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Biotest AG — Investor Presentation 2022
Jun 30, 2022
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Investor Presentation
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June 30, 2022
Disclaimer
This document has been prepared by GRIFOLS, S.A. (GRIFOLS or the "Company") exclusively for use during the 2022 Investor and Analyst Day on June 30, 2022. 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.
Agenda
| Time (all in CET) | Topic | |||
|---|---|---|---|---|
| 10:30-11:00 am | Breakfast | |||
| 11:00-11:05 am | Welcome | Nuria Pascual | ||
| 11:05-11:15 am | Introductory Remarks | Raimon Grifols | ||
| 11:15-11:50 am | Plasma | Peter Allen | ||
| 11:50-12:00 am | Egypt and Canada |
Daniel Fleta | ||
| 12:00-12:45 am | Biopharma | William Zabel, Joana Sàbat | ||
| 12:45 am-1:00 pm | Diagnostic | Antonio Martínez | ||
| 1:00-2:15 pm | Lunch | |||
| 2:15-2:45 pm | Innovation | Albert Grifols Coma-Cros, César Cerezo, Carter Keller | ||
| 2:45-3:30 pm | Biotest | Joana Sàbat, Jörg Schüttrumpf | ||
| 3:30-4:00 pm | Financials | Alfredo Arroyo | ||
| 4:00-4:15 pm |
Final Remarks | Víctor Grifols Deu | ||
| 4:15-5:00 pm | Q&A |
Grifols has supported patients amid unprecedented times through the generosity of its donors and commitment of its 25,000 employees
Reinforcing our mission through a sustainable approach, strengthening…


Reinforcement of Plasma Supply in the Past 2 Years…
Expanding and Diversifying Our Plasma Network, Capacities and Capabilities

6
Strengthening our fractionation capacity 15 ML/year
Note: plasma centers as of June 30, 2022; SRAAS not included in the 400+ figure as it is not fully consolidated in Grifols' financials

… Sees the Business Strongly Positioned Today
Expanding and Diversifying Our Plasma Network, Capacities and Capabilities

7
Note: plasma centers as of June 30, 2022; SRAAS not included in the 400+ figure as it is not fully consolidated in Grifols' financials
Innovation Ecosystem to Drive Growth and Profitability

Bolstered With the Biotest Acquisition

Streamlining Our Organizational Model… Plasma


The "New Grifols" … To Strengthen the Core Plasma

Creation of full-fledged Business Units
- Enhanced effectiveness and operational efficiencies
- Stronger governance model
- Accountability over execution
- Less operational complexity
- Greater speed and agility through organizationwide services
- Reduce time-to-market reaction
Supply
Innovation
Reorganization
Operating With a Sustainable Approach
The First in the Industry to Have a Set of 3 Policies Reflecting Our Commitments
Pioneers in developing a Plasma Donors Policy
Reconfirming our pledge to Patients and Patient Organizations
Underscoring
+
Human Rights
30 Goals for 2030 across the organization
- ✓ 50% of women in Senior Management positions
- ✓ Achieve 100 training hours/employee per year
- ✓ Increase number of social outreach initiatives and social initiatives investment by 50%
- ✓ Donate 240 million international units of clotting factor medicines to support hemophilia patients in developing countries
- ✓ Increase by 10% financial contributions to the Jose Antonio Grifols Lucas Foundation
- ✓ Achieve >60-80% of total spending on suppliers assessed by ESG criteria
our respect for
Donors and Patients: At the Heart of Our Operations
Commitment to Donors and Patients
Social Value
For PATIENTS
€28,600M+
positive impact of 4 main plasma proteins (IG, Albumin, Alpha-1, pd Factor VIII)
€1,800M+ For DONORS
Physical and psychological wellbeing Financial stability Educational Better health
expenses
Note: The Social Return on Investment (SROI) method aims to gain a deeper understanding of an organization's social, environmental and economic impact. The SROI method offers Grifols a valuable cost-benefit analysis. The SROI uses individual assessments to measure the change in stakeholders' lives because of Grifols' activities. The SROI framework is not a financial framework and derives from the social accountancy. Therefore, the framework attempts to put a number on qualitative issues, and it will always show approximate values.
€700M+
€20M+
dedicated to patient advocacy groups and organizations
For LOCAL COMMUNITIES
Impact on Society Enhancing Our Operations' Multiplier Effect

Our Foundations Socio-economic Impact


Note: Grifols determined the socio-economic impact of its operations in terms of wealth generation and job creation in the United States, Spain, Germany and Ireland. The input-output framework is an accounting instrument that represents all production and distribution operations of an economy in a given timeframe. This model enables observing the different flows of intersectoral transactions in a specific economy in a reference year. In addition, it allows us to observe a series of effects about the production of the system, which appear broken down between the direct or initial, indirect and total effects, which suppose the sum of the previous ones.

Our Team Is in Our Top Priorities
Grifols Talent

14
Talent development

Building On Our Ambitious 2030 Environmental Goals
Environmental Responsibility




+15%
energy efficiency per unit of production

Circular economy
continue implementing new measures

100% (from 70%) electricity consumption from renewable energies


Recognized Among the World's Most Sustainable Companies


The new Sant Cugat (Barcelona) office building and auditorium awarded LEED Gold certification (Leadership in Energy & Environmental Design)
Commercial: Bioscience
Ensuring Sustained Growth and Profitability Through Three Pillars A Unique Combination of Plasma Capacity and Capabilities

1
Expanding global plasma collections with the highest standards of quality and safety
Leveraging integrations through technology, standardization and efficiencies
18
2
3
Donor & Employee experience excellence

Successfully Executing Our Strategic Plan…


… to Consolidate a Broad Global Footprint of 400+ Centers
By the end of 2022

Expansion of our plasma-center network

Note: Number of plasma centers expected by the end of 2022; SRAAS not included in the 400+ figure as it is not fully consolidated in Grifols' financials

On Track to Satisfying Growing Plasma Demand Accelerating Plasma Collection Throughout 2022

1Comparing first 4 weeks of 2022 with last 4 weeks of 2022 (as of week 25) 2 Comparing first 25 weeks of 2022 with first 25 weeks of 2021
60
70
80
90
100
110
120
130

On Track to Satisfying Growing Plasma Demand Accelerating Plasma Collection Throughout 2022
- Current macro-economic context drives momentum
- Contribution from new and recently acquired centers
- Regular centers return to pre-pandemic weekly levels
- New donor compensation scheme
- Higher talent retention
- New plasmapheresis devices roll-out process to end by year-end – increasing donation yields and efficiencies
- Digital marketing enhancement
- Both COVID-19 headwinds and U.S. government stimulus impacts are behind us
+ Tailwinds - Headwinds
- B1/B2 visa restrictions on U.S southern border continue to impact donation levels. Plasma collections upside if these constraints are ultimately lifted
- Donor compensation still high
- Persistence of inflationary and labor pressures

10%
15%
20%
25%
Global Plasma Market Position Supports Leadership in Plasma-Proteins Market Share
Open plasma centers market share evolution
(% of open plasma centers)


Note: both graphs including U.S. and EU data
Plasma volumes market share evolution

(Industry donations)
- 10.000.000 20.000.000 30.000.000 40.000.000 50.000.000 60.000.000

Rapid Inorganic Expansion Over the Past 4 Years
A Strong Integration Response Led to Greater Efficiency Gains


Leveraging Technology to Optimize Ongoing Efficiencies
Increasing Business Process Optimization
Digital Transformation BECS migration Benefits

- Improved documentation and workflow
- Automated paperless 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
- Donor screening devices that reduce cycle time and allow for automated data entry

Leveraging Technology to Optimize Ongoing Efficiencies
New Devices Enhance Donor and Employee Experience
250 Digital Transformation Device migration Benefits

- NexSys designed with data management, safety features and usability enhancements to improve yield and efficiency:
- Integrated touch screen
- Integrated scanner
- Integrated to BECS
- Aurora Xi with greater storage capacity; updated algorithms provide faster separation process to decrease donation cycle time and improve yield:
- More precise controls and settings of device operating capabilities optimize collection volume while efficiently managing donation supplies
0
50
100
150

Leveraging Our Capabilities
Process Enhancement From Different Approaches
Process efficiencies
- Reduce complexities in the donor center towards standardization of our systems of record and infrastructure
- Better access to donors and potential donors through online appointment and communication platforms
- Rapid donor care management

Donor-center network management
- Diversify the donor demographics to expand the unique donor count
- Focus on donor retention and donation frequency by high service delivery

One global plasma organization Talent development
- Share expertise and best practices across Grifols plasma organizations
- Implement standardization across plasma organizations preserving local environment
- Orientation to global change and innovation

- Academy continues to expand virtual training programs and partnerships
- 350+ graduates from Academy's leadership development program
- 50k+ training hours (all modalities)


Leveraging Technology to Optimize Efficiencies
Delivering on Improvements Derived From Optimizing Diversification


Technology delivering better targeting for donor recruitment, while enhancing donor experience and loyalty:
- Legacy BECS transitioned out
- Electronic System Appointment
- Donor visibility for upcoming donations
Donations per Employee Hour

Talent development, effectiveness and efficiency initiatives have led to a higher donations processed per employee due to:
- Process standardization
- Efficiency gain in donor registration process
- Paperless process
2021 2022 +2% Average Yield
Average liters of plasma per unit are increasing (higher yield) as a result of technology

Average Liters per Center Demonstrate Positive Momentum
Communication Programs Delivering the Potential
Average Liters per Center*

* Regular centers excluding U.S.-Mexican Border

Employee and Donor Experience Drive Our Mission
Mastering Both Experiences Enables Achieving the Average Liters per Center Target
Employee experience Donor experience
Substantially improve employee engagement through technology, tools and training

Delight donors at every touchpoint resulting in continual and reliable collections

Higher Donor and Employee Engagement and Retention
Delivering on the employee and donor experience makes the difference, what ensures Grifols can withstand competition and market fluctuations

Donors Feel Good Knowing Their Plasma Helps Patients Around the World Success Depends Upon the Donor Experience PRE-DONATION POST DONATION Ongoing dialogue and predictive digital communications inspire donor promotion IN-CENTER EXPERIENCE Multi-channel communications with strong digital presence targeting donor segments Memorable experiences Donation centers become a destination CULTURE OF SERVICE
Powered by Grifols technology and digital infrastructure
Donors' online activity, behavior and in-center experience are captured and analyzed, providing a 360-degree real-life view about the donor
The Development of Donor Experience
Technology and Data Infrastructure Support Donor Experience

Successfully Encouraging People to Donate Plasma Building Momentum Through Our U.S. Recruitment Campaigns
In 2020, we launched the industry's first national campaign, doubling new donor numbers at the height of COVID. Since then, U.S. coverage continues to grow
- ✓ Leveraged donor segmentation data to target attractive future donor audiences
- ✓ Expanded across broadscale channels: digital, video ads, streaming TV and radio, local media and sponsorships
- ✓ Launched lead generation and lead nurturing emails, capturing nearly 250k prospects, with higher conversions, engagement and frequency

Moving forward…
- Continue to build awareness and engagement with future donors, using uninterrupted recruitment campaigns
- Gained momentum, building on continued learnings to expand and refine recruitment messaging and tactics
- Expand digital presence across channels to secure market leadership, reaching and converting future donors to new donors
Building Momentum Through Our U.S. Recruitment Campaigns
35
Successfully Encouraging People to Donate Plasma

| Omni-Channel Marketing Plan | ||||
|---|---|---|---|---|
| Programmatic Audio & Video | Meredith Partnership (online publications) & NBCU Partnership |
|||
| NFL Digital | ||||
- Raised broad awareness on the benefits and need of plasma donations
- Recruited new donors and recapture donors who lapsed in plasma donations
- Reinforced messaging of life saving medicines and donor compensation benefits
- Delivered recruitment diversity within targeted demographics
Significantly Increasing the Number of New Donors in Europe Through Our National Recruitment Campaigns
In 2021, we launched the first German national campaign to highlight benefits for donors, increasing new donor numbers during the pandemic. The number of new donors has since increased significantly
- ✓ New approach: modern, young and eye-catching
- ✓ Key visuals: show pleasing images or benefits related to donating plasma
- ✓ Target group: young people and individuals facing economic difficulties in pandemic times
- ✓ Multichannel: online, digital, social ads, streaming TV and radio, out-of-home ads, public transport
- ✓ Key element: landing page with appointment system

Moving forward…
- Expand digital tools and insights of donors needs and motivation for data-driven marketing campaigns
- Delimitation from competitors and leadership by using donor-experience technologies and services
- Greater awareness of plasma donation is indispensable to produce life-saving medicines
Significantly Increasing the Number of New Donors in Europe Through Our National Recruitment Campaigns
- ✓ Extension of the targeted demographics from young to older
- ✓ Expansion of leadership position in social media & online among competitors
- ✓ Development of data-driven marketing along the customer journey
- ✓ Implement a wide range of new technology/systems and upgrade donor app
2021 Performance "Deserve More Than Respect" Monthly New Donor Performance



Leveraging a Unique Combination of Plasma Capacity & Capabilities to Accelerate Performance
| Double-digit plasma growth addresses expected plasma needs for 2022 to meet strong underlying demand |
Current macro-economic context drives momentum on plasma collections |
Successful execution of expansion plan through strong integration response |
|---|---|---|
| The reorganization will enable to fully capture benefits of scale and integration |
Reinforcing Donor and Employee Experience to gain further efficiencies while ensuring sustainable growth |
Continue to build plasma awareness and donor marketing campaigns to support further plasma donations |
Game-Changing Initiatives to Become a Blueprint for Other Countries Responding to the Global Need for a Sustainable Plasma Model
PLASMA AS A STRATEGIC ASSET

"The World Health Organization urges state members to take all the necessary steps to establish, implement and support nationally-coordinated, efficientlymanaged and sustainable blood and plasma programs according to the availability of resources, with the aim of achieving self-sufficiency, unless special circumstances preclude it"1
COVID-19 pandemic Increased emphasis on the importance of plasma supply and its limitations
Growing demand for plasma-derived therapies
+
+
New indications and higherprevalence diseases
Diagnosis and prescriptions are increasing

1 World Health Organization (WHO) (https://www.who.int/publications/i/item/WHA63.12)
Self-Sufficiency Management Models Responding to the Global Need for a Sustainable Plasma Model

Fractionation Capacity Global Footprint Ensuring Sufficient Capacity

26mL in 2026 U.S. Spain Ireland Germany Canada Egypt

Canada: Leveraging Our Experience and Capabilities…
Well-Positioned to Satisfy the Country's Needs

Source: Global Market Database, 2021 preclosing

Grifols Canada Therapeutics (GCT) Canada Egypt Strategic Location


Canada Site Facts Construction of a New State-Of-The-Art Plant
Acquired by Grifols October 1, 2020
Located in Technoparc Montreal, Quebec
Plot: 63,134 m2 Built: 19,865 m2
3-story building
Manufacturing, warehouse & QC lab and admin building


Canada Current Facility Canada Egypt


Canada Expansion Project Construction


Albumin Conversion – Phase I, August 2022 Canada Egypt

Albumin Purification
Overcoming Challenges to Strengthen Egypt's Healthcare System Egypt: Delivering On Our Promises Through a Pioneering Model


Achievements Clear the Path for Future Milestones
Year 1: Grifols Successfully Laid the Foundations of the Egypt Project


First EDA1 Licensed Donor Center in Egypt
Paving the Way for the First Integrated Plasma-Supply Platform in Africa



Donor center, plasma testing labs, plasma freezers warehouse, Grifols Academy for Plasmapheresis and plasma operations offices
1 Egyptian Drug Authority (EDA)
Plans on Track for the Construction of 20 Donor Centers
10 Plasma Collection Centers Projected in Wave 1 (10+ in Wave 2)

Canada Egypt

Plans on Track for the Manufacturing Site Construction Canada Egypt


Key Takeaways Responding to the Global Need for a Sustainable Plasma Model
| Self-sufficiency is crucial to guarantee the sustainability of plasma-derived medicines supply |
Grifols positions to serve as a best-in-class partner through private or public/private initiatives to support a sustainable plasma model |
Grifols' unique know-how and leadership in engineering and operations represents a competitive advantage to execute these projects |
|---|---|---|
| Milestones in Egypt and Canada reflect how Grifols delivers on its promises |
The implementation of international quality standards strengthens the safety & efficacy of our medicines |
Best positioned to capture new opportunities… Becoming a blueprint for other countries to increase plasma self-sufficiency levels |
Poised for performance…
… in an essential and growing market

Grifols Is Well Positioned to Get Back to Growth
Driven by Biopharma Strengths

Underlying Demand Supports Further Growth
Core growth products
show positive trend in Q1'22 vs. Q1'21
| IgG | Back to growth, driving Biopharma sales recovery |
|---|---|
| Albumin | Strong start of the year, driven by sales in China and U.S. |
| Alpha-1 | Increasing market share and sustained growth during 2021 and 2022 |
| HyperRAB® | Consolidated market leader, growing year over year |
Bioscience Revenues
(EUR in millions, growths at cc)

Underlying Demand Supports Further Growth
Main geographies
show significant recovery in Q1'22 vs. Q1'21

China
Recovering high-single-digit growth
Strong albumin growth driving double-digit-growth
Sustained growth Europe
Bioscience Revenues (EUR in millions, growths at cc)

Deep Knowledge and Capabilities Coupled With a Focus on Therapeutic Areas Building on Biopharma Portfolio With Recent Product Launches

Immunology and Neurology


Gamunex®-C Recognized as the #1 Prescribed IG for CIDP Leading an Increasingly Competitive U.S. CIDP1 Market

% Share IG CIDP Procedures


Source: LexisNexis Trending Data, Medical Claims only; and Gamunex®-C and GammaKed share a J-code 1 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Immunology

Xembify® Continues to Gain U.S. Market Share
Supporting Patients by Providing a New Solution That HCPs1 Rely On

Over 1,000 U.S. HCPs have prescribed Xembify® since its launch and 87% continue to prescribe it
Source: Grifols Internal data Health Care Practitioners (HCPs) Last Twelve Months (LTM) Primary Immunodeficiency (PI)

… and market share evolution in PI3
-5%
Immunology

SCIG Represents 23% of Volume in EU/Australia … While Expanding to New Geographies Outside the U.S.
SCIG continues to grow

Sources: (i) Grifols Database provisional data 2021 (accessed May'22); (ii) Grifols ATU Study 2022. Base: All HCPs. Germany (n=40), France (n=40), Italy (n=40), Spain (n=40) UK (n=40) Nordics (n=29) and Australia (n=36)
Launching Xembify® in several European countries throughout 2022 and 2023 leveraging on increasing growth of SCIG preference over IVIG
Preferred route of administration for IG therapy by market (% HCPs)


helping IG franchise to grow high-single-digit YoY
Pulmonology
Prolastin®1 Shows Steady Growth in 2021 and Q1'22 Leading the Alpha-1 Market for 35 Years

Source: Grifols Internal data 1 Prolastin® includes all Grifols Alpha-1 brands Pulmonology

Leading the Alpha-1 Market for 35 Years Prolastin®1 Shows Steady Growth in 2021 and Q1'22

Sustained and reliable product supply… … backed by Patient Support Programs
Helping ensure HCPs and patients have access to Prolastin® when and where it is needed
Context
Competitor alpha-1 product shortage
in Q4'20-Q1'21 challenged treatment
continuity in EU
Grifols was ready to immediately put in place all efforts, guaranteeing Prolastin® to patients
Patient health management programs provide personalized care and home infusion
- ✓ Personalized support and benefits beyond therapy
- ✓ Significant improvements in compliance with therapy and health outcomes after intervention year2
1 Prolastin® includes all Grifols Alpha-1 brands
2 Sandhaus RA, Turino G, Brantly ML, et al. The diagnosis and management of alpha1-antitrypsin deficiency in the adult. J COPD Foundation. 2016;3(3):668-682

Record Sales in 2021 HyperRAB® Driving Hyperimmunes Portfolio
Rabies IG Market (2021)

Comprehensive HRIG1 Solution
First and only high-potency HRIG that enables the delivery of more of the total dose per mL at the wound site, regardless of the wound size or patient weight 2,3,4

Graph source: Grifols Database provisional data 2021 (accessed May'22) 1Human rabies immune globulin (HRIG)
2 HyperRAB (rabies immune globulin [human]) Prescribing Information. Grifols.
3Siegel J. Rabies Immune Globulin: Ensuring Administration Safety. Pharmacy Practice News Special Edition. 2019: 47-52. 4Manning SE, Rupprecht CE, Fishbein D, et al; Advisory Committee on Immunization Practices Centers for Disease Control and Prevention (CDC). Human rabies prevention—United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2008;57(RR-3):1-28
Intensive care & Hepatology
Designed, Engineered and Manufactured by Grifols Albutein FlexBag™ Successful Launch

High degree of satisfaction among customers…
First and only 5% 500mL offers convenience
Availability of both 5% and 25% strengths
Storage and portability vs. vials
Ease of use/administration vs. vials
Environmentally-friendly design
Albutein FlexBag™ 18% of U.S. Albutein® sales in 2022 … reflected in revenues backed by fast adoption in the U.S.
Q2 21 Q3 21 Q4 21 Q1 22 launch 5% launch
1 Albutein® includes all Grifols albumin brands
Hematology

Tavlesse® Continues to Gain Traction
Successfully Launched in Multiple European Countries, Including EU41
Sales volume (last 12 months)

Sources: Internal data; (i) Price and Reimbursement ; (ii) Health Technology Assessment 1 Includes France, Germany, Italy and Spain

Vistaseal® Market-Leading Fibrin Sealant in the U.S.
Recovery of Elective Surgical Procedures Following Pandemic-Related Interruptions

Poised for performance…
… in an essential and growing market

Immunology
Operating in an Essential and Growing Market Further Growth in IG Market Driven by Progress in PI1 Diagnosis
PI underdiagnosis facts

1 Primary Immunodeficiency (PI)
- 2Routes J, et al. J Clin Immunol. 2016;36:450-461
- 3 Primary Immunodeficiencies (PID) – Driving Diagnosis for Optimal Care in Europe, European Reference Paper
- 4 Modell V. Immunol Res. 2007;38(1-3):43-47
- 5 French MA, Tangye SG. J Infect Dis. 2019;jiz230. doi:10.1093/infdis/jiz230
6 Grifols Internal Source


Immunology
Operating in an Essential and Growing Market Further Growth in IG Market Driven by Progress in PI1 Diagnosis
PI underdiagnosis facts
Average diagnosis 12.4 years2
Undiagnosed 70-90%3
500,000 undiagnosed 4 (NIH estimates)
>400 related-genetic defects5
1 Primary Immunodeficiency (PI)
- 2 Routes J, et al. J Clin Immunol. 2016;36:450-461
- 3 Primary Immunodeficiencies (PID) – Driving Diagnosis for Optimal Care in Europe, European Reference Paper 4 Modell V. Immunol Res. 2007;38(1-3):43-47
5 French MA, Tangye SG. J Infect Dis. 2019;jiz230. doi:10.1093/infdis/jiz230
Grifols Strategic Imperative Truncating time to diagnosis and treatment
Uniquely positioned to leverage our expertise in IG replacement therapy and diagnostics to improve the rate and time to an appropriate PI diagnosis

Grifols is actively partnering with insurers and patient groups to apply artificial intelligence programs to identify patients who may benefit from laboratory or genetic testing to detect the possibility of an underlying immune deficiency exists
Immunology and Neurology
Plans on Track for Xembify® to Treat New Key Indications e.g., CLL1 and HGG2 SID Market Continues to Expand in Hematological Malignancies


IG growth in SID Grifols has a Clinical
- Increased use of SID-inducing medication in oncological and autoimmune indications
- Extended survival rates of cancer patients
- Hypogammaglobulinemia occurs in up to 85% of patients4,5
Infections are major cause of death in patients with CLL
- 1 Chronic Lymphocytic Leukemia (CLL)
- 2 Hypogammaglobulinemia (HGG)
- 3 US PPTA Distribution Data
- 4 Friman V et al. Hematol Oncol. 2016;1-12: doi 10.1002/hon.2323. [Epub ahead of print]
- 5 Seppänen M. Clin Exp Immunol. 2014;178(Suppl 1):10-13.


Development Plan for HGG and CLL with Xembify®
Pulmonology

Accelerating AATD1 Diagnosis as Our Primary Goal
Further Expanding Our Testing Program Worldwide

1 Alpha-1 Antitrypsin Deficiency (AATD)
6Sandhaus RA, Turino G, Brantly ML, et al. The diagnosis and management of alpha1-antitrypsin deficiency in the adult. J COPD Foundation. 2016;3(3):668-682.
2 Campos MA, Wanner A, Zhang G, et al. Trends in the diagnosis of symptomatic patients with alpha1-antitrypsin deficiency between 1968 and 2003. Chest. 2005;128(3):1179-86.
3World Health Organization. Alpha 1-antitrypsin deficiency: memorandum from a WHO meeting. Bull World Health Organ. 1997;75(5):397-415.
4McElvaney NG, Stoller JK, Buist AS, et al. Baseline characteristics of enrollees in the National Heart, Lung and Blood Institute registry of α1-antitrypsin deficiency. Chest. 1997;111(2):394-403.
5ATS, ERS. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900.
7Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2021 Report
Pulmonology

Accelerating AATD1 Diagnosis as Our Primary Goal
8.3 years2
Dedicated Efforts to Increase the Diagnosis Ratio
AATD underdiagnosis facts
Avg. delay between the onset of symptoms and diagnosis
2.72 avg. number of physicians seen by patients before diagnosis
Patients present with common respiratory symptoms3,4
Diagnosis does not depend on clinical presentation alone Laboratory testing is the only way to make the diagnosis2,5,6,7
Undiagnosed Alpha-1 patients >90%
6Sandhaus RA, Turino G, Brantly ML, et al. The diagnosis and management of alpha1-antitrypsin deficiency in the adult. J COPD Foundation. 2016;3(3):668-682.
1 Alpha-1 Antitrypsin Deficiency (AATD)
2 Campos MA, Wanner A, Zhang G, et al. Trends in the diagnosis of symptomatic patients with alpha1-antitrypsin deficiency between 1968 and 2003. Chest. 2005;128(3):1179-86.
3World Health Organization. Alpha 1-antitrypsin deficiency: memorandum from a WHO meeting. Bull World Health Organ. 1997;75(5):397-415.
4McElvaney NG, Stoller JK, Buist AS, et al. Baseline characteristics of enrollees in the National Heart, Lung and Blood Institute registry of α1-antitrypsin deficiency. Chest. 1997;111(2):394-403.
5ATS, ERS. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900.
7Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2021 Report
Intensive care & Hepatology

Potentially Increasing Albumin Opportunity in Critical Care Supporting Regular Albutein®1 Use as a Disease Modifying Treatment
Hepatology facts

of global population with NAFLD2 , the most common cause of chronic liver disease3
14 million cirrhosis cases 2 nd leading cause of years lost of working life4
Liver transplant is the only procedure available today to avoid further complications and death

global market growth potential stemming from regular albumin use (>€400M)
1Albutein® includes all Grifols albumin brands
- 2Non-alcoholic fatty liver disease
- 32022 NAFLD Endocrinology-AASLD guidelines
- 42021 EASL–Lancet Liver Commission on Liver Disease
- 5WHO Sepsis Fact Sheets
- 62021 Surviving sepsis campaign 7Hydroxyethyl-starch (HES)

Grifols Hepatology Program
Albumin medicine role in hepatology is explained by albumin blood levels (albuminemia), supporting its regular use as a disease modifying treatment
transferring this concept into
critical care area opportunity
48.9M cases of sepsis leading to 20% of all global deaths5
No conclusive guidance on the choice of fluid and resuscitation protocols exists as of today6
Albumin 1-time use to recover hypovolemia evolving to albuminemia-base treatment (Albios Balance/Ariss)
HES7 threat as a result of EMA's recent decision to suspend marketing authorization in EU
Key Takeaways Poised for Performance in an Essential and Growing Market
| Global plasma-derived proteins market is an attractive market that continues to grow |
IG, Alpha-1 and albumin defy the normal life-cycle of a pharmaceutical product and keep growing |
key brands: Gamunex®, Strong Xembify®, Prolastin®, Albutein® and HyperRAB® |
|---|---|---|
| Building on Biopharma portfolio by adding new proteins with a specialized focus on therapeutic areas |
Expansion of PI and SID markets expected to outpace potential erosion from new technologies |
Grifols' Diagnostic offers an unparalleled opportunity to continue increasing diagnosis rates and support Biopharma growth |
A New Leadership to Accelerate Diagnostic
Streamlining the Business Unit to Increase Effectiveness and Drive Efficiencies

Focus and deep knowledge within the Diagnostic Business Unit
Changes implemented in the Business Unit
Diagnostic Mission
Improving care for donors and patients by providing laboratorians with innovative diagnostics tools
Growing the Business Based On Three Strategic Pillars

Regulatory innovation & digital transformation

Combining Capabilities to Accelerate Growth
Broad Portfolio of Platforms, Know-How and Global Presence


Driven by COVID-19 Innovation and Strong Underlying Business Diagnostic Division Reported Solid Growth in 2021
Revenues (EUR in millions)

Core business of NAT achieved sustained growth and continued to consolidate in the main markets (U.S.
NAT testing addressed the emergency of new pathogens (Zika, COVID-19) and represents an opportunity for new segments
Constant growth in Blood Typing Solutions (BTS)
Note: growths at constant currency (cc), which excludes exchange rate fluctuations vs. PY

Increasing Presence in Key Markets
Strategic Partnerships and Alliances to Drive Further Growth


Expanding Grifols' Blood Collection Capabilities Immunohematology Market Delivering Strong Growth

New red blood cells manufacturing facility in San Diego

BTS constant growth led by DG Gel® System sales and fueled by Erytra Eflexis®

85
Note: CAGR at constant currency (cc), which excludes exchange rate fluctuations vs. PY

Supporting Biopharma Through High-ROI1Programs
accelerate diagnostic globally
Grifols' testing program continues to
Successful Alpha-1 Testing Strategy

Validated, Convenient and Efficient Diagnostic Solution
- Cost-effective
- FDA approved
- Scientific Societies Support


Life-saving therapy for those patients who need it
1 Return On Investment (ROI)
2 Chronic Obstructive Pulmonary Disease (COPD)

Our Journey to an Innovative Program…


… To Achieve a New Milestone
Over The Counter 510(k) Filing Submitted to FDA: AlphaID™ at Home

Over The Counter innovative solution to expand the U.S. screening program

While Embracing Future Initiatives Including Biotest Projects Expanding the Model to Support Biopharma Growth
Alpha-1 patients Basis for innovative testing strategies
1 Primary Immunodeficiency (PI) 2 Secondary Immunodeficiency (SID) 3 Inherited AT deficiency (hATd) 4Antithrombin III (ATIII)


Grifols, Already Compliance With New In Vitro Diagnostics Medical Devices European Regulation (IVDR)
First Certifications for the New IVDR Received in December 2021

Grifols on track with the initial IVDR timing
Additional transition period (until May 2024) not needed

Promonitor Quick IFX
one of the first near-patient testing devices approved under the IVDR
Grifols will ensure on-time delivery of IVDR certification for all relevant products
Digital Transformation Promotes Higher Performance
91
Advanced Software Solutions and a New Customer Portal
Key strategic solutions to streamline customer operations
1 2
New Bloodstream software as a single point management system for the NAT testing laboratory
New middleware solution connecting blood typing data across laboratory network system to improve patient care, enhance operational efficiency and minimize risks
Digital platform for technical documentation of our products: Going Green

- All information, one site
- Quick and easy access
- Granted up-to-date documentation
- Digital safety environment
Key Takeaways Evolving Business Model to Strengthen Competitiveness
| Strengthened leadership to increase effectiveness and drive efficiencies |
Broad portfolio of platforms, assets and global presence to outperform competition and grow value |
Secured U.S. key large customer while poised to increase penetration to fast-growing Chinese market through strategic alliance with SRAAS |
|---|---|---|
| Unique diagnostic capabilities to expand Grifols' Biopharma core markets and beyond |
Grifols Alpha-1 OTC breakthrough testing to achieve FDA regulatory remarkable milestone |
Enhanced field digitalization to support further growth |
June 30, 2022
Accelerating Innovation Through 3 Key Objectives
Further evolving our innovation organization 1

3
Gaining focus and speed in our pipeline (from past to present)

Focus on Scientific Areas While Elevating Controlling and PMO1

Rationalizing Portfolio & Establishing Result-Oriented Processes
Further evolving our innovation organization 1
Gaining focus and speed in our pipeline (from past to present)
Building new innovation models (paving the future)
Optimizing and re-prioritizing our R&D portfolio…

+
… while adopting a result-oriented governance

Clear direction with a 2030 Ambition target

Stronger business-weight (i.e., commercial, financial return) into project approval and prioritization processes

Increased weight of milestones achievement into bonus scheme
3
New Approaches: Developing a 360-Degree Innovation Ecosystem

Balanced Risk-Value Pipeline
| Discovery | Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | Phase 4 / Regulatory | LCM | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Immunology | ++ | recIG | IVIG-PEG | Xembify® Europe |
||||||
| Spike in PdIG with enriched recombinant libraries (PI) |
IVIgG Next Gen PI |
Xembify® | Xembify® Prefilled syringes |
|||||||
| Xembify® in CLL |
Bi-weekly dose | |||||||||
| Hepatology/ | ++ | PRECIOSA D.Cirrhosis (Alb.20%) | FlexBag® US, EUR |
|||||||
| Intensive Care |
APACHE ACLF (Alb 5%) |
|||||||||
| Pulmonology | Alpha-1 AT Non-cystic fibrosis bronchiectasis |
Alpha-1 AT 15% (SC) AAT deficiency |
SPARTA - Prolastin-C® EUR |
Prolastin® EU 4-5gr vials |
||||||
| Hematology | + | Fibrinogen Cong. Deficiency & severe hypofibrinogen ATIII in Sepsis*** Fibrinogen |
||||||||
| Fostamatinib** ITP – Refractory patients |
||||||||||
| Acquired Deficiency IVIgG Next Gen - ITP |
||||||||||
| … | Others | ++ | GIGA 564 GIGA 2328 Anti-CTLA-4 Anti-CTLA-4 mAb Oncology mAb Oncology |
AKST4290 nAMD & DR |
AKST1210 ESRD-CI |
Fibrin Sealant Biosurgery Pediatric Use |
||||
| +++ | Trimodulin sCAP |
|||||||||
| Infectious Diseases |
GIGA 2339 HBV Recombinant hyperimmune Ig |
Cytotec® Pregnancy (CMV infection) |
||||||||
| Neurology | +++ | GRF6019 | ABvac40 AD |
|||||||
| AKST 1220 CADASIL |
AD GRF6021 PD with Dementia |
AKST4290 PD |
AMBAR-Next | |||||||
| Detailed next Plasma projects Non-plasma projects Biotest projects |
* Project of AlbaJuna (Grifols' invested company); ** Licensed rights from Rigel Pharmaceuticals in EU and other countries; *** Partnership with Endpoint Health
Notable Progresses in 4 Core Projects


1 Hepatitis B Virus (HBV)
5 th Leading Cause of Death Worldwide Alzheimer's Disease Therapy: An Urgent Unmet Need
Progressive disease in which dementia symptoms gradually worsen over several years No cure to date but research continues, and treatments are available to alleviate symptoms

Sources: Alzheimer's Disease International, Worlds Alzheimer's Report 2015, https://www.alz.org/Alzheimers-dementia/what-is-dementia

AMBAR-Next in Alzheimer's Xembify® in CLL
ATIII in sepsis
GigaGen & HBV
R&D Efforts Encompass the Entire Development Path
Innovation Strategy in Neurogenerative Diseases (ND)
Discovery
Plasma Proteome Chronokines
Understanding of plasma at the molecular level in healthy and disease states
Discovery of chronokines proteins with biological impact that changes with age
Pipeline expansion of therapeutic plasma fractions, small molecules, antibodies
Explore therapeutic benefit of plasma proteins in a wide range of CNS1 disorders
1 Central Nervous System (CNS); 2 Alzheimer's Disease (AD); 1 Parkinson Disease (PD); 4 Mild Cognitive Impairment (MCI)
| Clinical Development Programs | ||||
|---|---|---|---|---|
| Plasma Fractions & Small Molecules |
Active Immunotherapy | |||
| GRF-6019 | Abvac40 | |||
| GRF-6021 | vaccine against Ab40 | |||
| Proprietary plasma fraction inducing neurogenesis 2 clinical programs |
Placebo-controlled AB1601 trial in 120 very early AD and |
in AD2 and PD3 patients with dementia in phase II

Restore pharmacological properties of Albumin

Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
AMBAR-Next: Slowing Clinical Decline of Mild-to-Moderate AD
Confirmatory Albumin and Plasma Exchange to Treat Alzheimer's

Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
Chronic Lymphocytic Leukemia (CLL) Targeting the Fastest-Growing Patient Segment for IG Therapy
Accumulation of monoclonal, mature CD5+B cells in the peripheral blood, bone marrow, and secondary organs1 No definitive cause has been established; targeted therapy regimens proven as efficacious treatments

1Burger JA. 2 Secondary Immunodeficiencies (SID); 3 Hypogammaglobulinemia (HGG); 4 Wintrobe MM, Hasenbush LL.; 5Hansen MM.; 6Morra E, Nosari A, Montillo M.; 7Hamblin AD, Hamblin TJ. 8Morrison VA.; 9Dhalla F, Lucas M, Schuh A, Bhole M, Jain R, Patel SY, et al.

Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
Xembify® to Prevent Infections in CLL Patients
Treating Patients with Concomitant HGG and Recurrent or Severe Infections

Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
Outlook for U.S. Potential if Treatment Proven ATIII in Sepsis: Very High Burden of Healthcare Costs

Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
Disruptive Diagnostic to Identify Thrombate III Responders
Global Collaboration Agreement and Solid Partnership With Endpoint Health

Gene expression array (Biocartis device)
Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
- IVD test using small blood sample
- 15 marker array developed and validated in over 900 sepsis patients
- Gene expression array evaluating innate and adaptive immune response, complement, adaptive suppression and coagulation
• Developed by Endpoint Health
- Distributed/sold by Endpoint Health + IVD partner
- Novel assay, system and algorithms / IP protected
- FDA authorized system and sample collection device
107
for severe sepsis

Building the Future to Treat Severe Sepsis Next Steps
| So far | Solid partnership with Endpoint Health (EPH) | |||||
|---|---|---|---|---|---|---|
| • Supplying ATIII to conduct clinical trials • Manufacturing capacity • Advice on clinical development and regulatory activities (led by EPH) |
||||||
| Currently | EPH is waiting results of an observational study, which results will… • Guide the pre-IND package submission to the FDA • Help inform the design of the upcoming Phase II study |
|||||
| Moving forward |
Evaluate the feasibility of the Phase III study design with regards to endpoints and mortality event rates |
GigaGen Captures & Recreates Complex Antibody Repertories
World-Leading Immune Genomics Technology for Drug Discovery


Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
Chronic HBV1 : Widespread Disease With Significant Morbidity
Despite Currently Available Therapies and Vaccines

1 Hepatitis B Virus (HBV)
- 2 Global Data report: Hepatitis B Virus Infection – Global Drug Forecast and Market Analysis to 2029
- 3 WHO (https://www.who.int/news-room/fact-sheets/detail/hepatitis-b)
4 Hepatitis B Foundation (hepb.org)
Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
Xembify® in CLL
AMBAR-Next in Alzheimer's ATIII in sepsis
GigaGen & HBV
Anti-HBV Recombinant Polyclonal

• Recombinant polyclonal antibody therapy (rHBIG) targeting HBV surface antigens
- Composed of >1,000 antibodies
- Derived from antibody sequences from human donors following HBV vaccine booster
- Polyclonal therapy ensures retained targeting of the many genotypes present and the large number of escape mutant variants that arise
Neutralizing potency of > 1,000x that of plasma-derived HBV hyperimmune therapy
Potency
In vitro and in vivo models demonstrate efficacy potential GMP manufacturing initiation planned for Q4 2022


GigaGen's Antibody Platform Potential
rHBIG1 : the First Chapter

| Recombinant Polyclonal Antibody Therapies |
• Completely new class of therapeutics uniquely enabled by the GigaGen platform • Capability that Grifols alone possesses • Additional recombinant polyclonal therapeutics for infectious disease, immunology, transplant and other areas will be enabled with rHBIG's success |
|---|---|
| Monoclonal Antibodies |
• Some indications are best addressed with monoclonal antibody treatments • GigaGen's platform rapidly identifies rare, highly potent antibodies with unique activities from natural immune systems |

1 Recombinant Hepatitis B Virus Immunoglobulin (rHBVIG)
Key Takeaways Accelerating Innovation: Gaining Focus & Speed in Our Pipeline
| Gaining focus and speed in our pipeline by rationalizing our portfolio and adopting a more result-oriented governance |
Building new innovation models in digital and data, China and precision medicine |
Seeking U.S. indication for Xembify® in CLL, the fastest growing patient segment for IG therapy |
|---|---|---|
| Leading the mild-to-moderate Alzheimer's space with AMBAR Next, a confirmatory trial for our AMBAR program |
Partnering with Endpoint Health to treat severe sepsis with ATIII, an innovative precision medicine approach |
GigaGen's novel technology to create recombinant polyclonal antibody drugs for a wide range of infectious diseases |
Maximizing Opportunities for Both Companies…
Grifols and Biotest: A Transformational Transaction

Bringing in Precision Therapies, Fibrinogen and Trimodulin, and Cytotect® … Accelerating Grifols' Innovation Pipeline
| Discovery | Pre-Clinical | Phase 1 | Phase 2 | Phase 3 | Phase 4 / Regulatory | LCM | |||
|---|---|---|---|---|---|---|---|---|---|
| recIG | IVIG-PEG | Xembify® Europe |
Xembify® | ||||||
| Immunology | ++ | Spike in PdIG with enriched PdIG recombinant recombinant libraries (PID) libraries (PI) |
IVIgG IVIgG Next Gen PID Next Gen PI |
Xembify® | Prefilled syringes | ||||
| Xembify® in CLL |
Bi-weekly dose | ||||||||
| Hepatology/ | ++ | PRECIOSA D.Cirrhosis D.Cirrhosis (Alb.20%) |
FlexBag® | ||||||
| Intensive Care |
APACHE ACLF (Alb 5%) |
US, EUR |
|||||||
| Pulmonology | Alpha-1 AT Non-cystic fibrosis bronchiectasis |
Alpha-1 AT 15% (SC) AAT deficiency |
Prolastin-C® SPARTA - EUR |
Prolastin® EU 4-5gr vials |
|||||
| Hematology | + | ATIII | in Sepsis*** | Fibrinogen Cong. Deficiency & severe hypofibrinogen Fibrinogen Acquired Deficiency IVIgG Next Gen - ITP |
Fostamatinib** ITP – Refractory patients |
||||
| … | Others | ++ | GIGA 564 GIGA 2328 Anti-CTLA-4 Anti-CTLA-4 mAb Oncology mAb Oncology |
AKST4290 nAMD & DR |
AKST1210 ESRD-CI |
Fibrin Sealant Biosurgery Pediatric Use |
|||
| GIGA 2339 |
Trimodulin IgM sCAP |
||||||||
| Infectious Diseases |
+++ | HBV Recombinant hyperimmune Ig |
Cytotect® Cytotect Pregnancy Pregnancy (CMV infection) |
||||||
| Neurology | +++ | AKST 1220 CADASIL |
GRF6019 AD GRF6021 PD with Dementia |
ABvac40 AD AKST4290 PD |
AMBAR-Next | ||||
| * Project of AlbaJuna (Grifols' invested company); ** Licensed rights from Rigel Pharmaceuticals in EU and other countries; *** Partnership with Endpoint Health Plasma projects |
Non-plasma projects | Biotest projects |
Fibrinogen: An Unparalleled Opportunity to Boost Revenue per Liter and Expand Margins
117
Fibrinogen is an abundant, large, and complex protein, which makes it ideally suited to be isolated from human plasma. It accounts for 95% of all coagulation factors in the blood
Fibrinogen promotes platelet aggregation. It is converted to fibrin which forms the connecting glue in blood clots
Fibrinogen concentrate is a highly pure preparation of human fibrinogen that can be used to safely replace the absence or deficit of fibrinogen safer, much faster and with greater efficiency and precision than the current options of fresh frozen plasma or cryoprecipitates




Pregnancy
Playing an Essential Role in Blood Clotting and Hemostasis Treating Acquired and Congenital Fibrinogen Deficiency
- Very rare, inherited bleeding disorder in which the body's ability to form blood clots is impaired
- Fibrinogen is used for treatment and prophylaxis of bleeding episodes in these patients
Congenital deficiency Acquired deficiency
- Body's own fibrinogen lost due to major bleeding during elective surgical procedures or unexpected trauma events
- Fibrinogen is the first coagulation factor missing in major blood loss
- Replacement of lost fibrinogen is critical to restore effective hemostasis

Source: IMS Data 2-2017, Internal Critical bleeding market research, LEK Critical Bleeding market assessment 2017, and Biotest market research
Deficiency 0-1 g/L
Pregnancy
Monitoring Patient Coagulation Status Allows Administering Precise Therapies Clotting Assessment: Critical to Monitor Deficiency
Prediction of massive transfusion requirement
Creation of goal-directed and individualized coagulation algorithms that may improve patient outcome
Distinguish the most important coagulation deficiencies (including fibrinogen)

Most widely-used devices… TEG® ROTEM®
Point-of-Care (PoC) diagnostic… … bringing in positive market implications
- Goal-oriented treatment protocols proposed for bleeding management in surgery and trauma patients
- Rapidly developing field of acute medicine

Source: Benes, Jan et al. "Viscoelastic Methods of Blood Clotting Assessment - A Multidisciplinary Review." Frontiers in medicine vol. 2 62. 14 Sep. 2015, doi:10.3389/fmed.2015.00062
Promising Results in Both Clinical Trials
| Phase I/III study: Largest clinical trial in congenital fibrinogen deficiency worldwide Treatment of adults and children |
||||||
|---|---|---|---|---|---|---|
| Congenital FD1 |
Results confirm high expectations regarding efficacy and safety… • Expected pharmaco-kinetics and -dynamics (Phase I), excellent efficacy and safety (Phase III) • 175 bleeding events (BEs) treated in 36 patients of all age groups • Overall hemostatic response assessments of 175 BEs demonstrated a treatment success in nearly all cases • Study completed |
|||||
| Acquired FD1 |
Phase III study in severe spinal surgery and pseudomyxoma peritonei (tumor) surgery • Non-inferiority study compared to standard of care (fresh frozen plasma or cryoprecipitate) • Interim analysis with 120 subjects (June '22) confirms planned patient number • Recruitment ongoing – 150 of 200 patients recruited • Other interim analysis to define final sample size expected in December '22 |
decision to treat Fibrinogen Spinal surgery Fresh frozen plasma major blood Fibrinogen loss Tumor surgery Cryoprecipitate |
Pregnancy
Acquired Fibrinogen Deficiency Indication: Broader Adoption and Opportunity
Fibrinogen consumption per capita (g/1000 inhab.)

Source: MRB
1 FFP: Fresh-frozen plasma

Seizing Fibrinogen's Large Market Opportunity
Current Trends Underscore Its Potential While Further Benefiting Patients

Improved Point-of-Care diagnostics
- Increasing knowledge, availability and reimbursement worldwide
- Precision Therapy

Increased awareness
- European and Canadian guidelines
- Diagnostic companies and plasmaderived medicines companies increasing education on Precision Therapy
Change of market dynamics
• Shortage of cryoprecipitate during pandemic driving fibrinogen concentrate usage with improved customer experience in the U.S.
Expected CAGRs 19-27 (volume)
+13.5%
Not considering potential Acquired Deficiency indication
+200%
If Acquired Deficiency indication is obtained (based on Canada example)

Source: MRB, November 2021
Trimodulin: A Potential Blockbuster
Unique Polyvalent IG Composition

Important functions
- Recognizes pathogens, also part of innate immune system
- IgM and IgA can be secreted and are present directly on the pulmonary surface
- Strong anti-inflammatory effects by acting through cellular receptors
- Scavenge virulence factors, such as lipopolysaccharides which lead to inflammation
- Binds and modulates activated coagulation factors, complement factors, and cytokines
| IVIG | Trimodulin | ||
|---|---|---|---|
| IgM | - | ~23% | |
| IgA | - | ~21% | |
| IgG | ≥95% | ~56% | |
| Patient target |
e.g., patients with immunodeficiency |
Clinical development in severe COVID-19 and sCAP1 |
1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU)
Pregnancy
A High Unmet Medical Need sCAP1 : A Leading Cause of Illness and Death Worldwide2
Pneumonia requiring supportive therapy within a critical care environment

23-58%4,5 mortality range
no significant changes over the past decades despite the availability of improved broad-spectrum antibiotics
1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU)
- 2 Wunderink 2014, N Engl J Med 370;6.
- 3 Chest Journal (CHEST) (chestnet.org)
- 4 Woodhead, 2006, Critical Care 10:S1, p3.
- 5 Sirvent et al. 2013, Med. Intensiva 37:308e 15.


Changing the sCAP1 Treatment Paradigm
Trimodulin Improves Patient Response With Further Decrease in Mortality

- ✓ overshooting immune-mediated tissue damage
- ✓ risk for lung inflammation, severe sepsis, septic shock, respiratory and multi-organ failure

✓ Prevention of secondary infections
1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU)
Extensive Development Program in Severe Pneumonia
Patient Groups and Disease Stages for Optimal Therapy Identified in Phase II Studies

1 U.S: Food Drug and Administration; 2 European Medicines Agency; 3 Paul-Ehrlich-Institute;
Pregnancy
Leveraging on Phase II Results to Start Phase III Trials in 2022

Randomized, placebo-controlled, double-blind, multi-center, phase III trials investigating the efficacy and safety of Trimodulin in adult hospitalized subjects
480-780 subjects
- Subjects on invasive mechanical ventilation (within <12h)
- Subjects with inflammation (CRP >70 mg/L)
- SARS-CoV-2 negative

sCAPpatients COVID-19 patients
334 subjects
- Subjects on low-flow oxygen, high-flow oxygen, NIV
- Subjects with early systemic inflammation

Pregnancy
Potential Addressable Markets Grifols' Capacities Help Address the Opportunity
| Potential treatment | OPPORTUNITY | |||||
|---|---|---|---|---|---|---|
| sCAP | Adjunctive treatment of patients with severe Community Acquired Pneumonia (sCAP) who require invasive mechanical ventilation and have CRP1 >70 mg/L |
initial target population sCAP market size >80,000 ~350,000 patients/year patients • Significant upside due to higher price depends on clinical trials' data |
||||
| COVID-19 | Add-on therapy to standard of care in adult patients with severe COVID-19 and CRP ≥50 mg/L |
• Early approval will be beneficial for faster sCAP approval • Development risk covered by public funding • Even with vaccination, >20,000 patients/year in EU are expected over the next three years |
Source: Biotest market research 1 C-reactive protein (CRP)
No Direct Competitors for Trimodulin in sCAP1
Harnessing the Opportunity to Address a Critical Medical Need

No direct competitors: no IgM enriched immunoglobulins on the market or in clinical trials High medical need: high mortality rate despite antibiotics or antivirals Commercial advantageous pricing opportunity
1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU) 2 Intensive Care Unit (ICU)

Pregnancy
No Approved Treatment for This Disease CMV1 Infection: A Disease With Large Unmet Medical Need

Disease background
Fibrinogen Trimodulin Cytotect®
Pregnancy
Potential Effective Treatment to Increase Awareness and Diagnosis Very Low Awareness of CMV Infection in Pregnancy

Fig: National CMV Foundation; (www.nationalCMV.org) (adapted)
First Treatment to Prevent Transmission from the Mother to the Unborn Child Cytotect®: Tackling CMV1 With a High-Potential Specialty Protein
It binds to CMV and avoids infections of host cells and presents CMV particles for phagocytosis

Fibrinogen Trimodulin Cytotect®
Pregnancy
Modulates and interacts with immune cells (dendritic cells, monocytes, B- and T-cells), exerting a positive immunological balance
Anti-CMV antibodies in Cytotect® are actively shuttled through the placenta
These CMV-specific antibodies block the infection from all CMV genotypes and from virus variants that are resistant to virostatics
1 Cytomegalovirus (CMV)
Pregnancy
Significant Transmission Reduction When CMVIG1 Is Administered Clinical Experience Suggests Good Efficacy of Cytotect®

1 CMVIG: Cytomegalovirus Immunoglobulin
2 No intervention group (n=108), Maternal-fetal transmission at gw20: 35,2% (38/108). Kagan et al. Ultrasound Obstet Gynecol 2019; 53(3): 383-390
3 Treatment group (n=153), Maternal-fetal transmission at gw20: 6,5% (10/153). Kagan et al. Ultrasound Obstet Gynecol 2021; 57: 560-567
Following Primary Maternal Infection With Gestational Age ≤ 14 Weeks PreCyssion Trial: Prevention of Maternal-Fetal CMV Transmission

Objective:
Demonstrate efficacy and safety of Cytotect® in preventing maternal-fetal transmission of CMV

Study Design
- Pivotal, clinical Phase III
- Open-label
- Single-arm
- Prospective
- Multicenter
- With historical control group
- 80 subjects – 13 of 80 patients recruited (as of June 15, 2022). Recruitment dependent on the course of the pandemic (hygiene measures reduce CMV transmissions).
Pregnancy
Success of Cytotect® Represents an Important Opportunity Experts Unveil the Uniqueness of Anti-CMV
Number of births per year

(0.5% - 1.0% of all newborns) Neonates with congenital CMV infection
15,000 - 30,000 18,000 - 36,000 EU51
Pediatric infectious disease experts acknowledge Hyper anti-CMV and antivirals are the only therapeutic alternatives to treat these cases
Important opportunity behind phase III success
Diagnostic tools could be developed, leveraging on Grifols' expertise, to accelerate treatment adoption
Source: Centers for Disease Control and Prevention (CDC): Congenital CMV Infection | CDC 1 Includes France, Germany, Italy, Spain and United Kingdom
Grifols' Scale and Commercial Strength: Key to Unfold the Full Value of a New Generation of Plasma Medicines
| Fibrinogen | Trimodulin | Cytotect® Pregnancy |
||
|---|---|---|---|---|
| Expected market approval |
2024-2025 (combined approval: acquired & congenital deficiency) |
2024-2025 | 2024-2025 | |
| Key considerations |
• Results of AdFIrst study for acquired FD1 (interim results June '22) and completed phase I/III trial in congenital FD will serve as the basis for the combined approval in Europe • FDA meeting in H2'22 to provide guidance on acceptance of clinical data for BLA |
• Study duration dependent on interim analysis results • Approval timelines assuming earlier TRICOVID trial success |
• As for now, only European market approval is considered • Intention in the mid-term to seek U.S. market opportunity |
|
| 1 FD: Fibrinogen deficiency |
Grifols' Scale and Commercial Strength: Key to Unfold the Full Value of a New Generation of Plasma Medicines
| Fibrinogen | Trimodulin | Cytotect® Pregnancy |
|||
|---|---|---|---|---|---|
| Revenues/ Margins |
Significantly improving revenue per liter and margins |
||||
| opportunity | USD 30-50M | USD ~300M | USD ~30M | ||
| increased capabilities |
• Greater commercial reach • Complementary presence in important markets (US) • Ability to develop new markets |
• Scalability of production volumes • Full market potential of the main indications becomes addressable |
• Commercial reach and promotion • Diagnostic capabilities |
||
| combined opportunity |
400-800M USD |
1-2 Bn USD |
TBD | ||
| Potential upsides |
Leveraging on Diagnostic capabilities Expanding into other geographies (e.g., China) |
Peritonitis/lymphopenic sepsis: USD >1Bn each Transplant: USD >30M Pediatric sepsis: USD 80M USD 0.2Bn Multi-drug-resistance: |
Potential upside from U.S. USD >200M |
Grifols and Biotest: A Transformational Transaction to Maximize Both Opportunities
| Acquisition enhancing Grifols and Biotest opportunities while accelerating pipeline |
Expanding and diversifying plasma sourcing by adding 31 European centers and increasing revenue footprint in EMEA |
Shared values and culture based on strong family heritage |
|---|---|---|
| Two precision therapies (fibrinogen and trimodulin) and a new indication for Cytotect® with an expected market approval by 2024-2025 |
Unique opportunity to boost revenue per liter and expand margins |
Contributing to increase fibrinogen opportunity up to USD 400-800M and trimodulin to USD 1-2Bn |
Strong Underlying Fundamentals
Committed to Long-Term Growth
- Global player in the attractive plasma market (7.2%1 CAGR2017-2020 for the industry) with strong position in the U.S.
- Leaders in diagnostic solutions to screen whole-blood and plasma
- Strengthening global presence in China through SRAAS strategic alliance, Europe, Middle East and Africa, and Canada (operations in 100+ countries and subsidiaries in 30+)
- Largest plasma-center network (400+) and industrial capacity (22mL+) to support underlying demand
- Reinforced pipeline to deliver a balanced risk-value portfolio

Note: CAFR at constant currency (cc), which excludes exchange rate fluctuations vs. PY
1 The Worldwide Plasma Proteins Market, MRB, February 2022
Doubling-Down Efforts to Increase Performance in the Past 2 Years
| Reinforced plasma capabilities | Biotest | Global footprint |
|---|---|---|
| and capacities, supporting | investment bolstering | while |
| acceleration of plasma | innovation, adding two unused | strengthening presence in Europe, |
| collections | plasma proteins | China, Canada and Egypt |
| CAPEX and R&D investments to support future growth |
Commitment to achieve deleverage |
Divested non-strategic assets while executing on structural cost savings |
2021 Key Financials Full Year Performance Marked by COVID-19
| (EUR in millions) | H1'21 | H2'21 | 2021 |
|---|---|---|---|
| Revenue | 2,537 | 2,397 | 4,933 |
| % Growth | +2.3% | (9.8%) | (3.7%) |
| Gross Margin | 1,114 | 849 | 1,963 |
| % Margin | 43.9% | 35.4% | 39.8% |
| R&D | 159 | 196 | 355 |
| SG&A | 507 | 555 | 1,062 |
| EBITDA | 635 | 327 | 962 |
| % Margin | 25.0% | 13.6% | 19.5% |
| EBITDA Adjusted | 637 | 377 | 1,014 |
| % Margin | 25.1% | 15.8% | 20.6% |
| Group Profit | 267 | (78) | 189 |
Note: all growths at constant currency (cc), which excludes exchange rate fluctuations vs. PY
The decline in plasma volumes caused by COVID-19 was the primary driver of extraordinary financial impacts
- Lower collections and higher cost per liter impacted revenues and margins particularly in H2 2021
- Strong underlying demand backed by price increases
- Higher R&D and SG&A due to the integration of new companies, transaction and restructuring costs, and inflationary pressures
Bioscience Constrained by Plasma Supply While the Other Divisions Grew in 2021
143

- Underlying demand strong of key proteins
- Plasma supply constrained IG volume growth, especially in the U.S.
- Strong performance of new product launches: Xembify® gaining traction, VISTASEALTM and TAVLESSE®
- Growth driven by COVID-19 test sales in Spain and Hungary (+34% vs. 2020)
- Underlying NAT donor screening impacted by Zika testing mandate termination; whole-blood donations strong in the U.S. and Japan
- Blood Typing Solutions strong growth also contributed due to higher volume in the U.S.

• Plasma sales to third-parties increased based on pre-existing supply agreements

- Strong growth following normalization of hospital pharmacy investments
- Noteworthy sales of Pharmatech, and IV therapy
- Contract manufacturing growth stemmed from albumin bags and third-party sales
Note: all growths at constant currency (cc), which excludes exchange rate fluctuations vs. PY
Underlying EBITDA Margin Revealed Strong Fundamentals


EBITDA Reported
Reported / Underlying EBITDA Margin 1
1 Reported EBITDA for 2017-2019, and Underlying EBITDA for 2020 as per FY21 Results Presentation

Investments in plasma and innovation pipeline…
… to accelerate growth and profitability
145
Strategically Invested to Support and Accelerate Growth

Biotest: A Transformational Investment
Complementary Business to Boost Performance
- Family business founded in 1946, HQ in Dreieich (Germany)
- Specialized on immunology and hematology
- Broad plasma pipeline to be launched in the short-term
- Direct commercial presence in 10 countries, marketed in 90+
- Manufacturing sites reaching 3mL plasma production capacity
- Strong presence in Europe: 31 plasma centers*


Adjusted EBITDA2
Excludes mainly Next Level Project costs (production and R&D costs)

147

Investments in plasma and innovation pipeline…

… to accelerate growth and profitability
148

Outlook H1 2022 Improving Performance in the First Half of 2022

Performance leveraging on:
- Accelerated plasma collections already reached pre-COVID weekly levels
- Price increases on key proteins
- Robust underlying demand
- Product mix driven by subcutaneous immunoglobulin (SCIG)
- Higher alpha-1 patient base and strong albumin demand
- Partially impacted by albumin positive temporary effect in H1'21 due to commercial integration with SRAAS
EBITDA Margin
Reported

20-22% Significant sequential improvement vs. H2 2021
- Higher plasma volumes, price increases, product and country mix
- Financial discipline: cost savings and R&D prioritization
- Inflationary labor costs persist
- Donor compensation still high
- Fixed plasma costs decline as volume recovers
1 Constant currency (cc), which excludes exchange rate fluctuations vs. PY
Positive Performance for 2022 and Beyond
Expected Strong H2 Performance
Plasma
Collections expected to continue accelerating throughout 2022 driven by:
- New and recently-acquired centers
- Larger volumes from regular centers
- Plasma collections upside if B1/B2 visa restrictions in the U.S. southern border are lifted
- Technological, digital and operational enhancements

- Strong underlying demand
- Global price improvements
- Product and geo mix
Sequential gradual expansion
- Triggering plasma volume +
- Cost savings +
- Still high donor compensation; inflationary pressures including wages -
Revenues
Margins
Despite Short-Term Challenges, Commitment to Deleveraging Remains Firm
Deleveraging path supported by…
| 1 | Gradual sequential EBITDA improvement |
• Plasma collection momentum • Strong underlying demand • Global price improvements • Product mix • Lower cost per liter |
|||||
|---|---|---|---|---|---|---|---|
| Business optimization | EUR 100M Structural cost plan and R&D prioritization savings |
||||||
| Cash dividends | No cash dividends until leverage ratio <4x | ||||||
| 2 | Reinforcing our financial discipline |
• Hemostasis technology line (USD 25M) (Oct'21) Sale of VCN Biosciences (USD 75M1 • ) (Oct'21) Divestments • Closure of the production of blood bags (Nov'21) • Sale of Hospital Software BU (USD 100M) (already agreed) |
|||||
| CAPEX | Lowering CAPEX in 2022 and 2023 as already well-invested |
||||||
| M&A | Not pursuing any meaningful M&A |
151 1 Includes an initial cash payment of USD 4.7 million, the assumption of USD 2.4 million of VCN liabilities and USD 70.3 million in payments, contingent upon the achievement of clinical-development and regulatory milestones over the next six years
Prepared to Respond to the Current Macro-economic Context
| Inflationary pressures driving higher incentive to donate Inflation Impact on labor costs No significant impact on energy costs (<1% of cost per liter) |
||
|---|---|---|
| Interest rates | Optimized financial structure. Low exposure to interest rate hikes, since c.65% of debt tied to a fixed interest rate |
|
| Exchange rate EUR/USD |
FX tailwind in 2022 |
|
| Ukraine-Russia | No direct commercial or industrial presence in Ukraine/Russia Representing <0.3% of total sales |
|
| Supply chain | Cross-licensing of our industrial facilities supporting efficient supply chain management |
Low Exposure to Interest Rates Hike: 65% Fixed

Investments in Plasma and Innovation Pipeline to Accelerate Growth and Profitability
| During 2020 and 2021, Grifols invested to drive further revenue growth and margin expansion |
Plasma collection momentum supports sequential performance improvement |
Delivered on commitments: divestments and cost optimization |
|---|---|---|
| Focus on value creation assets to fuel cash flow and margins |
Deleveraging remains a key priority, levering on EBITDA improvement and cash flow generation |
Prepared to respond to the current macro-economic context |
Final Remarks
Our Commitments

Leveraging sustainability leadership to enhance financial and non-Financial performance

Accelerating Innovation and Optimizing Our Portfolio…


… With Strong Pipeline Enhanced by Grifols' Scalability and Broader Commercial Reach
| Accelerated priority projects… | + …strengthened with Biotest acquisition |
|||
|---|---|---|---|---|
| Market potential | Market potential | |||
| Xembify® in SID (CLL) |
~USD 1Bn | Fibrinogen® | 400-800M USD |
|
| ATIII in Sepsis | ~ USD 1Bn |
Trimodulin | 1Bn+ USD |
|
| AMBAR-Next | 1Bn+ USD |
CMV IG Hyper | 200-300M USD |
|
| GigaGen Platform | 1Bn+ USD |
|||
| Additional proteins to boost revenue per liter and expand margins |

Biopharma | Strong Business Fundamentals Support Biotest Acquisition


Diagnostic | Securing U.S. NAT Business While Untapping China Opportunity Through SRAAS Agreement
Long-term agreement:

- CTS will operate Grifols testing labs
- Grifols will supply NAT instrumentation and testing
- ✓ Long-term NAT supply agreement
- ✓ Increasing efficiency of Grifols labs leveraging on CTS expertise
- ✓ Building a long-term partnership with largest lab in the world
CTS agreement + Distribution agreement through SRAAS

- Integrated commercial model combining Grifols' heritage with SRAAS commercial expertise and broad reach
- Leverage SRAAS branding
- Fastest IVD market worldwide with untapped market potential
- Value chain consolidation with the streamlining of all operations from importation to distribution
Fuel immunohematology (IH) business line to achieve leadership position

Bio Supplies | High Growth and Profitability Business With the Full Integration of Access Biologicals
| Bio Supplies | Access Biologicals + |
High growth engine for the future | |
|---|---|---|---|
| • Leverages discarded products from Biopharma • Finds niche markets |
Vertical integration to obtain higher margin from Grifols products |
Bio Supplies Commercial1 2.6x Including Access Biologicals pro-forma 2.0x |
|
| Commercial knowledge to grow | |||
| in cell culture market |
|||
| Enhanced Bio Supplies portfolio | |||
| 2018 2021 |
|||
| EBIT 35-40% |
Key customers: Biotechnology research & manufacturing and Diagnostic industries
1 Bio Supplies Commercial includes sales of biological products for non-therapeutic use

Optimizing Our Business | Focusing On Value-Creation Businesses While Achieving Structural Cost Savings


Evolving Our Organization to Reinforce Competitiveness
Streamlined Value-Driven Business Units to Increase Effectiveness and Efficiencies
Biopharma Plasma Procurement Diagnostic Bio Supplies Others (Healthcare Solutions) Operations Co-CEOs 1 Full-fledged Business Units 2 Streamlined value-driven organization 3 End-to-end business ownership Enhanced effectiveness and operational efficiencies Stronger governance model Accountability over execution Cutting down on the complexity Key support functions provide speed & agility Reduce time-to-market reaction One Grifols Building Principles Scientific Innovation Corporate Quality Finance Human Resources Industrial Services Former Bioscience Division split into Biopharma and Plasma Procurement Services Corporate Comms. Corporate Affairs Digital Corp. Dev. Legal & DP Strategy & Transformation
Key Takeaways Delivering on Commitments Outlined in 2020 and 2021

June 30, 2022
- 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: 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
- Anti-thymocyte globulin (ATG): blood serum that contains antibodies that bind with human T cells. It is given to the patient before a stem cell transplant to destroy T cells and decrease the risk of graft-versus-host disease
- ASFA: American Society for Apheresis An organization of physicians, scientists, and allied health professionals whose mission is to advance apheresis medicine for patients, donors, and professionals 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
- Bullous pemphigoid: is an autoimmune disease that appears when the immune system attacks the skin and causes blisters, more common in the elderly
- 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)
- Cognitive impairment: Alterations in thinking, learning, memory, judgment, and decision making
- 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
-
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 gender linked 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
- 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
- GMP: Good manufacturing practice
- GPO: Group Purchasing Organization
- HAE (Hereditary Angioedema): Rare but serious genetic disorder characterized by recurrent episodes of severe swelling (angioedema), particularly of the face and airways, and abdominal cramping. It is caused by low levels or improper function of the C1- esterase inhibitor protein
- HBV: Hepatitis B Virus
- HCV: Hepatitis C Virus
- Hematocrit: value that is defined by the amount of blood volume occupied by red blood cells, with respect to that occupied by total blood
- 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:
- - Hemophilia A: genetic deficiency of coagulation Factor VIII, which causes increased bleeding (usually affects males)
- - Hemophilia B: genetic deficiency of coagulation Factor IX
-
Hemotherapy: Treatment of a disease using blood, blood components and its derivatives
- HIV: Human Immunodeficiency Virus
- Hyperimmune globulins: type of immunoglobulins prepared in a manner similar to human normal immunoglobulin, except that the donor has high titers of antibodies against an 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
- 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 infusedinto the circulatory system through a needle
- Lipemic plasma: plasma with a cloudy and/or milky appearance, caused by excess lipids (hyperlipidemia) mainly cholesterol and/or triglycerides in the blood, which in some cases becomes evident
-
MRB: Marketing Research Bureau
-
Molecular Diagnostic: Discipline that studies genomic (DNA) and proteomic (proteins)expression patterns and uses the information to distinguish between normal, precancerous, and canceroustissues 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 tracking. 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
- NAT: Nucleic Acid Amplification Testing
- Neurology: Science that deals with the anatomy, functions and organic disorders of nerves and the nervous system
- Northamerica: includes the U.S. and Canada
- Ophthalmology: branch of medicine and surgery that deals with the diagnosis and treatment of eye diseases
- Pandemic: The worldwide spread of a new disease
- Parkinson's Disease: complex neurodegenerative disorder in which each patient experiences a different combination of motor and non-motor symptoms
- 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
- 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
-
Plasma proteomic: describes the high throughput analysis of plasma biomarkers using very powerful, sensitive and specific instruments
-
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 sufficientquantities of plasma to cover the manufacturing needs for the different plasma protein therapies
- Pneumology: is the specialty that takes care of the diagnosis and treatment of respiratory diseases Pulmunologists treat everything related to the respiratory system from asthma to tuberculosis
- PPTA: Plasma Protein Therapeutics Association
- Primary arthroplasty: Surgery performed to replace damaged joints for various reasons, such as hip fractures, osteoarthritis or other rheumatic diseases, by artificial joints called prostheses
- Primary immunodeficiency (PI): 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
- 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
- Proteome: set of proteins that an organism synthesizes from the genes it contains to give the cell its individual character. This set of proteins determines what organisms are like, how their bodies work and how they behave
- 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
- Recovered plasma: plasma derived from whole blood collected in blood donations
-
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
-
Rh (Rhesus) blood group system: Most important blood group system after ABO. The Rh blood group system consists of 50 defined blood-group recombinant proteins, among which the five recombinant proteins D,C, c, E and are the most important. The commonly used terms Rh factor, Rh positive and Rh negative refer to the D antigen only
- 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: 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
- Single-cell transcriptomics: technique to characterize cell identity
- SCIG/SubQ: Sub-cutaneous
- 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