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Grifols S.A. — Investor Presentation 2021
Jun 3, 2021
1834_rns_2021-06-03_f36177cc-760c-4516-b1f4-fae091972317.pdf
Investor Presentation
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2021 Investor and Analyst Day
June 3, 2021
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. Forwardlooking 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.
2021 Investor and Analyst Day
Agenda
Investor & Analyst Day June 21
Introductory Remarks
Building Upon Our Core Commitments
Raimon Grífols – Co-CEO
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Grifols Proved Its Resilience and Commitment in 2020 by...
Overcoming adversity and adapting to change
2020
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
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
…and Doubling Our Efforts in Three Core Areas
2020: Emphasizing the Importance of Plasma
A Global Model of Sustainable Plasma
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 2019, 68% of total plasma collected comes from U.S. (from the 57% in 2010) (MRB)
In Europe, self-sufficiency levels short fall by 40% (1)
Plasmatology
First Scientific Journal Dedicated to Plasma Science
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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Strengthening Our Fundamentals
Efforts to Secure Plasma Supply and Promote Our Innovation Strategy
Grifols Continues Its Path of Sustainable Growth
Global Century-Old Company Built On Strong Values and Ethical Principles
Sustainability: A Strategic Pillar
Reinforcing Our Governance and Sustainability Strategy
Creation of…
Sustainability Committee
- Establish the core environmental, social and governance principles and commitments in our business model
- Oversee the integration of financial and non-financial information in our ESG initiatives
Sustainability Policy
… to continue driving our sustainability strategy
Grounded on 4 pillars
Integrated in our corporate strategy
Investor & Analyst Day June 21
Plasma Supply and Manufacturing
Accelerating the Execution of Our Expansion Plan
Eduardo Herrero – President, Bioscience Industrial Group
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Investor & Analyst Day June 21
Plasma Operations 1
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Key Drivers to Support Further Growth Plasma Supply: Leveraging Grifols' Competitive Advantage
Strengthening a global plasma-center network to ensure plasma supply and promote long-term sustainable growth
2021 Investor & Plasma Supply: Leveraging Grifols' Competitive Advantage
Multilevel Strategy to Increase Plasma Supply
Analyst Day June 21
U.S. and European Plasma Collections in 2021
Solid Rebound in Germany. Steady Recovery in U.S. Since April
- 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
2021 Investor & Analyst Day June 21
Analyst Day June 21 Strengthening Grifols' Plasma-Center Network
Diversification Plasma Center Capacity Business Optimization
Advancing the Execution of the Expansion Plan
- 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
Global Footprint to Support Sustainable Growth
Expanding and Diversifying Grifols' Presence
Diversification Plasma Center
Business Optimization
Capacity
Global Footprint to Support Sustainable Growth
Expanding and Diversifying Grifols' Presence
Diversification Plasma Center
Business Optimization
Capacity
Global Footprint to Support Sustainable Growth Diversification Plasma Center
Capacity Business Optimization
Expanding and Diversifying Grifols' Presence
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
Global Footprint to Support Sustainable Growth
Diversification Plasma Center Capacity Business Optimization
Expanding and Diversifying Grifols' Presence
| Plasma Centers |
CHINA | SRAAS |
|---|---|---|
| Operating | 270 (1) |
38 (3) |
| Under Construction | 20 (2) |
3 |
| Total | 290 | 41 |
Bolster presence in the Middle East and Africa
Access to new sources of plasma to reduce dependency on U.S. plasma
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
| 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 |
2021 Investor & Analyst Day
June 21
Global Footprint to Support Sustainable Growth
Diversification Supports Business Continuity
450 Plasma Centers1 Grifols Global Presence by 2022 Strategy
USA EU China Egypt
- 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
Analyst Day
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Leveraging Technology to Optimize Efficiencies
Digital Transformation
Investor & Analyst Day June 21
Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Integrated Technology to Enhance Donor Experience
Information from nearly 1 million active donors
Plasma-center personnel engage with donors
in Donor Hub
to donors
+13 million emails
Over 220K donors registered
Grifolsplasma.com
Automated marketing campaigns and multiple digital and tech tools
+100k text messages and push notifications sent
Business Optimization
• More new donors
Capacity
- Increasing plasma donations
- Loyalty and satisfaction
- Diversification
- Process efficiency
- Greater awareness and education
- Reliable and intuitive process
Analyst Day June 21
Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Capacity
Process Enhancement
- 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
One Grifols Fleet Management
- Plans to open concept centers in new areas in 2021 and beyond
- Establish Grifols' standards in acquired centers and increase average volume
Testing Optimization Talent Development
- 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)
Analyst Day June 21 Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Digital Transformation
Logistics Management System Grifols Testing Lab System
- 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
Capacity
Business Optimization
- Consolidate all plasma laboratory screening processes into one new corporate/global laboratory information management system
- This global system will cover endto-end plasma laboratory processes
Grifols Navigation System Artificial Intelligence
- 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
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Analyst Day June 21
Leveraging Technology to Optimize Efficiencies Diversification Plasma Center
Expected Improvements Derived From Business Optimization
Capacity
Business Optimization
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Analyst Day June 21
Donor Commitment Compensation Impact
Capacity Optimization
Business
Leveraging Other Costs
Donor Commitment Compensation
Donor commitment compensation increased in 2020 to recognize donor loyalty, COVID-19 challenges and better compete in the current plasma market
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
Donor Commitment Compensation Other Operating Costs
Investor & Analyst Day June 21
Manufacturing 2
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Analyst Day June 21
Inventory Levels to Rebound in 2H 2021 Efficient Inventory Management Ensured Ongoing Operations
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
2021 Investor & Strong Inventory Position and Efficient Supply Chain
Operations Supports Product Delivery
- 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 has increased since 2017
- Trend continues to show strong growth
Analyst Day June 21
Analyst Day June 21
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Digital Transformation 2019-2023
End-to-End Integrated Planning (E2E)
▪ Supply chain improvement through coordination and automation of the process
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
Accelerating the Execution of Our Expansion Plan Key Takeaways
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
Business optimization thanks to technology enhancements including digitalization and a fully integrated supply chain
Innovation-led improvements will drive growth of plasma supply
Robust inventory management has ensured essential product deliveries and greater efficiencies
Solid recovery expected throughout 2021
Investor & Analyst Day June 21
Innovation Strategy
Expanding Our Reach: Disease Management Beyond Plasma-Derived Therapies
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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Investor & Analyst Day June 21
Accelerating Grifols' Innovation Through A New Leadership
1
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Expanding Grifols' Global Innovation Footprint
Setting Three Large Hubs
12
last 3 years
Grifols' Therapeutic Areas and Platforms
A Pioneering Ecosystem to Promote Knowledge and New Opportunities
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Scientific Innovation Office
Integrating Internal and External Innovation
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
Grifols' Innovation Ambition
Sizable, Diversified, Steady Revenue Contribution
Investor & Analyst Day June 21
Grifols' Innovation Ambition
Sizable, Diversified, Steady Revenue Contribution
Investor & Analyst Day June 21
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A Pipeline to Achieve a Risk-value Balanced Portfolio
Delivering A Comprehensive Pipeline to Support Our Patients
| 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® Bi-weekly dose |
Xembify® Prefilled syringes |
|
| Hepatology | 2 GRI programs | Albumin 20% ACLF (APACHE) Albumin 5% Decompensated Cirrhosis (PRECIOSA) |
FlexBag® US 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 Fibrinogen Acquired Deficiency |
Fostamatinib*** AIHA indication 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 HIV Antibody HIV** GIGA 2070 COVID-19 |
GIGA 2050 COVID-19 |
||||
| Neurology | 3 GRI programs 5 ALK programs |
GRF6019 ABvac40 AD AD GRF6021 AKST4290 PD with PD Dementia |
* Alkahest; ** Project of AlbaJuna (Grifols' invested company); *** Licensed rights from Rigel Pharmaceuticals in EU and other countries
Caption
Commercial R&D
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Investor & Analyst Day June 21
Changing the Course in Neurology 2
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Dementia: A Global Challenge, a Personal Reality
Increasing Incidence of Dementia
Dementia involves loss of memory, language, problem-solving and other thinking abilities that are severe enough to interfere with daily life
"One of the major challenges of our generation"
We are facing a global challenge to find a cure, improve treatment, and ensure enough resources to enable people to live well with dementia
Sources: Alzheimer's Disease International, Worlds Alzheimer Report 2015, https://www.alz.org/alzheimers-dementia/what-is-dementia
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
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Investor & Analyst Day June 21
Holistic Approach to These Urgent Unmet Needs
Our Innovation Strategy in Neurogenerative Diseases (ND)
| Strategy Focus | |
|---|---|
| Diseases | Understanding the molecular basis of ND and those related with aging |
| Mechanism of Action (MoA) |
Disease-modifying therapies vs. Treating symptoms |
| Products | Antibody, small molecules, RNA-based drugs, plasma-derived drugs, etc… to be developed according to the validated therapeutic target |
R&D Efforts Covering the Whole Development Path
Our Innovation Strategy in Neurogenerative Diseases (ND)
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Plasma Is the Body's Highway of Communication
The Language of this Communication Encodes Health and Disease
The Balance in Plasma Proteins Determines Growth, Tissue Homeostasis, Apoptosis
We Apply Rigorous, Innovative Science to Derive Breakthrough Therapeutics from Plasma
2021 Investor & Analyst
Day June 21
Plasma Is a Rich Source of Proteins With Therapeutic Potential
We Are "Molecularizing" Plasma
We identify proteins in plasma that regulate vital functions in aging and disease
We have gained an unprecedented Understanding of Plasma Fractions
Our Research Platform
Understanding Plasma at a Molecular Level
Plasmatology
Innovation From Deep Analysis of the Plasma Proteome
7597 proteoforms
Molecular Choreography of Aging and Disease
Decoding Causal Relations of Disease Processes
Investor & Analyst Day June 21
Unprecedented Knowledge Base for Plasma-Derived Therapeutics
Best-in-class Plasma Proteomics
Proteomics Lead the Way to Disease Mechanisms
Most extensive profiling (>10,000 proteins) of healthy aging and diseases
Mass spectrometry, multiple array technologies
Plasma Fractions & Small Molecules
Differentiation between multiple diseases states (>60)
Increased interpretability of diseases by clustering
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2021 Investor & Plasma Fraction Improves Parkinson's Disease Dementia
Novel Therapeutic Candidates From Plasma
- Dementia associated with Parkinson's disease
- Randomized placebo-controlled study
- Two dosing periods of Plasma protein fraction
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
Studies From Baseline to Week 24 Superior Cognitive Effect to Standard of Care
Analyst Day June 21
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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; 2Dubois 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
Plasma Fraction Improves Mild-to-Moderate Alzheimer's Disease
Functional Improvements in Cognition and Daily Activities
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Moving Forward With the AMBAR Project
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Investor & Analyst Day June 21
Advancing Care in Immunology 3
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IG Replacement Therapy as the Mainstay Treatment for PID and SID Patients Primary and Secondary Immunodeficiency Driving IG Demand
1 MRB 2018: Analysis of Ig market in the U.S. 2018 and Forecast to 2025: 2Bousfiha et al. Primary Immunodeficiency Diseases Worldwide: More Common than Generally Thought. J Clin Immunol. 2013; 33:1-7; 3Internal Estimate ; 4Chronic Lymphocytic Leukemia
Expanding IG Replacement Therapy to Thousands of CLL Patients
CLL is the Fastest Growing Patient Segment for IG Therapy
HGG1 occurs in up to 85% of patients with CLL (due to malignancy itself and/or treatment)2,3
>60%mortality 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
Expected launch: 2026
CLL patients prescribed IG therapy expected to grow significantly
1 Hypogammaglobulinemia; 2Friman V et al. Hematol Oncol. 2016;1-12: doi 10.1002/hon.2323 [Epub ahead of print]; 3Seppänen M. Clin Exp Immunol. 2014;178(Suppl 1):10-13; 4Internal data
2021 Investor & High Market Potential for Gamunex® and Xembify® in CLL
Offering CLL Patients Flexibility in Site of Care
Analyst Day June 21
U.S. Leukemia Prevalence
Offering a Better Home Treatment Experience Improving Flexibility and Convenience
Xembify® Pre-filled Syringes Xembify® Biweekly Dosing
- Ideal for self-administration (manual push) and compatible with infusion pumps
- Ease of use and time-saving process
- Accurate pre-measured dosing
- Potentially helping to reduce medication errors
-
Reduces medical supply waste
-
Adds flexibility with new dosing regimen option
- Faster infusion rate (60ml/h)
- Opportunity to individualize dosing frequency
- Potential improvement in patient quality of life
Offering broader administration options provides a greater opportunity for treatment satisfaction and patient empowerment, which may support high levels of patient compliance
Analyst Day June 21
Advancing Towards Cutting-Edge Delivery Systems
Smart Pump System
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
Opportunity to leverage digital health platform to improve patient outcomes
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Investor & Analyst Day June 21
Shaping Cirrhosis Management in Hepatology
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Combination of Acute Treatment and Long-Term Albumin Use
Our Cirrhosis Management Perspective
Decompensated Cirrhosis
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Shaping the Future of Albumin
Our Innovation Strategy in Hepatology
| Albumin Most abundant protein in the body |
||
|---|---|---|
| Focus of investigation 15 years for more than Clinical & non-clinical program to understand Albumin's role in health and disease MoA and |
Albumin is widely used as a volume replacement/ expander fluid as a volume |
Albumin is shown to be altered in disease2,3 |
| these investigations… Concept of albumin as a pharmaceutical |
replacement/ expander fluid1 |
|
| with a multifactorial Mechanism of Action (focusing in hepatology and other |
Albumin's therapeutical potential Key discoveries in understanding
Albumin infusion shows clinical improvement in decompensated cirrhosis4 Plasma Protein Replacement with albumin may provide benefits across different diseases5,6
Investigations into albumin's potential use as a drug in complex diseases are underway
(focusing in hepatology and other diseases like Alzheimer)
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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
Exploring the Full Potential of Albumin
More Than Just a Volume Expander
Albumin Acts as a Multi-Target Disease-Modifying Agent
Its Function Correlates With Clinical Outcomes in Advanced Cirrhosis
Extensive Clinical Program
Albumin Treatment at Different Stages of Cirrhosis
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PRECIOSA Study: LTA Admin. to Revert Cirrhosis Progression
Prevention of Mortality in Subjects With Decompensated Cirrhosis and Ascites
Centers and Countries
~40 participating centers • Est. study end (LPLV): Q1 2023
U.S., Canada, Belgium, Denmark, France, Germany, Italy,
Spain and UK
Status (Apr 2021)
- Recruitment update: 129 subjects randomized (31%)
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Investor & Analyst Day June 21
APACHE Study: Bridging Therapy to Liver Transplant
ALADDIN Study: Understanding Disease Pathogenesis and PE-A 5% MoA
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
Translational research project supporting Apache, aim to provide key insights on ACLF and Albumin MoA
failure and ACLF in cirrhosis
PE A-5% mechanism of action in ACLF
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%)
N = 250 patients from EU participating in APACHE (59 randomized (24%), April 2021)
Capturing the Opportunity in Cirrhosis
Long-Term Albumin Use
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Investor & Analyst Day June 21
Thriving Against Infectious Diseases 5
| GRIFOLS | ||
|---|---|---|
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Analyst Day June 21
Leverage Our Learnings From Prior Efforts
Permanent Threat of Emerging Pathogens Calls for Developing New Therapies
Emerging Infectious Diseases (EID)
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 |
Deaths
The number of deaths from outbreaks recorded in the last two decades shows the big impact of infectious disease
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1Journal of Physiological Anthropology volume 39, Article number: 29 (2020); 2https://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-respiratorysyndrome-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
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Leveraging Our Capabilities to Fight Against an Emergent Pathogen Plasma Polyclonal Hyperimmunes Platform: Anti-COVID-19
10% Hyperimmune globulin IV
INSIGHT 012/OTAC
Study to evaluate its Safety and Efficacy in nonhospitalized patients with COVID-19
20% Hyperimmune globulin SC
C19-IG
Study to evaluate the safety and efficacy in infected asymptomatic ambulatory outpatients
Non-hospitalized patients age ≥ 55 with COVID-19 who have had COVID-19 symptoms ≤ 5 days
Target population
Ambulatory Asymptomatic patients with confirmed SARS-CoV-2 infection
Platform built from our vast experience in developing immunoglobulins from selected donors against specific pathogens
Investor & Recombinant and Polyclonal Hyperimmunes: GigaGen Platform
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2021
Analyst Day June 21
2021 Investor & Analyst
Day
GIGA-2050 Allows Clinical Validation of the GigaGen Platform
12,000 Anti-Coronavirus Antibodies Captured From 16 Convalescent Donors
June 21
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
Live SARS-CoV-2 Virus Neutralization
2021 Investor & Analyst
Day June 21
Grifols, in the Fight Against Pandemic
Commitment With Society and the World, Preparing for Future Challenges
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* )
Grifols is committed to society to keep working to bring new therapies
Not all countries have broad access to vaccines
COVID-19 is devastating in countries like India
New variants
that might become resistant to vaccines
Investor & Analyst Day June 21
Ophthalmology: Expanding Into a New Therapeutic Space 6
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Entering Into a New Therapeutic Space New Avenues for Research in nAMD and Diabetic Retinopathy
2021 Investor & Analyst Day
AKST4290: Blocking Eotaxin-Mediated Inflammation
Potent CCR3 Inhibitor for Multiple Therapeutic Indications
Blocking Eotaxin-CCR3 Signaling Reduces Retinal Inflammation
Addressing AMD and Diabetic Retinopathy
Eotaxin/CCR3 Binding increases
Membrane Permeability/Degradation
Immune Cell Recruitment
Cytokine Upregulation
Heightened Neuroinflammation & Neurodegeneration
2021 Investor & Analyst
Day June 21
AKST4290 Reduces Inflammation in the Eye
New Insights Into the Pathology of Eye Diseases: Cytokines and Immune Cells
Inflammatory Proteins from Circulating Plasma Accumulate in the Eye
AKST4290 Reduces Inflammatory Proteins and Infiltrating Immune Cells in the Eye
2020
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
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
- 87 -
An Oral Treatment Would Be Highly Desirable Diabetic Retinopathy: A Major Unmet Medical Need
Manifestations of DR Characteristics and Progression of DR
Phase 2 study in Diabetic Retinopathy (DR) with AKST4290
- 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
2021 Investor & Analyst Day June 21 Entering a Large and Growing Market Meeting the Challenge and Addressing the Opportunity Neovascular Age-Related Macular Degeneration (nAMD) Diabetic Retinopathy (DR)
Investor & Analyst Day June 21
Continuous Developments in Diagnostics 7
- 90 -
Analyst Day June 21 Diagnostics R&D Areas of Focus
Proteins
Immunohematology
DG Gel
New Antisera development
New gel card DG Gel DC Scan Plus testing
Multicard
Extended phenotyping
Drug Interference Solution
Kit to resolve daratumumab interference for cancer patients
Immunoassays for donor screening
Ultrasensitive SMC Assays in development
Discriminatory Multiplex: HIV/HCV, HBsAg
| HBcore | Chagas | HTLV |
|---|---|---|
| Syphilis | CMV | HBsAg |
| Confirmatory |
High throughput analyzer in development
Clinical Diagnostics
SARS CoV2 Antibody Test CE Marked
Promonitor – Biological Drug Monitoring
Promonitor Quick Anti-IFX & IFX
Promonitor Quick Anti-ADL & ADL
Recombinant Proteins
Grifols Portfolio (internal customers)
| Screening/Diagnostics | Therapeutics |
|---|---|
| • IAs for Donor Screening • Immunohematology |
• Alkahest (Neurodegeneration) • Biosciences (SARS CoV2) |
| CDMO Opportunities (external customers) |
Investor & Analyst Day June 21
Contract Development & Manufacturing at Grifols, Emeryville
Recombinant Protein Excellence in Microbial and Mammalian Systems
Combining the Chiron legacy of recombinant expression innovation with Grifols quality and excellence
Current Active Projects
Orphan drugs
Vaccines
Wound healing
Therapeutic enzymes
Continually expanding and adding new capabilities…
- 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
Analyst Day June 21 Diagnostics R&D Areas of Focus
Nucleic Acids
- 93 -
NAT Donor Screening
Lab Automation
Panther ART: to support greater lab automation and efficiency
Improved middleware
Other New Procleix® Assays
Babesia assay: CE Marked (Jan 2021)
Plasmodium assay: in development
New Multiplex Procleix® Assays
UltrioPlex® E assay
ArboPlex® assay
New Multiplex Assays for NAT Blood Screening
New Solutions to Enhance Testing Efficiency and Blood Safety
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
Increases laboratory efficiency:
Increases production efficiency by combining manufacturing operations
HIV-1 HIV-2 HCV HBV HEV IC
Multiplex format offers significant advantages to both customers and Grifols
and liquid waste)
Analyst Day June 21 Diagnostics R&D Areas of Focus
Nucleic Acids
NAT Donor Screening
Lab Automation
Panther ART: to support greater lab automation and efficiency
Improved middleware
Other New Procleix® Assays
Babesia assay: CE Marked (Jan 2021)
Plasmodium assay: in development
New Multiplex Procleix® Assays
Ultrio® Plex E assay
ArboPlex® assay
Clinical Diagnostics
Infectious Diseases
Procleix® SARS-CoV-2 assay
Grifols Diagnostics Rapid Response to Pandemic
Procleix® SARS-CoV-2 Assay Developed in <3 Months
Highly sensitive and specific detection of SARS-CoV-2 RNA
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
Our ultra-high sensitivity and long experience in donors testing allows testing in pools of samples improving efficiency
Over 10 million tests manufactured in San Diego
Test is widely used in select EU under license agreement and U.S. markets
EU1 : as an aid in diagnosis of COVID-19 (respiratory specimen testing)
US: organ/tissue donor screening to support transplant safety
Grifols' employee testing
SARS-CoV-2
Procleix ® Panther System
Collaboration Made SARS-CoV-2 Assay Project a Success!
- 97 -
Analyst Day June 21 Diagnostics R&D Areas of Focus
Nucleic Acids
NAT Donor Screening
Lab Automation
Panther ART: to support greater lab automation and efficiency
Improved middleware
Other New Procleix® Assays
Babesia assay: CE Marked (Jan 2021)
Plasmodium assay: in development
New Multiplex Procleix® Assays
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)
Gain FDA Clearance for AlphaID™ at Home Expanding AlphaID™ Testing to OTC Consumer Program
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
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
2021 Investor & Analyst
Day June 21
AlphaID™ at Home Genetic Health Risk Service
User Comprehension Study Overview
Our Goal Remains Firm
Accelerate Diagnosis to Stop Genetic Emphysema's Progression
is helping to accelerate diagnosis and is the basis for innovative testing strategies
Grifols WW Testing Program
>850,000 tests performed
Investor & Analyst Day June 21
Continuous Developments in Alpha-1 Diagnosis
Self-Testing Will Provide Benefits for Patients and HCPs
Allows for further developments that would accelerate testing by better addressing customers needs
Analyst Day June 21
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Market Size Opportunity
For Selected Projects
| Product | Indication | Market Size | |
|---|---|---|---|
| Immunology | SCIG / IVIG | SIDs-CLL | |
| ACLF | |||
| Hepatology | Albumin | LTA Cirrhosis | |
| Pulmonology | Alpha-1 AT | Non-CF Bronchiectasis | |
| Fostamatinib | AIHA | ||
| Haematology | Fibrinogen | Acquired Deficiency | |
| ATIII | New indication | (each) | |
| HIV Antibody | HIV | ||
| Ophthalmology / Others |
AKST4290 | nAMD & DR | |
| GIGA 564 | Anti-CTLA-4 Oncology | (each) | |
| Infectious | IgM | Bacteremia | |
| Diseases | GIGA2050 | COVID-19 | |
| GRF6019 | Alzheimer's Disease | ||
| AKST4290 | Parkinson's Disease with Dementia | ||
| Neurology | ABvac40 | Alzheimer's' Disease | (each) |
| GRF6021 | Parkinson's Disease |
Expanding Our Reach: Disease Management Beyond Plasma-Derived Therapies Key Takeaways
| 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
Focus on high prevalence and transformational therapies that meet global challenges with huge untapped potential
Transforming disease management in Neurology, Ophthalmology and Infectious Diseases through innovative platforms led by Alkahest and GigaGen
Exploring large opportunities on plasma: sharpen focus on CLL; shaping cirrhosis treatments and accelerating alpha-1 diagnostic
Strengthening pipeline in Diagnostic across the value chain and new diseases
Investor & Analyst Day June 21
Customer Centricity
Showing Strength and Successfully Managing Adversity
Lafmin Morgan – Chief Commercial Officer
- 105 -
2021 Investor & Analyst Day
June 21
Pandemic Impact on Healthcare
Short-Term Impacts Continue in 2021, but Receding
| Patients | Healthcare Hospitals & Providers Institutions |
Commercial Interactions |
||
|---|---|---|---|---|
| Diagnosis visits remain 12% below 2019 baseline, generating a -3,8% gap in Px1 |
Biopharma in-person patient visits were up 17% in March'21 with all specialties increasing1 |
Lab testing (all settings) still below 20192 |
Perceived value of 1-1 VC vs. in-person has fallen; both Specialists and PCPs now |
|
| Elective procedures still | The pandemic could cause | want more in-person1 | ||
| remain 15% below 2019 levels1 |
Total prescriptions recovering compared with 2020 (+6%)1 |
U.S. hospitals to face between \$53 billion and \$122 billion in revenue loss this year3 |
Total Biopharma details increased 13% in March'21 rising to 93% of baseline1 |
Sources: 1 IQVIA data published April 2021; 2 IQVIA data published September 2020; 3Hospital finances in 2021: 10 things to know (www.beckerhospitalsreview.com)
2021 Investor & Analyst Day
June 21
Pandemic Impact on Healthcare
Patients Are Facing Additional Challenges
Pandemic Impact on Healthcare
Providing Support, Bringing New Therapies and Looking for New Solutions
| Alpha-1 patients | PID/SID patients | ITP patients | COVID-19 patients |
|---|---|---|---|
| Patient Support Programs (US, EU and LATAM) |
Xembify® launch in the US |
Launch of Tavlesse® just after COVID-19 wave 1 |
Development and launch of TMA in <3 months |
| Home Infusion | Continuous support to patients groups |
R&D of therapies to fight against COVID-19 |
|
| AlphaIDTM in patient hands |
Demonstrating Resilience and Commitment to Sustainable Growth
Increasing Our Revenues in This Extraordinary Context
- 109 -
Investor & Analyst Day June 21
Continue Introducing Innovations to Address Customer Needs
Contributions From New Products >50% of Revenue Growth in 2020
ULTRIO PLEX E
• New flexible container to complement vials and broaden Grifols offering to customers
• US launch in 2021
Investor & Analyst Day June 21
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Robust Demand and Launch of New Products Bolster Bioscience
Revenues Reach EUR 4,241M With a 8% CAGR
40 consecutive quarters Sustained Quarter over Quarter growth for more than
Investor & Analyst Day June 21
Long Term Trends Continue to Support the Return to Strong Growth
- 113 -
Pulmonology: Our Goal Remains Firm
Accelerate Diagnosis and Stopping Genetic Emphysema's Progression
is helping to accelerate diagnosis and is the base for innovative testing strategies
Grifols WW Testing Program
>850,000 tests performed
- 114 -
Analyst Day June 21
Immunology: The First Step to Help Patients is Diagnosis
NIH Estimates 500,000 Undiagnosed PIDD Patients in the US1
DIAGNOSIS
Average PIDD diagnosis still takes 12.4 years2
- 115 -
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
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; 5Bonilla FA, et al. J Allergy Clin Immunol. 2015;136(5):1186-1205.e1-78
Investor & Analyst Day June 21
- 116 -
Immunology: SID Market Keeps Growing
Significant Room to Continue Helping Patients with SIDs
NEW USES AND INDICATIONS
SID market continues to grow in hematological malignancies and beyond
Driven by…
Increased use of SID-inducing medication in both oncological and autoimmune indications
Extended survival rates of cancer patients
Chronic Lymphocytic Leukemia (CLL) and Hypogammaglobulinemia (HGG)
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.)
Intensive Care and Hepatology
The Use of Albumin in Liver Disease Will Become a Key Growth Driver
NEW USES AND INDICATIONS
- 117 -
Investor & Analyst Day June 21
Immunology and Neurology
IgG per Capita Consumption Growth in the Coming Years
EXPANSION
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
Xembify®, Expanding Grifols IG Portfolio
Aiming to Meet the Large, Unmet Medical Need in PIDD
NEW PRODUCTS
Xembify® U.S. Sales Volume Since Launch
Xembify® sees growth in Q1 2021 through an accelerated base of patients and prescribers, paving the way for continuity and further adoption in 2021
10-15% of Grifols global IG sales will be Xembify®
of Xembify® prescribers continue to prescribe Prescribers Dec 2020 Mar 2021 90% Patients of Xembify® patients that 85%
Mar 2021
start, continue treatment
Dec 2020
Investor & Analyst Day June 21
Pandemic Has Not Been an Obstacle
Continue to Bring New Therapies for Chronic ITP Patients*
NEW PRODUCTS
Tavlesse® GER Sales Volume since Launch
Tavlesse® has been successfully launched in Q3 2020 in UK and Germany
Investor & Analyst Day June 21
Addressing Customer Needs Strengthening Our Market Position
- 121 -
Maintaining 2nd Market Position in IVIG and IVIG+SCIG Market
Delivering on Our Promises
In the face of increasingly tough competition (SCIG products) years ago we committed to keep outperforming
Xembify® launch and customer centric developments will allow us to keep strengthening our market position
Grifols IVIG growth vs. SCIG + IVIG market growth ('15-'19)
We maintain our 2 nd Market positionin
the IVIG market and even considering the IVIG + SCIG market
CAGRs
- 122 -
Our Solid Customer Centric Mindset is Key Alpha-1 Strong 70% Market Share Despite of Years of Competition
A strong customer centric mindset has permitted Grifols to improve market share in the middle of the global pandemic
| Reliable Supply | Patient Support | Testing Continued Innovation |
|---|---|---|
| ----------------- | ----------------- | --------------------------------- |
Sustained and reliable product supply
Important Alpha-1 product shortage from competitor in Q4'20 - Q1'21 challenged treatment continuity of hundreds of patients in EU during pandemic
Grifols, the Global Alpha-1 leader, was ready to immediately put in place all efforts thus guaranteeing therapy to patients
Our Solid Customer Centric Mindset is Key Alpha-1 Strong 70% Market Share Despite of Years of Competition
A strong customer centric mindset has permitted Grifols to improve market share in the middle of the global pandemic
Our Solid Customer Centric Mindset is Key Alpha-1 Strong 70% Market Share Despite of Years of Competition
A strong customer centric mindset has permitted Grifols to improve market share in the middle of the global pandemic
Novel Partnership Journey to Build on Complementarity
Investor & Analyst Day June 21
&
Investor & Analyst Day June 21
- 127 -
The Diagnostic Division Reported €776M Over 2020
Sustainable Growth Over the Last 5 Years
- 128 -
Global Leader in Blood Donor Screening
Plasma Testing Poised for Strong Growth
Blood donations tested
donations tested every minute with a Procleix® assay*
Plasma donations
We are converting all Grifols testing locations to Procleix® Instruments and Assays
Recent plasma center
Milestones and Innovations for Our Customers
Our Innovation Strategy Delivering on the Future Needs of Transfusion Patients
Customer Value Marketing – UltrioPlex E
Making an Impact in Blood Banks Operation
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
- 131 -
HEV INFECTIONS 20M WORLDWIDE
Laying the Foundation to Become a Leader in Immunohematology
Strong Resilience in Spite of a Global Pandemic
Execution Focused on Customers Continues to Fuel Growth
Continuous Success Across All Customer Segments With Highest Customer Loyalty
Investor & Analyst Day June 21
- 134 -
Investor & Analyst Day June 21
Weathering the Storm in 2020
COVID-19 Challenges Impacted Performance With a Few Important Exceptions
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
PharmacyKeeper achieved strong growth in 2020
Day June 21
Providing Life-Sustaining Products and Technology for Patients and Pharmacy Solutions During the Pandemic
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
Investor & Analyst Day June 21
- 137 -
Bio Supplies Diversifies the Revenue Base
Successful Business Expansion Over the Last 4 Years
- 138 -
Bio Supplies Commercial Grows by Double Digits
Building the Pillars to Assure Excellence in Long-Term Partnerships
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
High growth expectations driven by…
2021 Investor & Analyst Day June 21
Several companies using Grifols excipients in clinical trials
New industry applications for current portfolio
New products
Showing Strength and Successfully Managing Adversity Key Takeaways
| Customer and patient centricity has allowed us to be prepared for the future |
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 |
|---|---|---|
| Demonstrated ability to succeed in competitive markets |
Long-term trends also support growth in Diagnostic and Hospital divisions |
Bio Supplies is a growing high-margin business, significantly contributing to the development of new drugs and products |
Grifols, Along the Journey
Grifols is Uniquely Positioned to Help Patients and HCPs Along All the Way
2021 Investor and Analyst Day
June 3, 2021
Investor & Analyst Day June 21
New Business Models
Advocating Patients' Needs Through a Sustainable Global Plasma Model
Daniel Fleta – Chief Industrial Officer
- 143 -
2021 Global Dependency on U.S. Plasma
Investor & Analyst Day June 21
- 144 -
U.S. plasma collections are increasing at a faster rate than the global market
2021 Investor & The U.S. Leads Global Plasma Collections
Population (M) Plasma Collections (M L/year) Canada* 0.3 8.8 37.7 U.S. 45.9 138.7 331.0 5.2 46.1 112.8 Egypt - - 100.3 China 8.9 6.2 1,433.8 Liters per 1,000 population Austria, Czechia, Germany, Hungary Rest of Europe 3.9 6.1 634.3
Analyst Day June 21
- 145 -
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.
Global Dependency on U.S. Plasma
2018 IgG Plasma Usage vs. Plasma Collected (millions of liters)
If current landscape remains unchanged, the plasma surplus will grow in the U.S. while deficits will increase in other regions, particularly in Europe
Source: "Plasma Flows on a Global Level: Impact and Realities in Europe," Matthew Hotchko, PhD, Marketing Research Bureau, GPS Meeting, October 28-30, 2020.
- 146 -
Analyst Day June 21
Higher Demand for Plasma Driven by Healthcare Systems Development, New Indications and Higher-Prevalence Diseases
Worldwide Prevalence*
Diagnosis and prescriptions are increasing
Albumin – Alzheimer's and Cirrhosis
Ig – Secondary Immunodeficiencies (i.e. Oncology)
Other indications
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
- 147 -
Grifols Value Proposition for Plasma Self-Sufficiency Projects
Exceptional Synergies to Unlock the Potential of Strategic Projects
Tech.Transf. & EPCM Capabilities Grifols Engineering
- 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
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
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
Investor & Analyst Day June 21
Clearing the Path Towards Self-Sufficiency
Daniel Fleta – Chief Industrial Officer
- 149 -
Egypt at a Glance 2020
Investor & Analyst Day June 21
Strengthening Egypt's Healthcare System and Self-Sufficiency
Grifols Engineering, Industrial and Quality Expertise Offer a Unique Opportunity
Egypt
- Identification of plasmaderivatives as a strategic asset for the country
-
Improve Egypt's healthcare system
-
Know-how and technology
- Operations management
- Quality and safety
- Training
Strategic alliance between Grifols and the Egyptian government will help the country attain selfsufficiency of plasmaderived 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 selfsufficiency of world-class plasma products
2021 Investor & Analyst Day
June 21
Egyptian Plasma-Center Network
- 152 -
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
Egyptian Manufacturing Site
Medical City Development Plan in New Capital City
- 154 -
Manufacturing Site Location
Scope
Plasma logistics center, labs, vivarium, R&D, common areas, warehouses, utilities and manufacturing plants
- 155 -
Capacity 1 Million Liters of Plasma (expandable)
Fractionation, purification and fill-and-finish of:
- Coagulation factors
- Gammaglobulins
- Albumin
Analyst Day June 21
Manufacturing Plant
- 156 -
2021 Investor & Analyst
Day June 21
Clearing the Path Towards Self-Sufficiency Key Takeaways
| 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 |
Egypt offers growth potential as a fast-growing and developing nation and leading regional supplier to the Middle East and Africa |
|---|---|---|
| Clear willingness of the Egyptian government to set a legislative framework that promotes the viability and sustainability of this project |
Grifols Industrial through Grifols Engineering is uniquely poised to offer cutting-edge turnkey solutions |
Free up plasma and manufacturing capacity to serve other growing markets |
Investor & Analyst Day June 21
China
Progressing on Our Strategic Alliance Under a Successful New Business Model
Amarant Martínez – VP China Affairs Office
- 158 -
Great Potential on a 10-Year Horizon
At the Forefront of Global Health Spending
Investor & SRAAS Successfully Weathered COVID-19
Limiting Plasma Collections Impact to -2.0% vs. -9.3% of the Industry
2021
Analyst Day June 21
Source: Reports released by listed manufacturers 2020. Internal Analysis.
Sustained Double-Digit Growth Adds USD 500M+ Each Year
Leveraging Our Capabilities to Become Leaders in Albumin and IG
- 161 -
1Multinational corporations; 2Market share; Source: Institutes of Food and Drug Control.
Investor & Analyst Day June 21
Bioscience Commercial Platform Under SRAAS
From Third-Party Distribution Model to Strategic Partnership With Leading Manufacturer
| Albumin | FVIII |
|---|---|
| IVIG | PCC |
| IMIG | Fibrinogen |
| Hep B IG | Thrombin |
| Tetanus IG | Fibrin Sealant |
| Rabies IG |
- 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
Investor & Analyst Day June 21
Fastest Growing IVD Market With Great Potential
Implementing the Go-Direct Model
1 st 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
- 163 -
Advancing towards a Diagnostic integrated model for blood and plasma screening
China: A Dynamic Innovation Ecosystem
Capitalizing on New Opportunities
"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
- 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
| Centralized Testing |
Successful SRAAS Pilots according to Provincial Health Commission requirements |
Supporting authorities with Grifols' full-range capabilities |
|
|---|---|---|---|
| R&D | SRAAS development of IVIG 10% and SCIG 20% |
||
| Others | Take Innovation Beyond Plasma to China |
||
- 164 -
Sources: Chinese Aging Well Association-Alzheimer Branch; Jian Kang Shi Bao.
Progressing on Our Strategic Alliance Under a Successful New Business Model Key Takeaways
| Unparalleled growth potential across divisions |
Excellent performance amid these challenging times |
Continue delivering on execution in the second year of the alliance |
|
|---|---|---|---|
| Robust capabilities and broader portfolio through the integrated Bioscience commercial platform under SRAAS |
Advancing towards a Diagnostic integrated model |
Innovation as a key element within the alliance |
|
Investor & Analyst Day June 21
Canada
Leveraging Our Experience and Capabilities to Meet the Needs of National Customers
Joel Abelson – President Bioscience Commercial
- 166 -
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
Only large-scale domestic manufacturing facility and uniquely positioned for continued growth across full platform of service offerings
Grifols is supporting Canada's path towards selfsufficiency by partnering with Canadian Blood Services to enhance security of supply in a novel proof-ofconcept partnership model
One of the highest IG usage per capita with one of the lowest plasma donation rates
The pandemic heightened the urgency for plasma selfsufficiency/domestic production
- 167 -
Building On A Legacy
Over 30 Year History as the Primary Fractionator for Canada's Blood Operators
Canada's Blood Operators
Canadian Blood Services and Héma-Québec
- 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
Plasma Opportunity in Canada
One of the Highest IG per Capita. One of the Lowest Plasma Donation Rates
Canada is one of the highest users of Ig per capita…
243g per 1,000 population (CBS figures)
IG grams shipped and rate of sufficiency
• Canada's plasma volumes sent for fractionation are 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
8.8L collected per 1,000 population
(2017 data)
… but has one of the lowest plasma donation rates
• Few source plasma (apheresis) collection centers have been established (non-remunerated model)
primarily from recovered plasma
(for which no alternative exists)
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.
On the Path Towards Self-Sufficiency
Enhancing Domestic Supply Security Through Partnership With CBS
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 proofof-concept approach aimed at offering an optimized collections model that leverages Canadian Blood Services' extensive expertise and industry best practices for plasma collection.
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
"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
Key Takeaways
Investor & Analyst Day June 21
Leveraging Our Experience and Capabilities to Meet the Needs of National Customers
| 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 |
Strengthening Grifols' presence in Canada, building on a legacy of partnership in Canada's blood system |
|---|---|---|
| Market opportunity as demand continues to grow and IG use per capita is one of the highest in the world |
Only large-scale domestic manufacturing facility |
Uniquely positioned for continued growth across full platform of service offerings |
Investor & Analyst Day June 21
Driving Resource Allocation to Support Further Growth and Profitability
Alfredo Arroyo – Chief Financial Officer
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Investor & Analyst Day June 21
Delivering on Our Commitments
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Investor & Analyst Day June 21
Delivering on Our Commitments
2020 IAD Key Takeaways
| Driving long-term sustainable growth across all divisions |
Reinforcing our international expansion through SRAAS in China and alliances in Canada and Egypt |
Increasing plasma supply through organic and inorganic initiatives |
|---|---|---|
| Integrated innovation efforts as a core strategic pillar |
Continuous CAPEX to support future growth |
Deleveraging and securing liquidity remain key priorities |
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Investor & Analyst Day June 21
Delivering on Our Commitments
2020 IAD Key Takeaways
Investor & Analyst Day June 21
Proven Resilience During Unprecedented Times 2
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Proven Resilience During Unprecedented Times
2020 COVID Impacts
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Analyst Day June 21
Investor & Proven Resilience During Unprecedented Times
2021 COVID Impacts
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
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Investor & Analyst Day June 21
3
Key Drivers to Support Further Growth and Profitability
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Analyst Day June 21
Key Drivers to Support Further Growth and Profitability Fit for Growth
Structural costs optimization plan
Divest non-strategic business lines
Cost Optimization and Divest Non-Strategic Lines
Resetting Cost Base to Promote Innovation
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
Divest Non-Strategic Business Lines
- 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
Focus on Deleveraging and Securing Liquidity
6 Strategic Investments Led to a Higher Leverage Ratio
2021 Investor & Analyst Day June 21
Debt and leverage ratio remain a key priority
Efforts to reduce debt without missing strategic opportunities
Securing liquidity
Investor & Analyst Day June 21
M&A to Support Growth and Profitability 4
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Investor & Successful Track Record to Support Growth
Demonstrated Ability to Successfully Expand
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2021
Analyst Day June 21
Investor & Analyst Day June 21
Securing Our Plasma Supply
Consolidating Our Competitive Advantage
Increase Grifols' plasma supply and expand, diversify and reinforce our plasma-center network
Q4 2020 Acquisition of 11 plasma centers from Green Cross
- 11 U.S.-based plasma centers that obtain 350k liters of plasma/year
- USD 90 million
Q1 2021 Acquisition of 25 plasma centers from BPL
- 25 U.S.-based plasma centers that obtain 1m liters of plasma/year
- USD 370 million
Q2 2021 Acquisition of 7 plasma centers from Kedrion
• 7 U.S.-based plasma centers that obtain 240k liters of plasma/year
• USD 55 million
Q1 2021 Plasma Supply Agreement in Hungary
• 7 Hungary-based plasma centers that obtain 120k liters of plasma/year
Enhancing Our Innovation Strategy
Integrating Alkahest and GigaGen
Diversifying and reinforcing our pipeline by exploring solutions beyond plasma in order to accelerate our plan for sustained margin expansion
Acquisition of the remaining 55% equity of GigaGen
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 56% stake of GigaGen
- Acquisition of the remaining 56% share capital of the U.S. biopharmaceutical company
- USD 80 million
Global Expansion Through New Business Models
Canada, Egypt and China Lead the Way
Multi-level approach to enter new markets and become a reliable long-term partner while helping countries bolster their self-sufficiency
October 1, 2020 Closing of the acquisition of Green Cross fractionation plant in Canada
- 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
Strategic alliance with the Egyptian government
November 24, 2020
• The plasma centers will initially collect around 600k liters plasma/year. The plant will have a fractionation capacity of up to 1m liters/year
SRAAS Continues to Outperform
Delivering Solid Performance
P&L Variations
- 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
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1
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
Driving Resource Allocation to Support Further Growth and Profitability Key Takeaways
| Streamlined focus on value creation fundamentals |
Active efforts to divest non-strategic line of businesses |
Increasing profitability through driving innovation |
|---|---|---|
| Deleveraging and liquidity remain a key priority |
Successful track record of organic and inorganic growth |
Clear focus on ESG and integrated reporting Half Year earnings release |
Investor & Analyst Day June 21
Environmental, Social and Governance
Shaping the Industry's Sustainability Standards
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Thomas Glanzmann – Vice-Chairman of Grifols' Board of Directors and Chairman of Grifols' Sustainability Committee Nuria Pascual – VP Corporate Treasury & Investor Relations Officer
Investor & Analyst Day June 21
Building on Our Heritage to Foster Sustainability as a Strategic Pillar
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Investor & Analyst Day June 21
Sustainability in Our DNA Since 1909…
Built Historically on Our Strong Corporate Values
Investor & Analyst Day June 21
… Strengthened Through Our Governance
Commitment Based on Ethical Leadership and Internationally Recognized
Integrating Sustainability in Our Strategy
On the Path Towards 2030 and Beyond Led by Our 4 Pillars
Investor & Analyst Day June 21
Sustainability Plan: Our Commitments 2
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2021 Sustainability Plan: Our Commitments
Investor & Analyst Day June 21
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Our People Is Our Top Priority
Our Commitment Promotes Equality, Diversity, Inclusion and Development
Our People Is Our Top Priority
Equal Opportunities, Diversity and Professional Development
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Commitment to Donors and Patients
Ensuring Non-Discrimination and Donor Health, Safety and Well-Being
Commitment to Donors and Patients
Grifols' Commitment to Patients is Based on Three Pillars
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Analyst Day June 21
Commitment to Donors and Patients
Our Sustainable Business Model Pursues Social Value
(1) Corresponds to the high end of the sensitivity analysis performed
Day
Our Contribution to Social Progress
Investor & Analyst June 21 Social Action Plan
Education
Help promote access to education and equality of opportunities in communities where Grifols operates
Contribute to driving positive change: gender equality, ethics and values
Build close ties in donor communities and areas where production facilities are located
Community programs in other countries and humanitarian aid
Promote and improve access to healthcare
Direct and foundation-led initiatives
Promote science as a driver of positive change
Contribute to recover and enhance natural and environmental patrimony
Direct initiatives and joint projects in collaboration with nature conservation associations
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Environmental Responsibility
Our Six Commitments for 2030
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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 |
Non-discrimination and measures to ensure donors' health, safety and well-being |
|---|---|---|
| Supporting patients through access to treatment, awareness campaigns and support programs |
Creating social value beyond financial performance |
Significant progress on 2030 environmental targets |
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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Excelling in Grifols' Core Pillars
Since 2005, We Have Excelled in 3 Core Pillars Leading to a 10 Fold Growth
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A Solid Basis
Emerging Stronger From the Pandemic; Results to Start Paying Off in the Short-term
1 10 of 20 centers to be opened during 2021; 2. Total DCs opened from 2020 Q4 until end of 2021
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Innovation
Investor & Analyst Day June 21
Collecting Results From New Innovation Approach While Paving the Way for the Future
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 … +
Recent innovation results Foundations for innovation as growth engine
New Scientific Innovation Organization
Expand towards a holistic approach in our core therapeutic areas (Internal, External, Plasma, Non-plasma)
Powerful legacy & promising platforms
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Investor & Innovation
2021
Analyst Day June 21 A Global Ecosystem to Deliver Value in Our Core Therapeutic Areas
Therapeutic areas
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Revenue
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Investor & Innovation
2021
Analyst Day June 21
Moving Forward, Innovation Will Be the Engine of Profitable Growth
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2021 Investor and Analyst Day
June 3, 2021
Investor & Analyst Day June 21
Glossary
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Glossary
2021 Investor & Analyst Day June 21
- 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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Glossary
2021 Investor & Analyst Day June 21
- 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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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.
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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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.