Global Executive Briefing - COVID-19 Update: June 2020 - Iqvia
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Global Executive Briefing COVID-19 Update: June 2020 © 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Agenda + Pandemic Status: Updated Spread of COVID-19, Transitioning to Stability An update on the spread, and a measure to assess reopening indicators Speaker: Murray Aitken, SVP, IQVIA and Executive Director, IQVIA Institute for Human Data Science + Medical Outlook: Virology, Disease Sequela, and R&D Progress New learnings, new concerns, and the progress toward treatments and vaccines Speaker: Jeff Spaeder, Chief Medical & Scientific Officer, IQVIA + Resuming momentum in clinical trials Moving from response to recovery Speaker: Costa Panagos, President, R&D Operations, IQVIA + COVID-19: A catalyst of change A look ahead to 2021 and beyond, and the long term impact and implications for life sciences Speaker: Marla Kessler, SVP, Strategy Marketing and Communications Speaker: Alistair Grenfell, President Europe, Middle East, Africa, and South Asia Speaker: Murray Aitken 2
Executive Briefing: COVID-19 Update Section 1: Transition to stability Murray Aitken SVP, IQVIA Executive Director, IQVIA Institute for Human Data Science June 2020 © 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Global look at where we are in the COVID-19 pandemic Not yet peaked Peaked but not yet Less than Rebounded at < 20% of peak 20% of peak Countries: 52 Countries: 47 Countries: 65 Countries: 7 Populat: 3.5bn Populat: 1.8bn. Populat: 2.5bn Populat: 0.05bn • South Asia • US • UK • Most of Europe • Carib/LATAM • Africa • Russia • Others • East Asia • Med/Mid-East/Africa • Latin America • AU/NZ • E. Europe • Middle East • Sweden 44% 23% 32% 1% population population population population Source: OWID.org; IQVIA Institute. IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 4
Future COVID-19 impact is regional and heterogeneous Significant international and regional variation: disproportionate impact on lower socio-economic + minority groups New York Active cases/100k population New Jersey California Michigan Florida Massachusetts Pennsylvania USA Louisiana Projected total confirmed cases per 100k: 855 (range: 748-1025) Active cases/100k population Active cases/100k population 40 Hungary Hungary Poland 45 (44-48) Romania 30 Projected total 20 confirmed Poland India cases per 91 (87-100) 10 100k: Projected total confirmed cases 0 per 100k: 39 (range: 31-53) Romania 110 (102-119) Source: IQVIA Active Cases Curve Simulator. IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 5
Transitioning to stability Readiness to reopen alignment with health system utilization New York Re-opening Readiness Index 136 Population: 19.6Mn 106 • Rt level Total cases to date: 362,758 104 Rt 0.79 • Positive testing ratio 81 Positive Testing 1.2% • Testing level per capita 121 • Contact tracing planning and 86 Testing Per Capita 2.3% implementation Contact Tracing 3.25 • Granularity and quality of case reporting Granularity / Quality 86 Elective Procedures 18% Health Services Utilization Index 41 • Elective procedures 18 of baseline Institutional visits 31% 31 34 60 • Institutional visits Lab Diagnostics 62% • Diagnostic lab tests 62 Office Visits 34% • Office visits New to Brand Prescriptions 60% • New to brand prescriptions Source: COVID tracking project; Rt.live; IQVIA Real World Claims; IQVIA Institute. IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 6
Executive Briefing: COVID-19 Update Section 2: Medical update and outlook Dr. Jeffrey Spaeder, M.D. Chief Medical and Scientific Officer, IQVIA June 2020 © 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Learning from history, how do pandemics spread and end? Perspectives on future scenarios SPREAD Persistent Spanish flu Repeated large community spread version 2.0 outbreaks ‘Medical’ end ‘Social’ end Virus impact minimized by development Societies adopt varying philosophies to of medical interventions, or mutates respond to the virus END Prevention and Mutation Treatments Minimization Moderation Vaccines Taiwan Sweden Source: IQVIA Global Supplier & Association Relations perspectives, May 2020; https://www.nytimes.com/2020/05/10/health/coronavirus-plague-pandemic-history.html IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 8
SARS CoV-2 mutations are relatively infrequent although D614G mutation has quickly become dominant globally Adaptive pressures could impact future transmission as well as efficacy of vaccines based upon earlier viral characteristics SARS CoV-2 in Wuhan (D614 in orange) SARS-CoV-2 spike protein Impact of viral mutations: • SNP mutations (green) • Increased likelihood of mutations as infections increase • D614G mutation (red) • Efficacy of vaccines based upon earlier versions of virus • Accuracy of diagnostic tests • Transmission capacity • Severity of infection • Potential need for booster vaccines doi.org/10.1101/2020.04.29.069054doi doi.org/10.1101/2020.04.28.066977doi IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 9
COVID-19 is more than just a respiratory disease Diffuse distribution of ACE2 and two-phase immune response complicates clinical course including neuropsychiatric effects Source: https://arxiv.org/ftp/arxiv/papers/2003/2003.12773.pdf IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 10
The components of successful vaccine development Treatments save patients, vaccines save populations Vaccine platform or Scientific Successful Compound Institutions delivery mechanism Phase components execution of studies AZD1222 Univ. Oxford & AZ Adenovirus vaccine 2b/3 • Correct target • Sufficiently large Ad5-nCoV CanSino Biologics Adenovirus vaccine 2 • Successful and long-term event rate mRNA-1273 Moderna mRNA vaccine 2 generation of protective • Sufficiently long immunity enough duration Beijing Institute of Unnamed Biological Products & Inactivated vaccine 1/2 Sinopharm BNT162 BioNTech & Pfizer mRNA vaccine 1/2 Distribution Manufacturing capability capacity NVX- Novavax Protein subunit 1/2 CoV2373 • Prioritization and • Rapid scaling up Inactivated virus with coordination • Public-private PiCoVacc Sinovac adjuvant 1/2 • “Last mile” efforts partnerships Beth Israel Unnamed Deaconness & Adenovirus vaccine Janssen Source: Lancet 2020;395:1751-1752 and IQVIA insight. IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 11
Potential integration of therapies under development High risk individuals (Prophylactic treatment) Healthcare providers Vaccine for (Prophylactic treatment) population Patient infected with SARS-CoV-2 Severity of illness Plasma- Immune derived Rx Viral modulation Symptom inhibition treatment Immunity Mild / Moderate Moderate / Severe symptoms symptoms Serology testing IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 12
Univ. of Minnesota Results of notable clinical studies post-exposure (-) French case report study (+) China study RCT (-) Australia HCP VA Study prophylaxis (ongoing) ACTT (+: 15 vs. 11 real-world study (-) Hydroxy- days inpatient and chloroquine WHO SOLIDARITY mortality trend) study (ongoing) IL-6 inhibitor Remdesivir Leronlimab (+) Case reports (+) IL=-6 inhibitor >600 Tocilzumab (+/-) ongoing Supportive IL-6 inhibitor clinical therapies Sarilumab (-) China case-reports (+) studies Anticoagulation (+) NYU series (+) Key Convalescent + in combination plasma with ribavirin and = demonstrates positive benefit interferon 1b Lopinavir/ = negative effect or outcome ritonavir = neutral or ongoing study (-) vs. standard US safety studies (+) WHO SOLIDARITY of care study with and without interferon (ongoing) Source: https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 13
Executive Briefing: COVID-19 Update Section 3: Recovery in R&D Costa Panagos President, R&D Operations, IQVIA June 2020 © 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Pharmaceutical company decisions on clinical trial continuity have largely remained stable since end of April Clinical trial continuity among Selected clinical trial continuity statements – top 50 pharma April/May 2020 (n=30 companies with public statements) “While Biogen does expect there will be some impact to timelines for some of its clinical programs, it still expects the vast majority of the 13% 10 remaining near-term readouts to occur before the end of 2021.” Delay existing enrollment “Clinical trials are continuing and we are leveraging our digital tools 10% to limit the disruption caused by the pandemic. We are seeing Delay new trials only 53% slowdowns in new enrollments in ongoing clinical studies and start- up with new studies. At this time we remain confident the impact on Attempt to maintain and our ongoing clinical trials is manageable. Looking ahead for the leverage remainder of the year, we do not expect delays in our planned 23% continuity 2020 regulatory submissions.” Delay new trials solutions on case and existing by case basis patient enrollment “While some of our clinical trial sites remain paused for new patient recruitment, we endeavor to continue our clinical research programs with the wellbeing of our patients as our guiding principle. We assess the situation continuously and where it is safe for patients and in line with local regulations, we have restarted patient recruitment at some sites for most of our ongoing studies..” Source: IQVIA secondary research; company websites and press releases. IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 15
The site perspective: Challenges and opportunities for support Key challenges during COVID-19 What would help IP accountability 12% 28% 27% Not enough Not enough staff staffto and/or time and/or time devote to 26% study to devote to study 17% EDC data entry 17% 21% ReviewingReviewing my site database/chart review to my site database/chart 17% 13% 20% find potential review subjects to find potential subjects 20% EDC query resolution 19% 19% Time for patient education about studies 22% 17% Investigator site file upkeep 22% 17% Patient phone screening and scheduling 22% 14% Pre-screeningPre-screening patients/referrals patients/referrals from outside from outside sources sources 26% 8% 7% Follow-up Follow-up with with current current study study subjects subjects to 4% resume their study to resume visits their study visits 29% 2% Additional staff to Remote Access Additional staff to Additional staff to Additional staff to Monitoring visit prep 36% conduct Technology contact new referral contact patients schedule chart/database (eSource, eReg, patients currently enrolled in appointments with reviews to look for eMR, Telemedicine) studies current patients Engaging and retaining patients 38% potential patients Major impact Minor impact Source: IQVIA US and Canada Site Survey (n=138). IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 16
COVID post-containment operational recovery framework Enabling exit, limiting disruption from COVID-19 at a project portfolio level Study level Country level Site level Patient level Macro level planning Country level situation Site access, protocol Patient return to sites using tools at portfolio / and regulatory situation at site and site and enrolment re- project level expectations staff workload forecast IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 17
Recovery curve forecast Rate at which sites and patients return to pre-COVID activities Forecast site reopen dates • By country and region • By US state • By therapeutic area Forecast patient activity • Early: screening and randomization activities • Late: post randomization Managing recovery with timely, adaptable Forecast site reopen at a study-site level forecasting powered by machine learning Scenario planning simulations on shifting peak dates (5, 10, 15 days) and government regulations scenarios (none; mild; strict) IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 18
Accelerated innovation is paving the way for a new normal Achieving agility with patient-centric design and the right technological infrastructure Pre-COVID Post-COVID Protocol simplification Complex, inflexible protocols Protocols that reduce patient burden and have built-in option to incorporate remote study approaches; leverage common protocols on basket studies Remote site monitoring/source data verification and remote visits Primarily on-site operations Shift towards remote Site selection and initiation visits with remote site support and increased hybrid of onsite/remote (at home) patient visits Novel trial design/hybridization of studies Traditional randomized trials Master/Platform protocols, real world comparator arms, merging of real world modalities and early phase engagement and planning Digitization of study procedures Site-based study procedures Further evolution of digital patient options for clinical trial data collection such as ePRO, vitals, spirometry, ocular exam, ECGs, glucose monitoring, oximetry, etc. Digital patient engagement Limited patient communication Increased use of digital communications to keep patients informed and engaged while reducing burden and increasing retention IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 19
Executive Briefing: COVID-19 Update Section 4: COVID-19: A catalyst for change Marla Kessler SVP, Strategy, Marketing, and Communications, IQVIA Alistair Grenfell President, Europe, Middle East, Africa and South Asia, IQVIA Murray Aitken SVP, IQVIA Executive Director, IQVIA Institute for Human Data Science June 2020 © 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Looking to 2021 Driving forces that could shape the healthcare landscape Virus evolution and Economic and Private sector therapeutic policy impact activation response Progress in availability of safe and Depth of impact, speed of Extent to which private sector effective vaccine and treatment return and level of policy stakeholders seize the options to prevent hospitalization responses opportunity to restructure, and and manage severe cases embrace and activate change IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 21
Behavior shifts Driving forces shift behaviors Enhanced value and New patient journey Emerging GTM model evidence requirements Magnitude of disruption Potential behavior shifts No major shift expected Potentially to be highly disruptive Patients Personal health engagement; Technology adoption Providers Restricted rep access; Increased tele-health adoption Public payers Reallocation of budget from drugs to health services Consideration of integration, consolidation. Investment in Private payers innovation. Hospitals Shifted role of hospitals; Opening of new treatment centers Pharmacy More e-Pharmacy; Increase in home-delivery IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 22
Business model under pressure Pre-COVID costs growing faster than net revenue, eroding returns P&L squeeze: Revenue and cost growth (indexed to 2010) 5-yr CAGR 140 R&D Expense ~5% 130 COGS ~4% Index to 2010 = 100 Net Revenue ~3% 120 SG&A Expense ~3% 110 100 90 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 Aggregated industry P&L, top 25 Pharma companies, Source: Company Financial Report ; IQVIA Thought Leadership analy sis 2020 C IQVIA Q Global Executive Briefing: COVID-19QJune |2020; Copyright | S 2020 | COIQVIA. CO 23
Implications for life sciences New capabilities to adapt across the value chain TODAY FUTURE Refocus portfolio strategy on high-unmet need areas R&D / Portfolio • Focus on oncology and specialty Innovative use of RW evidence Strategy • On-site complex protocol studies Tech-enabled execution Long-term follow-up COVID-19 patients Safety • Traditional PV requirements Evidence on COVID-19 impact Supply and • Dependent on foreign API Consider domestic / collaborative manufacturing to prevent • Consistent and frequent distribution / wholesale any supply issues or policy changes Manufacturing Pricing and • Price benchmarks Plan for new evidence requirements Market Access • External technology review Accelerated focus on value demonstration Enhance support for patients within new care sites • Disease state and treatment education focus Patient Support • On-site specialist referrals Strengthen pathways and guidelines to empower patients in and Engagement care seeking behaviors • Hospital driven treatment and care Remote monitoring and tele-health continuation • Share of voice based customer engagement Local precision and coordination GTM Model • Coverage and frequency models (F2F focus) Call-center based remote engagement • Key account management Scientific / clinically focused field-team IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 24
Profitability impacts Operating margin at some risk (2021-2022) Large pharma baseline* Impacts Rationale 2019 actual Disruption in demand from April to June, offset by forwarding Net sales 100% buying in March, and return in July-Dec at 95% of 2019 level Slight increase due to shifting some production to COGS 28% more expensive locations Initial investment in virtual technology off-set by SG&A 27% more significant rebalance of field force investment R&D 19% Maintain program at same absolute level Operating margin 25% Management priorities and actions to maintain operating margin Source: Company financial statements for 15 largest companies by global pharmaceutical sales; IQVIA Institute. IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 25
Building a more resilient ecosystem Transitioning to the future with a stronger healthcare system Re-establishing a stronger system: Embrace the role of technology COVID-19 pandemic as an accelerator of change that Digital Global promotes efficiency in customer engagement and ways of innovation connectivity working Learn from global community Global healthcare and life science community learns from historic response Increase value to healthcare system Re-setting assessment of ICU capacity, testing Value capabilities, vaccine infrastructure and innovative calibration therapeutics to optimize health system and life science value IQVIA Global Executive Briefing: COVID-19 June 2020; Copyright 2020 IQVIA. 26
Thank you For more information, please visit IQVIA.com/COVID19 Or contact us at insights@iqvia.com
Disclaimer The analyses, their interpretation, and related information contained herein are made and provided subject to the assumptions, methodologies, caveats, and variables described in this report and are based on third party sources and data reasonably believed to be reliable. No warranty is made as to the completeness or accuracy of such third party sources or data. As with any attempt to estimate future events, the forecasts, projections, conclusions, and other information included herein are subject to certain risks and uncertainties, and are not to be considered guarantees of any particular outcome. All reproduction rights, quotations, broadcasting, publications reserved. No part of this presentation may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without express written consent of IQVIA. Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries. 28
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