication-specific
- Availability of Big Data on outcomes & patient data to target usage
- Protecting Access to Medicare Act (PAMA) aims to move diagnostics to mkt
prices – implementation expected Jan. 2017
• But legislation to impose drug price controls unlikely
• Orphan drugs remain a safe haven
• Oncology costs a concern, management growing slowly
• Biosimilar industry still in infancy: pricing and adoption unknown until ’17-20
28
Source: Leerink Partners Equity Research
29. FOR INSTITUTIONAL USE ONLY
CERTAIN THERAPEUTIC CATEGORIES MORE IMMUNE THAN OTHERS
29
Source: Leerink Partners Equity Research, Company Information, IMS, BiotechNow.org, EvauatePharmaWorldPreview2014
30. FOR INSTITUTIONAL USE ONLY
WHAT TO WATCH: RISING COMPETITION
30
Source: 2016, EvaluatePharma®, Evaluate Ltd.
31. FOR INSTITUTIONAL USE ONLY
July ’15 – February ’16 Biotech Stock Impact by Profitability and Cash Availability
WHAT TO WATCH: BIOTECH CASH AFFECTING PERFORMANCE
31
Source: FactSet, Leerink Partners Equity Research; Years of Cash calculation: (Cash & ST Investments) / (Net Income of trailing 4 quarters). NBI components,
excluding n=2 companies with insufficient market data. Prices 7/16/15 – 3/2/16.
32. FOR INSTITUTIONAL USE ONLY
• Healthcare investing is uniquely characterized by Binary Events
• Investors can take positions and/or hedge ahead of time
• Data releases, particularly at medical meetings
Example: Intra-Cellular Therapies (ITCI, $31.42) second Ph III schizophrenia
data mid-2016. Up/down: +$15-20/shr; -$10-15/shr
• FDA approvals open the door to commercialization, watch launch trajectory
• Legal decisions
• Reimbursement decisions
WHAT TO WATCH: BINARY EVENTS: CATALYST TRACKER
32
Source: Leerink Partners Equity Research, Catalyst Tracker, Price as of 3/7/16
33. FOR INSTITUTIONAL USE ONLY
• Major Pharma
• Biotech
• Specialty Pharma
• Life Science Tools & Diagnostics
• Medical Technology
• Managed Care
• Facilities
• HCIT (Healthcare Information Technology)
• PBMs & Distributors
• Digital Health
INDUSTRY SECTORS
33
34. FOR INSTITUTIONAL USE ONLY
• Companies can enjoy competitive advantages for years:
• Real Intellectual Property
- Product Patents run 20 years
- Orphan Diseases have 7 years of exclusivity (Orphan Drug Act of 1983)
- Biologic data exclusivity is 12 yrs., NCE (New Chemical Entity) is 5 yrs.
• Barriers to Entry
- FDA and EU regulatory authorities
• To minimize risk, investors can wait until after Ph III data to invest in Biopharma
- Probability of success for Ph III is 62%
BIOPHARMA IS INHERENTLY ATTRACTIVE
34
Source: Tufts University Center for the Study of Drug Development, 11/18/14
35. FOR INSTITUTIONAL USE ONLY
PROBABILITIES OF SUCCESS FOR PRODUCTS IN DEVELOPMENT
Permission for use of Cost of Developing a New Drug November 18, 2014, provided by Joseph A. DiMasi, Tufts Univ.
35
36. FOR INSTITUTIONAL USE ONLY
1-2 years 2-3 years 3-4 years 1-2 years 12-14 years
2x
6-8x
12-24x
Scientific
insight /
promise
Proof of
concept –
phase Ib/II
Confirmation
of efficacy /
expansion of
indications
Peak
expected
value
Erosion of expected value
+100% +2-300% +1-200%
Approval / launch
Product profile
limitations
• Efficacy
• Side effects emerge
Competitors
emerge
• Same target or
pathway
• New target or
pathway
Generic threat
looms
Indication expansion
STOCK SELECTION STRATEGY: Biopharma Product Value Begins to Be Eroded
Shortly After First Commercialization in Many Cases; New Indications Can Offset Erosion
Source: Leerink Partners Equity Research, FactSet
37. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- Emerging from patent cliffs, in transition from small molecule drugs to biologics
with more innovation and faster growth; attractive dividends
• Outlook: Mixed
- Tailwinds from demographics & higher utilization of drugs
- Pharma & Biotech are melding as new therapeutic categories emerge:
Examples: Immuno-Oncology (I-O), Gene Therapy
- Operating leverage grows after initial product launch, especially if a “pipeline
in a product”
- Headwinds: Price/ Payer Pressure, competition, patent expirations, Fx –
consensus estimates have trended slightly downward since mid-2015
Source: Leerink Partners Equity Research
MAJOR PHARMA: OUTLOOK
37
38. FOR INSTITUTIONAL USE ONLY 38
2016 ESTIMATES TREND SLIGHTLY DOWNWARD SINCE MID-2015
Source: FactSet, Leerink Partners Equity Research
2016 EPS Consensus Estimate Change From 7/31/2015
2016 Sales Consensus Estimate Change From 7/31/2015
PFE
SNY
MRK
NVS
AZN
GSK
LLY
NVO
BMY
-15%
-10%
-5%
0%
5%
7/1/2015 8/1/2015 9/1/2015 10/1/2015 11/1/2015 12/1/2015 1/1/2016
PFE
SNY
MRK
NVS
AZN
GSK
LLY
NVO
BMY
-10%
-5%
0%
5%
7/1/2015 8/1/2015 9/1/2015 10/1/2015 11/1/2015 12/1/2015 1/1/2016
Mean
Mean
• BMY is an
outlier to the
downward
trend
• PFE upward
revision
reflects AGN
transaction
39. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- Transition from internal innovation to line extensions & acquisitions
• Outlook: Cautious Near Term, Positive Long Term
- Headwinds: Product launches slower & lower, price scrutiny, FX
- Mid-2016 and beyond: Reaccelerating growth
Fundamentals of drug profitability unchanged, high Returns on Capital
Scientific breakthroughs leading to higher success rates
Major medical & societal needs still to be addressed
Regulators & payers accommodating to genuine breakthroughs
- Valuations have fallen sharply
- Sector corrections typically last 2-3 Qs, but can persist for 18-24 months
LARGE CAP BIOTECH: OUTLOOK
39
Source: Leerink Partners Equity Research
40. FOR INSTITUTIONAL USE ONLY
HISTORIC SECTOR CORRECTIONS
40
-30%
-20%
-10%
0%
10%
20%
30%
40%
Quarterly Performance of NBI vs. S&P 500
+164%+32%+290%
2-3 quarter period of
12-22%
underperformance
before recovery
Source: Leerink Partners Equity Research
41. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- Smid cap Biotech drives much of industry’s innovation
• Outlook: Selectivity Near Term, Positive Long Term
- Tailwinds: FDA’s commitment toward increased transparency, receptiveness to
patient advocacy groups and accelerated approval timelines
- Pricing power for innovation in the US still appears robust, esp. Orphan
- Unmet needs to be met by innovation in anemia, neurology, gene therapy, etc.
- What to watch:
Reimbursement headwinds in EU, US
Cash runway
SMID CAP BIOTECH: OUTLOOK
41
Source: Leerink Partners Equity Research
42. FOR INSTITUTIONAL USE ONLY
ORPHAN DRUG STOCKS HAVE OUTPERFORMED THE REST OF BIOTECH
42
Orphan drug index constituents: AMAG, BMRN, CYTK, SRPT, IONS, ALNY, PTCT, AEGR, FBIO, ALXN, SHPG, FOLD, GENTY, HPTX, INSM, JAZZ, NPSP, QCOR, RPTP, UTHR, VPHM, PBT-ASX, ORPH, DSCO, BLUE,
PRQR, SAGE, GWPH, QURE, ONCE, RTRX, ZFGN
Source: FactSet, 2/19/16
43. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- In transition: Legacy cos. focused on drug delivery & generics, now moving to
a hybrid model including brands and orphan diseases (e.g., SHPG).
- Not the same as “specialty drugs”
• Outlook: Mixed
- Tailwinds: Demographics & higher utilization of drugs
- Low cost of debt & lower tax domiciles have led to accretive M&A, but supply
of targets is shrinking due to sector consolidation
- Headwinds: Reimbursement pressure for undifferentiated brands, but some
categories are more insulated (orphan diseases)
- Timeline for Biosimilars unpredictable. Less competition but greater
development risk, legal, and regulatory uncertainties
SPECIALTY PHARMA & GENERICS: OUTLOOK
43
Source: Leerink Partners Equity Research
44. FOR INSTITUTIONAL USE ONLY
LARGE MARKET POTENTIAL FOR BIOSIMILARS
44
Source: Leerink Partners Equity Research
45. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- Providing the tools for the genomic revolution or “precision medicine.” To help
with risk assessment, diagnosis, to guide therapy, and measure progression
• Outlook: Mixed
- Genomics becoming prevalent throughout Healthcare
- Biomedical research funding poised to improve
- Many new product cycles in diagnostics
- Underleveraged balance sheets and asset scarcity
- What to watch:
Reimbursement pressure in diagnostics.
Regulatory clarity on FDA regulation of lab-developed tests
China macro growth slowing, but structural reforms benefit scientific
development, HC, testing for environment, food safety
LS TOOLS & DIAGNOSTICS: OUTLOOK
45
Source: Leerink Partners Equity Research
46. FOR INSTITUTIONAL USE ONLY
BIOMEDICAL RESEARCH FUNDING POISED TO IMPROVE
Source: Leerink Partners Equity Research; Chart represents y/y change in research funding
46
IMPROVEMENT IN U.S. ACADEMIC/GOV’T, PHARMA/BIOTECH DRIVE THE DELTA
47. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- Med Tech cos. develop and manufacture devices and supplies sold to
hospitals, physician groups or patients (example of latter: insulin pumps)
- Many small innovative cos., which are frequently acquired by large caps
• Outlook: Positive
- Positive view with improving utilization trends, stable pricing
- Strong balance sheets provide significant financial flexibility & M&A potential
- What to watch:
Shift to value-based system / bundled payments / vendor consolidation –
requires alignment with drs.
Pricing pressure in some segments
MEDICAL TECHNOLOGY: OUTLOOK
47
Source: Leerink Partners Equity Research
48. FOR INSTITUTIONAL USE ONLY
• Implication: Implant price remains the highest priority in vendor selection for hospital admins, highlighting a commoditized
large joint product category. Differentiation going forward will likely require increased investment in technologies that can
increase procedure efficiency or in manufacturers offering solutions across multiple product lines.
BUNDLED PAYMENTS: VALUE OF INNOVATION IS CHANGING
Source: Leerink Partners Equity Research, MEDACorp Survey, “Bundled Payments,” February 2016
53%
23%
13%
5% 5%
3%
0%
10%
20%
30%
40%
50%
60%
Implant Price Services/Technologies that
Increase Procedure
Standardization/Efficiency
Breadth of Product Offering
Across Multiple Service Lines
OR Rep Service Availability of New
Technologies
Breadth of Product Offering
within Service Line
%ofrespondentsrankingfactorhighest
Which factor is most important when considering a vendor for bundled payments? (n=40)
49. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- MCOs are insurance cos. that manage healthcare costs, & provide and
finance these services to patients
• Outlook: Positive
- Bullish with a favorable policy outlook
- Ongoing privatization of Medicaid and Medicare
- Losses on public exchanges likely to stabilize
- Commercial margins poised to expand as pricing hardens and costs muted
(value-based care, growth in high-deductible plans)
- Mega mergers offer a meaningful call option to the upside, in our view
- Benefit from rising interest rates with strong balance sheets, cash flow
MANAGED CARE (MCO): OUTLOOK
49
Source: Leerink Partners Equity Research
50. FOR INSTITUTIONAL USE ONLY 50
SECULAR TAILWINDS SHOULD CONTINUE TO FUEL MEMBERSHIP
GROWTH IN MEDICARE ADVANTAGE
Source: CMS, Kaiser, MedPac, Leerink Partners Equity Research
We Expect 50% Penetration of Medicare Advantage by 2019 in the Base Case
No
Suppleme
ntal
Coverage,
10%
Medigap,
16%
MA, 28%
Employer
Sponsored
, 24%
Medicaid,
21%
Other
Public
Coverage,
1%
Under 1/3rd of Seniors Covered By
Employers
As Employers Continue To Drop Retiree Coverage
Starting 2011, Baby Boomers Start Aging Into Medicare Eligibility At The Rate Of 10K Per Day
Under 1/3rd of Seniors Covered By Employers
0
10
20
30
40
50
60
70
80
90
MedicareEnrollment(MM)
Starting 2011, Baby Boomers Start Aging Into Medicaire Eligibiility
First Baby Boomer Turns 65
Last Baby Boomer Turns 65 and
First Reaches Life Expectancy
66%
46%
36%
40% 40% 40%
35% 36% 35%
32%
34%
32%
29% 28%
26% 26% 25%
28%
25%
23%
0%
10%
20%
30%
40%
50%
60%
70%
1988 1991 1993 1995 1998 1999 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Percentage of Employers (200 + EES) Offering Retiree Health Benefits
51. FOR INSTITUTIONAL USE ONLY
PRIVATIZATION OF 60% of MEDICAID, A $500+B ENTITLEMENT
51
52. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- Hospitals, mental health facilities.
• Outlook: Bearish
- Bearish on acute hospitals, positive on behavioral health, outsourcing,
outpatient care
- Headwinds: worsening bad debt, tough volume comps, wage inflation,
contract labor rates, drug cost spend
- Medium-term pressure from Medicare privatization & value-based care
- Behavioral care growth faster with unmet need for mental health treatment,
roll-up of fragmented marketplace
HEALTHCARE FACILITIES: OUTLOOK
52
Source: Leerink Partners Equity Research
53. FOR INSTITUTIONAL USE ONLY 53
CMS HAS AN AGGRESSIVE GOAL OF 50% OF PAYMENTS LINKED
TO VALUE-BASED CARE BY 2018
Source: CBO; Leerink Partners Equity Research & Estimates
54. FOR INSTITUTIONAL USE ONLY 54
Source: U.S. BLS, AHA, S&P Healthcare, Leerink Partners Equity Research & Estimates
PRIVATIZATION OF MEDICARE PRESSURING INPATIENT ADMISSIONS
79%
73%
76%
83%
80%
72%
Aggregate Medicare, only Employer-Sponsored Medicare Advantage Medigap Medicare Cost
%RespondentNot Hospitalized In LastTwo Years
Per our MEDACorp survey of American Seniors in Nov. 2015, we
observed the lower utilization of services and procedures by MA
enrollees versus traditional Medicare. While this may be partly
driven by self-selection, we believe tighter control by private
MCOs is a contributor.
55. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- HCIT is hospital-based (in-patient) and office-based (ambulatory) systems.
• Outlook: Positive
- Positive but divergence between winners & losers
- Meaningful use incentive program continues to drive adoption of EHR
(Electronic Health Records), but market more penetrated
- Shift to value-based HC leading to adoption of Population Health Mgt.
technologies (data exchange, patient engagement tools)
- Hospital consolidation a positive for top vendors to gain share
- Shift toward cloud-based solutions benefits recurring revenues
- What to watch:
Market share shifts in a more mature market
HCIT (Healthcare Information Technology): OUTLOOK
55
Source: Leerink Partners Equity Research
56. FOR INSTITUTIONAL USE ONLY
GROWTH IN HCIT SPENDING SLOWING, BUT TOTAL HCIT $ SPEND STABLE
56
Vendor
Allscripts
Athena
Cerner
DocuTap
eClinical
Epic
GE
Greenway
McKesson
QSII
Practice Fusion
Grand Total
Source: MEDACorp Survey, "Ambulatory EMR Purchasing Trends," March 2015
If your practice
purchase more
No - We will
not purchase
any more
licenses, 41.0%
Yes - We will
buy 5-10%
more licenses,
38.5%
Yes - We will
buy 11-20%
more licenses,
17.9%
Yes - We will
buy 21%+
more licenses,
2.6%
Do you plan to purchase more licenses either due to
growth or expansion or any other reason? n=39
Source: CDC/NCHS National Ambulatory Medical Care Survey January 2014, Leerink Partners Equity Research
PERCENTAGE OF OFFICE-BASED DRS. WITH AN EHR 41% WILL NOT PURCHASE ANY MORE LICENSES
57. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- The convergence of the healthcare system with digital technology leading to
“Digital Disruption”
The largest community for physicians is online (WBMD), physician services
has no clinics (TDOC), repository of data has no patients (FIT)
• Outlook: Positive
- Demand-pull: Consumer Empowerment, high deductible plans, drive need for
cost tools and access to their data
- Supply-push: As consumers & drs. have shifted time on-line, ads will follow
- Employers spending more on Digital Health benefits
- Big data will optimize care with next-generation analytics
DIGITAL HEALTH: OUTLOOK
57
Source: Leerink Partners Equity Research
58. FOR INSTITUTIONAL USE ONLY
DIGITAL HEALTH LIFECYCLES
58
Source: Leerink Partners Equity Research
59. FOR INSTITUTIONAL USE ONLY
• Description of Sector:
- Supply chain for drugs. Distributors sell to hospitals, retail. PBM (Pharmacy
Benefit Managers) process and pay Rx claims, manage formularies, negotiate
discounts & rebates.
• Outlook: Mixed with a positive bias
- Aging demographics favorable for drug usage
- Specialty drug spending growing +15% annually, a tailwind
- Generic drug launches benefit the supply chain
- What to watch:
Tailwinds from generic launches and inflation now slowing
PBMs & DRUG DISTRIBUTORS: OUTLOOK
59
Source: Leerink Partners Equity Research
60. FOR INSTITUTIONAL USE ONLY
GENERIC LAUNCHES SLOWING
60
Source: CVS, Investor day presentation, December, 2015
61. FOR INSTITUTIONAL USE ONLY
GENERIC PRICE INFLATION SLOWING
61
Source: IMS health, Leerink Partners LLC
Note: The quarterly weighted average generic price inflation was calculated by weighting each drug based on its mix of sales for a given calendar year.
Only drugs that were available in the year ago period are included in a given quarter's inflation calculation.
IMS Health quarterly WAC pricing and sales figures were pulled by NDC code which distinguished each drug by dosage
1.2% 1.2%
-3.0%
-18.1%
-3.2%
-5.0%
-2.1%
-12.4%
-2.2%
1.0% 0.9%
5.2%
12.2%
13.5%
11.8%
4.6% 5.4%
8.1%
5.0%
-20.0%
-15.0%
-10.0%
-5.0%
0.0%
5.0%
10.0%
15.0%
20.0%
1Q:11 2Q:11 3Q:11 4Q:11 1Q:12 2Q:12 3Q:12 4Q:12 1Q:13 2Q:13 3Q:13 4Q:13 1Q:14 2Q:14 3Q:14 4Q:14 1Q:15 2Q:15 3Q:15
Weighted Average y/y WAC Generic Price Inflation by Quarter
62. FOR INSTITUTIONAL USE ONLY 62
ACKNOWLEDGEMENT:
Tessa Romero of Leerink Partners Equity Research contributed to this
report. Her contribution is greatly appreciated.
63. HEALTHCARE March 7, 2016
Disclosures Appendix
Analyst Certification
I, Alice C. Avanian, CFA, certify that the views expressed in this report accurately reflect my views and that no part of
my compensation was, is, or will be directly related to the specific recommendation or views contained in this report.
64. HEALTHCARE March 7, 2016
Distribution of Ratings/Investment Banking Services (IB) as of 12/31/15
IB Serv./Past 12
Mos.
Rating Count Percent Count Percent
BUY [OP] 161 73.20 63 39.10
HOLD [MP] 59 26.80 4 6.80
SELL [UP] 0 0.00 0 0.00
Explanation of Ratings
Outperform (Buy): We expect this stock to outperform its benchmark over the next 12 months.
Market Perform (Hold/Neutral): We expect this stock to perform in line with its benchmark over the next 12
months.
Underperform (Sell): We expect this stock to underperform its benchmark over the next 12 months.The degree
of outperformance or underperformance required to warrant an Outperform or an Underperform rating should
be commensurate with the risk profile of the company.
For the purposes of these definitions the relevant benchmark will be the S&P 600® Health Care Index for
issuers with a market capitalization of less than $2 billion and the S&P 500® Health Care Index for issuers with
a market capitalization over $2 billion.
66. LEERINK PARTNERS LLC EQUITY RESEARCH
Director of Equity Research John L. Sullivan, CFA (617) 918-4875 john.sullivan@leerink.com
Associate Director of Research Alice C. Avanian, CFA (617) 918-4544 alice.avanian@leerink.com
Associate Director of Research James Kelly (212) 277-6096 jim.kelly@leerink.com
Director of Therapeutic Research Geoffrey C. Porges, MBBS (212) 277-6092 geoffrey.porges@leerink.com
Major Pharmaceuticals Seamus Fernandez (617) 918-4011 seamus.fernandez@leerink.com
Le-Yi Wang, Ph.D. (617) 918-4568 leyi.wang@leerink.com
Specialty Pharmaceuticals Jason M. Gerberry, JD (617) 918-4549 jason.gerberry@leerink.com
Derek C. Archila (617) 918-4851 derek.archila@leerink.com
Etzer Darout, Ph.D. (617) 918-4020 etzer.darout@leerink.com
Large Cap Biotechnology Geoffrey C. Porges, MBBS (212) 277-6092 geoffrey.porges@leerink.com
Mid and Small Cap Biotechnology Joseph P. Schwartz (617) 918-4575 joseph.schwartz@leerink.com
Seamus Fernandez (617) 918-4011 seamus.fernandez@leerink.com
Michael Schmidt, Ph.D. (617) 918-4588 michael.schmidt@leerink.com
Paul Matteis (617) 918-4585 paul.matteis@leerink.com
Jonathan Chang, Ph.D. (617) 918-4015 jonathan.chang@leerink.com
Richard Goss (617) 918-4059 richard.goss@leerink.com
Dae Gon Ha, Ph.D. (617) 918-4093 daegon.ha@leerink.com
Mayank Mamtani, MSc. (617) 918-4887 mayank.mamtani@leerink.com
Mark Sevecka, Ph.D. (617) 918-4022 mark.sevecka@leerink.com
Life Science Tools & Diagnostics Dan Leonard (212) 277-6116 dan.leonard@leerink.com
Kevin C. Chen (212) 277-6045 kevin.chen@leerink.com
Michael A. Sarcone, CFA (212) 277-6013 michael.sarcone@leerink.com
Medical Devices, Cardiology Danielle Antalffy (212) 277-6044 danielle.antalffy@leerink.com
Puneet Souda (212) 277-6091 puneet.souda@leerink.com
Medical Devices, Orthopedics Richard Newitter (212) 277-6088 richard.newitter@leerink.com
Ravi Misra (212) 277-6049 ravi.misra@leerink.com
Healthcare Services, Managed Ana Gupte, Ph.D. (212) 277-6040 ana.gupte@leerink.com
Care & Facilities
Healthcare Technology David Larsen, CFA (617) 918-4502 david.larsen@leerink.com
& Distribution Christopher Abbott (617) 918-4010 chris.abbott@leerink.com
Digital Health Steven Wardell (617) 918-4097 steven.wardell@leerink.com
Matt Dellelo, CFA (617) 918-4812 matt.dellelo@leerink.com
Sr. Editor/Supervisory Analyst Mary Ellen Eagan, CFA (617) 918-4837 maryellen.eagan@leerink.com
Supervisory Analysts Randy Brougher randy.brougher@leerink.com
Robert Egan bob.egan@leerink.com
Amy N. Sonne amy.sonne@leerink.com
New York
299 Park Avenue, 21st floor
New York, NY 10171
(888) 778-1653
Boston
One Federal Street, 37th
Floor
Boston, MA 02110
(800) 808-7525
San Francisco
255 California Street, 12th Floor
San Francisco, CA 94111
(415) 905-7200