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Copyright©2020byBostonConsultingGroup.Allrightsreserved.
COVID-19 Vaccines
and Therapeutics
October 23, 2020
Global Health Care
Webinar
Copyright©2020byBostonConsultingGroup.Allrightsreserved.
1
Copyright©2020byBostonConsultingGroup.Allrightsreserved.Copyright©2020byBostonConsultingGroup.Allrightsreserved.
The situation surrounding COVID-19 is dynamic and rapidly evolving,
on a daily basis. Although we have taken great care prior to
producing this presentation, it represents BCG’s view at a particular
point in time. This presentation is not intended to: (i) constitute
medical or safety advice, nor be a substitute for the same; nor (ii) be
seen as a formal endorsement or recommendation of a particular
response. As such you are advised to make your own assessment as
to the appropriate course of action to take, using this presentation as
guidance. Please carefully consider local laws and guidance in your
area, particularly the most recent advice issued by your local (and
national) health authorities, before making any decision.
Special
Disclaimer
2
Copyright©2020byBostonConsultingGroup.Allrightsreserved.
State of pipeline for Covid
vaccines and therapeutics
Emily Serazin
Managing Director &
Partner
Washington D.C.
Key considerations for
manufacturing, distribution
and procurement
Phil Berk
Managing Director &
Senior Partner
Boston
Potential scenarios for
vaccine roll out
Josh Kellar, PhD
Managing Director &
Partner
Chicago
3
Copyright©2020byBostonConsultingGroup.Allrightsreserved.
4 main vaccine platforms are under development, with 10 in phase-3
Nucleic acid Viral vector Protein subunit Virus
Description
• Genetic info. for cells to
make "safe" viral proteins
• Prior vaccines: - None
• Replicating and non-
replicating approaches
• Prior vaccines: - Ebola
• Immune-stimulating
component of the virus
• Prior vaccines: Malaria,
Hepatitis B
• Inactivated or weakened
form of the virus
• Prior vaccines: Dengue,
Polio, TB, etc.
Current
status
• Moderna in Ph 3
• BioNTech, Pfizer in Ph 3
• Other companies in Ph
1/2 & preclinical phases
• Oxford/AstraZeneca
candidate in Ph 2b/3
• CanSino candidate in Ph3
• Gamaleya (Russia)- Ph 3
• Bharat Biotech launched
Ph 1 in July 2020
• Novavax in Ph 3
• Other companies in Phase
1/2 or pre-clinical
• Sinopharm (Wuhan &
Beijinh) & Sinovac
inactivated candidates in
Ph 3, prelim. Positive
results announced in June
# of
candidates
40+ 40+ 80+ 10+
Example
companies
Novel technologies Traditional technologies
Source: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
In / approved for phase 3
Non-exhaustive
Copyright©2020byBostonConsultingGroup.Allrightsreserved.
4
As of 21 Sep 2020
200+
vaccine candidates
10 candidates already in Phase III
Note: The timeline represented is highly dependent on Phase III vaccine results including safety and efficacy data and hence, subject to change;
1. Ph III trials involve a large number of volunteers (e.g., 10s of 1000s) to test efficacy & safety of vaccine; 2. Phase II studies involve small number
of volunteers (e.g., 100-1000) & are intended to provide preliminary information about a vaccine’s ability to produce its desired effect; 3. Phase I
clinical studies involve initial testing in very small number of volunteers (e.g., 20-100) to test the safety profile; 4. Emergency Use Authorization;
5. Oxford University/AstraZeneca voluntarily paused Ph. III trials to review the safety event on a UK patient; trials have since resumed in UK, India
but remain suspended in some other countries; 6. Janssen's (J&J) candidate has been registered and authorized to start Phase III trials, however,
they are currently not recruiting. Trials are expected to start in end of September; 7. Beijing Institute of Biological Products; 8. Wuhan Institute
of Biological Products; 9. Gamaleya Research Institute; 10. Trials are expected to continue till end of 2021 & 2022 for different candidates, as per
WHO, clinicaltrials.gov. However, companies are expected to start approval applications with initial phase 3 results. 11. Global AZ trial paused on
Sept 6. due to reported adverse neurological reaction, restarted in the UK but on-hold in US as of Sep 24th. 12. Global Jansen/J&J trial paused on
Oct. 13 due to unexplained illness in of the study volunteers Source: Guggenheim, Wells Fargo, Bloomberg, FT, Cowen, NYT, Milken Institute,
Morgan Stanley, NIH, clinicaltrials.gov, WHO, Press Search, BCG
Oxford Uni., AstraZeneca5 (UK)
BioNTech (Germany), Pfizer (US)
Moderna; NIH (US)
Sinovac (China)
BIPB7 & Sinopharm (China)
WIPB8 & Sinopharm (China)
CanSino Biologics (China)
Gamaleya9 - Sputnik V (Russia)
Janssen (J&J)6 (US)
Potential timelines for candidates currently in Phase III using WHO definition
~50,000
~44,000
~30,000
~9,000
~15,000
~15,000
~40,000
~40,000
~60,000
Start of phased approval process10Start of phase III trials
Jul Aug Sep Oct Nov Dec Jan ’21Jun
Targeted Ph III
enrollment We are here
Russia registers Sputnik V
Q1 2021
16
10
3
10Phase III1
Phase I/II
174
Phase II2
Phase I3
Pre-Clinical
213
(WHO, Milken Institute)
Trial on pause in
certain geographies11
Expected EUA4 by
US FDA for one or
more candidates
later this year,
subject to initial
phase III readouts
Novavax (US) ~10,000 Q1 2021
Trial on pause in
certain geographies12
5
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Therapeutics in development include novel and repurposed classes
Monoclonal Antibodies Antivirals Antivirals Host-directed
Description
• Purified antibody
molecule which binds to
SARS-CoV-2 Spike protein
and neutralizes it
• Small molecules and
proteins which interfere
with viral replication
• Leverages existing small-
molecule antivirals from HIV,
HCV, and influenza to block
replication of SARS-CoV-2
• Prevent downstream
consequences of viral
infection, including
hyperinflammation
and respiratory failure
Current
status
• Regeneron, Eli Lilly,
Vir/GSK in Ph 2/3 trials
• Lilly released Ph2 data
showing that its mAb
reduced hospitalizations
by 72%
• Merck/Ridgeback
(Molnupiravir) oral
polymerase inhibitor
beginning Ph 3 trials
• Remdesivir reduces time to
recovery by ~4 days and
improves clinical status
• Other drugs, like favipiravir,
and sofosbuvir have shown
promise but require
confirmation
• Dexamethasone
demonstrated 30%
reduction in mortality
• IL-6 inhibitors have
largely failed in Ph3
trials
# of
candidates
30+ <10 100+ 200+
Example
companies
Novel Therapeutics Repurposed Therapeutics
Source: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
1 – AJ Pharma (PK) has a PH 3 testing deal with CanSino Bio.
Non-exhaustive
6
Copyright©2020byBostonConsultingGroup.Allrightsreserved.
100+ actionable therapeutics trials expected to read out by end of year
Abbreviations: ASAQ: Artesunate Amodiaquine; FPV: Favipiravir; PA: pyronaridine-artesunate; PegIFNλ: Peg-Interferon-Lambda; NTZ: Nitazoxanide; SOF/DAC: Sofosbuvir/Daclatasvir
Note: This view is not meant to show prioritized drug candidates but rather provide a non-comprehensive overview on actionable and non-actionable clinical trial read-outs in the coming months; Source: Clinicaltrials.gov, press releases, WHO
Q4 Q1 Q2Q3
2020 2021
Today
Antivirals mAbsHost-directed
Rivaroxaban (GMRI, COALIZIO)
Losartan
(ACOVACT,
PRAETOR)
Rivaroxaban (PREVENT)
Colchicine
(COLCORONA)
Colchicine
(COLCHI-COVID)
Colchicine (COLCOVID)
Colchicine (ACTCOVID)
Nitazoxanide (Romark Hospitalized) Nitazoxanide
(C3-RCT)
SOF/DAC
(REVOLUTION)
SOF/DAC (DISCOVER)
Remdesivir (SOLIDARITY)
Famotidine (Northwell)
Favipiravir (Turkey MoH) Favipiravir (Saudi MoH) Favipiravir
(PIONEER-NHS)
Favipiravir
(NHS-Glasgow)
Losartan (COVERAGE) Losartan
(UMN)
VIR-7831 (COMET-ICE)
AZD7442
(PrEP/PEP)
REGN-CoV2 (Mild)
REGN-CoV2
(PEP)
REGN-CoV2 (Hospitalized)
LY-CoV555 (BLAZE-2)
LY-CoV555 (ACTIV-2)
LY-CoV555 (ACTIV-3)
LY-CoV555
(BLAZE-1)
REGN-CoV2
(Mild – Prelim)
MK-4482 (MK-4482-02/01 Ph2/3 – Preliminary) MK-4482 (MK-4482-02/01 Ph2/3 – Final)
Nitazoxanide (Romark PreP/PEP)
Nitazoxanide
(Romark Mild)
Repurposed
Tx
Novel
Tx
Non-exhaustive
Losartan (ACTCOVID)
Interferon (ACTT-3)Interferon (SOLIDARITY)
SOF/DAC (COVER)
Nitazoxanide (Brazil)
Favipiravir (Dr. Reddy)
Favipiravir
(Mt. Sinai)
Atazanavir
(REVOLUTION)
LY-CoV555 + 016
(BLAZE-4)
AT-527 (Mild –
planned)
7
Copyright©2020byBostonConsultingGroup.Allrightsreserved.
Supply Chain: Multiple elements to end-to-end design for large-scale COVID-19
vaccines and therapeutics
Materials &
components
Bulk antigen /
Tx mfg.
Formulation Filling Packaging
Lot release /
QA
Source: BCG Analysis
Testing / QC
Logistics, Storage, and Distribution
Information and Analytics
Need to anticipate requirements, bottlenecks, and interventions for each element
8
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Estimating 2021 Capacity for Monoclonal Antibodies
Treatments complement but cannot substitute for an immunization program
Source: BCG interviews with companies producing COVID-19 specific mAbs
Process efficiency
(biologics drug
substance only)
Available "upstream"
capacity
Expected dose per
patient
Yield: 3 – 5g compound/liter;
potentially higher with optimization
Product recovery rate: 75%
From ~1300KL
Possibly up to 3000KL
From 0.7 up to 8g per patient
Number of patients treated
Likely in single-digit millions
• potentially as low as ~400K or up to 15MM
9
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Deployment & manufacturing: Emerging vaccine portfolio presents multiple
challenges
Platform Candidate Considerations for deployment Considerations for manufacturing
Viral Vector
Nucleic
acid
Protein
sub-unit
Virus-based
Source: MarketWatch "Moderna and Pfizer’s COVID-19 vaccine candidates require ultra-low temperatures" (Aug 2020), interviews with experts on vaccines and biopharma operations
Ultra-cold
chain
required
(<-20° C)
Novel
platforms
likely will
require
enhanced
pharmaco
vigilance
systems
Manufacturing process requires BSL-2
conditions, reducing # of viable facilities
Slow tech transfer process likely to lengthen
lead time
Manufacturing tech may allow for easier
and faster expansion and/or repurposing
of existing facilities;
Key dependency is skilled labor
Traditional vaccine platforms likely easiest
to repurpose and scale facilities
GMP certification of new/repurposed facilities
likely requires regulator inspections
Multi-dose
vials without
preservative
will require
high-
throughput
delivery
strategies
2 doses
required
(at defined
intervals)
1 dose
required
Manufacturing process requires segregation
from other products and higher containment
requirements – reducing # of viable facilities
+
+
10
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Procurement: Countries racing to pre-purchase
vaccine doses through bilateral and multilateral deals
800
280
1,560
190
530
220
600
331
67
747
38
128
211
3,900
Total doses (M)
Population (M)
486
47
0
460
356
120
EU: 1,560
USA: 800
GAVI COVAX
AMC: 600
Japan: 530
UK: 280
Brazil: 220
Canada: 190
Committed vaccine doses from public deals (Millions)
Note:- Press research till 21st Sept; AZ – AstraZeneca; 1- 300 by EU, 400 through Inclusive Vaccine Alliance
GAVI COVAX
AMC
868
1,420
Total doses and population
Non-exhaustive; includes figures
cited from last 30 days in on-going
negotiations
11
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Multiple variables lead to complexity of vaccine rollout
Key variables
for vaccine
rollout
Communications &
Policy Guidance
Development updates, vaccine
guidance, and availability info
Adoption
Public demand and
acceptance
Supply chain stability
Manufacturing capacity,
distribution, and delivery systems
Safety & Monitoring
programs
Tracking of doses, safety, side effects
and outcomes
Vaccine efficacy
Number of 'successful' candidates and degree of efficacy
Copyright©2020byBostonConsultingGroup.Allrightsreserved.
11
12
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Two scenarios highlight how rollout could unfold
'Things go very well' 'A complex sequence of events'
Fall 2020
Dec 2021
Multiple candidates prove highly efficacious
(<80%) and receive US FDA approval for limited
release before the end of 2020
Robust supply chain with ample manufacturing
capacity, organized distribution and aligned
package and storage requirements
Rigorous safety & monitoring programs follow
up on all vaccinated individuals, ensuring dose
completion and tracking adverse events
Clear, consistent communications make it easy
to understand when people can access a
vaccine, where they can get it and why it's
critical
Rapid adoption following vaccine approval for
all adults in Spring 2021 and pandemic is
declared officially over by end of 2021 in the US
Fall 2020
Fall 2022
One of the first three candidates show moderate
efficacy (~60%) leading to initial approval; trials
continue for all three candidates
Inconsistent communications with conflicting
guidance regarding immediate vaccination
versus waiting for additional readouts
Unstable supply chain with inadequate supply
capacity, disorganized distribution and dose
wastage from misaligned packaging and storage
Challenges in safety & monitoring with
difficulty interpreting results and many
patients not receiving second dose
Slow adoption with low consumer confidence
until an efficacious second-wave vaccine emerges
in mid-2022, ending the pandemic in Fall 2022
13
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Be prepared for non-pharmacological interventions to last
through 2021
Three-part agenda critical to success
• Fund and build the infrastructure to test, track, and trace to
contain the virus and mitigate harm through the first half of
2021
• Support a massive, unified mobilization analogous to a
wartime effort to roll out safe and effective vaccines and
therapeutics
• Maintain research momentum for additional vaccines and
therapies even if we have a successful initial vaccine
This must be a global agenda - We won't be safe anywhere
until we are safe everywhere
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Conclusions
13
14
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THANK YOU
14
15
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The services and materials provided by Boston Consulting Group (BCG) are subject to BCG's Standard Terms
(a copy of which is available upon request) or such other agreement as may have been previously executed by BCG.
BCG does not provide legal, accounting, or tax advice. The Client is responsible for obtaining independent advice concerning
these matters. This advice may affect the guidance given by BCG. Further, BCG has made no undertaking
to update these materials after the date hereof, notwithstanding that such information may become outdated
or inaccurate.
The materials contained in this presentation are designed for the sole use by the board of directors or senior management of
the Client and solely for the limited purposes described in the presentation. The materials shall not be copied or given to any
person or entity other than the Client (“Third Party”) without the prior written consent of BCG. These materials serve only as
the focus for discussion; they are incomplete without the accompanying oral commentary and may not be relied on as a
stand-alone document. Further, Third Parties may not, and it is unreasonable for any Third Party to, rely on these materials
for any purpose whatsoever. To the fullest extent permitted by law (and except to the extent otherwise agreed in a signed
writing by BCG), BCG shall have no liability whatsoever to any Third Party, and any Third Party hereby waives any rights and
claims it may have at any time against BCG with regard to the services, this presentation, or other materials, including the
accuracy or completeness thereof. Receipt and review of this document shall be deemed agreement with and consideration
for the foregoing.
BCG does not provide fairness opinions or valuations of market transactions, and these materials should not be relied on or
construed as such. Further, the financial evaluations, projected market and financial information, and conclusions contained
in these materials are based upon standard valuation methodologies, are not definitive forecasts, and are not guaranteed by
BCG. BCG has used public and/or confidential data and assumptions provided to BCG by the Client. BCG has not
independently verified the data and assumptions used in these analyses. Changes in the underlying data or operating
assumptions will clearly impact the analyses and conclusions.
The situation surrounding COVID-19 is dynamic and rapidly evolving, on a daily basis. Although we have taken great care
prior to producing this presentation, it represents BCG’s view at a particular point in time. This presentation is not intended
to: (i) constitute medical or safety advice, nor be a substitute for the same; nor (ii) be seen as a formal endorsement or
recommendation of a particular response. As such you are advised to make your own assessment as to the appropriate
course of action to take, using this presentation as guidance. Please carefully consider local laws and guidance in your area,
particularly the most recent advice issued by your local (and national) health authorities, before making any decision.
Disclaimer
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BCG - Covid-19 vaccines and therapeutics-October2020

  • 1. 0 Copyright©2020byBostonConsultingGroup.Allrightsreserved. COVID-19 Vaccines and Therapeutics October 23, 2020 Global Health Care Webinar Copyright©2020byBostonConsultingGroup.Allrightsreserved.
  • 2. 1 Copyright©2020byBostonConsultingGroup.Allrightsreserved.Copyright©2020byBostonConsultingGroup.Allrightsreserved. The situation surrounding COVID-19 is dynamic and rapidly evolving, on a daily basis. Although we have taken great care prior to producing this presentation, it represents BCG’s view at a particular point in time. This presentation is not intended to: (i) constitute medical or safety advice, nor be a substitute for the same; nor (ii) be seen as a formal endorsement or recommendation of a particular response. As such you are advised to make your own assessment as to the appropriate course of action to take, using this presentation as guidance. Please carefully consider local laws and guidance in your area, particularly the most recent advice issued by your local (and national) health authorities, before making any decision. Special Disclaimer
  • 3. 2 Copyright©2020byBostonConsultingGroup.Allrightsreserved. State of pipeline for Covid vaccines and therapeutics Emily Serazin Managing Director & Partner Washington D.C. Key considerations for manufacturing, distribution and procurement Phil Berk Managing Director & Senior Partner Boston Potential scenarios for vaccine roll out Josh Kellar, PhD Managing Director & Partner Chicago
  • 4. 3 Copyright©2020byBostonConsultingGroup.Allrightsreserved. 4 main vaccine platforms are under development, with 10 in phase-3 Nucleic acid Viral vector Protein subunit Virus Description • Genetic info. for cells to make "safe" viral proteins • Prior vaccines: - None • Replicating and non- replicating approaches • Prior vaccines: - Ebola • Immune-stimulating component of the virus • Prior vaccines: Malaria, Hepatitis B • Inactivated or weakened form of the virus • Prior vaccines: Dengue, Polio, TB, etc. Current status • Moderna in Ph 3 • BioNTech, Pfizer in Ph 3 • Other companies in Ph 1/2 & preclinical phases • Oxford/AstraZeneca candidate in Ph 2b/3 • CanSino candidate in Ph3 • Gamaleya (Russia)- Ph 3 • Bharat Biotech launched Ph 1 in July 2020 • Novavax in Ph 3 • Other companies in Phase 1/2 or pre-clinical • Sinopharm (Wuhan & Beijinh) & Sinovac inactivated candidates in Ph 3, prelim. Positive results announced in June # of candidates 40+ 40+ 80+ 10+ Example companies Novel technologies Traditional technologies Source: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines In / approved for phase 3 Non-exhaustive
  • 5. Copyright©2020byBostonConsultingGroup.Allrightsreserved. 4 As of 21 Sep 2020 200+ vaccine candidates 10 candidates already in Phase III Note: The timeline represented is highly dependent on Phase III vaccine results including safety and efficacy data and hence, subject to change; 1. Ph III trials involve a large number of volunteers (e.g., 10s of 1000s) to test efficacy & safety of vaccine; 2. Phase II studies involve small number of volunteers (e.g., 100-1000) & are intended to provide preliminary information about a vaccine’s ability to produce its desired effect; 3. Phase I clinical studies involve initial testing in very small number of volunteers (e.g., 20-100) to test the safety profile; 4. Emergency Use Authorization; 5. Oxford University/AstraZeneca voluntarily paused Ph. III trials to review the safety event on a UK patient; trials have since resumed in UK, India but remain suspended in some other countries; 6. Janssen's (J&J) candidate has been registered and authorized to start Phase III trials, however, they are currently not recruiting. Trials are expected to start in end of September; 7. Beijing Institute of Biological Products; 8. Wuhan Institute of Biological Products; 9. Gamaleya Research Institute; 10. Trials are expected to continue till end of 2021 & 2022 for different candidates, as per WHO, clinicaltrials.gov. However, companies are expected to start approval applications with initial phase 3 results. 11. Global AZ trial paused on Sept 6. due to reported adverse neurological reaction, restarted in the UK but on-hold in US as of Sep 24th. 12. Global Jansen/J&J trial paused on Oct. 13 due to unexplained illness in of the study volunteers Source: Guggenheim, Wells Fargo, Bloomberg, FT, Cowen, NYT, Milken Institute, Morgan Stanley, NIH, clinicaltrials.gov, WHO, Press Search, BCG Oxford Uni., AstraZeneca5 (UK) BioNTech (Germany), Pfizer (US) Moderna; NIH (US) Sinovac (China) BIPB7 & Sinopharm (China) WIPB8 & Sinopharm (China) CanSino Biologics (China) Gamaleya9 - Sputnik V (Russia) Janssen (J&J)6 (US) Potential timelines for candidates currently in Phase III using WHO definition ~50,000 ~44,000 ~30,000 ~9,000 ~15,000 ~15,000 ~40,000 ~40,000 ~60,000 Start of phased approval process10Start of phase III trials Jul Aug Sep Oct Nov Dec Jan ’21Jun Targeted Ph III enrollment We are here Russia registers Sputnik V Q1 2021 16 10 3 10Phase III1 Phase I/II 174 Phase II2 Phase I3 Pre-Clinical 213 (WHO, Milken Institute) Trial on pause in certain geographies11 Expected EUA4 by US FDA for one or more candidates later this year, subject to initial phase III readouts Novavax (US) ~10,000 Q1 2021 Trial on pause in certain geographies12
  • 6. 5 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Therapeutics in development include novel and repurposed classes Monoclonal Antibodies Antivirals Antivirals Host-directed Description • Purified antibody molecule which binds to SARS-CoV-2 Spike protein and neutralizes it • Small molecules and proteins which interfere with viral replication • Leverages existing small- molecule antivirals from HIV, HCV, and influenza to block replication of SARS-CoV-2 • Prevent downstream consequences of viral infection, including hyperinflammation and respiratory failure Current status • Regeneron, Eli Lilly, Vir/GSK in Ph 2/3 trials • Lilly released Ph2 data showing that its mAb reduced hospitalizations by 72% • Merck/Ridgeback (Molnupiravir) oral polymerase inhibitor beginning Ph 3 trials • Remdesivir reduces time to recovery by ~4 days and improves clinical status • Other drugs, like favipiravir, and sofosbuvir have shown promise but require confirmation • Dexamethasone demonstrated 30% reduction in mortality • IL-6 inhibitors have largely failed in Ph3 trials # of candidates 30+ <10 100+ 200+ Example companies Novel Therapeutics Repurposed Therapeutics Source: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines 1 – AJ Pharma (PK) has a PH 3 testing deal with CanSino Bio. Non-exhaustive
  • 7. 6 Copyright©2020byBostonConsultingGroup.Allrightsreserved. 100+ actionable therapeutics trials expected to read out by end of year Abbreviations: ASAQ: Artesunate Amodiaquine; FPV: Favipiravir; PA: pyronaridine-artesunate; PegIFNλ: Peg-Interferon-Lambda; NTZ: Nitazoxanide; SOF/DAC: Sofosbuvir/Daclatasvir Note: This view is not meant to show prioritized drug candidates but rather provide a non-comprehensive overview on actionable and non-actionable clinical trial read-outs in the coming months; Source: Clinicaltrials.gov, press releases, WHO Q4 Q1 Q2Q3 2020 2021 Today Antivirals mAbsHost-directed Rivaroxaban (GMRI, COALIZIO) Losartan (ACOVACT, PRAETOR) Rivaroxaban (PREVENT) Colchicine (COLCORONA) Colchicine (COLCHI-COVID) Colchicine (COLCOVID) Colchicine (ACTCOVID) Nitazoxanide (Romark Hospitalized) Nitazoxanide (C3-RCT) SOF/DAC (REVOLUTION) SOF/DAC (DISCOVER) Remdesivir (SOLIDARITY) Famotidine (Northwell) Favipiravir (Turkey MoH) Favipiravir (Saudi MoH) Favipiravir (PIONEER-NHS) Favipiravir (NHS-Glasgow) Losartan (COVERAGE) Losartan (UMN) VIR-7831 (COMET-ICE) AZD7442 (PrEP/PEP) REGN-CoV2 (Mild) REGN-CoV2 (PEP) REGN-CoV2 (Hospitalized) LY-CoV555 (BLAZE-2) LY-CoV555 (ACTIV-2) LY-CoV555 (ACTIV-3) LY-CoV555 (BLAZE-1) REGN-CoV2 (Mild – Prelim) MK-4482 (MK-4482-02/01 Ph2/3 – Preliminary) MK-4482 (MK-4482-02/01 Ph2/3 – Final) Nitazoxanide (Romark PreP/PEP) Nitazoxanide (Romark Mild) Repurposed Tx Novel Tx Non-exhaustive Losartan (ACTCOVID) Interferon (ACTT-3)Interferon (SOLIDARITY) SOF/DAC (COVER) Nitazoxanide (Brazil) Favipiravir (Dr. Reddy) Favipiravir (Mt. Sinai) Atazanavir (REVOLUTION) LY-CoV555 + 016 (BLAZE-4) AT-527 (Mild – planned)
  • 8. 7 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Supply Chain: Multiple elements to end-to-end design for large-scale COVID-19 vaccines and therapeutics Materials & components Bulk antigen / Tx mfg. Formulation Filling Packaging Lot release / QA Source: BCG Analysis Testing / QC Logistics, Storage, and Distribution Information and Analytics Need to anticipate requirements, bottlenecks, and interventions for each element
  • 9. 8 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Estimating 2021 Capacity for Monoclonal Antibodies Treatments complement but cannot substitute for an immunization program Source: BCG interviews with companies producing COVID-19 specific mAbs Process efficiency (biologics drug substance only) Available "upstream" capacity Expected dose per patient Yield: 3 – 5g compound/liter; potentially higher with optimization Product recovery rate: 75% From ~1300KL Possibly up to 3000KL From 0.7 up to 8g per patient Number of patients treated Likely in single-digit millions • potentially as low as ~400K or up to 15MM
  • 10. 9 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Deployment & manufacturing: Emerging vaccine portfolio presents multiple challenges Platform Candidate Considerations for deployment Considerations for manufacturing Viral Vector Nucleic acid Protein sub-unit Virus-based Source: MarketWatch "Moderna and Pfizer’s COVID-19 vaccine candidates require ultra-low temperatures" (Aug 2020), interviews with experts on vaccines and biopharma operations Ultra-cold chain required (<-20° C) Novel platforms likely will require enhanced pharmaco vigilance systems Manufacturing process requires BSL-2 conditions, reducing # of viable facilities Slow tech transfer process likely to lengthen lead time Manufacturing tech may allow for easier and faster expansion and/or repurposing of existing facilities; Key dependency is skilled labor Traditional vaccine platforms likely easiest to repurpose and scale facilities GMP certification of new/repurposed facilities likely requires regulator inspections Multi-dose vials without preservative will require high- throughput delivery strategies 2 doses required (at defined intervals) 1 dose required Manufacturing process requires segregation from other products and higher containment requirements – reducing # of viable facilities + +
  • 11. 10 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Procurement: Countries racing to pre-purchase vaccine doses through bilateral and multilateral deals 800 280 1,560 190 530 220 600 331 67 747 38 128 211 3,900 Total doses (M) Population (M) 486 47 0 460 356 120 EU: 1,560 USA: 800 GAVI COVAX AMC: 600 Japan: 530 UK: 280 Brazil: 220 Canada: 190 Committed vaccine doses from public deals (Millions) Note:- Press research till 21st Sept; AZ – AstraZeneca; 1- 300 by EU, 400 through Inclusive Vaccine Alliance GAVI COVAX AMC 868 1,420 Total doses and population Non-exhaustive; includes figures cited from last 30 days in on-going negotiations
  • 12. 11 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Multiple variables lead to complexity of vaccine rollout Key variables for vaccine rollout Communications & Policy Guidance Development updates, vaccine guidance, and availability info Adoption Public demand and acceptance Supply chain stability Manufacturing capacity, distribution, and delivery systems Safety & Monitoring programs Tracking of doses, safety, side effects and outcomes Vaccine efficacy Number of 'successful' candidates and degree of efficacy Copyright©2020byBostonConsultingGroup.Allrightsreserved. 11
  • 13. 12 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Two scenarios highlight how rollout could unfold 'Things go very well' 'A complex sequence of events' Fall 2020 Dec 2021 Multiple candidates prove highly efficacious (<80%) and receive US FDA approval for limited release before the end of 2020 Robust supply chain with ample manufacturing capacity, organized distribution and aligned package and storage requirements Rigorous safety & monitoring programs follow up on all vaccinated individuals, ensuring dose completion and tracking adverse events Clear, consistent communications make it easy to understand when people can access a vaccine, where they can get it and why it's critical Rapid adoption following vaccine approval for all adults in Spring 2021 and pandemic is declared officially over by end of 2021 in the US Fall 2020 Fall 2022 One of the first three candidates show moderate efficacy (~60%) leading to initial approval; trials continue for all three candidates Inconsistent communications with conflicting guidance regarding immediate vaccination versus waiting for additional readouts Unstable supply chain with inadequate supply capacity, disorganized distribution and dose wastage from misaligned packaging and storage Challenges in safety & monitoring with difficulty interpreting results and many patients not receiving second dose Slow adoption with low consumer confidence until an efficacious second-wave vaccine emerges in mid-2022, ending the pandemic in Fall 2022
  • 14. 13 Copyright©2020byBostonConsultingGroup.Allrightsreserved. Be prepared for non-pharmacological interventions to last through 2021 Three-part agenda critical to success • Fund and build the infrastructure to test, track, and trace to contain the virus and mitigate harm through the first half of 2021 • Support a massive, unified mobilization analogous to a wartime effort to roll out safe and effective vaccines and therapeutics • Maintain research momentum for additional vaccines and therapies even if we have a successful initial vaccine This must be a global agenda - We won't be safe anywhere until we are safe everywhere Copyright©2020byBostonConsultingGroup.Allrightsreserved. Conclusions 13
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