Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
June 03 2021 - 11:16AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF THE
SECURITIES EXCHANGE ACT OF 1934
For the month June 2021
(Commission File No. 001-35193)
Grifols, S.A.
(Translation of registrant’s name into English)
Avinguda de la Generalitat, 152-158
Parc de Negocis Can Sant Joan
Sant Cugat del Valles 08174
Barcelona, Spain
(Address of registrant’s principal executive
office)
Indicate by check mark whether the registrant files or will file annual
reports under cover Form 20-F or Form 40-F.
Form 20-F x
Form 40-F o
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101 (b) (1):
Yes o
No x
Indicate by check mark if the registrant is submitting the Form 6-K
in paper as permitted by Regulation S-T Rule 101 (b) (7):
Yes o
No x
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
Yes o
No x
If “Yes” is marked, indicate below the file number assigned
to the registrant in connection with Rule 12g3-2(b): 82- . .
Grifols, S.A.
TABLE OF CONTENTS
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2021 Investor and Analyst Day
June 3, 2021
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2021
Investor &
Analyst
Day
June 21
Disclaimer
This document has been prepared by GRIFOLS, S.A. (GRIFOLS or the “Company”) exclusively for use during the 2021 Investor and Analyst Day
on June 3, 2021. Therefore it cannot be disclosed or made public by any person or entity with an aim other than the one expressed above, without
the prior written consent of the Company. The Company does not assume any liability for the content of this document if used for different
purposes thereof. The information and any opinions or statements made in this document have neither been verified by independent third parties
nor audited; therefore no express or implied warranty is made as to the impartiality, accuracy, completeness or correctness of the information or
the opinions or statements expressed herein. Neither the Company, its subsidiaries nor any entity within the GRIFOLS group or any subsidiaries,
the company’s advisors or representatives assume liability of any kind, whether for negligence or any other reason, for any damage or loss arising
from any use of this document or its contents. Neither this document nor any part of it constitutes a contract, nor may it be used for incorporation
into or construction of any contract or agreement.
IMPORTANT INFORMATION
This document does not constitute an offer or invitation to purchase or subscribe shares, in accordance with the provisions of the Spanish
Securities Market Law (Royal Legislative Decree 4/2015, of 23 October, as amended and restated from time to time), Royal Decree 1310/2005, of
November 4, and its implementing regulations. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a
request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any other jurisdiction.
FORWARD-LOOKING STATEMENTS
This document contains forward-looking information and statements about GRIFOLS based on current assumptions and forecast made by
GRIFOLS management, including pro forma figures, estimates and their underlying assumptions, statements regarding plans, objectives and
expectations with respect to capital expenditures, synergies, products and services, and statements regarding future performance. Forward-
looking statements are statements that are not historical facts and are generally identified by the words “expected”, “potential”, “estimates” and
similar expressions.
Although GRIFOLS believes that the expectations reflected in such forward-looking statements are reasonable, various known and unknown risks,
uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or
performance of the Company and the estimates given here. These factors include those discussed in our public reports filed with the Comisión
Nacional del Mercado de Valores and the Securities and Exchange Commission, which are accessible to the public. The Company assumes no
liability whatsoever to update these forward-looking statements or conform them to future events or developments. Forward-looking statements
are not guarantees of future performance. They have not been reviewed by the auditors of GRIFOLS.
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Agenda
2021 Investor and Analyst Day
Closing 7:30pm
7:00 - 7:30pm
5:20 - 5:35pm
Environmental, Social and Governance
Thomas Glanzmann, Nuria Pascual 6:25 - 6:45pm
Finance
Alfredo Arroyo
6:05 - 6:25pm
Welcome 3:00 - 3:05pm
Introductory Remarks
Raimon Grífols
3:05 - 3:15pm
Plasma Supply and Manufacturing
Eduardo Herrero
3:15 - 3:35pm
Innovation Strategy
Albert Grífols Coma-Cros, José Terencio, Karoly
Nikolich, Joana Sàbat, Antonio Martínez
3:35 - 4:50pm
Customer Centricity
Lafmin Morgan
4:50 - 5:20pm
Break
Q&A
5:35 - 6:05pm
New Business Models
Daniel Fleta, Amarant Martínez,
Joel Abelson
Final Remarks
Víctor Grífols Deu 6:45 - 7:00pm
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2021
Investor &
Analyst
Day
June 21
Building Upon Our Core Commitments
Introductory Remarks
Raimon Grífols – Co-CEO
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2021
Investor &
Analyst
Day
June 21
2020
Grifols Proved Its Resilience and Commitment in
2020 by...
Overcoming adversity and adapting to change
Recognizing more than ever the generosity of donors for their
ongoing contribution toward enhancing people's health
and well-being
Driving our expansion plan and helping countries achieve
plasma self-sufficiency
Accelerating our efforts to innovate
Expressing our gratitude to our 24,000 employees for their
commitment and dedication
Strengthening our commitment to patients by ensuring
continuous delivery of their treatments
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2021
Investor &
Analyst
Day
June 21
The Importance of
Plasma
Strengthening Our
Fundamentals
Committed to
Sustainability
…and Doubling Our Efforts in Three Core Areas
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2021
Investor &
Analyst
Day
June 21
A Global Model of Sustainable Plasma
2020: Emphasizing the Importance of Plasma
Grifols promotes
new business models
Acquisition in
Canada
Joint Venture in
Egypt
Strategic Alliance in
China
Only 29% of countries obtain their hemoderivatives
through nationally collected plasma (WHO)
Since 2010 global plasma collections are
growing but U.S. dependency has also been
increasing (MRB)
In Europe, self-sufficiency levels short
fall by 40% (1)
1 “Plasma Flows on a Global Level: Impact and Realities in Europe” Matthew Hotchko, PhD, Marketing Research Bureau, GPS Meeting, October 28-30, 2020.
In 2019, 68% of total plasma collected comes
from U.S. (from the 57% in 2010) (MRB)
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2021
Investor &
Analyst
Day
June 21
First Scientific Journal Dedicated to Plasma Science
Plasmatology
Plasmatology aspires to become a scientific
point of reference in the field of
plasma science
It gathers all research, from basic research
to clinical application
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2021
Investor &
Analyst
Day
June 21
Efforts to Secure Plasma Supply and Promote Our Innovation Strategy
Strengthening Our Fundamentals
43+ plasma
centers
+11
+25
+7
Q4 2020
Q1 2021
Q2 2021
7+ plasma
centers
New business models
Latest plasma centers transactions
Acquisition of
remaining equity
(55%)
Q3 2020
Acquisition of
remaining equity
(56%)
Q1 2021
Enhancing Egypt’s
healthcare infrastructure
with the construction of
manufacturing installations
and 20 plasma centers
(2H 2021)
Consolidating our position
in China, a market with
tremendous growth potential
Collaborating with national health systems
to help them achieve self-sufficiency and better
serve patients
Hungary
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2021
Investor &
Analyst
Day
June 21
Global Century-Old Company Built On Strong Values and Ethical Principles
Grifols Continues Its Path of Sustainable Growth
1
16
12
5
8
3
2
Corporate Headquarters
R&D Centers
Bioscience Division
Centers
Diagnostic Division
Centers
Hospital Division
Centers
Bio Supplies
Division Centers
Industrial Facilities
4
Grifols affiliates
Presence through
distributors
Emeryville
Los Angeles
San Diego
Denver
Memphis
Clayton
Raleigh-Durham
San Carlos
South San Francisco
Leipzig
Düdingen
Melbourne
Barcelona
Murcia
Bilbao
San Sebastian
Zaragoza
Andorra
Dublin
Alliance with Shanghai RAAS
Fengxian facility
Hefei Tonrol facility
Zhengzhou RAAS
Haikang
Brazil
Montreal
Operations in 100+ countries
Subsidiaries in 30+ countries
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2021
Investor &
Analyst
Day
June 21
Reinforcing Our Governance and Sustainability Strategy
Sustainability: A Strategic Pillar
Sustainability Policy
• Establish the core environmental, social and
governance principles and commitments
in our business model
Sustainability Committee
Creation of…
• Oversee the integration of financial and
non-financial information in our ESG initiatives
… to continue driving our
sustainability strategy
Talent Pool
Commitment with Patients
and Donors
Social Impact
Environmental Responsibility
Grounded on 4 pillars
Integrated in our corporate strategy
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2021
Investor &
Analyst
Day
June 21
Accelerating the Execution of Our Expansion Plan
Plasma Supply and Manufacturing
Eduardo Herrero – President, Bioscience Industrial Group
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2021
Investor &
Analyst
Day
June 21
Plasma Operations
1
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2021
Investor &
Analyst
Day
June 21
Key Drivers to Support Further Growth
Plasma Supply: Leveraging Grifols’ Competitive Advantage
Diversification Plasma Center Capacity Business Optimization
Strategic alliances and joint
ventures to reinforce Grifols’
global expansion
Pursuit of business
excellence through technology
investments and ongoing
improvements
Sustainable plasma collection
growth and expansion with
the highest standards of quality
and safety
Strengthening a global plasma-center network to ensure plasma supply
and promote long-term sustainable growth
1 2 3
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2021
Investor &
Analyst
Day
June 21
Multilevel Strategy to Increase Plasma Supply
Plasma Supply: Leveraging Grifols’ Competitive Advantage
-15%
Despite a significant downturn in
Q2 2020 followed by a gradual
recovery, Grifols was able to limit its
plasma supply impact to 15%
Main drivers for increasing plasma supply
Diversification
Donor Center Capacity
Business Optimization
1
2
3
Grifols advances the execution of its expansion plan aimed at
expanding its plasma collections levels:
• Acquisition of plasma centers in the U.S. and EU
• Opening of new donor centers
Donations per donor center increase annually as technology
and standardization optimize processes
New Centers COVID19 2019 Acquisitions 2020 Efficiencies Recovery 2021
Volume (Liters of plasma)
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2021
Investor &
Analyst
Day
June 21
U.S. Collections vs PY20
(%)
Solid Rebound in Germany. Steady Recovery in U.S. Since April
U.S. and European Plasma Collections in 2021
U.S. Plasma
Collections
Europe Plasma
Collections
Europe Collections vs PY20
(%)
2021 baseline avg. collections
2021 baseline avg. collections
2020 baseline avg. collections
2020 baseline avg. collections
▪ Exhaustive safety measures to reduce donor fear factor have
contributed to collections recovery
▪ Global plasma awareness, acquisitions and donor marketing
and recruitment campaigns have attracted new donor profiles
▪ Plasma supply has been supported by acquisitions, new
center openings and contracts negotiations
March 31,
2021
March 31,
2021
+10-20%
FY2021E
vs. 2020A
Volume (Liters of plasma)
May 31, 2021
May 31, 2021
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2021
Investor &
Analyst
Day
June 21
Advancing the Execution of the Expansion Plan
Strengthening Grifols’ Plasma-Center Network
312
58
10
0
100
200
300
400
500
600
2016 2018 2020 2021 2022 2024 2026
171
380
520
• Execution plasma expansion plan
since 2016
• Number of plasma centers have
duplicated over the last 5 years and
continue to grow
• More than 500 centers by 2025
• Expansion and diversification
plans are ambitious and represent
one of Grifols’ main priorities in
plasma supply
• Third-party supply agreements
in the EU and U.S. to secure
additional reliable plasma source
+12% CAGR
Diversification Plasma Center
Capacity
Business
Optimization
EU plasma centers U.S. plasma centers ROW plasma centers
x2
x3
Number of plasma centers
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2021
Investor &
Analyst
Day
June 21
Plasma Centers
United States Spain
Czech Republic
Slovakia
Expanding and Diversifying Grifols’ Presence
Global Footprint to Support Sustainable Growth
Plasma Collection
190
2017
Canada
Agreements
9 locations
18 locations
~25 locations
6 locations
Diversification Plasma Center
Capacity
Business
Optimization
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2021
Investor &
Analyst
Day
June 21
Germany
China Egypt
Hungary
Italy
Agreements
~25 locations
8 locations
4 locations
11 locations
27 locations
370 plasma centers
Plasma Centers
312
7
48
3
Shanghai RAAS (26.2%):
41 plasma centers
GEPD1 (49%):
20 plasma centers
Strategic Alliances and JVs
1. GEPD = Grifols Egypt for Plasma Derivatives
Diversification Plasma Center
Capacity
Business
Optimization
Expanding and Diversifying Grifols’ Presence
Global Footprint to Support Sustainable Growth
2021
United States Spain
Czech Republic
Slovakia Canada
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2021
Investor &
Analyst
Day
June 21
Expanding and Diversifying Grifols’ Presence
Global Footprint to Support Sustainable Growth Diversification Plasma Center
Capacity
Business
Optimization
Recent Plasma Supply Transactions
43 Plasma Centers Across 13 States 7 Plasma Centers in Hungary
Grifols continues to expand and diversify its U.S.-
based plasma-center network
Leveraging mature and licensed centers leads to
an immediate increase in plasma supply
Through these acquisitions, Grifols broadens its
footprint to new states and regions
Grifols continues to expand and diversify its
access to European plasma adding plasma
centers from Hungary
This transaction strengthens Grifols’ leadership in
Europe in terms of geographic scope and use
of EU-approved plasma
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2021
Investor &
Analyst
Day
June 21
Expanding and Diversifying Grifols’ Presence
Global Footprint to Support Sustainable Growth
No plasma centers
≤ 10 plasma centers
11 to 20 plasma centers
+20 plasma centers
Plasma Centers CHINA SRAAS
Operating 270(1) 38(3)
Under Construction 20(2) 3
Total 290 41
Source: Reports released by manufacturers. Updated on Apr. 26, 2021
(1)Includes 26 branch centers; (2) includes 2 branch centers; (3) includes 1 branch center
41 centers in
11 provinces
Bolster presence in the
Middle East and Africa
Access to new sources of
plasma to reduce
dependency
on U.S. plasma
Diversification Plasma Center
Capacity
Business
Optimization
Strategic Alliance with SRAAS (closed in 2020) Joint Venture with Egyptian Government (2020)
20 plasma collection centers (1ML/year)
Manufacturing facilities:
• Fractionation plant (1ML/year Capacity)
• Purification and fill-and-finish plant
• Plasma and final-product warehouse
• Plasma and product quality control lab
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2021
Investor &
Analyst
Day
June 21
Diversification Supports Business Continuity
Global Footprint to Support Sustainable Growth
72%
13%
10%
5%
USA EU China Egypt
450 Plasma Centers1
Grifols Global Presence by 2022 Strategy
1 Includes SRAAS plasma centers and Grifols Egypt (JV)
• Global footprint and global expansion
• Diversification by:
• Opening plasma donation centers in
new countries
• Strategic alliances
• Joint ventures
• Organic and inorganic growth
• New market opportunities
• Increasing presence in the US by acquisitions
and new centers
Diversification Plasma Center
Capacity
Business
Optimization
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2021
Investor &
Analyst
Day
June 21
Digital Transformation
Leveraging Technology to Optimize Efficiencies
• Paperless donor record
• Automated manufacturing records using handheld
computing devices
• Streamlined process flows and reduction of
manual verification steps thanks to software
automation
• Labor optimization via paperless and process
automation
2020 2021 2022 2023 2024
BECS Migration
Legacy BECS New BECS
Diversification Plasma Center
Capacity
Business
Optimization
Digital Transformation Benefits
Increase business process optimization while
improving the donor experience through…
• New plasmapheresis device to decrease the
donation cycle time and increase yield
• Donor screening devices that reduce cycle time
and allow for automated data entry
Process improvements to enhance the donor
experience
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2021
Investor &
Analyst
Day
June 21
Integrated Technology to Enhance Donor Experience
Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Capacity
Business
Optimization
Donor Segmentation
• More new donors
• Increasing plasma donations
• Loyalty and satisfaction
• Diversification
• Process efficiency
• Greater awareness and
education
• Reliable and intuitive process
Benefits
Information from nearly
1 million active donors
Plasma-center personnel
engage with donors
Over 220K donors registered
in Donor Hub
+13 million emails
+100k text messages and
push notifications sent
to donors
Automated marketing
campaigns and multiple
digital and tech tools
Grifolsplasma.com
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2021
Investor &
Analyst
Day
June 21
Process Enhancement
Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Capacity
Business
Optimization
• Grifols’ own production anticoagulant
sodium citrate is being rolled out in
Grifols’ plasma-center network
• Grifols 0.9% sodium chloride is being
used in own plasma-centers network
• Plans to open concept
centers in new areas in 2021
and beyond
• Establish Grifols’ standards in
acquired centers and
increase average volume
• Grifols’ lab testing capacity aligned to support growth
(36M+ samples in 2023)
• All U.S. NAT test labs in GDS
• Efforts to optimize testing to increase yield
(2ml/donation)
• Significant reduction test turn-around times (~48 hrs)
• Academy continues to deliver virtual
programs during Covid-19
• 300+ graduates from Academy’s
leadership development program
• 19,000+ eLearnings and 30,000
training hours since the establishment
of the Academy (2009)
One Grifols Fleet Management
Talent Development Testing Optimization
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2021
Investor &
Analyst
Day
June 21
Digital Transformation
Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Capacity
Business
Optimization
• New enhanced global plasma
management system to benefit all
Grifols Plasma Logistics centers
• Process optimization and greater
efficiencies by scaling it up across
all centers
• Consolidate all plasma laboratory
screening processes into one new
corporate/global laboratory
information management system
• This global system will cover end-
to-end plasma laboratory processes
• Grifols’ own donor center
software management system
• Manages donor center activities
such as donor and unit suitability
and shipments
• Establish optimal levels of
commitment compensation
based on analytics and market
environment
• Leveraging AI tools to set an
adequate volume of plasma
donations to meet future demand
Logistics Management System Grifols Testing Lab System
Artificial Intelligence Grifols Navigation System
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2021
Investor &
Analyst
Day
June 21
Expected Improvements Derived From Business Optimization
Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Capacity
Business
Optimization
1 excludes donor commitment compensation
2019 2023
-10%
Qualified donor flow time expected to
shorten as a result of new technology
enhancements:
• Legacy BECS transitioned out
• Electronic System Appointment
• Donor visibility for upcoming
donations
Qualified Donor Flow Time
2019 2023
+6%
Average liters of plasma per centers
are increasing as a result of
technology to capture higher yield
Average Liter per Center
2019 2023
Effectiveness and efficiency
initiatives have led to a lower cost
per liter due to:
• Better balance of labor
• Efficiency gain in donor
registration process
• Paperless process
Cost per Liter1
-6%
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2021
Investor &
Analyst
Day
June 21
Leveraging Other Costs
Donor Commitment Compensation Impact
2019 2020 2021
Donor Commitment Compensation
Other Operating Costs
Diversification Plasma Center
Capacity
Business
Optimization
Cost per Liter (CPL)
Donor commitment compensation increased in 2020
to recognize donor loyalty, COVID-19 challenges and
better compete in the current plasma market
Donor Commitment Compensation
Compensation increase does not imply the same
increase on total cost due to the weight of different
drivers
Donor commitment compensation represents ~25% of
total CPL
Grifols leverages other costs in 2021 to partially offset
the donor commitment compensation levels
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2021
Investor &
Analyst
Day
June 21
Manufacturing
2
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2021
Investor &
Analyst
Day
June 21
Inventory Levels to Rebound in 2H 2021
Efficient Inventory Management Ensured Ongoing Operations
Dec-20 Dec-18 Dec-17 Dec-19 Dec-21
Thanks to strong inventory management policies,
Grifols was able to build a significant stockpile of the
main 4 proteins and plasma over the last 4 years
and partially offset the 2020 impact
This position ensures product delivery by enabling an
agile response to market variability and
uncertainties
Inventory levels are expected to grow by the end of
2021
Total Inventory in Liters
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2021
Investor &
Analyst
Day
June 21
Operations Supports Product Delivery
Strong Inventory Position and Efficient Supply Chain
Filling vials per year
2018 2017 2019 2020 2021
+4.1%
growth
• Packaging vials per year has increased since 2017
• Trend continues to show strong growth
• Filling vials per year has been on the rise since 2017
• This trend is evidence of the robust inventory
management in place
Packaging vials per year
2018 2017 2019 2020 2021
+6.2%
growth
Grifols’ Filling Operations Grifols’ Packaging Operations
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2021
Investor &
Analyst
Day
June 21
Gaining Efficiencies While Reducing Costs
Digital Transformation 2019-2023
Digital
Transformation
Electronic
Batch
Record
(EBR)
Plant
Information
(PI)
Virtual
Reality
Artificial
Intelligence
Robotic
Process
Automation
(RPA)
End-to-End
Planning
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2021
Investor &
Analyst
Day
June 21
Digital Transformation 2019-2023
2019 2020 2021 2022
Electronic Batch Record (EBR)
▪ Electronic batch record with workflow enforcement, electronic
workflow for approval of batch documentation (paperless)
Plant Information (PI)
▪ Capture information across the whole site, real-time visibility across
production lines
Virtual Reality
▪ Virtual reality to support industrial processes including training
and virtual tours
Artificial Intelligence1
▪ Application of AI-based behavioral models and supercomputing
designs to increase yield in all steps of downstream
End-to-End Integrated Planning (E2E)
▪ Supply chain improvement through coordination and automation of
the process
1External support until 2021. To start developing internal functional capability in 2022
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- 34 -
2021
Investor &
Analyst
Day
June 21
Grifols continues to reinforce its
global plasma-center network to
secure plasma supply and support
long-term sustainable growth
Grifols advances the execution of
its plasma expansion and plan
through diversified organic and
inorganic growth,
as well as optimized efficiencies
Solid recovery expected
throughout 2021
Business optimization thanks to
technology enhancements
including digitalization and a
fully integrated supply chain
Robust inventory management
has ensured essential product
deliveries and greater efficiencies
Accelerating the Execution of Our Expansion Plan
Key Takeaways
Innovation-led improvements
will drive growth of plasma supply
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- 35 -
2021
Investor &
Analyst
Day
June 21
Expanding Our Reach: Disease Management Beyond
Plasma-Derived Therapies
Innovation Strategy
Albert Grífols Coma-Cros – Chief Scientific Innovation Officer
Karoly Nikolich – Alkahest’s CEO
José Terencio – VP Innovation
Joana Sàbat – VP Bioscience Global Marketing
Antonio Martínez – President Diagnostic Scientific & R&D
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- 36 -
2021
Investor &
Analyst
Day
June 21
Accelerating Grifols’ Innovation Through A
New Leadership
1
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- 37 -
2021
Investor &
Analyst
Day
June 21
Setting Three Large Hubs
Expanding Grifols’ Global Innovation Footprint
LA, San Diego,
CA Bioscience
and Diagnostic
Research
Triangle Park,
NC
Bioscience
Barcelona, Bilbao and
Zaragoza, Spain
Bioscience and Diagnostic
Düdingen, Switzerland
Diagnostic
R&D Sites
Andorra
Immunology
Dublin
Bioscience
12
R&D sites
+30%
investment
last 3 years
1,100+
employees
€1,500M+
investment over
the last 5 years
Hub SF Area, CA
Emeryville,
San Carlos &
South San
Francisco, CA
Bioscience
and Diagnostic
Hub RTP, NC
Hub Europe
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- 38 -
2021
Investor &
Analyst
Day
June 21
A Pioneering Ecosystem to Promote Knowledge and New Opportunities
Grifols’ Therapeutic Areas and Platforms
Therapeutic Areas
Immunology
Hepatology
& Intensive Care
Neurology
Infectious
Diseases
Pulmonology
Hematology
Ophthalmology
Innovation Ecosystem
Platforms - Technologies
Immune repertoire capture and analysis Plasma Proteomics, Fractionation &
Purification
GRIFOLS
INTERNAL
RESEARCH
INVESTIGATOR
SPONSORED
RESEARCH
EXTERNAL
RESEARCH
COLLABORATIONS
INVESTED
COMPANIES
(e.g. Araclon,
AlbaJuna)
NEW
PLATFORMS
(e.g. Alkahest,
GigaGen)
STRATEGIC
ALLIANCES
Machine learning for target discovery Single-cell transcriptomics
Therapeutic target selection and validation Neuronal functional assay platform
Polyclonal recombinant expression &
manufacturing
Mammalian cell line for site-directed
integration
Antibody therapeutics Artificial Intelligence informatics
Small molecule therapeutics
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- 39 -
2021
Investor &
Analyst
Day
June 21
Integrating Internal and External Innovation
Scientific Innovation Office
Albert Grífols Coma-Cros
Chief Scientific Innovation Officer
Vicente Blanquer
VP R&D &
Regulatory affairs
Karoly Nikolich
CEO Alkahest
José Terencio
VP Innovation,
Grifols Innovation
and New
Technologies
(GIANT)
Eva Bastida
VP Scientific &
Medical Affairs
Matt Murawski
VP Bioscience/
Diagnostic
Scientific
Development
Séamus McCooey
Director Global
Intellectual
Property
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- 40 -
2021
Investor &
Analyst
Day
June 21
2020 2030
Sizable, Diversified, Steady Revenue Contribution
Grifols’ Innovation Ambition
~4%
Revenue from new product launches
Progressively incorporating
non-plasma assets to
balance our plasma portfolio
Incorporation of technological
platforms which create
synergies accelerating internal
R&D projects
Holistic approach combining
both internal and external
capabilities
Focus on therapeutic areas
Patient centricity
and beyond
20%+
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|
- 41 -
2021
Investor &
Analyst
Day
June 21
Sizable, Diversified, Steady Revenue Contribution
Grifols’ Innovation Ambition
By Product
60%
40%
2025 2015
5%
95%
Non-
plasma
Plasma
By Category By Source
35%
40%
25%
2015 2025
30%
50%
20%
60%
40%
10%
90%
2025 2015
Guidance
R&D
investment
distribution
(includes
Internal &
External)
External
Alkahest,
GIANT
Internal
• Late-stage assets synergistic
with commercial capabilities
• Early-stage assets in winning
platforms to build non-plasma
capabilities
Diversify in Non-plasma, while
keeping Plasma in the core
Accelerate investment in New
Products and Indications
R&D to move focus from LCM to
New Product/Indications
Leverage External Innovation to
build long-term capabilities in new
fields (therapeutic areas, platforms)
• Licensing in & licensing out
New
Product
Lifecycle
Mgmt.
(LCM)
New
Indication
|
|
- 42 -
2021
Investor &
Analyst
Day
June 21
Delivering A Comprehensive Pipeline to Support Our Patients
A Pipeline to Achieve a Risk-value Balanced Portfolio
Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Phase 4 /
Regulatory LCM
Immunology 2 GRI programs
1 GIGA program
rSCIG
Spike in PdIG with
enriched libraries (PID)
SCIG/IVIG
SIDs-CLL IVIG-PEG
Xembify®
Europe Xembify®
Prefilled syringes Xembify®
Bi-weekly dose
Hepatology 2 GRI programs
Albumin 20%
ACLF (APACHE)
FlexBag®
US
Albumin 5%
Decompensated
Cirrhosis (PRECIOSA)
FlexBag®
EUR
Pulmonology
Alpha-1 AT
Non-cystic fibrosis
bronchiectasis
Alpha-1 AT
15% (SC)
AAT deficiency
Prolastin-C®
EUR (SPARTA)
Prolastin®
EU 4-5gr vials
Haematology 2 GRI programs
ATIII
New indication
Fostamatinib***
AIHA indication
Fibrinogen
Acquired Deficiency
Fibrinogen
Congenital Deficiency
and severe
hypofibrinogen
Ophthalmology
/ Others
6 GRI programs
3 ALK programs
2 GIGA programs
GIGA 564
Anti-CTLA-4 Oncology
AKST4290
& DR
Fibrin Sealant
Biosurgery pediatric
Use
Infectious
Diseases
4 GRI programs
2 GIGA programs
IgM
Bacteremia
GIGA 2050
COVID-19
HIV Antibody
HIV**
GIGA 2070
COVID-19
Neurology 3 GRI programs
5 ALK programs
GRF6019
AD
ABvac40
AD
GRF6021
PD with
Dementia
AKST4290
PD
* Alkahest; ** Project of AlbaJuna (Grifols’ invested company); *** Licensed rights from Rigel Pharmaceuticals in EU and other countries
|
|
- 43 -
2021
Investor &
Analyst
Day
June 21
Caption
R&D Commercial
|
|
- 44 -
2021
Investor &
Analyst
Day
June 21
Changing the Course in Neurology
2
|
|
- 45 -
2021
Investor &
Analyst
Day
June 21
Increasing Incidence of Dementia
Dementia: A Global Challenge, a Personal Reality
>50
80
152
2021 2030 2050
x3
Dementia Incidence Worldwide
(in Million people)
Sources: WHO, Alzheimer’s Disease International, Worlds Alzheimer Report 2015, https://www.alz.org/alzheimers-dementia/what-is-dementia
1T
2T
2018 2030
x2
Dementia Total Costs
(in USD T)
Dementia involves loss of memory, language, problem-solving and other
thinking abilities that are severe enough to interfere with daily life
We are facing a global challenge to find a cure,
improve treatment, and ensure enough resources
to enable people to live well with dementia
“One of the major challenges
of our generation”
|
|
- 46 -
2021
Investor &
Analyst
Day
June 21
5th Leading Cause of Death in the World
Slowing Down Alzheimer’s Progression: An Urgent Unmet Need
Worldwide Prevalence % of Dementia Cases By Age Mortality
>35 million
>65y/o
Majority are
leading cause
of mortality
5th dementia
cases
60-70%
Accounts for
200,000
<65 y/o have
younger-onset
AD
but…
Alzheimer’s worsens over time. It is a progressive disease , where dementia symptoms
gradually worsen over a number of years
No current cure, but treatments for symptoms are available and research continues
patients
Sources: Alzheimer’s Disease International, Worlds Alzheimer Report 2015, https://www.alz.org/alzheimers-dementia/what-is-dementia
|
|
- 47 -
2021
Investor &
Analyst
Day
June 21
Seeking New Mechanisms and Agents Without Burdensome Side Effects
Slowing Down Parkinson’s Progression: An Urgent Unmet Need
Current treatments address symptoms only and late stage pipeline unlikely to change
treatments algorithm
Parkinson Disease Dementia (PDD) is a complex neurodegenerative disorder where each
patient experience different combination of motor and non-motor symptoms
Worldwide Prevalence By Gender Increasing Trend Total Costs
x1.5
Men are
more likely
Prevalence
growing
$52 billion
/year
due to aging population
and longer disease
duration
to have PDD healthcare costs in
the U.S.
>10 million
patients
Sources: Parkinson Foundation; Aarsland D, Kurz MW. The epidemiology of dementia associated with Parkinson disease. J Neurol Sci. 2010 Feb 15;289(1-2):18-22. doi: 10.1016/j.jns.2009.08.034. Epub 2009 Sep 4. PMID: 19733364
prevalence of dementi
a in Parkinson Disease
is close to
30%
|
|
- 48 -
2021
Investor &
Analyst
Day
June 21
Our Innovation Strategy in Neurogenerative Diseases (ND)
Holistic Approach to These Urgent Unmet Needs
Diseases
Mechanism of
Action (MoA)
Products
Strategy Focus
Understanding the molecular basis of ND
and those related with aging
Antibody, small molecules, RNA-based drugs,
plasma-derived drugs, etc… to be developed
according to the validated therapeutic target
Disease-modifying therapies
Treating symptoms
vs.
|
|
- 49 -
2021
Investor &
Analyst
Day
June 21
Plasma Fractions &
Small Molecules Plasma Proteome Chronokines
Our Innovation Strategy in Neurogenerative Diseases (ND)
R&D Efforts Covering the Whole Development Path
Discovery Clinical Development Programs
Understanding of plasma at the
molecular level in healthy and
disease states
Expanding a pipeline of
therapeutic plasma fractions,
small molecules, antibodies
Explore therapeutic benefit of
plasma proteins in a wide range
of CNS1 disorders
Discovery of Chronokines
proteins with biological
impact changing with age
Active
Immunotherapy
GRF-6019
Proprietary plasma fraction
inducing neurogenesis
2 clinical programs
in AD and PD patients with
dementia in phase II
ASKT-4290
Small molecule,
antagonist of CCR3
in PD patients in phase II
Abvac40
vaccine against Ab40
Placebo-controlled AB1601
trial in 120 very early AD and
MCI2 patients in phase II
Two Pillar Strategy
Plasmapheresis
Albumin replacement +
1 Central Nervous System; 2 Mild Cognitive Impairment
Remove toxic moieties from
systemic and brain compartments
Restore pharmacological
properties of Albumin
Reference
centers
GRF-6021
|
|
- 50 -
2021
Investor &
Analyst
Day
June 21
The Language of this Communication Encodes Health and Disease
Plasma Is the Body’s Highway of Communication
We Apply Rigorous, Innovative Science to
Derive Breakthrough Therapeutics from Plasma
The Balance in Plasma Proteins Determines
Growth, Tissue Homeostasis, Apoptosis
|
|
- 51 -
2021
Investor &
Analyst
Day
June 21
We Are “Molecularizing” Plasma
Plasma Is a Rich Source of Proteins With Therapeutic Potential
We identify proteins in plasma that
regulate vital functions in aging and
disease
We have gained an unprecedented
Understanding of Plasma Fractions
1 2 3 4 Whole
Plasma Fraction
|
|
- 52 -
2021
Investor &
Analyst
Day
June 21
Cutting Edge
Functional Readouts
Cohort &
Plasma
Fraction
proteomics
Integration with AI
and bioinformatics
Single cell
transcriptomics Multi Organ MoA ‘omics
Neurology
Ophthalmology
Frailty
Opportunistic
Baseline 14 21 28 35 42 49
0
2
4
6
8
10
12
14
P
a
w
W
i
t
h
d
r
a
w
a
l
T
h
r
e
s
h
o
l
d
(
g
)
Mechanical Allodynia (Von Frey)
Sham
Vehicle
PF
rh Albumin
Days post CCI
***
**** **** ****
CCI
treatment
**
****
**** **** **** ****
Imaging
Behavior
Understanding Plasma at a Molecular Level
Our Research Platform
Platform Protein Validation Indication Specific Validation
|
|
- 53 -
2021
Investor &
Analyst
Day
June 21
Innovation From Deep Analysis of the Plasma Proteome
Plasmatology
7597 proteoforms
Treatment Treatment
Treatment Treatment
0.5
- 0.5
0
1000s of Proteins Across
Aging & Diseases
Alzheimer’s disease treatment with
plasma protein fraction
|
|
- 54 -
2021
Investor &
Analyst
Day
June 21
Decoding Causal Relations of Disease Processes
Molecular Choreography of Aging and Disease
|
|
- 55 -
2021
Investor &
Analyst
Day
June 21
Proteomics Lead the Way to Disease Mechanisms
Unprecedented Knowledge Base for Plasma-Derived Therapeutics
Plasma Fractions &
Small Molecules
Best-in-class Plasma
Proteomics
Most extensive profiling (>10,000
proteins) of healthy aging and
diseases
Mass spectrometry, multiple array
technologies
Differentiation between multiple
diseases states (>60)
Increased interpretability of
diseases by clustering
Alzheimer’s Disease Associated Proteins
|
|
- 56 -
2021
Investor &
Analyst
Day
June 21
Novel Therapeutic Candidates From Plasma
Plasma Fraction Improves Parkinson’s Disease Dementia
Dosing 1
Visit
s
5 daily
doses
5 daily
doses
Visit
s
End of
Study Baseline
Dosing 2
• Dementia associated with Parkinson’s disease
• Randomized placebo-controlled study
• Two dosing periods of Plasma protein fraction
Study Design
Results
Cognitive functions improved
Statistically meaningful differences between
Plasma Fraction and Placebo
Safety and tolerability of dosing paradigm
favorable
Effect size superior as compared with currently
used cognitive enhancer agents
GRF6021: D-KEFS Letter Fluency Improvement
I
m
p
r
o
v
e
m
e
n
t
2.8 2.6
3.2
5.3
St udy Drug
DKEFS Difference From Placebo Across Various
Studies From Baseline to Week 24
Rivastigmine Donepezil 5mg Donepezil 10mg GRF6021
Rivastigmine1 Donepezil Donepezil GRF6021
5mg2 10mg2
Superior Cognitive Effect to Standard of Care
Improvement
1 Schmitt FA, Farlow MR, Meng X, Tekin S, Olin JT. Efficacy of rivastigmine on executive function in patients with Parkinson's disease dementia. CNS Neurosci Ther. 2010;16(6):330-336. doi:10.1111/j.1755-5949.2010.00182.x; 2 Dubois B, Tolosa E, Katzenschlager R, Emre M, Lees AJ, Schumann G, Pourcher E, Gray J,
Thomas G, Swartz J, Hsu T, Moline ML. Donepezil in Parkinson's disease dementia: a randomized, double-blind efficacy and safety study. Mov Disord. 2012 Sep 1;27(10):1230-8. doi: 10.1002/mds.25098. Epub 2012 Aug 22. PMID: 22915447
|
|
- 57 -
2021
Investor &
Analyst
Day
June 21
Functional Improvements in Cognition and Daily Activities
Plasma Fraction Improves Mild-to-Moderate Alzheimer’s Disease
Dosing 1
Visit
s
5 daily
doses
5 daily
doses
Visit
s
End of
Study Baseline
Dosing 2
• Mild to Moderate Alzheimer’s Disease (MMSE 12-24)
• Two doses: 100mL and 250mL GRF6019
• Two dosing periods of Plasma protein fraction
Study Design
Results
Cognitive and daily activity functions improved
Safety and tolerability of two doses (100mL and
250mL per day for 5 days) favorable
Cognitive and functional improvements supported
by large number of preclinical mechanistic studies
Additional placebo-controlled studies will be
required
• ADAS-cog 11 change
from baseline
• Comparison to
historic controls
• Activities of daily
living (ADCS-
ADL23) change
from baseline
• Comparison to
historic controls
Analysis of plasma fractions ongoing
|
|
- 58 -
2021
Investor &
Analyst
Day
June 21
Plan to Open Reference Centers to Gather RWD1 on Alzheimer’s Disease
Moving Forward With the AMBAR Project
1 Real World Data
Based on current AMBAR data of Plasmapheresis + Albumin replacement
Objectives Sites
To implement current AMBAR treatment in
selected centers
To create Real World Data (RWD) to
produce Real World Evidence (RWE)
To test the model prior to a wider spread
Barcelona
Fundació ACE
Site in operation Next candidate countries
|
|
- 59 -
2021
Investor &
Analyst
Day
June 21
Moving Forward With the AMBAR Project
|
|
- 60 -
2021
Investor &
Analyst
Day
June 21
Advancing Care in Immunology
3
|
|
- 61 -
2021
Investor &
Analyst
Day
June 21
18%
30%
52% PID
SID
Others
IG Replacement Therapy as the Mainstay Treatment for PID and SID Patients
Primary and Secondary Immunodeficiency Driving IG Demand
IG Use by Indication
1 MRB 2018: Analysis of Ig market in the U.S. 2018 and Forecast to 2025: 2 Bousfiha et al. Primary Immunodeficiency Diseases Worldwide: More Common than Generally Thought. J Clin Immunol. 2013; 33:1-7; 3 Internal Estimate ; 4 Chronic Lymphocytic Leukemia
PID and SID make up
48% of IG usage1
2018-2025 CAGR by Indication (IG volume)3
9.3%
5.6%
6.4%
8.1%
9.4%
8…
9.5%
6.2%
7.1%
8.6%
6.0%
PID CLL 4 Other
conditions
Underdiagnosed
by 50% 2
Strong growth in PID/SID, derived from increasing awareness and
broader risk identification for PID diagnosis and new SID indications
<10% eligible CLL patients
receive IG therapy
*
*SID to underlying disease or treatment
*
|
|
- 62 -
2021
Investor &
Analyst
Day
June 21
0
10.000
20.000
30.000
40.000
50.000
60.000
70.000
80.000
CLL is the Fastest Growing Patient Segment for IG Therapy
Expanding IG Replacement Therapy to Thousands of CLL Patients
U.S. CLL Patients Forecast 4
(in Thousands)
+12%
CLL patients prescribed IG therapy expected to grow
significantly
HGG1 occurs in up to 85% of
patients with CLL (due to
malignancy itself and/or treatment)2,3
mortality >60%
Associated with a high rate of infections
that account for
Program to include both IVIG and
SCIG for CLL SID U.S. indication.
Unique for SCIG
Opportunity to add clinical evidence to
differentiate IG portfolio in markets
with approved SID indications
1 Hypogammaglobulinemia; 2 Friman V et al. Hematol Oncol. 2016;1-12: doi 10.1002/hon.2323 [Epub ahead of print]; 3 Seppänen M. Clin Exp Immunol. 2014;178(Suppl 1):10-13; 4 Internal data
Expected launch: 2026
|
|
- 63 -
2021
Investor &
Analyst
Day
June 21
Offering CLL Patients Flexibility in Site of Care
High Market Potential for Gamunex® and Xembify® in CLL
https://www.lls.org/facts-and-statistics/facts-and-statistics-overview/facts-and-statistics
CLL
38%
Leukemia Cases
~4%
of IG sales
262m
>1bn
2021 2031
x4
U.S. CLL IG Market Potential
(in €)
U.S.
Leukemia
Prevalence
376,508
|
|
- 64 -
2021
Investor &
Analyst
Day
June 21
Offering a Better Home Treatment Experience
Improving Flexibility and Convenience
Xembify® Pre-filled Syringes Xembify® Biweekly Dosing
Ease of use and time-saving process
Accurate pre-measured dosing
Reduces medical supply waste
Offering broader administration options provides a greater opportunity for treatment
satisfaction and patient empowerment, which may support high levels of patient compliance
Expected launch: 2023 Expected launch: 2024
Ideal for self-administration (manual push) and
compatible with infusion pumps
Potentially helping to reduce medication errors
Faster infusion rate (60ml/h)
Adds flexibility with new dosing regimen option
Potential improvement in patient quality of life
Opportunity to individualize dosing frequency
|
|
- 65 -
2021
Investor &
Analyst
Day
June 21
Smart Pump System
Advancing Towards Cutting-Edge Delivery Systems
Opportunity to leverage digital health platform to improve patient outcomes
Improving IVIG & SCIG home infusion
treatment experience
Simplify the infusion process, improve
ease of use, and add mobility/freedom
Bluetooth connectivity to an
app/dashboard
Superior features over disposable
wearable devices
Expected launch: 2023
|
|
- 66 -
2021
Investor &
Analyst
Day
June 21
Shaping Cirrhosis Management in
Hepatology
4
|
|
- 67 -
2021
Investor &
Analyst
Day
June 21
Our Cirrhosis Management Perspective
Combination of Acute Treatment and Long-Term Albumin Use
1 Internal estimates; 2 Acute on chronic liver failure; 3 Volk et al. Hepatol. Comm. VOL. 4, NO. 8, 2020
Decompensated Cirrhosis
>14.5 million
High prevalence
patients1
Quality of life is
often poor
High burden for
patients, caregivers
and society
Total Costs
>$9.5 billion
/year in the U.S.3 Liver transplant is the
only procedure
available today to avoid
further complications and
death
Grifols extensive research and
clinical program with innovative
Albumin treatment approaches
offers opportunities to patients by
slowing disease progression and
bridging for liver transplant
Resolution Regression
2
Multiple organ
failure
+
Systemic
inflammation
|
|
- 68 -
2021
Investor &
Analyst
Day
June 21
Our Innovation Strategy in Hepatology
Shaping the Future of Albumin
1 Vincent JL et al. Crit Care. 2014;18(4):231; 2 Garcia-Martinez R et al. Hepatology. 2013;58(5):1836-46; 3 Costa M et al. J Alzheimers Dis. 2018;63(4):1395-404; 4 Caraceni P et al. Lancet. 2018; 5 Boada M et al. Alzheimers Dement (N Y). 2019;5:61-9; 6 Laleman W et al. Can J
Gastroenterol Hepatol. 2018;2018:1027152
Albumin’s therapeutical potential
Key discoveries in understanding
Albumin is
widely used as a
volume
replacement/
expander fluid as
a volume
replacement/
expander fluid1
Albumin is
shown to be
altered in
disease2,3
Albumin infusion
shows clinical
improvement in
decompensated
cirrhosis4
Investigations
into albumin’s
potential use as
a drug in
complex
diseases are
underway
Plasma Protein
Replacement
with albumin
may provide
benefits across
different
diseases5,6
Most abundant protein in the body
Albumin
Focus of investigation
for more than 15 years
and MoA
Concept of albumin as a pharmaceutical
with a multifactorial Mechanism of
Action
Clinical & non-clinical program
to understand Albumin’s role in health and disease
these investigations…
(focusing in hepatology and other
diseases like Alzheimer)
|
|
- 69 -
2021
Investor &
Analyst
Day
June 21
More Than Just a Volume Expander
Exploring the Full Potential of Albumin
1 Biere AL et al . J Biol Chem. 1996;271:32916–32922; 2 Colombo G et al. Antioxid. Redox Signal. Dec 2012.1515-1527.http://doi.org/10.1089/ars.2012.4702; 3 Casulleras M et al. Sci. Transl. Med. 2020; Vol. 12, Issue 566, eaax5135
Most abundant
protein
(Plasma & CSF)
Maintains
intravascular volume
Immunomodulatory
effects3
Main extracellular
antioxidant
Free radical scavenger2
Main transporter
(fatty acids, drugs,
metabolites, metals, Aβ1)
|
|
- 70 -
2021
Investor &
Analyst
Day
June 21
Its Function Correlates With Clinical Outcomes in Advanced Cirrhosis
Albumin Acts as a Multi-Target Disease-Modifying Agent
Sources: Horrillo et al. J. Hepat. 73:S756; The International Liver Congress. August 25-28 2020 ; Horrillo et al. The international Liver Congress. June 23-26 2021 (Abstract accepted); Oettl et al. J Hepatol. 2013 Nov;59(5):978-83; Baldassarre, et al. Hepatology 2021 Mar 12
* Decompensated
Cirrhosis & ACLF
Baseline Along Treatment
[Alb]
Alb transport
Alb oxidation
Alb glycation
Disease
severity
Albumin
treatment
[Alb]
Alb transport
Alb oxidation
Disease
severity
|
|
- 71 -
2021
Investor &
Analyst
Day
June 21
Albumin Treatment at Different Stages of Cirrhosis
Extensive Clinical Program
Resolution Regression
LTA1 with Albumin 20%
(hyperoncotic) Plasma Protein
Replacement plus
Albumin 5%
3
Advanced chronic liver
disease (10-35y)
Compensated
cirrhosis
(10-15y)
Decompensated
cirrhosis
(2-4y)
ACLF
(30 day)
Transplant or
death
Multiple organ
failure
+
Systemic
inflammation
Translational
research
1 Long-Term Albumin Use
|
|
- 72 -
2021
Investor &
Analyst
Day
June 21
Prevention of Mortality in Subjects With Decompensated Cirrhosis and Ascites
PRECIOSA Study: LTA Admin. to Revert Cirrhosis Progression
Phase 3 1:1 Randomized
Open label International /
Multi-center
410 subjects
with decompensated cirrhosis
and ascites (12 months follow-up)
SMT
SMT + Albumin 20%
(1,5g/kg bw every 10 ± 2 d)
~40 participating centers • Est. study end (LPLV): Q1 2023
• Recruitment update: 129 subjects randomized (31%)
Centers and Countries
U.S., Canada, Belgium, Denmark, France, Germany, Italy,
Spain and UK
Status (Apr 2021)
|
|
- 73 -
2021
Investor &
Analyst
Day
June 21
ALADDIN Study: Understanding Disease Pathogenesis and PE-A 5% MoA
APACHE Study: Bridging Therapy to Liver Transplant
Remove endogenous / exogenous toxic
substances and damaged albumin
Plasma Protein
Replacement
Therapeutic 5% Albumin
Improvement of Albumin
levels and anti-oxidant
and transport functions
Effects of Plasma Protein Replacement with Human Serum Albumin 5% (PE-A 5%) on Short-term
Survival in Subjects with "Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality
Design Centers Status (Apr 2021)
Ph3, 1:1 randomized,
multicenter, open label enrolling
380 ACLF subjects (90 days
FU): SMT vs SMT + PE A-5%
40 centers from US and 8 EU
countries
• Est. study end (LPLV): 2Q
2022
• Recruitment update: 109
subjects randomized (29%)
Translational research project supporting
Apache, aim to provide key insights on ACLF and
Albumin MoA
N = 250 patients from EU participating in APACHE
(59 randomized (24%), April 2021)
Mechanism of systemic
inflammation, organ
failure and ACLF in
cirrhosis
PE A-5%
mechanism
of action in
ACLF
|
|
- 74 -
2021
Investor &
Analyst
Day
June 21
Long-Term Albumin Use
Capturing the Opportunity in Cirrhosis
1 Healthcare Practitioners; 2 Decompensated cirrhosis with ascites and treated by specialist excluding 20% of patients receiving HCV treatment
Global Opportunity
>14.5 million
patients
8-10% target
target population2
If ONLY 10% of patients
were treated based on
PRECIOSA protocol
+15%
of current
Albumin
market >€400
million
2 out of 3 HCP1
likely to prescribe LTA to
prevent decompensations
according to ANSWER study data
(Market research 2020)
Improved overall
survival by +38%
Reduced cost of
hospitalization
Positive impact
on quality of life
Total %
Adoption
Innovator
s
Early
Adopters
Early
Majority
Late
Majorit
y
Laggards
Progressive adoption
expected as new
evidence is provided
key for LTA wide adoption
x
x
Acute use Chronic use
x100
x100 higher albumin
consumption with
Preciosa Protocol
compared to acute uses
|
|
- 75 -
2021
Investor &
Analyst
Day
June 21
Thriving Against Infectious Diseases
5
|
|
- 76 -
2021
Investor &
Analyst
Day
June 21
Permanent Threat of Emerging Pathogens Calls for Developing New Therapies
Leverage Our Learnings From Prior Efforts
Emerging Infectious Diseases (EID)
Deaths
813 284 812
11,325
76
3,530,58
2
SARS Influenza A
H1N1
MERS EBOLA ZIKA SARS-CoV-2
2002-2003 2009-2010 2012 2014-2016 2015 2019-2021
1Journal of Physiological Anthropology volume 39, Article number: 29 (2020); 2 https://www.who.int/csr/sars/country/2003_07_11/en/; 3The Lancet Infectious Diseases, 12(9), 687-695. doi:10.1016/S1473-3099(12)70121-4; 4 https://www.ecdc.europa.eu/en/middle-east-respiratory-
syndrome-coronavirus-mers-cov-situation-update; 5https://www.cdc.gov/vhf/ebola/history/2014-2016-outbreak/index.html; 6https://apps.who.int/iris/bitstream/handle/10665/204348/zikasitrep_5Feb2016_eng.pdf;jsessionid=2E8C110C039D151C1EE6B384A9F064A8?sequence=1; 7WHO
The number of deaths from outbreaks recorded in the last
two decades shows the big impact of infectious disease
Issue of global concern as incidence has
increased dramatically in recent years
Transmission and spread at an
unprecedented speed influenced by
human-related factors1
Globalization
Climate change
Human-wild animal interface
Antimicrobial resistance
Host susceptibility
Behavior changes
|
|
- 77 -
2021
Investor &
Analyst
Day
June 21
Our Innovation Strategy in Infectious Diseases: Passive Immunization
Plasma and Recombinant Polyclonal Immunoglobulins Platforms
Address diseases caused by
unmet and emergent pathogens
Focus on development of
products to boost the
immune system
IgM
Polyclonal
hyperimmune
globulins
against specific
pathogens
Technological platforms 2
Plasma polyclonal
hyperimmunes from
convalescent or vaccinated
donors
1
Recombinant
polyclonal hyperimmunes using
GigaGen technology
2
GIGA-2050
Anti-COVID-19
first polyclonal recombinant
hyperimmune to be tested in humans
2 (IV and SC)
Anti-COVID-19
to be used in prophylaxis or early
diagnosed patients
|
|
- 78 -
2021
Investor &
Analyst
Day
June 21
Leveraging Our Capabilities to Fight Against an Emergent Pathogen
Plasma Polyclonal Hyperimmunes Platform: Anti-COVID-19
Platform built from our vast experience in developing immunoglobulins from
selected donors against specific pathogens
10% Hyperimmune globulin IV
INSIGHT 012/OTAC
Study to evaluate its Safety and Efficacy in non-
hospitalized patients with COVID-19
Non-hospitalized patients age ≥ 55
with COVID-19 who have had COVID-
19 symptoms ≤ 5 days
Target population
C19-IG
Study to evaluate the safety and efficacy in infected
asymptomatic ambulatory outpatients
Ambulatory Asymptomatic patients
with confirmed SARS-CoV-2 infection
Target population
20% Hyperimmune globulin SC
|
|
- 79 -
2021
Investor &
Analyst
Day
June 21
Boost a Novel Method to Generate a Wide Range of Immunoglobulins
Recombinant and Polyclonal Hyperimmunes: GigaGen Platform
Keating et al., Nature Biotechnology, 2021
Capture Immune repertoire
=
x Trillions
Patented microfluidics,
molecular biology, and
cell engineering
processes
Unlimited quantities of
the new class of
therapeutic can be made
from a few donors with
potent antibody
responses
Donors can be
humanized mice,
vaccinated donors, or
convalescent donors
Antibodies can be
engineered for high
potency, immune
effector activity, long
half-life
Re-create
|
|
- 80 -
2021
Investor &
Analyst
Day
June 21
>12,000 Anti-Coronavirus Antibodies Captured From 16 Convalescent Donors
GIGA-2050 Allows Clinical Validation of the GigaGen Platform
Live SARS-CoV-2 Virus Neutralization
Drug product has 100-
fold higher potency
than convalescent
plasma from the same
donors
Clustergram of Antibody Sequence Diversity
Manufacture as a recombinant monoclonal antibody
(rMAB), regulatory framework generally followed standard
rMAB
Acute monkey toxicity study showed no drug-related
events at the highest dose tested (475 mg drug / kg body
weight)
IND reviewed by FDA with no clinical holds
First dose in Phase I clinical study: enrollment ongoing
Enrichment for neutralizing antibodies
Sorting for binders to SARS-CoV-2 RBD, and removing
antibodies that don’t bind, reduces diversity but enriches
neutralizing titer
|
|
- 81 -
2021
Investor &
Analyst
Day
June 21
Commitment With Society and the World, Preparing for Future Challenges
Grifols, in the Fight Against Pandemic
as vaccination progresses
number of COVID-19 new cases is expected to
be significantly reduced
in developed economies with massive access to vaccines
Vaccination is still
well below
herd immunity targets
(25% of US population
won’t be vaccinated*)
>14 million
new COVID-19 cases
in 2022
Not all countries have broad access to vaccines
COVID-19 is devastating in countries like India
New variants
that might become resistant to vaccines
Grifols is committed to
society to keep working
to bring new therapies
Source: KFF Covid-19 vaccine monitor: KFF COVID-19 Vaccine Monitor Dashboard | KFF
|
|
- 82 -
2021
Investor &
Analyst
Day
June 21
Ophthalmology: Expanding Into a
New Therapeutic Space
6
|
|
- 83 -
2021
Investor &
Analyst
Day
June 21
Entering Into a New Therapeutic Space
New Avenues for Research in nAMD and Diabetic Retinopathy
Neovascular Age-Related Macular Degeneration (nAMD) Diabetic Retinopathy (DR) 2
Leading cause of blindness aged >60
Expensive & burdensome
Current treatment: Intra-Vitreal Injections (IVT)
Significant challenges
Treatment cost
Not all patients respond to treatment
Frequent office visits
Poor adherence due to complex drug regimens
1
2
3
4
Outcomes are well
below RCTs1
in real world practice
1 Randomized Controlled Trial; 2 Joseph M. Coney, MD Am J Manag Care. 2019;25:S311-S316
x1.6
>400 M
629M
2021 2045
Diabetes Prevalence Most common
microvascular
complication of
Diabetes
3.2 million
estimated to be visually impaired
as a consequence of DR
Early detection
and treatment prevent 50%- 70%
of its associated blindness
|
|
- 84 -
2021
Investor &
Analyst
Day
June 21
Potent CCR3 Inhibitor for Multiple Therapeutic Indications
AKST4290: Blocking Eotaxin-Mediated Inflammation
200
150
100
50
0
Protein Level
20 40 60 80 Age (years) 0
Increased in Age & Disease Normalization of Inflammatory &
Immunomodulatory Cascades
Decreased Infiltration of Immune
Cells (macrophages, t-cells,
eosinophils)
Reduced microgliosis
Downregulated Inflammatory
Cytokines
In Eosinophils, Endothelial
cells, T cells & Monocytes
Chronokine Target: Eotaxin Receptor (GPCR): CCR3 Therapeutic Treatment: AKST4290
|
|
- 85 -
2021
Investor &
Analyst
Day
June 21
Addressing AMD and Diabetic Retinopathy
Blocking Eotaxin-CCR3 Signaling Reduces Retinal Inflammation
Eotaxin/CCR3 Binding increases
Choroid
Bruch’s
RPE
Sclera
Photoreceptors
VEGF TNFa/ IL17 … Immune Cell Macrophage Microgliosis Eosinophil Eotaxin Bound CCR3
Membrane Permeability/Degradation
Heightened Neuroinflammation
& Neurodegeneration
Immune Cell Recruitment
Cytokine Upregulation
|
|
- 86 -
2021
Investor &
Analyst
Day
June 21
New Insights Into the Pathology of Eye Diseases: Cytokines and Immune Cells
AKST4290 Reduces Inflammation in the Eye
2020
Inflammatory Proteins from Circulating Plasma Accumulate in the Eye
Vehicle
NaIO3
NaIO3+4290
0
2
4
6
8
MIG/CXCL9
p
g
/
m
L
***
***
*
Vehicle
NaIO3
NaIO3+4290
0
1
2
3
RANTES/CCL5
p
g
/
m
L
*** **
***
Vehicle
NaIO 3
NaIO 3
+4290
0
4000
8000
Myeloid Cells
#
C
e
l
l
s
****
***
*
***
Vehicle
NaIO 3
NaIO 3
+4290
0
500
1000
1500
2000
Monocytes
#
C
e
l
l
s
****
****
**
Vehicle
NaIO 3
NaIO 3
+4290
0
50
100
150
200
Neutrophils
#
C
e
l
l
s
****
****
**
Vehicle
NaIO 3
NaIO 3
+4290
0
50
100
150
200
250
CD4+ T cells
#
C
e
l
l
s
****
**** ****
AKST4290 Reduces
Inflammatory Proteins and
Infiltrating Immune Cells in
the Eye
|
|
- 87 -
2021
Investor &
Analyst
Day
June 21
nAMD Patients Treated With Oral AKST4290
Positive Phase 2a in Age-Related Macular Degeneration
Naïve patients (201) Mean (Median) N (%)
Overall BCVA Gain +7.0 (8) 29 (100%)
“Responders”
≥5 Letter BCVA Gain +14.9 (11.5) 16 (55%)
≥10 Letter BCVA Gain +17.3 (15.5) 12 (41%)
≥15 Letter BCVA Gain +23.2 (22) 6 (21%)
RPE-DH Change -79.3 (31) 19 (66%)*
CST Change -13.9 (-4) 29 (100%)
* 19 of 29 subjects with RPE Detachment
Change in BCVA from Baseline
Strong improvement in Best Corrected Visual Acuity: similar to standard of care aVEGF1 injections into the eye
Oral agent a substantial advancement compared to the high treatment burden of current intravitreal aVEGF
1 Vascular Endothelial Growth Factor
|
|
- 88 -
2021
Investor &
Analyst
Day
June 21
An Oral Treatment Would Be Highly Desirable
Diabetic Retinopathy: A Major Unmet Medical Need
• CAPRI: A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants
with Moderately Severe to Severe Diabetic Retinopathy
• N = 80; Randomization = 1:1 (AKST4290 400 mg BID: placebo to match); at 25 US sites
• Dose = 400mg BID (orally) for 24 weeks treatment
• Rationale: AKST4290 improved vision in AMD patients and may also have a similar effect in DR
• Anti-inflammatory activity of the compound would slow or block the progression of the pathology of DR
Manifestations of DR Characteristics and Progression of DR
Phase 2 study in Diabetic Retinopathy (DR) with AKST4290
|
|
- 89 -
2021
Investor &
Analyst
Day
June 21
Entering a Large and Growing Market
Meeting the Challenge and Addressing the Opportunity
Source: Global data, nAMD and DR Global Drug Forecast and Market Analysis
Neovascular Age-Related Macular Degeneration (nAMD) Diabetic Retinopathy (DR)
$5.3 billion
$7.9
billion
2018 2025
1.5x
Continues to increase
due to advancing age of
the general population
>1.5 million
treated
$3.6 billion
$8.6
billion
2019 2029
2.4x
>3.2
need treatment
million
A preventive
treatment could
reach an even
broader
population
Data from US, EU4, UK and JP
Data from US, EU4, UK, JP, Australia and China
|
|
- 90 -
2021
Investor &
Analyst
Day
June 21
Continuous Developments in Diagnostics
7
|
|
- 91 -
2021
Investor &
Analyst
Day
June 21
Proteins
Diagnostics R&D Areas of Focus
DG Gel
Multicard
Drug Interference Solution
Immunohematology
New Antisera development
New gel card DG Gel DC Scan Plus testing
Extended phenotyping
Kit to resolve daratumumab interference for
cancer patients
Immunoassays for donor screening
Ultrasensitive SMC Assays in development
Discriminatory Multiplex: HIV/HCV, HBsAg
HBcore
Syphilis
Chagas
CMV
HTLV
HBsAg
Confirmatory
High throughput analyzer in development
SARS CoV2 Antibody Test CE Marked
Promonitor – Biological Drug Monitoring
Clinical Diagnostics
Promonitor Quick Anti-IFX & IFX
Promonitor Quick Anti-ADL & ADL
Grifols Portfolio (internal customers)
CDMO Opportunities (external customers)
Recombinant Proteins
Screening/Diagnostics Therapeutics
• IAs for Donor Screening
• Immunohematology
• Alkahest
(Neurodegeneration)
• Biosciences (SARS-
CoV2)
|
|
- 92 -
2021
Investor &
Analyst
Day
June 21
Recombinant Protein Excellence in Microbial and Mammalian Systems
Contract Development & Manufacturing at Grifols, Emeryville
Molecular and process design to
make novel proteins
Continually expanding and adding new capabilities…
Process development and
optimization to improve yields and
generate efficiencies
Material production for toxicology,
formulation studies, clinical trials
and GMP commercial production
Research
Development
Production
• New Pilot Plant for scale-up and GxP material production
• New hosts to expand options in mammalian and yeast expression
• New single-use equipment for fermentation and purification
Combining the Chiron legacy of
recombinant expression innovation
with Grifols quality and excellence
Assay development to
support new medicines
Current Active Projects
Orphan drugs
Vaccines
Wound healing
Therapeutic enzymes
Broad Range of Services for Therapeutic
and Diagnostic Projects
|
|
- 93 -
2021
Investor &
Analyst
Day
June 21
Nucleic Acids
Diagnostics R&D Areas of Focus
Lab Automation
Other New Procleix® Assays
New Multiplex Procleix® Assays
NAT Donor Screening
Panther ART: to support greater lab
automation and efficiency
Improved middleware
Babesia assay: CE Marked (Jan 2021)
Plasmodium assay: in development
UltrioPlex® E assay
ArboPlex® assay
|
|
- 94 -
2021
Investor &
Analyst
Day
June 21
New Solutions to Enhance Testing Efficiency and Blood Safety
New Multiplex Assays for NAT Blood Screening
Assays on Procleix® Panther system recently launched or under development
Procleix® UltrioPlex E assay: results for 5 viruses into single reaction:
HIV-1, HIV-2, HCV, HBV, and HEV
Procleix® ArboPlex Assay: results for 5 arthropod-borne viruses (or “arboviruses”)
into a single reaction: West Nile, Usutu, chikungunya, dengue, and Zika viruses
Other multiplex assay concepts in feasibility
Multiplex format offers significant advantages to both customers and Grifols
Increases laboratory efficiency:
• Same labor and instrument needs for delivery of more results faster
• No need to manage multiple assay kits; reduction in waste (tips/other disposables
and liquid waste)
Increases production efficiency by combining manufacturing operations
HIV-1 HIV-2
HCV HBV
HEV IC
|
|
- 95 -
2021
Investor &
Analyst
Day
June 21
Nucleic Acids
Diagnostics R&D Areas of Focus
Lab Automation
Other New Procleix® Assays
New Multiplex Procleix® Assays
NAT Donor Screening
Panther ART: to support greater lab
automation and efficiency
Improved middleware
Babesia assay: CE Marked (Jan 2021)
Plasmodium assay: in development
Ultrio® Plex E assay
ArboPlex® assay
Clinical Diagnostics
Infectious Diseases
Procleix® SARS-CoV-2 assay
|
|
- 96 -
2021
Investor &
Analyst
Day
June 21
SARS-CoV-2
Procleix® Panther System
Procleix® SARS-CoV-2 Assay Developed in <3 Months
Grifols Diagnostics Rapid Response to Pandemic
Highly sensitive and specific detection of SARS-CoV-2 RNA
Over 10 million tests manufactured in San Diego
Test is widely used in select EU under license agreement and U.S. markets
CE marked: May 2020
Assay runs on fully automated Procleix® Panther system
Among most sensitive EUA NATs according to results from testing FDA
SARS-CoV-2 Reference Panel
EU1: as an aid in diagnosis of COVID-19 (respiratory specimen testing)
US: organ/tissue donor screening to support transplant safety
Grifols’ employee testing
1 Under a license agreement with a third party
Our ultra-high sensitivity and long experience in donors testing allows
testing in pools of samples improving efficiency
|
|
- 97 -
2021
Investor &
Analyst
Day
June 21
Collaboration Made SARS-CoV-2 Assay Project a Success!
LA, San Diego,
CA Bioscience
and Diagnostic
Research
Triangle Park,
NC
Bioscience
Barcelona, Bilbao and
Zaragoza, Spain
Bioscience and Diagnostic
Düdingen, Switzerland
Diagnostic
R&D Sites
Andorra
Immunology
Dublin
Bioscience
Hub SF Area, CA
Emeryville,
San Carlos &
South San
Francisco, CA
Bioscience
and Diagnostic
Hub RTP, NC
Hub Europe
|
|
- 98 -
2021
Investor &
Analyst
Day
June 21
Nucleic Acids
Diagnostics R&D Areas of Focus
Lab Automation
Other New Procleix® Assays
New Multiplex Procleix® Assays
NAT Donor Screening
Panther ART: to support greater lab
automation and efficiency
Improved middleware
Babesia assay: CE Marked (Jan 2021)
Plasmodium assay: in development
UltrioPlex® E assay
ArboPlex® assay
Clinical Diagnostics
Infectious Diseases
Procleix® SARS-CoV-2 assay
Specialty/Genetic Testing
Development of GRIFOLS Genetic
Service for A1AT Deficiency
testing, direct to patients (Over-
The-Counter)
|
|
- 99 -
2021
Investor &
Analyst
Day
June 21
Gain FDA Clearance for AlphaID™ at Home
Expanding AlphaID™ Testing to OTC Consumer Program
Order online AlphaID™
at Home
Use AlphaID™ At Home
Saliva Collection Kit at
home
Ship saliva
collection device
with collected
sample to lab
Access report online via
secure patient portal
Over-the-Counter (OTC) Innovative Solution to expand the U.S. screening program
The OTC At Home Service is in the design and development stage
AlphaID™ At Home Genetic
Health Risk Service Website
AlphaID™ At Home Saliva
Collection Kit
A1AT Genotyping Test
for OTC
Genetic Health Risk
Service Result Report
|
|
- 100 -
2021
Investor &
Analyst
Day
June 21
User Comprehension Study Overview
AlphaID™ at Home Genetic Health Risk Service
Two rounds of interviews
• Pilot study of stage 4
• Representing U.S population
Educational module
5 Types of reports
• 4 batches of 10 individuals
• Retrospective think-a-loud
interviews
• Michigan area
• Online interviews
(pandemia)
Stage 4:
• 100 individuals x report
• Representing U.S population
comprehension score
for each domain
Purpose
Results
Limitations
Next Steps
x
Feb 20 Dec 20 Nov 19 May 21
Ad Board FDA Presub
≥90%
Stage 1 Stage 2
Jul 21
Stage 3 Stage 4
Refine Result Reports to
improve comprehension
Test Result Reports &
Questionnaires
Finalize Result Reports &
Comprehension Study Protocol
80 interviews
125 interviews
User Comprehension
Study
500 interviews
|
|
- 101 -
2021
Investor &
Analyst
Day
June 21
Accelerate Diagnosis to Stop Genetic Emphysema’s Progression
Our Goal Remains Firm
is helping to accelerate diagnosis and is
the basis for innovative testing strategies
>850,000
tests
performed
>190,000
deficient patients
found
Grifols WW Testing Program
>15,000
severe patients
diagnosed
>90%
Alpha-1 patients
remain undiagnosed
|
|
- 102 -
2021
Investor &
Analyst
Day
June 21
Self-Testing Will Provide Benefits for Patients and HCPs
Continuous Developments in Alpha-1 Diagnosis
Allows for further developments that
would accelerate testing by better
addressing customers needs
Maximize DTC
campaigns potential
Enable
Telemedicine related
tools
Reduce Alpha1
screening workload
Facilitate familiar
screening
Self-Testing, Multiple Benefits
Patients HCPs
Empower
COPD
patients
Simplify Alpha-
1 Dx process
|
|
- 103 -
2021
Investor &
Analyst
Day
June 21
For Selected Projects
Market Size Opportunity
Product Indication Market Size
Immunology SCIG / IVIG SIDs-CLL
Hepatology Albumin
ACLF
LTA Cirrhosis
Pulmonology Alpha-1 AT Non-CF Bronchiectasis
Haematology
Fostamatinib AIHA
Fibrinogen Acquired Deficiency
ATIII New indication
Ophthalmology
/ Others
HIV Antibody HIV
AKST4290 nAMD & DR
GIGA 564 Anti-CTLA-4 Oncology
Infectious
Diseases
IgM Bacteremia
GIGA2050 COVID-19
Neurology
GRF6019 Alzheimer’s Disease
AKST4290 Parkinson’s Disease with Dementia
ABvac40 Alzheimer's’ Disease
GRF6021 Parkinson’s Disease
(each)
(each)
(each)
0-500M
USD
500-1,000M
USD
1,000-3,000M
USD
>3,000M USD
|
|
- 104 -
2021
Investor &
Analyst
Day
June 21
New leadership and governance
to effectively foster and support
breakthrough innovation
Executing on our Innovation
Strategy within and outside the
plasma space to achieve a more
risk-value balanced portfolio
Strengthening pipeline in
Diagnostic across the value chain
and new diseases
Focus on high prevalence and
transformational therapies that
meet global challenges with huge
untapped potential
Exploring large opportunities on
plasma: sharpen focus on CLL;
shaping cirrhosis treatments and
accelerating alpha-1 diagnostic
Expanding Our Reach: Disease Management Beyond Plasma-Derived Therapies
Key Takeaways
Transforming disease management
in Neurology, Ophthalmology and
Infectious Diseases through
innovative platforms led by
Alkahest and GigaGen
|
|
- 105 -
2021
Investor &
Analyst
Day
June 21
Showing Strength and Successfully Managing
Adversity
Customer Centricity
Lafmin Morgan – Chief Commercial Officer
|
|
- 106 -
2021
Investor &
Analyst
Day
June 21
Patients
Elective procedures still
remain 15% below 2019
levels1
Diagnosis visits remain
12% below 2019 baseline,
generating a -3,8% gap in
Px1
Sources: 1 IQVIA data published April 2021; 2 IQVIA data published September 2020; 3 Hospital finances in 2021: 10 things to know (www.beckerhospitalsreview.com)
Healthcare
Providers
Total prescriptions
recovering compared with
2020 (+6%)1
Biopharma in-person
patient visits were up 17%
in March’21 with all
specialties increasing1
Commercial
Interactions
Perceived value of 1-1 VC
vs. in-person has fallen; both
Specialists and PCPs now
want more in-person1
Total Biopharma details
increased 13% in March’21
rising to 93% of baseline1
Hospitals &
Institutions
Lab testing (all settings)
still below 20192
The pandemic could cause
U.S. hospitals to face
between $53 billion and
$122 billion in revenue loss
this year3
Short-Term Impacts Continue in 2021, but Receding
Pandemic Impact on Healthcare
|
|
- 107 -
2021
Investor &
Analyst
Day
June 21
Patients Are Facing Additional Challenges
Pandemic Impact on Healthcare
Alpha-1 patients PID/SID patients ITP patients COVID-19 patients
Patients at increased risk of COVID-19 severe illness
coping with additional challenges on top of their conditions…
Isolation and
Uncertainty Therapy administration
Follow up and
monitoring: labs tests,
follow up visits. Etc.
|
|
- 108 -
2021
Investor &
Analyst
Day
June 21
Providing Support, Bringing New Therapies and Looking for New Solutions
Pandemic Impact on Healthcare
Alpha-1 patients PID/SID patients ITP patients COVID-19 patients
Patient Support Programs
(US, EU and LATAM)
Home Infusion
AlphaIDTM in patient
hands
Xembify® launch in the US
Continuous support to
patients groups
Launch of Tavlesse® just
after COVID-19 wave 1
Development and launch
of TMA in <3 months
R&D of therapies to fight
against COVID-19
|
|
- 109 -
2021
Investor &
Analyst
Day
June 21
Contributions from new products
4,050
4,318 4,487
5,099
5,340
2016 2017 2018 2019 2020
(EUR in millions)
>50% revenue growth
2020
Increasing Our Revenues in This Extraordinary Context
Demonstrating Resilience and Commitment to Sustainable Growth
|
|
- 110 -
2021
Investor &
Analyst
Day
June 21
Contributions From New Products >50% of Revenue Growth in 2020
Continue Introducing Innovations to Address Customer Needs
ULTRIO PLEX E
FlexBag
• New flexible
container to
complement vials
and broaden
Grifols offering to
customers
• US launch in 2021
|
|
- 111 -
2021
Investor &
Analyst
Day
June 21
Bioscience
1
|
|
- 112 -
2021
Investor &
Analyst
Day
June 21
Revenues Reach EUR 4,241M With a 8% CAGR
Robust Demand and Launch of New Products Bolster Bioscience
6.8% 7.9% 8.0%
8.9% 7.5%
2016 2017 2018 2019 2020 2020
40 consecutive quarters
Sustained Quarter over
Quarter growth for more than
(Sales and % growth vs. PY)
1 Growth at constant currency
|
|
- 113 -
2021
Investor &
Analyst
Day
June 21
Long Term Trends
Continue to Support the Return
to Strong Growth
|
|
- 114 -
2021
Investor &
Analyst
Day
June 21
Accelerate Diagnosis and Stopping Genetic Emphysema’s Progression
Pulmonology: Our Goal Remains Firm
is helping to accelerate diagnosis and is
the base for innovative testing strategies
>850,000
tests
performed
>190,000
deficient patients
found
Grifols WW Testing Program
>15,000
severe patients
diagnosed
>90%
Alpha-1 patients
remain undiagnosed
|
|
- 115 -
2021
Investor &
Analyst
Day
June 21
NIH Estimates 500,000 Undiagnosed PIDD Patients in the US1
Immunology: The First Step to Help Patients is Diagnosis
1 Modell V. Immunol Res. 2007;38(1-3):43-47; 2. Routes J, et al. J Clin Immunol. 2016;36:450-461. 3Boyle JM, Buckley RH. J Clin Immunol. 2007;27(5):497-502; 4 French MA, Tangye SG. J Infect Dis. 2019;jiz230. doi:10.1093/infdis/jiz230;
5 Bonilla FA, et al. J Allergy Clin Immunol. 2015;136(5):1186-1205.e1-78
Grifols is uniquely positioned to leverage our expertise in IG replacement therapy and
diagnostics to improve the rate and time to an appropriate PIDD diagnosis
~250,000
1:1200 3
diagnosed with PIDD
~400
genetic defects
responsible for PIDD2
Incidence of
1 in 2000
live births5
Important burden
for the healthcare
system1
Undiagnosed PIDD
$102,736
Diagnosed PIDD
$22,696
Average PIDD diagnosis still takes 12.4 years2
DIAGNOSIS
|
|
- 116 -
2021
Investor &
Analyst
Day
June 21
Significant Room to Continue Helping Patients with SIDs
Immunology: SID Market Keeps Growing
1 US PPTA Distribution Data;; 2 Friman V et al. Hematol Oncol. 2016;1-12: doi 10.1002/hon.2323. [Epub ahead of print]; 3 Seppänen M. Clin Exp Immunol. 2014;178(Suppl 1):10-13.
SID: Secondary Immune Deficiency (not an FDA approved indication in the U.S.)
Chronic Lymphocytic Leukemia (CLL) and Hypogammaglobulinemia (HGG)
2018 2025
Grifols has a clinical
development plan for HGG
and CLL, as part of our
continued commitment to
SIDs patients
CLL
38%
Most common type
of leukemia in adults
Infections are major cause of death in 25% to 50% of patients with CLL3
HGG occurs
in up to 85% of
patients
at some point (due to malignancy itself
and/or treatment)2,3
SID market continues to grow in
hematological malignancies and beyond
NEW USES AND INDICATIONS
Driven by…
Increased use of SID-inducing medication in
both oncological and autoimmune indications
Extended survival rates of cancer patients
|
|
- 117 -
2021
Investor &
Analyst
Day
June 21
The Use of Albumin in Liver Disease Will Become a Key Growth Driver
Intensive Care and Hepatology
Sources: Internal data
2019 Albumin Category Use
Hepatology
22%
Albumin use in Hepatology (%)
>50%
highest albumin consumption per capita
Italy
driven by Albumin Chronic use adoption in decompensated cirrhosis
There is no treatment for decompensated
cirrhosis other than liver transplant
NEW USES AND INDICATIONS
|
|
- 118 -
2021
Investor &
Analyst
Day
June 21
IgG per Capita Consumption Growth in the Coming Years
Immunology and Neurology
Sources: MRB & International use
Raising awareness on PIDD
diagnosis and treatment
Growing uses and
indications in SIDs
2013-2020 per capita consumption (g/000 Population) for top markets worldwide
Global IgG average per capita
consumption is still far from
reaching its full potential
EXPANSION
0
50
100
150
200
250
300
350
2020 2013
|
|
- 119 -
2021
Investor &
Analyst
Day
June 21
Xembify® sees growth in Q1 2021 through an accelerated base of patients and
prescribers, paving the way for continuity and further adoption in 2021
Aiming to Meet the Large, Unmet Medical Need in PIDD
Xembify®, Expanding Grifols IG Portfolio
Nov-19
Dec-19
Jan-20
Feb-20
Mar-20
Apr-20
May-20
Jun-20
Jul-20
Aug-20
Sep-20
Oct-20
Nov-20
Dec-20
Jan-21
Feb-21
Mar-21
Xembify® U.S. Sales Volume Since Launch
10-15% of Grifols global
IG sales will be Xembify®
Sources: Internal data
2025
of Xembify®
prescribers
continue to
prescribe
Prescribers
Dec
2020
Mar
2021
90%
Patients
Dec
2020
Mar
2021
of Xembify®
patients that
start, continue
treatment
85%
NEW PRODUCTS
|
|
- 120 -
2021
Investor &
Analyst
Day
June 21
Continue to Bring New Therapies for Chronic ITP Patients*
Pandemic Has Not Been an Obstacle
Sources: Internal data; * ITP Patients who are refractory to other treatments; 1 Price and Reimbursement ; 2 Health Technology Assessment
Tavlesse® has been successfully launched in Q3 2020 in UK and Germany
Tavlesse® GER Sales Volume since Launch
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9
Achieved targets
through to Q1 2021 for
UK and Germany
Continuing
P&R1 process
in Germany
Continuing HTA2 and
subsequent
reimbursement in UK
Launch timelines in
progress for further 8
EU countries in
Q3 and Q4 2021
NEW PRODUCTS
|
|
- 121 -
2021
Investor &
Analyst
Day
June 21
Addressing Customer Needs
Strengthening Our Market Position
|
|
- 122 -
2021
Investor &
Analyst
Day
June 21
In the face of increasingly tough competition
(SCIG products) years ago we committed to
keep outperforming
Delivering on Our Promises
Maintaining 2nd Market Position in IVIG and IVIG+SCIG Market
Sources: Internal data
Grifols IVIG growth vs. SCIG + IVIG
market growth (‘15-’19)
We maintain our
2nd Market
position in
the IVIG market and
even considering the
IVIG + SCIG market
Xembify® launch and customer centric
developments will allow us to keep strengthening
our market position
(in Million grams)
CAGRs
166 184 199 213 232 249
0
50
100
150
200
250
300
0
5
10
15
20
25
30
35
40
45
50
2015 2016 2017 2018 2019 2020
Total Market IVIG+SCIG Grifols
|
|
- 123 -
2021
Investor &
Analyst
Day
June 21
Our Solid Customer Centric Mindset is Key
Alpha-1 Strong 70% Market Share Despite of Years of Competition
Sources: Internal data
Reliable Supply Patient Support Testing Continued
Innovation
A strong customer centric mindset has permitted Grifols to
improve market share in the middle of the global pandemic
Alpha-1 antitrypsin Market 2020
>70%
Grifols
Grifols, the Global Alpha-1 leader, was ready to immediately put
in place all efforts thus guaranteeing therapy to patients
Important Alpha-1 product shortage from
competitor in Q4’20 - Q1’21 challenged
treatment continuity of hundreds of
patients in EU during pandemic
Sustained and reliable product supply
|
|
- 124 -
2021
Investor &
Analyst
Day
June 21
Our Solid Customer Centric Mindset is Key
Alpha-1 Strong 70% Market Share Despite of Years of Competition
Reliable Supply Patient Support Testing Continued
Innovation
Patient disease management programs
provide personalized care and home
infusion, a vital resource during COVID-19
Ensuring treatment continuity with
Home Infusion services
Supporting beyond treatment…
Psychological
support
Virtual
monographic
trainings on
“new normality”
Virtual
meetings with
HCPs and other
patients
A strong customer centric mindset has permitted Grifols to
improve market share in the middle of the global pandemic
|
|
- 125 -
2021
Investor &
Analyst
Day
June 21
Our Solid Customer Centric Mindset is Key
Alpha-1 Strong 70% Market Share Despite of Years of Competition
Reliable Supply Patient Support Testing Continued
Innovation
2018
AlphaID™
Cheek Swab
2013
Alphakit®
QuickScreen
1991
Finger stick
dry blood spot
We offer multiple Alpha-1 testing
solutions, addressing different customers
needs when they more need it
Alphakit™ online
orders grew
significantly in
2020
AlphaID™
approved to be
used in patients
hands under HCP
supervision (Spain)
A strong customer centric mindset has permitted Grifols to
improve market share in the middle of the global pandemic
|
|
- 126 -
2021
Investor &
Analyst
Day
June 21
Novel Partnership Journey to Build on Complementarity
&
2016
First meeting
between
Grifols &
Ethicon
Successful wet
lab testing of
VeraSeal®
Agreements
signed
2017
VistasealTM
U.S. market
launch
2019
2020
VistasealTM U.S.: Launch
completed
VistasealTM – OUS launch
2nd Ethicon Plasma
Protein - FDA approval
Globalization of
VeraSeal ®
2021
2018
Joint product/project
development work
continues
2022
VistasealTM launches
complete
Fibrin Sealant capacity
expansion
|
|
- 127 -
2021
Investor &
Analyst
Day
June 21
Diagnostic
2
|
|
- 128 -
2021
Investor &
Analyst
Day
June 21
Sustainable Growth Over the Last 5 Years
The Diagnostic Division Reported €776M Over 2020
-3.9% 6.8% 0.7%
1.1% 7.3%
2016 2017 2018 2019 2020
(Sales and % growth vs. PY)
2020
Strong resilient businesses
COVID-19 TMA test addressing a
medical emergency
Grifols continues to extend
partnerships with top customers
in the world (Korean Red Cross)
|
|
- 129 -
2021
Investor &
Analyst
Day
June 21
Plasma Testing Poised for Strong Growth
Global Leader in Blood Donor Screening
We are converting all
Grifols testing locations to
Procleix® Instruments and
Assays
Recent plasma center
acquisitions fueling growth
prospects 36M people impacted
every minute*
200+
Source: Internal Data; * Does not include plasma collections
Blood donations tested
donations tested
every minute with
a Procleix® assay*
70+ Plasma donations
|
|
- 130 -
2021
Investor &
Analyst
Day
June 21
Our Innovation Strategy Delivering on the Future Needs of Transfusion Patients
Milestones and Innovations for Our Customers
Panther® Art Ultrio® Plex E Babesia Menu Expansion
HEV
HIV-1
HIV-2
HBV HCV
ARBOVIRUSES
ZIKA WNV
CHIKUNGUNYA
DENGUE USUTU
PLASMODIUM
Complement Tests
|
|
- 131 -
2021
Investor &
Analyst
Day
June 21
Making an Impact in Blood Banks Operation
Customer Value Marketing – UltrioPlex E
Hepatitis E virus (HEV) is one of
the leading causes of acute viral
hepatitis worldwide
HEV-RNA screening of
blood donations implemented
in eight EU countries
Incidence of HEV infection
in Europe over 10 years
has grown by ten times
20M
HEV INFECTIONS
WORLDWIDE
48%
Reduction of
NAT Tests
40%
Free Floor
Lab Space
8%
Faster Release of
Results
40%
Free Floor
and Save Costs
45%
Free-up Lab Staff
50%
Gain Storage
Space
48%
Reduce
Environmental Impact
45%
Reduction of Lab
Staff Costs
40%
Save Energy
48%
Go Green
and Save Costs
|
|
- 132 -
2021
Investor &
Analyst
Day
June 21
Strong Resilience in Spite of a Global Pandemic
Laying the Foundation to Become a Leader in Immunohematology
Execution based on main pillars 4
Sales force
expansion
Customer
centric focus
Manufacturing
footprint
Portfolio
enhancement
Market share
growth
Focus
particularly after
sales support
Manufacturing
capacity for
strategic markets
R&D focus to
enhance the portfolio
of instrument and
reagents
|
|
- 133 -
2021
Investor &
Analyst
Day
June 21
Continuous Success Across All Customer Segments With Highest Customer Loyalty
Execution Focused on Customers Continues to Fuel Growth
Instruments placements
700+
Erytra-Eflexis®
Since launch on Q2 2017
Opportunities
180+
Opportunities
Won in 2020
Customer retention rate
+96%
Erytra-Eflexis®
Since launch on Q2 2017
Competitive conversions
+55%
Comprehensive Portfolio
|
|
- 134 -
2021
Investor &
Analyst
Day
June 21
Hospital
3
|
|
- 135 -
2021
Investor &
Analyst
Day
June 21
COVID-19 Challenges Impacted Performance With a Few Important Exceptions
Weathering the Storm in 2020
Hospitals have been significantly
impacted by COVID-19 driving decline in
Hospital Division revenues in 2020
Pharmatech business was impacted with
complex projects being delayed. As a
result, Pharmatech revenue declined
11.8% in 2020 after two consecutive
years of strong double digit growth
MedKeeper Sales
PharmacyKeeper achieved strong
growth in 2020
57.0%
47.6% 10.0%
21.0%
2017 2018 2019 2020
(Sales and % growth vs. PY)
|
|
- 136 -
2021
Investor &
Analyst
Day
June 21
Providing Life-Sustaining Products and Technology for Patients
and Pharmacy Solutions During the Pandemic
*KLAS Category Leader for IV Workflow Management five consecutive years
We remain a leader for IV Fluids in Iberia, helping to ensure
hospitalized patients receive needed sterile IV solutions
Grifols rapidly implemented medication control technology in new
treatment centers deployed during the outbreak in Spain
In the U.S., 93,000 compounded sterile preparations are made every
day with the help of PharmacyKeeper
When significant logistical challenges arose for distributing vaccines
within hospitals PharmacyKeeper enhanced its industry award
winning* IVWF software, to help optimize dispensing for patients
|
|
- 137 -
2021
Investor &
Analyst
Day
June 21
Bio Supplies
4
|
|
- 138 -
2021
Investor &
Analyst
Day
June 21
Successful Business Expansion Over the Last 4 Years
Bio Supplies Diversifies the Revenue Base
(Sales and % growth vs. PY)
206% -20%
41%
47%
67%
2016 2017 2018 2019 2020 2020
Vertical Integration supporting
Grifols divisions
Become a leading supplier of
Biological Materials for the IVD
Industry
Provide additional value to Grifols
products
|
|
- 139 -
2021
Investor &
Analyst
Day
June 21
Building the Pillars to Assure Excellence in Long-Term Partnerships
Bio Supplies Commercial Grows by Double Digits
Biopharma Diagnostic
Provide additional value to Grifols
proteins in niche markets
Vertical integration for Diagnostic IH by supplying blood
components as raw material while providing additional
value to non-suitable for fractionation plasma
Several companies
using Grifols excipients
in clinical trials
High growth expectations driven by…
New industry
applications for current
portfolio
New products
|
|
- 140 -
2021
Investor &
Analyst
Day
June 21
Grifols grew in 2020, with 50%
contribution to growth from
new products and achieving
40 consecutive quarters
growing QoQ
Long-term trends remain
robust for Bioscience
Customer and patient
centricity has allowed us to
be prepared for the future
Demonstrated ability to
succeed in competitive
markets
Bio Supplies is a growing
high-margin business,
significantly contributing to the
development of new drugs and
products
Showing Strength and Successfully Managing Adversity
Key Takeaways
Long-term trends also
support growth in
Diagnostic and Hospital
divisions
|
|
- 141 -
2021
Investor &
Analyst
Day
June 21
Grifols is Uniquely Positioned to Help Patients and HCPs Along All the Way
Grifols, Along the Journey
190k+
AATD diagnosed
patients worldwide
7/10
blood donations in N.A
are tested using systems
and assays developed by
Grifols Diagnostics
Commitment
with patients with
decompensated liver
cirrhosis
of CIDP patients
rely on Grifols
25%
|
|
2021 Investor and Analyst Day
June 3, 2021
|
|
- 143 -
2021
Investor &
Analyst
Day
June 21
Advocating Patients' Needs Through a
Sustainable Global Plasma Model
New Business Models
Daniel Fleta – Chief Industrial Officer
|
|
- 144 -
2021
Investor &
Analyst
Day
June 21
Global Dependency on U.S. Plasma
18,613
5,634
7,619
296 520
46,254
12,131
9,134
686 165
North America Latin America Asia Pacific Middle
East/Africa
Europe
+149%
+115%
+20%
+132% -68%
2010 2019
Source: MRB 2019 Global Blood & Plasma Collections Report
(in M Liters)
North
America
57%
North
America
68%
2010 2019
U.S. plasma collections are increasing at a faster rate than the global market
|
|
- 145 -
2021
Investor &
Analyst
Day
June 21
The U.S. Leads Global Plasma Collections
Sources: “UN World Population Prospects 2019 Data Booklet”; “Plasma Collections 2019” and “MRB 2019 Global Blood & Plasma Collections Report.”
Calculation from “Protecting Access to Immune Globulins for Canadians: Final Report of the Expert Panel,” Health Canada, 2018.
Population (M)
Plasma Collections
(M L/year)
37.7 0.3 8.8 Canada*
331.0 45.9 138.7 U.S.
112.8 5.2 46.1
100.3 -- Egypt
1,433.8 8.9 6.2 China
Liters per 1,000
population
Austria, Czechia,
Germany, Hungary
Rest of Europe 634.3 3.9 6.1
|
|
- 146 -
2021
Investor &
Analyst
Day
June 21
Global Dependency on U.S. Plasma
2018 IgG Plasma Usage vs. Plasma Collected (millions of liters)
Plasma collections Internal demand
41.8
26.6
+57%
15.2
14,5
Internal demand
14.5
Plasma collections
9.0
-38% 5.5
Plasma
surplus:
Plasma
shortage
Reliance on the U.S. to meet demand
United
States
European
Union
Source: “Plasma Flows on a Global Level: Impact and Realities in Europe,” Matthew Hotchko, PhD, Marketing Research Bureau, GPS Meeting, October 28-30, 2020.
If current landscape remains unchanged, the plasma surplus will grow in the U.S.
while deficits will increase in other regions, particularly in Europe
|
|
- 147 -
2021
Investor &
Analyst
Day
June 21
Higher Demand for Plasma Driven by Healthcare Systems
Development, New Indications and Higher-Prevalence Diseases
Diagnosis and prescriptions
are increasing
Other indications
Albumin – Alzheimer’s and Cirrhosis
Ig – Secondary Immunodeficiencies (i.e.
Oncology)
Fight emerging virus i.e. Ebola, COVID-19
*Total Prevalence calculations over 5,360,680 World Population >18years – Source UN World Population Prospects 2019_DataBooklet.
1 World Federation of Haemophilia; 2 Grifols patient counts (last update 10MAY2020): assume 50% of patients diagnoses receive treatment based in market knowledge and affiliate input. COPD Prev 10-18%. COPD, Diagnosis 10-50%; 3 Burden of Cirrhosis on Patients and Caregivers, 2020; ;
4 National Institute of Allergy and Infectious Diseases. Primary immune deficiency diseases (PIDDs). niaid.nih.gov/diseases-conditions/primary-immune-deficiency-diseases-PIDDs Accessed June 30, 2020; 5 https:/ww.who.int/news-room/fact-sheets/detail/sepsis
Worldwide Prevalence*
Coagulation Factors
• Hemophilia
• Von Willebrand disease
Hematology
+1.1M People with
Haemophilia1
Immunology & Neurology
Immunoglobulins
• Exposure to rabies, tetanus,
hepatitis A / B
• PIDD - Primary immunodeficiency
disease
• CIDP - Chronic inflammatory
demyelinating polyneuropathy
+6M People with
PIDD4
Albumin
• Chronic liver disease & cirrhosis
• Sepsis
• General and cardiac surgery
• Others including plasmapheresis, burns
Cirrhosis & Sepsis
+14.5MPeople with
cirrhosis3
Alpha-1
• Alpha-1-antitrypsin deficiency
Pulmonology
+185k People with
severe AATD2
+49M People with
sepsis5
|
|
- 148 -
2021
Investor &
Analyst
Day
June 21
Exceptional Synergies to Unlock the Potential of Strategic Projects
Grifols Value Proposition for Plasma Self-Sufficiency Projects
Tech.Transf. & EPCM Capabilities
Grifols Engineering
Local Presence, Global Reach
Unique Approach to Geographies
• Geographically focused strategy
• Partners as diverse as needed: Private
or public sector
• China Affairs Office: a successful model
Patients at the Core
Safety & Quality Long-term Partner
• Commitment to patients extending
access to plasma therapies worldwide
• Products quality and safety are in the
foreground built on the solid foundation
of a reliable plasma supply
• Comprehensive portfolio of products
and instruments to ensure quality; from
plasma testing solutions to DC
consumables manufacturing
• Multidisciplinary and highly qualified
team providing complete turnkey
solutions from conceptual design to
facility management and operation
• Proprietary technology development
• Optimization of CAPEX and control of
cost, timing and quality
Agility & Flexibilty Know-how Commitment & Reliability
|
|
- 149 -
2021
Investor &
Analyst
Day
June 21
Clearing the Path Towards Self-Sufficiency
Egypt
Daniel Fleta – Chief Industrial Officer
|
|
- 150 -
2021
Investor &
Analyst
Day
June 21
Median Age
Population growth
2 M/year
GDP growth
3.6%
Egypt at a Glance 2020
25
45
40
EU Egypt US Source: Egyptian Ministry of Planning and development
102 million inhabitants
12.0
29%
23.5
57%
5.6
14%
IVIG Albumin Pd FVIII
2019 Plasma Derived
Products Market value
Source: MRB THE PLASMA PROTEINS MARKET IN EGYPT 2019
$m Revenues
|
|
- 151 -
2021
Investor &
Analyst
Day
June 21
• Identification of plasma-
derivatives as a strategic
asset for the country
• Improve Egypt’s
healthcare system
Grifols Engineering, Industrial and Quality Expertise Offer a Unique Opportunity
Strengthening Egypt’s Healthcare System and Self-Sufficiency
• Know-how and technology
• Operations management
• Quality and safety
• Training
Strategic alliance
between Grifols and
the Egyptian
government will help
the country attain self-
sufficiency of plasma-
derived medicines
and enable market
expansion in the
Middle East
and Africa
Benefits
Free up plasma and
manufacturing
capacity
Additional plasma
procurement sources
Expansion
opportunities in other
territories
(Africa, Saudi Arabia, Kuwait, Qatar,
Bahrain, United Arab Emirates, Oman, Iraq,
Jordan, Lebanon, Syria and Yemen)
Grifols will have total management oversight for the design and
construction of facilities, operations, quality and safety to guarantee self-
sufficiency of world-class plasma products
Egypt
|
|
- 152 -
2021
Investor &
Analyst
Day
June 21
Egyptian Plasma-Center Network
|
|
- 153 -
2021
Investor &
Analyst
Day
June 21
October 6th Plasma-Donor Center
Plot area: 5,100 m²
• Paved area: 2,763 m²
• Green area: 500 m²
• Footprint main bldg.
and ancillary: 1,836 m²
Scope
Donor center, plasma testing labs, plasma freezers warehouse,
Grifols Academy for Plasmapheresis and plasma ops. offices
|
|
- 154 -
2021
Investor &
Analyst
Day
June 21
Green city:
Max. 40% bldg.
60% green field
Medical City Development Plan in New Capital City
Egyptian Manufacturing Site
New Capital City Highlights
Fully digitalized &
connected to
Industrial Zone
Size 170,000 Acres
|
|
- 155 -
2021
Investor &
Analyst
Day
June 21
Manufacturing Site Location
Capacity 1 Million
Liters of Plasma (expandable)
Fractionation, purification and fill-and-finish of:
• Coagulation factors
• Gammaglobulins
• Albumin
Scope
Plasma logistics center, labs, vivarium, R&D, common
areas, warehouses, utilities and manufacturing plants
|
|
- 156 -
2021
Investor &
Analyst
Day
June 21
Side View
Manufacturing Plant
322,500m3
m3 27,000
8,500Tn
105,000 m2
|
|
- 157 -
2021
Investor &
Analyst
Day
June 21
Global plasma collections are
growing but the U.S.
dependency is also
increasing
Higher demand of PDMP
due to healthcare systems
development, better diagnosis,
new indications and clinical
trials to treat high-prevalence
diseases
Free up plasma and
manufacturing capacity
to serve other growing markets
Egypt offers growth potential
as a fast-growing and
developing nation and
leading regional supplier to
the Middle East and Africa
Grifols Industrial through
Grifols Engineering is
uniquely poised to offer
cutting-edge turnkey solutions
Clearing the Path Towards Self-Sufficiency
Key Takeaways
Clear willingness of the
Egyptian government to set
a legislative framework
that promotes the viability and
sustainability of this project
|
|
- 158 -
2021
Investor &
Analyst
Day
June 21
Progressing on Our Strategic Alliance Under a
Successful New Business Model
China
Amarant Martínez – VP China Affairs Office
|
|
- 159 -
2021
Investor &
Analyst
Day
June 21
At the Forefront of Global Health Spending
Great Potential on a 10-Year Horizon
USA
46%
China
18%
Germany
Japan
France
RoW
25%
3%
3%
5% 42%
35%
10%
17%
2020 2030
9.3
+1.9 T
USD Tr
16.9
+2.1 T
+3.7 T
CAGR20-30
+11.4%
+4.5%
+6.2%
China
US
World
USD 27.3 billion
Plasma Protein Market in 2019 Global Health Spending: 2020 vs. 2030
China is the only country expected to achieve
double-digit growth over the next 10 years
Source: Grifols Global Plasma Database (excl. recombinant) and Fitch Solutions.
|
|
- 160 -
2021
Investor &
Analyst
Day
June 21
244 246
256 263
210
230
250
270
290
310
330
350
370
390
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
2017 2018 2019 2020
Collections SRAAS
Collections ex-SRAAS
Plasma centers
41 plasma centers
38 plasma centers +
3 under construction
(2 centers opened in last 6 months)
Limiting Plasma Collections Impact to -2.0% vs. -9.3% of the Industry
SRAAS Successfully Weathered COVID-19
Source: Reports released by listed manufacturers 2020. Internal Analysis.
14.4%
Others
+100 bps vs 2019
Plasma Collections by Company in 2020
#2 in China
Overall Industry Plasma Collections (‘000L)
China continues working
towards self-sufficiency
as a long-term objective 7,833
8,388
8,949
8,113
We expect a steady
increase of registered
donors and number of
plasma centers
Ongoing reforms to ease
restrictions on household
registration (Hukou) has
the potential to expand
donor base
CNBG
CBPO
Hualan
Pac.
Shuanglin
Boya +6.9% -9.3%
-2.0%
|
|
- 161 -
2021
Investor &
Analyst
Day
June 21
263 287 327
393 411 465
535
620
2013 2014 2015 2016 2017 2018 2019 2020
Leveraging Our Capabilities to Become Leaders in Albumin and IG
Sustained Double-Digit Growth Adds USD 500M+ Each Year
Albumin (tons) IG (tons)
+13.0%
MNCs1
Domestic
1 Multinational corporations; 2 Market share; Source: Institutes of Food and Drug Control.
+15.9%
+20.8% +27.5%
pdFVIII (M IU) Fibrinogen (kg)
+11.7% +14.6%
+25.0% +60.3%
113
167 152
218
267
339 334
2013 2014 2015 2016 2017 2018 2019 2020
426
32.9% 1
(+80.7% YoY)
35.7% 1
(+60.5% YoY)
147 178
252
483 471 445 436
2013 2014 2015 2016 2017 2018 2019 2020
699
16 18
22
28 27 26
30
2013 2014 2015 2016 2017 2018 2019 2020
35 16.8% 2
(+73.3% YoY)
5.1% MS2
2
(+20.2% YoY)
13.8%
(+42.8% YoY)
|
|
- 162 -
2021
Investor &
Analyst
Day
June 21
Integrated commercial platform
Direct-to-customer model
Control of sales flow and channel
Agility Seamless operational transition
completed with NO supply disruption
From Third-Party Distribution Model to Strategic Partnership With Leading Manufacturer
Bioscience Commercial Platform Under SRAAS
11 categories • Commercial team: 250+ FTEs
• Direct Sales & Distribution Management
• Hyperimmunoglobulins marketed directly to
the CDCs
• 500+ Commercial Partners
• 6,500+ Retail Pharmacies
• 700+ Grade III Hospitals
• 2,500+ Grade II Hospitals
Execution in 2021 Key Features
Q1 Q2 Q3 Q4
Biddings transition
and 1st batch release
January
SRAAS
appointed as
exclusive
distributor
+
April
First product shipment +
Comprehensive portfolio Full geographical reach, extensive coverage & expanded customer base
Albumin
IVIG
IMIG
Hep B IG
Tetanus IG
Rabies IG
FVIII
PCC
Fibrinogen
Thrombin
Fibrin Sealant
Contributing to
+
Full commercial strategy at play
|
|
- 163 -
2021
Investor &
Analyst
Day
June 21
Implementing the Go-Direct Model
Fastest Growing IVD Market With Great Potential
26.9
8.1
5.6
3.8
2.6 2.5
22.9
6.9
4.9
3.2 2.2 2.1
28.1
8.8
6.9
4.0
2.7 2.6
4.2%
4.9%
7.0%
4.6% 4.5%
3.8%
0%
1%
2%
3%
4%
5%
6%
7%
8%
0
5
10
15
20
25
30
US Japan China Germany Italy France
2019 2020e 2025e CAGR ('20e-'25e)
USD
In-Vitro Diagnostics Market
Sources: IVD Market Report, Markets and Markets, May 2020.
1st step: Reorganization of internal operations
by shifting from current partners towards integrated
commercial model
Phased implementation of NAT solutions at
SRAAS facilities (pool of 96)
Portfolio expansion under assessment:
• Ultrio Plex E (HEV, HIV-1,
HIV-2, HCV, HBV)
• New DG Gel Cards
Advancing towards a Diagnostic integrated model for blood and plasma screening
|
|
- 164 -
2021
Investor &
Analyst
Day
June 21
“2021-2030 Alzheimer's Disease
Prevention and Treatment Work
Plan”
To reach highest rate of: AD prevention
and treatment awareness rate; services
network; elderly cognitive function
screening rate
Supporting authorities
with Grifols’ full-range
capabilities
Capitalizing on New Opportunities
China: A Dynamic Innovation Ecosystem
Centralized
Testing
Successful SRAAS Pilots
according to Provincial Health
Commission requirements
R&D SRAAS development of IVIG
10% and SCIG 20%
Others Take Innovation Beyond
Plasma to China
• Center of Excellence at Great Bay Area, partnering with
leading institutions. Concept matches with country approach
• Group of Experts
• Clinical Program to generate real-world data and address
aspects of indications, reimbursement and guidelines
2020
>10M patients
2050
>30M patients
Sources: Chinese Aging Well Association-Alzheimer Branch; Jian Kang Shi Bao.
|
|
- 165 -
2021
Investor &
Analyst
Day
June 21
Unparalleled growth
potential across divisions
Excellent performance amid
these challenging times
Innovation as a key element
within the alliance
Continue delivering on
execution in the second year
of the alliance
Advancing towards a
Diagnostic integrated model
Progressing on Our Strategic Alliance Under a Successful New Business Model
Key Takeaways
Robust capabilities and
broader portfolio through
the integrated Bioscience
commercial platform
under SRAAS
|
|
- 166 -
2021
Investor &
Analyst
Day
June 21
Leveraging Our Experience and Capabilities to
Meet the Needs of National Customers
Canada
Joel Abelson – President Bioscience Commercial
|
|
- 167 -
2021
Investor &
Analyst
Day
June 21
Grifols is Well-Positioned to Meet Canada’s Needs
Deep experience in the
Canadian market, with
more than 30 years as the
primary fractionator for
Canada’s blood operators
One of the highest IG
usage per capita with one
of the lowest plasma
donation rates
The pandemic heightened
the urgency for plasma self-
sufficiency/domestic
production
Grifols is supporting
Canada’s path
towards self-
sufficiency by
partnering with
Canadian Blood
Services to enhance
security of supply in
a novel proof-of-
concept partnership
model
Only large-scale domestic
manufacturing facility and
uniquely positioned for
continued growth across full
platform of service offerings
Grifols Montreal Facility
|
|
- 168 -
2021
Investor &
Analyst
Day
June 21
Over 30 Year History as the Primary Fractionator for Canada’s Blood Operators
Building On A Legacy
• Accountable to Canadians for a safe, secure blood system
• Funded by the provincial and territorial Ministries of Health
• Responsible for procurement of plasma derived medicines Domestic
IG
60.4%
C1
(21.9%)
Albumin
3.2%
Others
9.6%
AAT
2.7%
vWF
2.2%
37.7 million
Total Population
Canadian Blood Services (CBS)
All regions except Québec
77%
Source: Market research Bureau, Canada 2019/20, Statistics Canada
1 Without recombinant factors (period 2019/20)
Canadian Blood Services and Héma-Québec
Canada’s Blood Operators
Canadian Plasma Proteins Market1
USD 582 million
Grams of IG distributed by
Blood Operators
Héma-Québec
Québec
23% 9,150 kg
29%
71%
Héma-Québec
Canadian Blood Services
16%
|
|
- 169 -
2021
Investor &
Analyst
Day
June 21
One of the Highest IG per Capita. One of the Lowest Plasma Donation Rates
Plasma Opportunity in Canada
• Canada’s plasma volumes sent for fractionation are
primarily from recovered plasma
• Few source plasma (apheresis) collection centers
have been established (non-remunerated model)
Liters collected per 1,000 population
United States: 113 L
Austria: 75 L
Czechia: 45 L
Germany: 36 L
Spain 8 L
Canada 8.8 L
Canada
243g per 1,000 population (CBS figures)
Canada is one of the highest users of Ig per capita…
8.8L collected per 1,000 population
… but has one of the lowest plasma donation rates
Sources: Bédard, J.P. (2020) “Navigating Complexity: Ensuring Security of Supply.” Canadian Blood Services, Jaworski, P. (2020) “Bloody Well Pay Them: The Case for Voluntary Remunerated Plasma.”
Adam Smith Research Trust, Medical Research Bureau, Canada 2019/20. Calculation from ‘Protecting Access to Immune Globulins for Canadians – Final Report of the Expert Panel. Health Canada. 2018.
0%
5%
10%
15%
20%
25%
0
1.000.000
2.000.000
3.000.000
4.000.000
5.000.000
6.000.000
7.000.000
2013-2014 2014-2025 2015-2016 2016-2017 2017-2018 2018-2019 2019-2020
IG grams shipped Sufficiency rate
IG grams shipped and rate of sufficiency
13.7% 21.7%
Risk modeling suggests 50%
target for IG sufficiency to meet
needs of critical patient groups
(for which no alternative exists)
7,000,000
6,000,000
5,000,000
4,000,000
3,000,000
2,000,000
1,000,000
(2017 data)
|
|
- 170 -
2021
Investor &
Analyst
Day
June 21
Enhancing Domestic Supply Security Through Partnership With CBS
On the Path Towards Self-Sufficiency
“Grifols, with more than three decades providing trusted plasma medicines to
Canadians, is extremely pleased to deepen its relationship with Canadian Blood Services
to expand Canada’s plasma-collection infrastructure to meet the growing demand for
plasma therapies and enhance the health and quality of life of the Canadian patients who
depend on them.”
Joel Abelson, President Grifols’ Bioscience Commercial Division
State-of-the-art plasma donor center
opens in Sudbury
Media Release
December 16, 2020
“Through a unique consultative partnership, we have had the opportunity to learn from
the best practices Grifols has refined to improve and streamline our plasma collections
in our new plasma donor centres. As the national blood authority, Canadian Blood
Services will continue to deliver on our mandate to support patients by operating the
national blood system guided by the principles outlined by Justice Horace Krever.”
Jean-Paul Bédard, Vice-President Plasma Operations, Canadian Blood Services
Lethbridge, Alberta
Kelowna, British Columbia
Sudbury, Ontario
Sudbury’s center is the first of three new Canadian
Blood Services dedicated plasma-donor centers that
are opening across Canada. First announced in
August 2019, these donor centers represent a proof-
of-concept approach aimed at offering an optimized
collections model that leverages Canadian Blood
Services’ extensive expertise and industry best
practices for plasma collection.
Sources: Media Release, December 16, 2020 “State-of-the-art plasma donor centre opens in Sudbury. Canadian Blood Services
|
|
- 171 -
2021
Investor &
Analyst
Day
June 21
Grifols’ is committed to
helping countries reach self-
sufficiency of plasma-
derived medicines
For 30+ years, Grifols has
been the primary fractionator
of Canadian plasma under
contract manufacturing
services
Uniquely positioned for
continued growth across full
platform of service offerings
Strengthening Grifols’
presence in Canada, building
on a legacy of partnership in
Canada’s blood system
Only large-scale domestic
manufacturing facility
Leveraging Our Experience and Capabilities to Meet the Needs of National
Customers
Key Takeaways
Market opportunity as
demand continues to grow and
IG use per capita is one of
the highest in the world
|
|
- 172 -
2021
Investor &
Analyst
Day
June 21
Driving Resource Allocation to Support Further
Growth and Profitability
Finance
Alfredo Arroyo – Chief Financial Officer
|
|
- 173 -
2021
Investor &
Analyst
Day
June 21
Delivering on Our Commitments
1
|
|
- 174 -
2021
Investor &
Analyst
Day
June 21
Driving long-term sustainable
growth across all divisions
Reinforcing our international
expansion through SRAAS in
China and alliances in Canada
and Egypt
2020 IAD Key Takeaways
Delivering on Our Commitments
Continuous CAPEX to
support future growth
Increasing plasma supply
through organic and inorganic
initiatives
Integrated innovation efforts
as a core strategic pillar
Deleveraging and securing
liquidity remain key priorities
|
|
- 175 -
2021
Investor &
Analyst
Day
June 21
2020 IAD Key Takeaways
Delivering on Our Commitments
Driving long-term sustainable
growth across all divisions
Continuous CAPEX to support
future growth
Increasing plasma supply
through organic and
inorganic initiatives
Integrated innovation efforts as
a core strategic pillar
Reinforcing our international
expansion through SRAAS in China
and alliances in Canada and Egypt
Deleveraging and securing
liquidity remain key priorities
(March ‘21 up to EUR 1bn+)
2016 2019
4.000
2017 2018 2020
500
3.500
4.500 +7%
Bioscience Diagnostic Bio Supplies Hospital
€m Revenues
+7%
+4%
+4%
+41%
268 271 252
332 308
2016 2018 2017 2019 2020
€1,400m+ in CAPEX over the last 5 years Efficiencies
Organic
growth
Inorganic
growth
€1,500m+ in innovation over the last 5 years
294 311 291
329
298
2016 2017 2020 2019 2018
Since last IAD…
U.S.
+43 plasma
centers
Since last IAD…
Hungary
+7 plasma
centers
Egypt
+20 plasma centers
(opening in 2H 2021)
(15-20 new plasma
centers in 2H)
|
|
- 176 -
2021
Investor &
Analyst
Day
June 21
Proven Resilience During Unprecedented Times
2
|
|
- 177 -
2021
Investor &
Analyst
Day
June 21
2020 COVID Impacts
Proven Resilience During Unprecedented Times
1,141 1,219 1,223
1,434
1,324
155
28.2% 28.2%
27.3%
28.1%
27.7%1
26%
27%
27%
28%
28%
29%
29%
30%
30%
0
200
400
600
800
1.000
1.200
1.400
1.600
2016 2017 2018 2019 2020
COVID Impact
EBTIDA
EBITDA Margin
4,050 4,318 4,487
5,099 5,340
2016 2017 2018 2019 2020 2020
2020
Revenues (€M)
EBITDA Reported (€M)
EUR -155m
Most significant impacts on EBITDA 2020 (€M)
+ -
Cost containment plan +112
NAT COVID test +49
Sub-activity costs -205
Lower Bioscience sales -111
Impact in P&L 2020
• Price increases
(mid-single digit growth)
• 50% of revenue growth
from new product launches
• Bioscience topline
performance impacted in
Q4 by lower plasma
collections
• Cost per liter increase
+ -
1 Excluding COVID-19 impact on EBITDA and considering reported sales
|
|
- 178 -
2021
Investor &
Analyst
Day
June 21
2021 COVID Impacts
Proven Resilience During Unprecedented Times
+ -
Estimated Impact in P&L for 2021
• Price increases (mid-single digit growth)
• Product mix including recent product launches
• Expected sales rebound in the last part of 2021
thanks to sustained solid demand and recovery in
plasma collections
• Optimization and efficiencies: Continuation of
most of the 2020 cost containment measures in
2021 and beyond
• Larger contribution from SRAAS
• Bioscience topline performance impacted
by lower plasma collections
• Cost per liter increase derived from higher
donor fees and fixed costs under absorption
• R&D efforts stemming from the integration and
development of new acquisitions
Solid Fundamentals: 2021 still some challenges. 2022 back on track
|
|
- 179 -
2021
Investor &
Analyst
Day
June 21
Key Drivers to Support Further Growth
and Profitability
3
|
|
- 180 -
2021
Investor &
Analyst
Day
June 21
Key Drivers to Support Further Growth and Profitability
Structural
costs
optimization plan
Divest
non-strategic
business lines
Deleveraging
Innovation
Fit for Growth
SG&A
R&D
Net Revenue
Gross Margin Profitability
Virtuous Cycle
|
|
- 181 -
2021
Investor &
Analyst
Day
June 21
Divest Non-Strategic Business Lines
Resetting Cost Base to Promote Innovation
Cost Optimization and Divest Non-Strategic Lines
Structural Cost Optimization Plan
• Identified further cost reduction opportunities
• Maintain EUR c.100m in annual run-rate cost
savings
• Targeted administrative and support functions,
as well as other non-strategic activities
• Driving improved focus on capital allocation on
core divisions/business lines
• Active efforts to divest non-strategic business
lines
• Each division will contribute to value creation
Increasing Profitability Through Driving Innovation
|
|
- 182 -
2021
Investor &
Analyst
Day
June 21
4.8
4.4
4.6
4.3
4.8
4.5
4.3
4.2
4.1
4.4
4.1
4.5
5.1
3,5
4
4,5
5
5,5
6
1Q2018 2Q2018 3Q2018 4Q2018 1Q2019 2Q2019 3Q2019 4Q2019 1Q2020 2Q2020 3Q2020 4Q2020 1Q2021
Strategic Investments Led to a Higher Leverage Ratio
Focus on Deleveraging and Securing Liquidity
Leverage
ratio
Target
Debt and leverage ratio
remain a key priority
Efforts to reduce debt
without missing strategic
opportunities
Securing liquidity
4.0x
COVID impact
Green Cross: 0.3x
Alkahest: 0.2x
Gigagen: 0.1x
BPL: 0.4x
Kedrion: 0.1x
|
|
- 183 -
2021
Investor &
Analyst
Day
June 21
M&A to Support Growth and Profitability
4
|
|
- 184 -
2021
Investor &
Analyst
Day
June 21
Demonstrated Ability to Successfully Expand
Successful Track Record to Support Growth
€m
2,303
2,621 2,742
3,355
3,935 4,050
4,318 4,487
5,099
5,340
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
CAGR
+10%
Talecris
(EV $4.0bn)
Novartis
Transfusion
Diagnostic
(EV $1.675bn)
Hologic, share
in NAT unit
(EV $1.85bn)
Interstate Blood Bank (IBBI)
(100%)
KedPlasma
6 plasma centers in the U.S.
Access Biologicals (49%)
Kiro Grifols (90%)
Haema (100%)
Biotest
24 plasma centers in the U.S.
MedKeeper (100%)
Alkahest (100%)
Green Cross (Korea)
Fractionation facility in Canada
and 11 centers in the U.S.
Alliance with Egyptian
government
BPL & Kedrion
32 plasma centers in the U.S.
GigaGen (100%)
2016-2020 Acquisitions
SRAAS
|
|
- 185 -
2021
Investor &
Analyst
Day
June 21
Consolidating Our Competitive Advantage
Securing Our Plasma Supply
• 25 U.S.-based
plasma centers that
obtain 1m liters of
plasma/year
• USD 370 million
Q1 2021
Acquisition of
25 plasma centers
from BPL
• 7 U.S.-based plasma
centers that obtain
240k liters of
plasma/year
• USD 55 million
Q2 2021
Acquisition of
7 plasma centers
from Kedrion
• 11 U.S.-based plasma
centers that obtain
350k liters of
plasma/year
• USD 90 million
Q4 2020
Acquisition of
11 plasma centers
from Green Cross
• 7 Hungary-based
plasma centers that
obtain 120k liters of
plasma/year
Q1 2021
Plasma Supply
Agreement in
Hungary
Increase Grifols’ plasma supply and expand, diversify and reinforce our
plasma-center network
|
|
- 186 -
2021
Investor &
Analyst
Day
June 21
Integrating Alkahest and GigaGen
Enhancing Our Innovation Strategy
September 7, 2020 March 9, 2021
• Its protein-targeted assets and
non-plasma derived
therapeutics projects can help
Grifols diversify while retaining its
focus on the science of plasma
• USD 146 million
Acquisition of the remaining
55% equity of GigaGen
Acquisition of the remaining
56% stake of GigaGen
• Acquisition of the remaining
56% share capital of the U.S.
biopharmaceutical company
• USD 80 million
Diversifying and reinforcing our pipeline by exploring solutions beyond
plasma in order to accelerate our plan for sustained margin expansion
|
|
- 187 -
2021
Investor &
Analyst
Day
June 21
Canada, Egypt and China Lead the Way
Global Expansion Through New Business Models
November 24, 2020
Strategic alliance with the
Egyptian government
• Strategic agreement to develop the local
plasma-derived therapies market by opening
20 plasma centers and building production
facilities in Egypt
• The plasma centers will initially collect around
600k liters plasma/year. The plant will have a
fractionation capacity of up to 1m liters/year
• Fractionation plant with a 1.5m-liter
annual capacity and two purification
plants
• Grifols is now the only large-scale
commercial manufacturer of plasma
products in Canada
• USD 370 million
October 1, 2020
Closing of the acquisition of Green
Cross fractionation plant in Canada
Multi-level approach to enter new markets and become a reliable long-term
partner while helping countries bolster their self-sufficiency
|
|
- 188 -
2021
Investor &
Analyst
Day
June 21
102
149
188
-220
88
202
-300
-200
-100
0
100
200
300
0
50
100
150
200
2018 2019 2020
EBITDA
Net Profit
38
126
179
0
50
100
150
200
2018 2019 2020 2018 2019 2020
Grifols Bx China
SRAAS
466
657
747
Delivering Solid Performance
SRAAS Continues to Outperform
2019 2020
Revenue 374
Variation
vs. 2018
149
88
+43%
+45%
+$307m
422
188
202
40% 45%
+7%
+20%
+118%
Variation
vs. 20192
24% 48%
($M)
1 Includes China, Hong Kong SAR, Taiwan and Macao SAR; 2 Growth rate based on currency consistency assumption
Margin
• Unparalleled short-, mid- and long-term growth opportunity
• China is Grifols’ third-largest sales market, representing its leading market
for albumin and third most important market for the Diagnostic Division
• High potential for value creation thanks to synergies
• Strong cash flow generation; no debt
• SRAAS has become the exclusive distributor of Grifols’ plasma-derived
products in China, with a robust sales network of 500+ distributors
EBITDA
Margin
SRAAS ($M)
P&L Variations
Net Profit
SRAAS + Grifols Bioscience in China1 ($M)
Revenue Trend EBITDA and Net Profit Trend Operating Cash Flow
|
|
- 189 -
2021
Investor &
Analyst
Day
June 21
Enhancing Investor Communications
Clear focus on ESG and
integrated reporting
Further promote our
transparency on
ESG-oriented initiatives
Recognized among the
world’s most sustainable
companies: DJSI, Euronext
Vigeo, FTSE4Good,
Bloomberg Gender Equality
Index and S&P Global
Ratings
Fluid and transparent
communications are
crucial, especially during
these unprecedented times
Grifols is intensifying its
efforts to maintain a
reinforced constant
dialogue with stakeholders
In light of the recently issued
norm by the Spanish Law
and embraced by the
Spanish Stock Exchange
(CNMV) and the fact that
Grifols’ performance is not
quarterly driven, the
company will henceforth
release its earnings results
on a half year basis
ESG Fluid and Transparent
Communications Earnings Releases
|
|
- 190 -
2021
Investor &
Analyst
Day
June 21
Streamlined focus on value
creation fundamentals
Active efforts to divest
non-strategic line of
businesses
Clear focus on ESG and
integrated reporting
Half Year earnings release
Increasing profitability
through driving innovation
Successful track record of
organic and inorganic
growth
Driving Resource Allocation to Support Further Growth and Profitability
Key Takeaways
Deleveraging and liquidity
remain a key priority
|
|
- 191 -
2021
Investor &
Analyst
Day
June 21
Shaping the Industry’s Sustainability Standards
Environmental, Social and Governance
Thomas Glanzmann – Vice-Chairman of Grifols’ Board of Directors
and Chairman of Grifols’ Sustainability Committee
Nuria Pascual – VP Corporate Treasury & Investor Relations Officer
|
|
- 192 -
2021
Investor &
Analyst
Day
June 21
Building on Our Heritage to Foster
Sustainability as a Strategic Pillar
1
|
|
- 193 -
2021
Investor &
Analyst
Day
June 21
Built Historically on Our Strong Corporate Values
Sustainability in Our DNA Since 1909…
Blood & plasma
screening: pathogen
testing with NAT
Technology
1909
1928
1943
1945
1951
1969
1989
2004
2014
2016
Transfusion
Flebula for indirect
blood transfusions
1st Private blood
& plasma bank
in Spain
1st anti-Rh
hyperimmune
globulin to prevent
blood incompatibility
Plasma exchange +
albumin as treatment
for Alzheimer’s
Hyperimmune
globulin to treat
Ebola
Plasma lyophilization
and preparation of
freeze-dried plasma for
transfusion (Spain)
Plasmapheresis
development,
facilitating plasma
collection & plasma
therapies
Plasma double virus
inactivation, coagulation
factors for hemophilia
Tests & specific
plasma therapies
for SARS-CoV-2
2020
Safety Effort Commitment Excellence Teamwork Innovation &
Improvement Pride
Our Core Values
|
|
- 194 -
2021
Investor &
Analyst
Day
June 21
Commitment Based on Ethical Leadership and Internationally Recognized
… Strengthened Through Our Governance
2020
Definition and approval
of sustainability
strategies, policies
and practices
• Establish the core principles and
commitments regarding environmental, social
and governance issues in our business model
• Supervise the integration of financial and
non-financial information in ESG initiatives
Audit
Committee
Board of
Directors
Appointments &
Remuneration
Committee
Sustainability
Committee
+ Sustainability Policy
Reinforce our fundamental
Principles and commitments
regarding our ESG responsibility
Sustainability Executive
Committee
Led by Investor Relations
Promote a well managed and
coordinated sustainability
strategy at all organizational levels
|
|
- 195 -
2021
Investor &
Analyst
Day
June 21
On the Path Towards 2030 and Beyond Led by Our 4 Pillars
Integrating Sustainability in Our Strategy
2030 Climate
change
strategy
Waste recovery
and eco-
efficiency
Economic performance
and innovation
Commitment to patients,
plasma and plasma donors
and bioethics
Attracting and
retaining talent,
occupational
health and safety
and welfare
Sustainability Plan
grounded on 4 pillars
Talent pool
Commitment with
patients and donors
Social impact
Environmental
responsibility
|
|
- 196 -
2021
Investor &
Analyst
Day
June 21
Sustainability Plan: Our Commitments
2
|
|
- 197 -
2021
Investor &
Analyst
Day
June 21
Sustainability Plan: Our Commitments
Our People
Commitment to
Donors and
Patients
Impact on
Society
Environmental
responsibility
|
|
- 198 -
2021
Investor &
Analyst
Day
June 21
Offer competitive pay
packages and properly
compensate employees
Encourage teamwork
to drive innovation by
sharing insights and
experiences
Ensure the ongoing
improvement of its
occupational health,
well-being and safety
Our Commitment Promotes Equality, Diversity, Inclusion and Development
Our People Is Our Top Priority
Offer a professional
development fostering
continuous training
Continued efforts to
promote effective
equality
Reflect a diverse and
inclusive company
|
|
- 199 -
2021
Investor &
Analyst
Day
June 21
Equal Opportunities, Diversity and Professional Development
Our People Is Our Top Priority
Gender
Pay Gap 3.1%
Spain
2.2%
U.S.
1.3%
Germany
2 M
Training
Hours
Diverse and inclusive company
Continuous training adapted to the
needs of each employee
62%
of promotions are
women
Workforce at Grifols
23,655 employees
40% 60%
88nationalities
Ongoing efforts to effectively promote equality
Professional development model focused on strengths
and areas for growth
36% 64%
99 hours
average per
person
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- 200 -
2021
Investor &
Analyst
Day
June 21
Ensuring Non-Discrimination and Donor Health, Safety and Well-Being
Commitment to Donors and Patients
Protecting the health,
safety, well-being and
dignity of plasma
donors is critical
Our donation centers
adhere to the highest
quality and safety
standards to guarantee
donors’ health
No distinction is made
with regard to the
volume of plasma
collected or donors’
weight
Compensation policy
applies equally to
all donors
Non-discrimination on
the basis of gender,
race, ethnicity or
socioeconomic status
Same quality and
safety criteria applied
in all Grifols plasma
centers and for all
donors
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- 201 -
2021
Investor &
Analyst
Day
June 21
Promoting patient engagement
by offering up-to-date information
about plasma-collection efforts
Grifols’ Commitment to Patients is Based on Three Pillars
Commitment to Donors and Patients
Collaborations
and Programs
Access to
treatments
Production capacity
and supply
commitment
Awareness campaigns to
highlight the role of plasma
Advocacy initiatives to help
patients receive access to
plasma-derived treatment
Comprehensive
support programs
Grifols has made strategic investments in recent years to increase
its access to plasma and led other initiatives to ensure an
uninterrupted supply of plasma-derived medicines throughout 2020
Price-setting policy grounded on
two core principles:
• Cost should never be an obstacle
to receiving optimal treatment
• Price should guarantee long-term
sustainability and reinforce
commitment to innovate
1
2
PatientCare programs
>€11 m of plasma-derived
medicines donated in 2020
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- 202 -
2021
Investor &
Analyst
Day
June 21
Our Sustainable Business Model Pursues Social Value
Commitment to Donors and Patients
Total Social Value Impact
€6.2bn
Donors
€1,828M
Social Value Ratio
2.1x
Community
€722M
Patients (1)
€3,636M
Physical and
psychological
well-being
Healthier lives
Educational
expenses
Financial stability
Healthcare access
Economic impact
in donor communities
Improvement in
Quality of Life
(1) Corresponds to the high end of the sensitivity analysis performed
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- 203 -
2021
Investor &
Analyst
Day
June 21
Social Action Plan
Our Contribution to Social Progress
Education
Health and
Well-being
Local Development
Environment
Help promote access to education and equality of
opportunities in communities where Grifols operates
Contribute to driving positive change: gender
equality, ethics and values
Promote and improve access to healthcare
Promote science as a driver of positive change
Direct and foundation-led initiatives
Build close ties in donor communities and
areas where production facilities are located
Community programs in other countries
and humanitarian aid
Contribute to recover and enhance natural
and environmental patrimony
Direct initiatives and joint projects in
collaboration with nature conservation
associations
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- 204 -
2021
Investor &
Analyst
Day
June 21
Creating Value Beyond Financial Performance
Our Contribution to Social Progress
Grifols’ Socio-Economic Contributions
growth
+15% €43bn Total economic
impact
New jobs +44k
2020
€7.5bn Total economic impact
x1.8 Grifols’ contributions
double its impact in
the U.S. economy
140k Total jobs
X6.2 Grifols generates 6.1
jobs in the U.S. for
every one job it creates
2015-2020
growth
+42%
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- 205 -
2021
Investor &
Analyst
Day
June 21
Our Six Commitments for 2030
Environmental Responsibility
Emissions Reduction Energy Efficiency Renewable Energies
Decarbonization Circular Economy Protect Biodiversity
Reduce greenhouse gas
emissions per unit of
production by
Increase energy
efficiency
per unit of production
Consume 70% of
electricity from renewable
sources
Facilitate
decarbonization in
business travel and
employee commutes
Continue to implement
measures in every stage
of the operational
life cycle
Protect biodiversity and
promote CO2 capture
on our properties
through the Grifols
Wildlife Program
40% 15% 70%
PROGRESS
IN 2020 20% PROGRESS
IN 2020 63% PROGRESS
IN 2020 5.4%
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|
- 206 -
2021
Investor &
Analyst
Day
June 21
Shaping the Industry’s Sustainability Standards
Key Takeaways
Since our beginnings in 1909,
we have continually
strengthened our commitment
to generate social impact
Our commitment promotes
equality, diversity, inclusion
and talent development
Significant progress
on 2030 environmental
targets
Non-discrimination and
measures to ensure donors’
health, safety and well-being
Creating social value beyond
financial performance
Supporting patients through
access to treatment,
awareness campaigns and
support programs
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- 207 -
2021
Investor &
Analyst
Day
June 21
Final Remarks
Innovation at the Core of Our Decisions to Drive
Profitable Growth
Víctor Grífols Deu – Co-CEO
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- 208 -
2021
Investor &
Analyst
Day
June 21
524
2005 2020 2015 2010
5,340
Since 2005, We Have Excelled in 3 Core Pillars Leading to a 10 Fold Growth
Excelling in Grifols’ Core Pillars
Plasma
Procurement
Engineering &
Manufacturing
Commercialization /
Global Expansion
Innovation
Focus in excelling in 3 out of
4 pillars
x10
Talecris
acquisition
IPO
|
|
- 209 -
2021
Investor &
Analyst
Day
June 21
+43 plasma
centers
+7 plasma
centers
JV Egypt
(+20 centers1)
SRAAS
partnership
Canada
alliance
Emerging Stronger From the Pandemic; Results to Start Paying Off in the Short-term
A Solid Basis
Increasing plasma
supply
(~80 centers2)
Expanding globally &
evolving industry
paradigm
Expanding innovation
ecosystem with new
and powerful
platforms
1 10 of 20 centers to be opened during 2021; 2. Total DCs opened from 2020 Q4 until end of 2021
+
Continue with
structural
costs
optimization plan
Divest
non-strategic
business lines
Margin improvement Recent activity to reinforce core business
+2 plasma
center
|
|
- 210 -
2021
Investor &
Analyst
Day
June 21
Collecting Results From New Innovation Approach While Paving the Way for the Future
Innovation
Foundations for innovation as growth engine Recent innovation results
New Scientific Innovation Organization
Expand towards a holistic approach in
our core therapeutic areas
(Internal, External, Plasma, Non-plasma)
Powerful legacy & promising platforms
Internal plasma
innovation
Plasma
innovation
out licensed
Non-plasma
innovation in
licensed
Diagnostics
Innovation SARS-CoV-2
… and still in ramp-up stage
50% of 2020 growth …
+
|
|
- 211 -
2021
Investor &
Analyst
Day
June 21
A Global Ecosystem to Deliver Value in Our Core Therapeutic Areas
Innovation
Footprint New Ecosystem
Therapeutic areas
Immunology
& Infectious Diseases
Hepatology
& Intensive Care
Neurology
Hematology
Pulmonology
Ophthalmology
Grifols
Internal
Research
Investigator
sponsored
research External
research
collaborations
(e.g. Universities, public &
private institutions)
Invested
companies
(e.g. Araclon,
AlbaJuna)
New
platforms
(e.g. Alkahest,
GigaGen)
Strategic
Alliances
(e.g. Rigel, J&J)
+1,100 employees
New
Addition
Research
Triangle
Park, NC
Bioscience
Düdingen, Switzerland
Diagnostic
Andorra
Immunology
Dublin
Bioscience
Hub SF Area, CA
Emeryville,
San Carlos
LA, San Diego
& South San
Francisco, CA
Bioscience
and Diagnostic
Hub RTP, NC Hub Europa
Barcelona, Bilbao and
Zaragoza, Spain
Bioscience and Diagnostic
|
|
- 212 -
2021
Investor &
Analyst
Day
June 21
Innovation to Drive Profitable Growth
Innovation Ambition
Structural
costs
optimization plan
Divesting
non-strategic
business lines
Project
prioritization
Revenue
Gross margin
Revenues from new product launches
Sources to
fund
innovation
2030+
4%
2020
20%
Steady product
launches
|
|
- 213 -
2021
Investor &
Analyst
Day
June 21
Moving Forward, Innovation Will Be the Engine of Profitable Growth
Innovation
2005 2020 2030 +
Plasma Procurement
Engineering & Manufacturing
Commercialization /
Global Expansion
Innovation
Stronger &
resilient
infrastructure
to deliver on
short term
Innovation as
an engine of
profitable
growth
Short – mid term Long term
Leading in industry paradigm
evolution
Harvesting
recent
innovation
results
|
|
2021 Investor and Analyst Day
June 3, 2021
|
|
- 215 -
2021
Investor &
Analyst
Day
June 21
Glossary
|
|
- 216 -
2021
Investor &
Analyst
Day
June 21
Glossary
• Alpha-1 antitrypsin deficiency (AATD): Inherited disease characterized by low levels of, or no,alpha-1 antitrypsin (AAT) in the blood. This
protein made in the liver, reaches other organs (such as the lungs), after being released into the blood stream, enabling its normal function.
• Albumin: The most abundant protein found in plasma (approximately 60% of human plasma). Produced in the liver, it is important in regulating
blood volume by maintaining the oncotic pressure of the blood compartment.
• Alzheimer’s disease (AD): This is the most common form of dementia. This incurable, degenerative, and terminal disease was first described
by German psychiatrist and neuropathologist Alois Alzheimer in 1906 and was named after him.
• American Society for Apheresis (ASFA): An organization of physicians, scientists, and allied health professionals whose mission is to
advance apheresis medicine for patients, donors and practitioners through education, evidence-based practice, research and advocacy
• Autoimmune disease: Condition in which the immune system mistakenly attacks healthy cells.
• Babesiosis/Babesia virus: Disease caused by microscopic parasites that infect red blood cells.
• Beta-amyloid: Protein strongly implicated in Alzheimer’s diseases. Beta-amyloid is the main component of certain deposits found in the brains
of patients of Alzheimer’s disease.
• CIDP (Chronic Inflammatory Demyelinating Polyneuropathy): Neurological disorder which causes gradual weakness, numbness, pain in
arms and legs and difficulty in walking.
• Cirrhosis: Medical condition which is a result of advanced liver disease. It is characterized by there placement of liver tissue by fibrosis (scar
tissue) and regenerative nodules (lumps that occur due to attempted repair of damaged tissue).
• Chronic Lymphocytic Leukemia (CLL): a type of cancer of the blood and bone marrow — the spongy tissue inside bones where blood cells
are made
• COVID-19: Infectious disease caused by a new strain of coronavirus. ‘CO’ stands for corona, ‘VI’ for virus, and ‘D’ for disease.
• ELISA: Enzyme-linked immunosorbent assay.
• EMA: European Medicines Agency.
• EPCM: Engineering, Procurement, Construction Management.
• Factor VIII or FVIII: This is an essential blood clotting factor also known as anti-hemophilic factor(AHF). In humans, Factor VIII is encoded by
the F8 gene. Defects in this gene results in hemophilia A, a sexlinked disease that occurs predominantly in males. FVIII concentrated from
donated blood plasma, or alternatively recombinant FVIII, or rFVIII can be given to hemophiliacs to restore hemostasis.
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- 217 -
2021
Investor &
Analyst
Day
June 21
Glossary
• Factor IX: This is an important blood clotting factor also known as Christmas factor or plasma thromboplastin component (PTC). It is one of the
serine proteases of the coagulation system and belongs to the peptidase family S1. In humans, a deficiency of this protein causes hemophilia
B, a sex-linked disease that occurs predominantly in males.
• FDA: Food and Drug Administration. U.S. Health Authority.
• Fibrin sealant: Surgical adhesive material derived from plasma.
• Fibrinogen: Coagulation factor found in human plasma crucial for blood clot formation.
• Fractionation: Process of separating plasma into its component parts, such as albumin, immunoglobulin, alpha-1 antitrypsin and coagulation
factors.
• HBV: Hepatitis B Virus.
• HCV: Hepatitis C Virus.
• Hematology: The study of blood, blood-forming organs, and blood diseases.
• Hemoderivative: Proteins obtained by fractionation of human blood plasma. See plasma derived proteins.
• Hemophilia: Genetic deficiency characterized by the lack of one of the clotting factors. It has two main variants:
ꟷ Hemophilia A: genetic deficiency of coagulation Factor VIII, which causes increased bleeding (usually affects males).
ꟷ Hemophilia B: genetic deficiency of coagulation Factor IX.
• Hemotherapy: Treatment of a disease using blood, blood components and its derivatives.
• HEOR: Health Economics Outcomes Research
• HIV: Human Immunodeficiency Virus.
• Hyperimmune globulin: class of immunoglobulins prepared in a similar way as for normal human immunoglobulin, except that the donor has
high titers of antibody against a specific organism or antigen in their plasma.
• IA: Immunoassays. These are systems available in several formats that may be used to detect antibodies, recombinant proteins or a
combination of the two.
• Immunoglobulins: Also known as antibodies, are proteins derived from plasma. They control de body’s immune response. They have multiple
indications and some of their main uses are to treat: (i) immune deficiencies, (ii) inflammatory and autoimmune diseases and (iii) acute
infections. IVIG is an immunoglobulin administered intravenously that contains IgG (immunoglobulin (antibody) G).
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- 218 -
2021
Investor &
Analyst
Day
June 21
Glossary
• Intravenous: Administration of drugs or fluids directly into a vein.
• Immunohematology: A branch of hematology related to the study of recombinant proteins and antibodies and their effects on blood and the
relationships between blood disorders and the immune system. Also referred to as Transfusional Medicine – blood bank, its main activities
include blood typing, compatibility tests and crossmatching and antibody identification.
• Immunology: This is a branch of biomedical science that covers the study of all aspects of the immune system in organisms. It deals with the
physiological functioning of the immune system in states of both health and disease; malfunctions (autoimmune diseases, hypersensitivities,
immune deficiency, transplant rejection) and the physical, chemical and physiological characteristics of the components of the immune system
in vitro, in situ, and in vivo.
• Immunoglobulin (IgG): Also known as antibodies, are proteins derived from plasma. They control de body’s immune response. They have
multiple indications and some of their main uses are to treat: (i) immune deficiencies, (ii) inflammatory and autoimmune diseases and (iii) acute
infections. IVIG is an immunoglobulin administered intravenously that contains IgG (immunoglobulin (antibody) G).
• ITP (Chronic immune thrombocytopenia): Autoimmune disorder in which patients produce antiplatelet autoantibodies and specialized white
blood cells that destroy their blood platelets. This results in a low blood platelet count (thrombocytopenia) that may produce bruising or
excessive bleeding.
• IVD: In vitro Diagnostic.
• IV solutions/Intravenous solution: Medicine or homogeneous mixture of a substance in liquid, enabling it to be infused into the circulatory
system through a needle.
• Molecular Diagnostics: Discipline that studies genomic (DNA) and proteomic (proteins)expression patterns and uses the information to
distinguish between normal, precancerous, and cancerous tissues at the molecular level.
• Monoclonal antibody (mAb): Antibody produced by a single clone of cells typically used in immunotherapy (such as in the treatment of
autoimmune or inflammatory disorders and cancer), diagnostic testing and cell identification and tracing. Monoclonal antibodies are a
cornerstone of immunology and are increasingly coming into use as therapeutic agents.
• Myasthenia Gravis (MG): Chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles that worsens after
periods of activity and improves after periods of rest. These muscles are responsible for functions involving breathing and moving parts of the
body.
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- 219 -
2021
Investor &
Analyst
Day
June 21
Glossary
• NAT: Nucleic Acid Amplification Testing.
• Neovascular Age-Related Macular Degeneration (nAMD): is a disease that impacts the central area of the retina in the eye, called the
macula.
• Neurology: Science that deals with the anatomy, functions and organic disorders of nerves and the nervous system.
• Ophthalmology: is a branch of medicine and surgery that deals with the diagnosis and treatment of disorders of the eyE
• Pandemic: The worldwide spread of a new disease.
• PCR: Polymerase chain reaction is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing
scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.
• pdFVIII: Plasma-derived Factor VIII.
• Parkinson Disease Dementia (PDD): complex neurodegenerative disorder where each patient experience different combination of motor and
non-motor symptoms
• Pharmacovigilance: Practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify
and evaluate previously unreported adverse reactions.
• Plasma: Yellow-coloured liquid part of the blood, consisting of a mix of a large number of proteins in solution.
• Plasma-derived proteins: Purified plasma proteins with therapeutic properties that are obtained through the fractionation of human plasma.
Albumin, immunoglobulins, factor VIII and alpha-1 antitrypsin are the main plasma proteins.
• Plasmapheresis: Plasmapheresis is a technique which separates plasma from other blood components, such as red blood cells, platelets and
other cells. These unused blood components are suspended in saline solution and immediately reinjected back into the donor. Because the
donor is only providing plasma and not whole blood, the recovery process is faster and better tolerated, and the donor is able to make
donations more frequently. Plasmapheresis was developed by Jose Antonio Grifols Lucas in the year 1951. It is the only procedure that is
capable of obtaining sufficient quantities of plasma to cover the manufacturing needs for the different plasma protein therapies.
• Plasma Proteomics: is a term which describes the high-throughput analysis of plasma biomarkers using very powerful, sensitive and specific
instruments.
• PPTA: Plasma Protein Therapeutics Association.
• Primary immunodeficiency (PID/PIDD): Inherited condition where there is an impaired immune response, weakening the immune system and
allowing infections and other health problems to occur more easily. It may be in one or more aspects of the immune system.
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- 220 -
2021
Investor &
Analyst
Day
June 21
Glossary
• ProlastinR/ProlastinR -C: This is a concentrated form of alpha-1 antitrypsin (AAT), derived from human plasma and approved only for chronic,
or ongoing, replacement therapy in people with genetic AAT deficiency. Given as prescribed, Prolastin raises the levels of AAT in the blood and
lungs. Raising the AAT level may help reduce the damage to the lungs caused by destructive enzymes.
• Pulmonology: is an area of medicine that focuses on the health of the respiratory system. Pulmonologists treat everything from asthma to
tuberculosis.
• Recombinant: Protein prepared by recombinant technology, coded by the manipulated gene. Procedures are used to join together segments
in a cell-free system (an environment outside a cell organism). They are known as highly potent medicines that are safe from off-target side
effects and take a shorter time to develop than small molecules.
• rFVIII: Recombinant Factor VIII is the antihemophilic factor A, obtained using recombinant DNA technology. With this technology, pure factor is
synthesized in the laboratory instead of being extracted from blood plasma.
• ROW: Rest of the World.
• SARS-CoV-2: Severe acute respiratory syndrome coronavirus 2 is the strain of coronavirus that causes coronavirus disease 2019 (COVID-19),
the respiratory illness responsible for the COVID-19 pandemic.
• Secondary immunodeficiency (SID) : Occurs when the immune system is compromised due to an environmental factor. Examples of these
outside forces include HIV, chemotherapy, severe burns or malnutrition.
• SCIG: Subcutaneous Immunoglobulin
• Thrombin: Enzyme that presides over the conversion of a substance called fibrinogen to fibrin, which promotes blood clotting.
• Transfusion medicine: Branch of medicine that encompasses among others, immunohematology, blood and plasma screening and blood
typing.
• West Nile Virus (WNV): Virus transmitted by mosquitoes. Humans are mainly infected through mosquito bites, but infection can occur through
organ transplantation and blood.
• Von Willebrand Disease (vWD): This is the most common hereditary coagulation abnormality described in humans, although it can also be
acquired as a result of other medical conditions. It arises from a qualitative or quantitative deficiency of von Willebrand factor (vWF), a
multimeric protein that is required for platelet adhesion.
• Zika virus: Infectious disease spread by the bite of an infected Aedes species mosquito.
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SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.
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Grifols, S.A.
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By:
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/s/ David I. Bell
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Name:
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David I. Bell
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Title:
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Authorized Signatory
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Date: June 3, 2021
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