6-K
Grifols SA (GRFS)
6-K
2022-06-30
For: 2022-06-30
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April 05, 2026
UNITED STATESSECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUERPURSUANT TO RULE 13a-16 OR 15d-16 OF THESECURITIES EXCHANGE ACT OF 1934
For the month June 2022
(Commission File No. 001-35193)
Grifols, S.A.
(Translation of registrant’s name into English)
Avinguda de la Generalitat, 152-158
Parc de Negocis Can Sant Joan
Sant Cugat del Valles 08174
Barcelona, Spain
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (1):
Yes ¨ No x
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (7):
Yes ¨ No x
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- . .
Grifols, S.A.
TABLE OF CONTENTS
| Item | Sequential Page Number |
|---|---|
| 1. <br> Investor and Analyst Day presentation, dated June 30, 2022 | 3 |
| June 30, 2022 | |
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| Disclaimer<br>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.<br>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<br>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<br>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<br>impartiality, accuracy, completeness or correctness of the information or the opinions or statements expressed herein. Neither the Company, its subsidiaries nor any<br>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<br>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<br>used for incorporation into or construction of any contract or agreement.<br>IMPORTANT INFORMATION<br>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<br>(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<br>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<br>securities, nor a request for any vote or approval in any other jurisdiction.<br>FORWARD-LOOKING STATEMENTS<br>This document contains forward-looking information and statements about GRIFOLS based on current assumptions and forecast made by GRIFOLS management,<br>including pro forma figures, estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to capital<br>expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical<br>facts and are generally identified by the words “expected”, “potential”, “estimates” and similar expressions.<br>Although GRIFOLS believes that the expectations reflected in such forward-looking statements are reasonable, various known and unknown risks, uncertainties and<br>other factors could lead to material differences between the actual future results, financial situation, development or performance of the Company and the estimates<br>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<br>Commission, which are accessible to the public. The Company assumes no liability whatsoever to update these forward-looking statements or conform them to future<br>events or developments. Forward-looking statements are not guarantees of future performance. They have not been reviewed by the auditors of GRIFOLS.<br>2 | |
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| Agenda<br>Time (all in CET) Topic<br>10:30-11:00 am Breakfast<br>11:00-11:05 am Welcome Nuria Pascual<br>11:05-11:15 am Introductory Remarks Raimon Grifols<br>11:15-11:50 am Plasma Peter Allen<br>11:50-12:00 am Egypt and Canada Daniel Fleta<br>12:00-12:45 am Biopharma William Zabel, Joana Sàbat<br>12:45 am-1:00 pm Diagnostic Antonio Martínez<br>1:00-2:15 pm Lunch<br>2:15-2:45 pm Innovation Albert Grifols Coma-Cros, César Cerezo, Carter Keller<br>2:45-3:30 pm Biotest Joana Sàbat, Jörg Schüttrumpf<br>3:30-4:00 pm Financials Alfredo Arroyo<br>4:00-4:15 pm Final Remarks Víctor Grifols Deu<br>4:15-5:00 pm Q&A<br>3 | |
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| 5<br>Grifols has supported patients amid unprecedented<br>times through the generosity of its donors and<br>commitment of its 25,000 employees<br>Reinforcing our mission through a sustainable approach, strengthening…<br>Plasma<br>Supply<br>Innovation<br>Reorganization<br>Note: Biotest employees included in the 25,000 figure | |
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| Broadening our<br>global footprint of<br>400+ centers<br>Expanding and Diversifying Our Plasma Network, Capacities and Capabilities<br>Reinforcement of Plasma Supply in the Past 2 Years…<br>Note: plasma centers as of June 30, 2022; SRAAS not included in<br>the 400+ figure as it is not fully consolidated in Grifols’ financials<br>2020 (before pandemic)<br>48<br>264<br>41 (through SRAAS)<br>Plasma<br>Supply<br>Innovation<br>Reorganization<br>Strengthening our<br>fractionation capacity 15 ML/year<br>6 | |
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| Strengthening our<br>fractionation capacity<br>Broadening our<br>global footprint of<br>400+ centers<br>Expanding and Diversifying Our Plasma Network, Capacities and Capabilities<br> … Sees the Business Strongly Positioned Today<br>Note: plasma centers as of June 30, 2022; SRAAS not included in<br>the 400+ figure as it is not fully consolidated in Grifols’ financials<br>1<br>1<br>(31 of )<br>Today<br>89<br>312<br>41 (through SRAAS)<br>+90 centers<br>in 2 years<br>Progress<br>Plasma<br>Supply<br>Innovation<br>Reorganization<br>22 ML/year +7 mL<br>in 2 years<br>7 | |
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| 8<br>Bolstered With the Biotest Acquisition<br>Innovation Ecosystem to Drive Growth and Profitability<br>Innovation ecosystem<br>Immunology<br>Hepatology &<br>Intensive Care<br>Neurology<br>Hematology<br>Pulmonology<br>Others<br>Infectious<br>diseases<br>7 therapeutic areas reinforces our pipeline<br>3 key projects to drive<br>revenue growth and<br>margin expansion<br>Fibrinogen<br>Trimodulin<br>Internal<br>research<br>Investigator<br>-sponsored<br>research<br>Investee<br>companies<br>New<br>platforms<br>Strategic<br>alliances<br>External<br>research<br>collaborations<br>Cytotect®<br>Plasma<br>Supply<br>Innovation<br>Reorganization<br> … | |
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| 9<br>Streamlining Our Organizational Model… Plasma<br>Supply<br>Innovation<br>Reorganization<br>Previous structure<br>Commercial Division Industrial Division<br>Corporate Services<br>Co-CEOs<br>Bioscience Diagnostic Hospital<br>Bioscience<br>Industrial<br>Group<br>Diagnostic<br>Industrial<br>Group<br>Quality<br>Bio Supplies<br>Division | |
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| 10<br>The “New Grifols”<br> … To Strengthen the Core Plasma<br>Supply<br>Innovation<br>Reorganization<br>Biopharma Plasma<br>Procurement Diagnostic Bio<br>Supplies<br>Others<br>(Healthcare<br>Solutions)<br>Operations<br>(Key support functions to drive Business Units’ performance)<br>Services<br>(Corporate services extended to all Grifols areas)<br>Co-CEOs<br>Creation of full-fledged Business Units<br>Enhanced effectiveness and operational<br>efficiencies<br>Stronger governance model<br>Accountability over execution<br>Less operational complexity<br>Greater speed and agility through organization-<br>wide services<br>Reduce time-to-market reaction<br>New structure | |
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| 11<br>The First in the Industry to Have a Set of 3 Policies Reflecting Our Commitments<br>Operating With a Sustainable Approach<br>Pioneers in<br>developing a<br>Plasma<br>Donors<br>Policy<br>Underscoring<br>our respect for<br>Human Rights<br>Reconfirming our<br>pledge to Patients<br>and Patient<br>Organizations<br>30 Goals for 2030<br>across the organization<br> ✓ 50% of women in Senior Management positions<br> ✓ Achieve 100 training hours/employee per year<br> ✓ Increase number of social outreach initiatives<br>and social initiatives investment by 50%<br> ✓ Donate 240 million international units of clotting<br>factor medicines to support hemophilia patients<br>in developing countries<br> ✓ Increase by 10% financial contributions to the<br>Jose Antonio Grifols Lucas Foundation<br> ✓ Achieve >60-80% of total spending on suppliers<br>assessed by ESG criteria<br>+ | |
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| Commitment to Donors and Patients<br>Donors and Patients: At the Heart of Our Operations<br> €1,800M+<br> €28,600M+<br>positive impact of 4 main plasma proteins<br>(IG, Albumin, Alpha-1, pd Factor VIII)<br>Social Value<br>For PATIENTS<br>For DONORS<br> €700M+<br>For LOCAL COMMUNITIES<br>dedicated to patient<br>advocacy groups and<br>organizations<br>Physical and<br>psychological wellbeing<br>Financial stability<br>Educational<br>expenses<br>Better health<br>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<br>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<br>from the social accountancy. Therefore, the framework attempts to put a number on qualitative issues, and it will always show approximate values.<br>12<br> €20M+ | |
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| Impact on Society<br>Enhancing Our Operations’ Multiplier Effect<br>Combined impacts in Spain,<br>U.S., Germany and Ireland<br>(vs. 140,000 in 2020)<br>141,500<br>jobs created<br>60%<br>stemming<br>from plasma<br>centers<br> €7,700M<br>economic impact<br>(vs. €7,500M in 2020) 40%<br>stemming<br>from plasma<br>centers<br>Socio-economic Impact Our Foundations<br>1998<br>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<br>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<br>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.<br>2008<br>13 | |
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| 25,000<br>employees<br>98<br>nationalities<br>Grifols Talent<br>Our Team Is in Our Top Priorities<br>60%<br>women<br>65%<br>promotions<br>are women<br>41%<br>senior<br>managers<br>are women<br>+2.8 million<br>total training hours<br>93%<br>online<br>training<br>hours<br>Spain 3.2%1<br>U.S. 2.1%2<br>Germany 0.5%<br>Adjusted Pay Gap<br>Ireland 0.1%<br>Diversity and inclusion<br>Talent development<br>Gender equality<br>772<br>employment of people<br>with disabilities<br>+29%<br>vs. 2020<br>+11%<br>nationalities vs. 2020<br>52%<br>aged 30-50 years old<br>included ( )<br>1 Average gender gap for similar jobs in Spain of 40.2%<br>2 Average gender gap for similar jobs in the U.S. of 33.2%<br>14 | |
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| Environmental Responsibility<br>Building On Our Ambitious 2030 Environmental Goals<br>-55% (from -40%)<br>GHG emissions per unit of production<br>+15%<br>energy efficiency per unit of production<br>100% (from 70%)<br>electricity consumption from<br>renewable energies<br>Mobility decarbonization<br>in business travel and commutes<br>Circular economy<br>continue implementing new measures<br>Biodiversity<br>protect it in our properties<br>15 | |
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| Recognized Among the World’s Most Sustainable Companies<br>The new Sant Cugat (Barcelona) office building and auditorium awarded LEED<br>Gold certification (Leadership in Energy & Environmental Design)<br>16 | |
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| Commercial: Bioscience | |
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| Expanding global<br>plasma collections<br>with the highest<br>standards of quality<br>and safety<br>1<br>Leveraging<br>integrations through<br>technology,<br>standardization and<br>efficiencies<br>2<br>Donor & Employee<br>experience excellence<br>3<br>Ensuring Sustained Growth and Profitability Through Three Pillars<br>A Unique Combination of Plasma Capacity and Capabilities<br>18 | |
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| 19<br>Successfully Executing Our Strategic Plan…<br>Through SRAAS<br>41<br>47 Germany<br>1 Austria<br>48 Europe<br>Contract Manufacturing Agreement: Canada<br>Contract Manufacturing Agreements:<br>Spain, Italy and Slovak Republic<br>Note: Number of plasma centers as of December 31, 2020; SRAAS<br>not included as it is not fully consolidated in Grifols’ financials<br>2020<br>264 North America<br>264 | |
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| 20<br> … to Consolidate a Broad Global Footprint of 400+ Centers<br>Through SRAAS 342 41<br>57 Germany<br>3 Austria<br>Czech Republic<br>11<br>Hungary<br>18<br>89 Europe<br>10<br>1<br>343 North America<br>Middle East<br>and Africa<br>150 159 171 190<br>257 295 312<br>366<br>2014 2015 2016 2017 2018 2019 2020 2021 2022<br>442<br>x2.9<br>Expansion of our<br>plasma-center network<br>including 31 plasma centers<br>Note: Number of plasma centers expected by the end of 2022; SRAAS not<br>included in the 400+ figure as it is not fully consolidated in Grifols’ financials<br>Contract Manufacturing Agreement: Canada<br>Contract Manufacturing Agreements:<br>Spain and Italy<br>By the end of 2022<br>Canada and Egypt as<br>new initiatives | |
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| 21<br>On Track to Satisfying Growing Plasma Demand<br>Accelerating Plasma Collection Throughout 2022<br>1 Comparing first 4 weeks of 2022 with last 4 weeks of 2022 (as of week 25)<br>2 Comparing first 25 weeks of 2022 with first 25 weeks of 2021<br>60<br>70<br>80<br>90<br>100<br>110<br>120<br>130<br>140<br>Q1 Q3 Q4<br>2020<br>Q2 Q1 Q3 Q4<br>2021<br>Q2<br> • Delta variant<br> • B1/B2 Visa issue<br> • High-donor fee tapers off<br>COVID-19<br>outbreak<br>U.S. fiscal<br>programs<br>Holiday<br>seasonal<br>impact<br>+20%<br>YTD vs. PY 2<br>Q1<br>2022<br>Week 25<br>Weekly evolution of plasma collections<br>+24%<br>Weeks 21-24<br>vs. Weeks 1-4 1 | |
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| 22<br>On Track to Satisfying Growing Plasma Demand<br>Accelerating Plasma Collection Throughout 2022<br>+ Tailwinds - Headwinds<br> • Current macro-economic context drives momentum<br> • Contribution from new and recently acquired centers<br> • Regular centers return to pre-pandemic weekly levels<br> • New donor compensation scheme<br> • Higher talent retention<br> • New plasmapheresis devices roll-out process to end by<br>year-end – increasing donation yields and efficiencies<br> • Digital marketing enhancement<br> • Both COVID-19 headwinds and U.S. government<br>stimulus impacts are behind us<br> • B1/B2 visa restrictions on U.S southern<br>border continue to impact donation levels.<br>Plasma collections upside if these constraints<br>are ultimately lifted<br> • Donor compensation still high<br> • Persistence of inflationary and labor pressures | |
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| 23<br>Global Plasma Market Position Supports Leadership in<br>Plasma-Proteins Market Share<br>22%<br>26% 26% 25%<br>10%<br>15%<br>20%<br>25%<br> -<br> 10.000.000<br> 20.000.000<br> 30.000.000<br> 40.000.000<br> 50.000.000<br> 60.000.000<br>2018 2019 2020 2021<br>Industry (PPTA & EPA) Donations Grifols Contribution<br>29% 30% 28% 29% 29%<br>71% 70% 72% 71% 71%<br>Grifols All Others<br>2018 2019 2021 2020 Q1 2022<br>Open plasma centers market share evolution<br>(% of open plasma centers)<br>Note: both graphs including U.S. and EU data<br>Plasma volumes market share evolution<br>(Industry donations) | |
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| 24<br>A Strong Integration Response Led to Greater Efficiency Gains<br>Rapid Inorganic Expansion Over the Past 4 Years<br>Acquisitions Integrations<br> • Operations<br> • Quality and safety<br> • Shared services systems<br> • Donor management<br>applications and<br>communications<br> • Technologies<br> • Human resources<br> • Culture<br>Consistency Efficiency<br> • Common SOPs1<br> • Similar technologies<br> • Standardized policies<br> • Uniformed practices<br> • Best practices adoptions<br> • Common training<br>development and execution<br> • Leverage on the center of<br>excellence<br>Q2 2021<br>25<br>Q1 2021<br>7<br>Q4 2020<br>11<br>Q3 2018<br>24<br>Q2 2019<br>35<br>Q1 2018<br>35<br>Q2 2019<br>4<br>1 Standard Operational Procedures (SOPs) | |
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| 25<br> • Improved documentation and workflow<br> • Automated paperless manufacturing<br>records using handheld computing devices<br> • Streamlined process flows and reduction of<br>manual verification steps thanks to software<br>automation<br> • Labor optimization via paperless and<br>process automation<br> • Donor screening devices that reduce cycle<br>time and allow for automated data entry<br>Increasing Business Process Optimization<br>Leveraging Technology to Optimize Ongoing Efficiencies<br>Digital Transformation<br>BECS migration Benefits | |
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| 26<br>New Devices Enhance Donor and Employee Experience<br>Leveraging Technology to Optimize Ongoing Efficiencies<br>0<br>50<br>100<br>150<br>200<br>250<br>2021 2022 2023<br>NexSys/Aurora Xi Legacy PCS<br>Digital Transformation<br>Device migration Benefits<br> • NexSys designed with data management, safety<br>features and usability enhancements to improve<br>yield and efficiency:<br> • Integrated touch screen<br> • Integrated scanner<br> • Integrated to BECS<br> • Aurora Xi with greater storage capacity; updated<br>algorithms provide faster separation process to<br>decrease donation cycle time and improve yield:<br> • More precise controls and settings of device<br>operating capabilities optimize collection volume<br>while efficiently managing donation supplies | |
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| 27<br>Process Enhancement From Different Approaches<br>Leveraging Our Capabilities<br> • Diversify the donor<br>demographics to expand the<br>unique donor count<br> • Focus on donor retention<br>and donation frequency by<br>high service delivery<br> • Reduce complexities in the donor<br>center towards standardization of our<br>systems of record and infrastructure<br> • Better access to donors and potential<br>donors through online appointment and<br>communication platforms<br> • Rapid donor care management<br> • Academy continues to expand<br>virtual training programs and<br>partnerships<br> • 350+ graduates from Academy’s<br>leadership development program<br> • 50k+ training hours (all modalities)<br> • Share expertise and best practices<br>across Grifols plasma organizations<br> • Implement standardization across<br>plasma organizations preserving local<br>environment<br> • Orientation to global change and<br>innovation<br>Process efficiencies<br>One global plasma organization Talent development<br>Donor-center network management | |
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| 28<br>Delivering on Improvements Derived From Optimizing Diversification<br>Leveraging Technology to Optimize Efficiencies<br>2021 2022<br>Technology delivering better targeting<br>for donor recruitment, while enhancing<br>donor experience and loyalty:<br> • Legacy BECS transitioned out<br> • Electronic System Appointment<br> • Donor visibility for upcoming<br>donations<br>Donor Retention Rate<br>2021 2022<br>Talent development, effectiveness and<br>efficiency initiatives have led to a higher<br>donations processed per employee<br>due to:<br> • Process standardization<br> • Efficiency gain in donor registration<br>process<br> • Paperless process<br>+11%<br>Donations per Employee Hour<br>2021 2022<br>+2%<br>Average liters of plasma per unit are<br>increasing (higher yield) as a result of<br>technology<br>Average Yield<br>+4% | |
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| 29<br>Communication Programs Delivering the Potential<br>Average Liters per Center Demonstrate Positive Momentum<br>Average Liters per Center*<br>Donor experience focus & marketing<br>campaigns partially offset by U.S. incentive<br>plans and Delta variant. Gradually<br>improving over the quarters<br>Recovery delayed due to<br>U.S. fiscal programs<br>Strong Q2’22 delivering the<br>potential to attract and<br>retain donors<br>* Regular centers excluding U.S.-Mexican Border<br>Q2’22 up to Week 25 Q2’21 Q1’22 Q3’21 Q4’21<br>+14%<br>+26% | |
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| 30<br>Higher Donor and Employee Engagement and Retention<br>Delivering on the employee and donor experience makes the difference,<br>what ensures Grifols can withstand competition and market fluctuations<br>Mastering Both Experiences Enables Achieving the Average Liters per Center Target<br>Employee and Donor Experience Drive Our Mission<br>Substantially improve employee<br>engagement through technology,<br>tools and training<br>Delight donors at every touchpoint<br>resulting in continual and reliable<br>collections<br>+<br>Employee experience Donor experience | |
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| EMPLOYMENT TENURE PRE-EMPLOYMENT and ONBOARDING<br>Grifols’ Employees Proudly Help Patients Around the World<br>Employee Experience Directly Impacts the Donor Experience<br>Opportunities for advancement, engagement,<br>progressive training and skill enhancement<br>IN-CENTER EXPERIENCE<br>Reputation for industry recruiting,<br>onboarding, wages and benefits<br>Strong training programs and a focus on team<br>building, ownership, and work-life balance<br>CULTURE OF SERVICE<br>How does employee experience impact the donor experience?<br>When employees feel part of a team<br>and that they matter they treat<br>donors in the same way<br>1<br>Well-trained and well-rested employees<br>are more confident and positive and will<br>delivering a more consistent and<br>exceptional donation experience<br>2<br>Long-term employees establish<br>meaningful connections with donors,<br>that stay loyal because they want to<br>continue to see their favorite employees<br>3<br>31 | |
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| Donors Feel Good Knowing Their Plasma Helps Patients Around the World<br>Success Depends Upon the Donor Experience<br>POST DONATION PRE-DONATION<br>Ongoing dialogue and predictive<br>digital communications inspire<br>donor promotion<br>IN-CENTER EXPERIENCE<br>Multi-channel communications<br>with strong digital presence<br>targeting donor segments<br>Memorable experiences<br>Donation centers become a destination<br>CULTURE OF SERVICE<br>Powered by Grifols technology and digital infrastructure<br>Donors’ online activity, behavior and in-center experience are captured<br>and analyzed, providing a 360-degree real-life view about the donor<br>32 | |
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| Technology and Data Infrastructure Support Donor Experience<br>The Development of Donor Experience<br>Data tools<br>and CRM<br>Trigger rules,<br>automation<br>Revenue<br>management<br>Predictive AI<br>Analyze data and tools<br>ORCHESTRATION INTEGRATION<br>Donor direct content<br>(email, SMS, apps,<br>servicing tools, chatbots)<br>Future donor content<br>(website, social media,<br>search listings, advertising)<br>In-center experience<br>Culture of service and<br>employee experience<br>Transactional /<br>Operations data<br>Market, demographic,<br>consumer data<br>Online & mobile activity<br>data (UX)<br>Marketing campaign data<br>Donor research/<br>segmentation<br>Customer service &<br>feedback data<br>Informs and elevates<br>donor experience<br>Customer data platform<br>Collect data at<br>every touch<br>33 | |
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| 34<br>Moving forward…<br> • Continue to build awareness and engagement with future donors, using uninterrupted recruitment campaigns<br> • Gained momentum, building on continued learnings to expand and refine recruitment messaging and tactics<br> • Expand digital presence across channels to secure market leadership, reaching and converting future donors to new donors<br>In 2020, we launched the industry’s first national campaign, doubling new donor numbers at the<br>height of COVID. Since then, U.S. coverage continues to grow<br>Give Your Light<br> ✓ Leveraged donor segmentation data to<br>target attractive future donor audiences<br> ✓ Expanded across broadscale channels:<br>digital, video ads, streaming TV and radio,<br>local media and sponsorships<br> ✓ Launched lead generation and lead<br>nurturing emails, capturing nearly 250k<br>prospects, with higher conversions,<br>engagement and frequency<br>Successfully Encouraging People to Donate Plasma<br>Building Momentum Through Our U.S. Recruitment Campaigns<br>2021 2022 2020<br>Answer The Call Show Your Good Side | |
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| 35<br>Successfully Encouraging People to Donate Plasma<br>Building Momentum Through Our U.S. Recruitment Campaigns<br> • Raised broad awareness on<br>the benefits and need of plasma<br>donations<br> • Recruited new donors and<br>recapture donors who lapsed<br>in plasma donations<br> • Reinforced messaging of life<br>saving medicines and donor<br>compensation benefits<br> • Delivered recruitment diversity<br>within targeted demographics<br>259MM<br>2.6MM<br>1.2MM<br>+29%<br>Impressions<br>Website<br>visits<br>Landing<br>page visits<br>Weekly<br>New<br>Donors<br>Launch Ramped-up<br>April May<br>Benefits 2022 Performance metrics<br>Omni-Channel Marketing Plan<br>Social Media<br>Search<br>Programmatic Audio & Video<br>NFL Digital<br>Meredith Partnership<br>(online publications) &<br>NBCU Partnership | |
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| 36<br>Moving forward…<br> • Expand digital tools and insights of donors needs and motivation for data-driven marketing campaigns<br> • Delimitation from competitors and leadership by using donor-experience technologies and services<br> • Greater awareness of plasma donation is indispensable to produce life-saving medicines<br>In 2021, we launched the first German national campaign to highlight benefits for donors, increasing<br>new donor numbers during the pandemic. The number of new donors has since increased significantly<br> ✓ New approach: modern, young and eye-catching<br> ✓ Key visuals: show pleasing images or benefits<br>related to donating plasma<br> ✓ Target group: young people and individuals facing<br>economic difficulties in pandemic times<br> ✓ Multichannel: online, digital, social ads, streaming<br>TV and radio, out-of-home ads, public transport<br> ✓ Key element: landing page with appointment system<br>Significantly Increasing the Number of New Donors in Europe<br>Through Our National Recruitment Campaigns<br>Deserve<br>More Than Respect<br>Rising Prices<br>Fuel & Energy<br>Help Twice<br>(Ukraine)<br>Save Lives<br> & Relax<br>2022 2021 | |
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| 37<br>1.806<br>2.308<br>2.672<br>2.509<br>2.360 2.444 32.304<br>35.852<br>41.739<br>38.989<br>37.257<br>40.074<br>610<br>1.500<br>2.440<br>3.050<br>4.270 3.980<br> ✓ Extension of the targeted demographics from young to older<br> ✓ Expansion of leadership position in social media & online among competitors<br> ✓ Development of data-driven marketing along the customer journey<br> ✓ Implement a wide range of new technology/systems and upgrade donor app<br>July June August<br>Ranking<br>Visibility<br>Website<br>visits<br>Monthly<br>New<br>Donors<br>May September October<br>5-fold<br>increase<br>in search<br>volume<br>10,000<br>more<br>+30% on<br>average<br>Jan Feb Mar Apr May<br>2021 2022<br>2021 Performance “Deserve More Than Respect” Monthly New Donor Performance<br>1st flight 2nd flight<br>Online Focused Multi-Channel Marketing:<br>Social media<br>SEO/SEA<br>Programmatic<br>audio & video<br>Online Advertorials<br>Partnerships<br>Guerilla<br>Out of home<br>Significantly Increasing the Number of New Donors in Europe<br>Through Our National Recruitment Campaigns | |
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| 38<br>Leveraging a Unique Combination of Plasma Capacity &<br>Capabilities to Accelerate Performance<br>Double-digit plasma growth<br>addresses expected plasma needs<br>for 2022 to meet strong underlying<br>demand<br>Current macro-economic context<br>drives momentum on plasma<br>collections<br>Successful execution of<br>expansion plan through strong<br>integration response<br>Continue to build plasma<br>awareness and donor marketing<br>campaigns to support further<br>plasma donations<br>Reinforcing Donor and Employee<br>Experience to gain further<br>efficiencies while ensuring<br>sustainable growth<br>The reorganization will enable to<br>fully capture benefits of scale<br>and integration | |
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| 39 | |
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| 40<br>Game-Changing Initiatives to Become a Blueprint for Other Countries<br>Responding to the Global Need for a Sustainable Plasma Model<br>New indications and higher-<br>prevalence diseases<br>Diagnosis and prescriptions<br>are increasing<br>COVID-19 pandemic Increased emphasis on the importance<br>of plasma supply and its limitations<br>Growing demand for plasma-derived therapies<br>Grifols’ capabilities make it ideally fitted<br>to serve as an international partner<br>Grifols Self-Sufficiency Program<br>Full range of services<br>Working with countries in building<br>sustainable plasma-collection models<br>Establish donor-center networks in other<br>countries with international quality standards<br>+<br>PLASMA AS A STRATEGIC ASSET<br>GRIFOLS COVERS<br>END-TO-END NEEDS<br>Manufacturing<br>capabilities<br>Engineering<br>competences<br>Quality &<br>safety<br>standards<br>Regulatory<br>know-how<br> “The World Health Organization urges state members<br>to take all the necessary steps to establish, implement<br>and support nationally-coordinated, efficiently-<br>managed and sustainable blood and plasma programs<br>according to the availability of resources, with the aim<br>of achieving self-sufficiency, unless special<br>circumstances preclude it”1<br>+<br>1 World Health Organization (WHO) (https://www.who.int/publications/i/item/WHA63.12) | |
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| 41<br>Self-Sufficiency Management Models<br>Responding to the Global Need for a Sustainable Plasma Model<br> • 1,000+ private<br>plasma donation<br>centers<br> • 80+ private plasma<br>and blood<br>donation centers<br> • Compensation<br>(legal limitations)<br> • Public Infrastructure<br> • Grifols provides<br>know-how<br> • Construction of<br>plasma centers<br> • Training<br> • Donor search & loyalty<br> • Grifols fractionated<br>plasma<br> • Altruistic donation<br> • Centralized public<br>model (blood banks<br>w/ limited autonomy)<br> • No specific plasma<br>programs<br> • Plasma fractionated<br>via contract manuf.<br>agreement<br> • In some regions,<br>greater plasma<br>collection focus &<br>capabilities<br> • Construction of<br>plasma centers<br> • Construction of a<br>fractionation and<br>purification plant<br>National self-sufficiency Lack of self-sufficiency<br>Public Model<br>(no compensation)<br>Private Model<br>(with compensation)<br>(Consulting)<br>Since 2019<br>(Joint<br>venture)<br>2020+<br>Since<br>70s-80s<br> • 300+ private<br>plasma donation<br>centers<br>Since 1996 Since 1960<br>Altruistic donation<br> • Reimbursement for<br>travel expenses<br> • Remuneration for<br>time off work<br>Altruistic donation<br> • Day-off paid<br>Public-Private Public Private | |
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| 42<br>Fractionation Capacity Global Footprint<br>Ensuring Sufficient Capacity<br>22mL as of today (June 2022)<br>26mL in 2026<br>U.S.<br>Spain<br>Ireland<br>Germany<br>Canada<br>Egypt<br>42<br>U.S.<br>Spain<br>Ireland<br>Germany | |
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| 43<br>Well-Positioned to Satisfy the Country’s Needs<br>Canada: Leveraging Our Experience and Capabilities…<br>Grifols has a local fractionation,<br>purification and fill & finish plant<br>Canadian plasma-derived therapies market<br>Mature and stable market with<br>high consumption of IgG levels<br> … but Canadian government<br>seeks to be more self-sufficient<br>Grifols is the best<br>positioned company in Canada<br>Only large-scale domestic<br>manufacturing facility and uniquely<br>positioned for continued growth across<br>full platform of service offerings<br>Deep experience in the Canadian<br>market, with more than 30 years as<br>the primary fractionator for<br>Canada’s blood operators<br>+<br>+<br>Source: Global Market Database, 2021 preclosing<br>2nd World<br>IgG Consumer<br>316 299 292<br>229 213<br>Belgium U.S. Canada Australia Switzerland<br>2021 IgG Kg / inhabitants | |
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| 44<br>GCT<br>Downtown<br>Airport<br>Grifols Canada Therapeutics (GCT) Canada Egypt<br>Strategic Location<br>Montreal | |
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| 45<br>Canada Site Facts<br>Construction of a New State-Of-The-Art Plant<br>Acquired by Grifols October 1, 2020<br>Located in Technoparc<br>Montreal, Quebec<br>Plot: 63,134 m2<br>Built: 19,865 m2<br>3-story building<br>Manufacturing, warehouse &<br>QC lab and admin building<br>Canada Egypt | |
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| 46<br>Canada Current Facility Canada Egypt | |
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| 47<br>Phase I August 22<br>+6,600 m2<br>Canada Expansion Project Construction<br>Gamunex<br>Expansion<br>Fractionation<br>Expansion<br>Warehouse<br>Expansion<br>Albumin<br>Purification<br>Canada Egypt<br>Phase II Sept ’23<br>Phase III Nov ’24 | |
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| 48<br>Albumin Conversion – Phase I, August 2022 Canada Egypt<br>Albumin<br>Purification | |
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| 49<br>National mandate to develop the<br>healthcare system<br>Plasma-derived medicines needed for<br>its growing population<br>Government committed to the<br>country’s self-sufficiency<br>Overcoming Challenges to Strengthen Egypt’s Healthcare System<br>Egypt: Delivering On Our Promises Through a Pioneering Model<br>Establish a public-private<br>partnership Master Joint Venture Agreement Signature 1<br>Plasma executive regulation Issued Law Number 8 of 2021 2<br>Develop the adequate<br>infrastructure<br>Plasma site allocations, constructions,<br>recruitment and training, storage<br>facilities, transportation<br>3<br>Creating community<br>awareness for plasma donation<br>Launch of plasma and donation<br>informational campaign 4<br>Challenge<br>1st<br>plasma center<br>opened<br>(+19 planned)<br>Egyptian plasma-derived<br>therapies market | |
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| 50<br>Apr 15<br>20 donor-<br>center network<br>Fractionation<br>plant Purification<br>plant<br>1st plasma<br>shipment to Spain<br>Achievements Clear the Path for Future Milestones<br>Master Joint Venture<br>Agreement Signature<br>2020<br>Grifols Egypt first employee<br>Testing laboratory operational<br>Egypt executive regulation for plasma release<br>Start of plasma collection<br>2021<br>6th October EDA1 license<br>PPTA approval for GEPD source membership<br>Canada Egypt<br>6th October inauguration (1st plasma center)<br>2022 2023 2024 2025<br>Nov 24<br>Jun 1<br>Oct 5<br>Oct 19<br>Dec 14<br>Dec 15<br>Jan 24<br>1 Egyptian Drug Authority (EDA)<br>50<br>Year 1: Grifols Successfully Laid the Foundations of the Egypt Project | |
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| 51<br>Paving the Way for the First Integrated Plasma-Supply Platform in Africa<br>First EDA1 Licensed Donor Center in Egypt<br>Donor center, plasma testing labs, plasma freezers<br>warehouse, Grifols Academy for Plasmapheresis<br>and plasma operations offices<br>1 Egyptian Drug Authority (EDA)<br>Canada Egypt | |
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| 52<br>10 Plasma Collection Centers Projected in Wave 1 (10+ in Wave 2)<br>Plans on Track for the Construction of 20 Donor Centers<br>1st Zone<br>SOUTH CAIRO<br>2nd Zone<br>EAST CAIRO<br>3rd Zone<br>CANAL ZONE<br>Maadi<br>Helwan<br>Misr Al Gadida<br>Military Institute<br>Nasr City<br>Port Said<br>Suez<br>Tal Kabeer<br>Ismailia<br>Canada Egypt<br>DC Wave 1<br>DC Wave 2<br>Manufacturing Plant<br>GEPD Offices<br>1st Donor Center open | |
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| 53<br>Canada Egypt Plans on Track for the Manufacturing Site Construction<br>New Administrative Capital | |
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| 54<br>Key Takeaways<br>Responding to the Global Need for a Sustainable Plasma Model<br>Self-sufficiency is crucial to<br>guarantee the sustainability of<br>plasma-derived medicines<br>supply<br>Grifols positions to serve as a<br>best-in-class partner through<br>private or public/private<br>initiatives to support a<br>sustainable plasma model<br>Grifols’ unique know-how and<br>leadership in engineering and<br>operations represents a<br>competitive advantage to<br>execute these projects<br>Best positioned to capture<br>new opportunities…<br>Becoming a blueprint for other<br>countries to increase plasma<br>self-sufficiency levels<br>The implementation of<br>international quality standards<br>strengthens the safety & efficacy<br>of our medicines<br>Milestones in Egypt and Canada<br>reflect how Grifols delivers on<br>its promises | |
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| 55 | |
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| Poised for<br>performance…<br> … in an essential<br>and growing market<br>56 | |
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| 57<br>Driven by Biopharma Strengths<br>Grifols Is Well Positioned to Get Back to Growth<br>1 The Worldwide Plasma Proteins Market, MRB, February 2022<br>Global plasma-derived proteins market is an<br>attractive market that continues to grow<br>FY20 sales<br>EUR 25Bn€ (7.2%1<br>CAGR 2017-2020)<br>Uniquely positioned with a specialized<br>focus on therapeutic areas<br>Pulmonology Immunology Intensive Care & Hepatology<br>Neurology Hematology Infectious diseases<br>IG, Alpha-1 and Albumin defy the normal life-cycle of<br>a pharmaceutical product<br>keep growing to address the<br>large unmet medical need<br>Bioscience Biopharma Reflects the opportunity<br>Therapeutic areas of expertise + Infrastructure = capability to deliver plasma and non-plasma<br>life-saving medicines globally | |
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| 58<br>7.9% 8.0% 8.9% 7.6% -5.9%<br>2017 2018 2019 2020 2021 2022<br>Bioscience Revenues<br>(EUR in millions, growths at cc)<br>Pandemic<br>impact<br>CAGR: +8.1%<br>2022<br>Core growth products<br>show positive trend in Q1’22 vs. Q1’21<br>Strong start of the year, driven by sales in<br>China and U.S. Albumin<br>Back to growth, driving Biopharma sales recovery IgG<br>Consolidated market leader, growing<br>year over year HyperRAB®<br>Increasing market share and sustained<br>growth during 2021 and 2022 Alpha-1<br>Underlying Demand Supports Further Growth | |
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| 59<br>Main geographies<br>show significant recovery in Q1’22 vs. Q1’21<br>Underlying Demand Supports Further Growth<br>7.9% 8.0% 8.9% 7.6% -5.9%<br>2017 2018 2019 2020 2021 2022<br>Bioscience Revenues<br>(EUR in millions, growths at cc)<br>Pandemic<br>impact<br>2022<br>Strong albumin growth driving double-digit-growth<br>China<br>Recovering high-single-digit growth<br>U.S.<br>Sustained growth<br>Europe<br>CAGR: +8.1% | |
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| 60<br>Deep Knowledge and Capabilities Coupled With a Focus on Therapeutic Areas<br>Building on Biopharma Portfolio With Recent Product Launches<br>Immunology and<br>Neurology<br>Treating immune deficiencies<br>and autoimmune disorders<br>Pulmonology<br>Treating AATD1, a genetic<br>condition that can lead to<br>serious lung disease<br>Infectious Diseases<br>Providing rapid immune<br>coverage in potentially life-<br>threatening situations<br>Hematology<br>Treating hemophilia and other<br>bleeding and clotting<br>disorders<br>Intensive Care and<br>Hepatology<br>Treating the critically ill<br>patient and the patient with<br>liver cirrhosis<br>Recent product launches<br>1 Alpha-1 Antitrypsin Deficiency (AATD)<br>New<br>formulation | |
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| 61<br>Gamunex®-C Recognized as the #1 Prescribed IG for CIDP<br>Immunology and Neurology<br>Leading an Increasingly Competitive U.S. CIDP1 Market<br>CIDP Market<br>Source: LexisNexis Trending Data, Medical Claims only; and Gamunex®-C and GammaKed share a J-code<br>1 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)<br>32% 31% 32% 32% 34%<br>0%<br>10%<br>20%<br>30%<br>40%<br>Q1 21 Q2 21 Q3 21 Q4 21 Q1 22<br>competitors<br>% Share IG CIDP Procedures | |
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| 62<br>Over 1,000 U.S. HCPs have prescribed Xembify®<br>since its launch and 87% continue to prescribe it<br>+141% YoY<br>LTM2 March’22<br>+3%<br>-5%<br>-1%<br>+3%<br>+1%<br>Competitor C Competitor A Competitor B Competitor D<br>volume growth since launch…<br>doubled market<br>share in a year<br>Immunology<br>Supporting Patients by Providing a New Solution That HCPs1 Rely On<br>Xembify® Continues to Gain U.S. Market Share<br>10-15%<br>of Grifols global<br>IG sales in 2025<br>Source: Grifols Internal data<br>1 Health Care Practitioners (HCPs)<br>2 Last Twelve Months (LTM)<br>3 Primary Immunodeficiency (PI)<br> … and market share evolution in PI3<br>(Last 12 months) | |
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| 63<br>Immunology<br>SCIG Represents 23% of Volume in EU/Australia<br> … While Expanding to New Geographies Outside the U.S.<br>Sources: (i) Grifols Database provisional data 2021 (accessed<br>May’22); (ii) Grifols ATU Study 2022. Base: All HCPs. Germany<br>(n=40), France (n=40), Italy (n=40), Spain (n=40) UK (n=40)<br>Nordics (n=29) and Australia (n=36)<br>SCIG continues to grow<br>(EU & Australia market)<br>Launching Xembify® in several European countries throughout 2022<br>and 2023 leveraging on increasing growth of SCIG preference over IVIG<br>Preferred route of administration for IG therapy by market (% HCPs)<br>2023 launches<br>33% 25%<br>39% 38% 35%<br>17%<br>45%<br>20% 25%<br>28%<br>13% 18%<br>24%<br>43%<br>48% 50% 33% 50% 48% 59%<br>13%<br>UK France Australia Spain Italy Nordics Germany<br>IVIG No preference SCIG<br>2022 launches + Czech Republic<br>Slovakia<br>UK France Australia Spain Italy Nordics Germany<br>SC market share<br>ambition 2030<br>ex-U.S.<br>14%<br>helping IG franchise to grow high-single-digit YoY<br> … leading to 2019 2020<br>+12%<br>2020 2021 | |
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| 64<br>Pulmonology<br>Prolastin®1 Shows Steady Growth in 2021 and Q1’22<br>Leading the Alpha-1 Market for 35 Years<br>Source: Grifols Internal data<br>1 Prolastin® includes all Grifols Alpha-1 brands<br>Steady growth…<br>Jan<br>2021<br>Dec<br>2021<br>March<br>2022<br>FY21 Q1’22<br> … in the Alpha-1 antitrypsin market<br>(worldwide market in 2021)<br> >70%<br>7 out of 10<br>Alpha-1 patients globally are<br>receiving Prolastin® | |
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| 65<br>Helping ensure HCPs and patients<br>have access to Prolastin® when and<br>where it is needed<br>Patient health management<br>programs provide personalized care<br>and home infusion<br>Pulmonology<br>Leading the Alpha-1 Market for 35 Years<br>Prolastin®1 Shows Steady Growth in 2021 and Q1’22<br>Sustained and reliable product supply…… backed by Patient Support Programs<br>Context<br>Competitor alpha-1 product shortage<br>in Q4’20-Q1’21 challenged treatment<br>continuity in EU<br> ✓ Personalized support and benefits<br>beyond therapy<br> ✓ Significant improvements in compliance<br>with therapy and health outcomes after<br>intervention year2<br>Grifols was ready to immediately put in place<br>all efforts, guaranteeing Prolastin® to patients<br>1 Prolastin® includes all Grifols Alpha-1 brands<br>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 | |
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| 66<br>Record Sales in 2021<br>HyperRAB® Driving Hyperimmunes Portfolio<br>Infectious diseases<br>Rabies IG Market (2021)<br>HyperRAB®<br> >80%<br>Graph source: Grifols Database provisional data 2021 (accessed May’22)<br>1 Human rabies immune globulin (HRIG)<br>2 HyperRAB (rabies immune globulin [human]) Prescribing Information. Grifols.<br>3 Siegel J. Rabies Immune Globulin: Ensuring Administration Safety. Pharmacy Practice News Special Edition. 2019: 47-52.<br>4 Manning SE, Rupprecht CE, Fishbein D, et al; Advisory Committee on Immunization Practices Centers for Disease Control<br>and Prevention (CDC). Human rabies prevention—United States, 2008: recommendations of the Advisory Committee on<br>Immunization Practices. MMWR Recomm Rep. 2008;57(RR-3):1-28<br> >1M patients<br>treated with HyperRAB®<br>since launch<br>Comprehensive HRIG1 Solution<br>First and only high-potency HRIG that<br>enables the delivery of more of the total<br>dose per mL at the wound site, regardless<br>of the wound size or patient weight 2,3,4 | |
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| 67<br>Intensive care & Hepatology<br>Designed, Engineered and Manufactured by Grifols<br>Albutein FlexBag™ Successful Launch<br>Albutein FlexBag™<br>18%<br>of U.S. Albutein® sales<br>in 2022<br>Q2 21 Q3 21 Q4 21 Q1 22<br>launch<br> … reflected in revenues backed by<br>fast adoption in the U.S.<br>5%<br>launch<br>First and only 5% 500mL offers convenience<br>Storage and portability vs. vials<br>Availability of both 5% and 25% strengths<br>Ease of use/administration vs. vials<br>High degree of satisfaction<br>among customers…<br>Environmentally-friendly design<br>1 Albutein® includes all Grifols albumin brands | |
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| 68<br>Sales volume (last 12 months)<br>On track<br>throughout 2021<br>First launching country<br>Germany<br>Successfully Launched in Multiple European Countries, Including EU41<br>Tavlesse® Continues to Gain Traction<br>Sources: Internal data; (i) Price and Reimbursement ; (ii) Health Technology Assessment<br>1 Includes France, Germany, Italy and Spain<br>x4<br>Launches proceeded<br>during the pandemic<br>Exceeding<br>volume targets in<br>Spain and Italy<br>Launch timelines in<br>progress for<br>12 more countries<br>in 2022-2023<br>Hematology | |
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| 69<br>Nordics, Puerto Rico, France,<br>Singapore, Netherlands<br>2021<br>Ongoing joint development of<br>innovative solutions<br>2nd plasma protein sourced from<br>Grifols approved in the U.S.<br>Recovery of Elective Surgical Procedures Following Pandemic-Related Interruptions<br>Vistaseal® Market-Leading Fibrin Sealant in the U.S.<br>Continued acceleration of<br>Vistaseal®/VERASEAL® launches<br>More to come…<br>Entering 3rd year post-launch<br>3rd plasma protein to deliver future<br>biosurgery products that address bleeding<br>and leak management in surgery<br>Hematology<br>Globalization and scale-up efforts underway<br>Spain, rest of APAC and<br>EMEA, and new markets<br>(Russia, Israel, Saudi Arabia)<br>2023<br>Germany, Austria, UK, Ireland 2020<br>Double-digit growth at cc worldwide in FY21 vs. FY20<br>Canada, Italy, Switzerland,<br>Estonia, Australia 2022<br>Baltics (2) 2022 | |
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| Poised for<br>performance…<br> … in an essential<br>and growing market<br>70 | |
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| 71<br>Operating in an Essential and Growing Market<br>Further Growth in IG Market Driven by Progress in PI1 Diagnosis<br>Average diagnosis 12.4 years2<br>Undiagnosed 70-90%3<br> >400 related-genetic defects5<br>500,000 undiagnosed 4<br>PI underdiagnosis facts<br>Immunology<br>1 Primary Immunodeficiency (PI)<br>2 Routes J, et al. J Clin Immunol. 2016;36:450-461<br>3 Primary Immunodeficiencies (PID) – Driving Diagnosis for Optimal Care in Europe, European Reference Paper<br>4 Modell V. Immunol Res. 2007;38(1-3):43-47<br>5 French MA, Tangye SG. J Infect Dis. 2019;jiz230. doi:10.1093/infdis/jiz230<br>6 Grifols Internal Source<br>(NIH estimates)<br>PI patients (in millions worldwide)6<br>PI prevalence Treated with IG<br>x12 | |
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| 72<br>Immunology<br>Operating in an Essential and Growing Market<br>Further Growth in IG Market Driven by Progress in PI1 Diagnosis<br>PI underdiagnosis facts<br>1 Primary Immunodeficiency (PI)<br>2 Routes J, et al. J Clin Immunol. 2016;36:450-461<br>3 Primary Immunodeficiencies (PID) – Driving Diagnosis for Optimal Care in Europe, European Reference Paper<br>4 Modell V. Immunol Res. 2007;38(1-3):43-47<br>5 French MA, Tangye SG. J Infect Dis. 2019;jiz230. doi:10.1093/infdis/jiz230<br>Average diagnosis 12.4 years2<br>Undiagnosed 70-90%3<br> >400 related-genetic defects5<br>500,000 undiagnosed 4 (NIH estimates)<br>Grifols is actively partnering with insurers and patient groups to<br>apply artificial intelligence programs to identify patients who<br>may benefit from laboratory or genetic testing to detect the<br>possibility of an underlying immune deficiency exists<br>Grifols Strategic Imperative<br>Truncating time to diagnosis and treatment<br>Uniquely positioned to leverage our expertise in IG<br>replacement therapy and diagnostics to improve the rate<br>and time to an appropriate PI diagnosis | |
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| 73<br>2020<br>2027<br>Immunology and Neurology<br>Plans on Track for Xembify® to Treat New Key Indications e.g., CLL1 and HGG2<br>SID Market Continues to Expand in Hematological Malignancies<br>1 Chronic Lymphocytic Leukemia (CLL)<br>2 Hypogammaglobulinemia (HGG)<br>3 US PPTA Distribution Data<br>4 Friman V et al. Hematol Oncol. 2016;1-12: doi 10.1002/hon.2323. [Epub ahead of print]<br>5 Seppänen M. Clin Exp Immunol. 2014;178(Suppl 1):10-13.<br>Increased use of SID-inducing medication in<br>oncological and autoimmune indications<br>Hypogammaglobulinemia occurs<br>in up to 85% of patients4,5<br>Extended survival rates of cancer patients<br>Infections are major cause of<br>death in patients with CLL<br>IG growth in SID Grifols has a Clinical<br>Development Plan for<br>HGG and CLL with<br>Xembify®<br>Continued commitment<br>to SIDs patients<br>(IG growth in SID worldwide) | |
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| 74<br> >950,000 tests<br>performed<br>Grifols’ worldwide testing program (since 2006)<br> >205,000<br>deficient<br>patients found<br> >16,000<br>severe patients<br>diagnosed<br>(vs. >850,000)(vs. >190,000)(vs. >15,000)<br>in Jun’2021 in Jun’2021 in Jun’2021<br>Further Expanding Our Testing Program Worldwide<br>Pulmonology<br>Accelerating AATD1 Diagnosis as Our Primary Goal<br>AATD underdiagnosis facts<br>8.3 years2<br>2.72<br>1 Alpha-1 Antitrypsin Deficiency (AATD)<br>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.<br>3 World Health Organization. Alpha 1-antitrypsin deficiency: memorandum from a WHO meeting. Bull World Health Organ. 1997;75(5):397-415.<br>4 McElvaney 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.<br>5 ATS, 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.<br>6 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.<br>7 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2021 Report<br>Grifols Strategic Imperative<br>Truncating time to diagnosis and treatment<br>Avg. delay between the onset of<br>symptoms and diagnosis<br>avg. number of physicians seen<br>by patients before diagnosis<br>Patients present with<br>common respiratory symptoms3,4<br>Diagnosis does not depend on clinical presentation alone<br>Laboratory testing is the only way to make the diagnosis2,5,6,7<br>+12% +8% +7% | |
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| 75<br>Dedicated Efforts to Increase the Diagnosis Ratio<br>Pulmonology<br>Undiagnosed<br>Alpha-1 patients<br> >90%<br>Accelerating AATD1 Diagnosis as Our Primary Goal<br>1 Alpha-1 Antitrypsin Deficiency (AATD)<br>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.<br>3 World Health Organization. Alpha 1-antitrypsin deficiency: memorandum from a WHO meeting. Bull World Health Organ. 1997;75(5):397-415.<br>4 McElvaney 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.<br>5 ATS, 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.<br>6 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.<br>7 Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2021 Report<br>AATD underdiagnosis facts<br>8.3 years2<br>2.72<br>Avg. delay between the onset of<br>symptoms and diagnosis<br>avg. number of physicians seen<br>by patients before diagnosis<br>Patients present with<br>common respiratory symptoms3,4<br>Diagnosis does not depend on clinical presentation alone<br>Laboratory testing is the only way to make the diagnosis2,5,6,7 | |
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| 76<br>Grifols Hepatology Program<br>Intensive care & Hepatology<br>Potentially Increasing Albumin Opportunity in Critical Care<br>Supporting Regular Albutein®1 Use as a Disease Modifying Treatment<br>1 Albutein® includes all Grifols albumin brands<br>2 Non-alcoholic fatty liver disease<br>3 2022 NAFLD Endocrinology-AASLD guidelines<br>4 2021 EASL–Lancet Liver Commission on Liver Disease<br>5 WHO Sepsis Fact Sheets<br>6 2021 Surviving sepsis campaign<br>7 Hydroxyethyl-starch (HES)<br>Hepatology facts<br>25%<br> >14 million<br>+15%<br>of global population with NAFLD2, the most<br>common cause of chronic liver disease3<br>cirrhosis<br>cases<br>Liver transplant is the only procedure available<br>today to avoid further complications and death<br>2nd leading cause of years<br>lost of working life4<br>global market growth potential stemming<br>from regular albumin use (>€400M)<br>Albumin medicine role in hepatology is explained by<br>albumin blood levels (albuminemia), supporting its<br>regular use as a disease modifying treatment<br>critical care area<br>transferring this<br>concept into<br>opportunity<br>48.9M cases of sepsis<br>leading to 20% of all<br>global deaths5<br>No conclusive guidance on the<br>choice of fluid and resuscitation<br>protocols exists as of today6<br>Albumin 1-time use to recover<br>hypovolemia evolving to<br>albuminemia-base treatment<br>(Albios Balance/Ariss)<br>HES7 threat as a result of EMA’s<br>recent decision to suspend<br>marketing authorization in EU | |
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| 77<br>Key Takeaways<br>Poised for Performance in an Essential and Growing Market<br>Global plasma-derived proteins<br>market is an attractive market<br>that continues to grow<br>IG, Alpha-1 and albumin defy<br>the normal life-cycle of a<br>pharmaceutical product and<br>keep growing<br>Strong key brands: Gamunex®,<br>Xembify®, Prolastin®, Albutein®<br>and HyperRAB®<br>Grifols’ Diagnostic offers an<br>unparalleled opportunity to<br>continue increasing diagnosis<br>rates and support Biopharma<br>growth<br>Expansion of PI and SID markets<br>expected to outpace potential<br>erosion from new technologies<br>Building on Biopharma portfolio<br>by adding new proteins with a<br>specialized focus on<br>therapeutic areas | |
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| 78 | |
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| 79<br>A New Leadership to Accelerate Diagnostic<br>Antonio Martínez<br>President<br>Operations R&D<br>Industrial,<br>Quality &<br>Regulatory<br>Sales &<br>Marketing<br>Customer<br>Technical<br>Service<br>Supply &<br>Demand<br>Planning<br>Controlling<br>Focus and deep knowledge within the Diagnostic Business Unit<br>Project Management<br>Office (PMO)<br>Alliance<br>Strategy Execution<br>Quality Assurance<br>(QA)<br>Regulatory<br>Customer<br>Engagement<br>Customer Experience<br>Changes implemented in the Business Unit<br>Streamlining the Business Unit to Increase Effectiveness and Drive Efficiencies | |
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| 80<br>Diagnostic Mission<br>Improving care for donors and<br>patients by providing laboratorians<br>with innovative diagnostics tools<br>80 | |
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| 81<br>Growing the Business Based On Three Strategic Pillars<br>Consolidate and<br>strengthen current<br>business<br>1<br>Support<br>Biopharma<br>2<br>Regulatory<br>innovation &<br>digital<br>transformation<br>3<br>81 | |
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| 82<br>TMA3 PoC4 NGS5 PCR6<br>Combining Capabilities to Accelerate Growth<br>Platforms Regulatory Knowledge<br>Global Sales & Customer Technical Support Proprietary/Partnership Technology<br>CLIA1 Labs<br>in U.S. & Europe<br>R&D capabilities &<br>manufacturing<br>facilities of In Vitro<br>Diagnostic (IVD)<br>devices<br>Extensive regulatory<br>knowledge in IVD and<br>Pharma fields<br>Sales & technical service in key countries<br>CDMO2<br>capabilities<br>for therapeutic<br>proteins<br>Over The Counter (OTC)<br>experience<br>Broad Portfolio of Platforms, Know-How and Global Presence<br>1 Clinical Laboratory Improvement Amendments (CLIA)<br>2 Contract development and manufacturing company (CDMO)<br>3 Transcription Mediated Amplification (TMA)<br>4 Point of Care (PoC)<br>5 Next Generation Sequencing (NGS)<br>6 Polymerase Chain Reaction (PCR) | |
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| 83<br>Driven by COVID-19 Innovation and Strong Underlying Business<br>Diagnostic Division Reported Solid Growth in 2021<br>Core business of NAT achieved sustained growth and<br>continued to consolidate in the main markets (U.S.<br>and China) 732 702 734 776 779<br>2017 2018 2019 2020 2021<br>Clinical Diagnostic & Others Blood Typing Solutions<br>Recombinant Proteins NAT COVID-19<br>NAT Donor Screening<br>Revenues<br>(EUR in millions)<br>CAGR: +2.8%<br>Note: growths at constant currency (cc), which excludes exchange rate fluctuations vs. PY<br>NAT testing addressed the emergency of new<br>pathogens (Zika, COVID-19) and represents an<br>opportunity for new segments<br>Constant growth in Blood Typing Solutions (BTS)<br>+3.5% | |
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| 84<br>Strategic Partnerships and Alliances to Drive Further Growth<br>Increasing Presence in Key Markets<br>Key collaboration agreements<br>Strategic long-term partner for Diagnostic:<br> • Consolidation of current business<br> • Innovation in partnership with a leading<br>testing player<br> • Growth: developing new assays for global<br>expansion<br>Strategic alliance:<br> • Exclusive distributor<br> • NAT: first order received<br>and en route to China | |
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| 85<br>Expanding Grifols’ Blood Collection Capabilities<br>Immunohematology Market Delivering Strong Growth<br>New red blood cells manufacturing facility in San Diego<br>BTS constant growth led by DG Gel® System sales and fueled by Erytra Eflexis®<br>Worldwide market<br>penetration<br> >7,000 instruments<br>50M gel cards<br>achieved in 2021<br>2017 2018 2019 2020 2021<br>CAGR:+8.5%<br>1st batch<br>qualified as a red<br>blood cell supplier<br>Note: CAGR at constant currency (cc), which excludes exchange rate fluctuations vs. PY | |
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| 86<br>Successful Alpha-1 Testing Strategy<br>Supporting Biopharma Through High-ROI1 Programs<br>Grifols’ testing program continues to<br>accelerate diagnostic globally<br>- Cost-effective<br>- FDA approved<br>- Scientific Societies Support<br>Life-saving therapy for those patients who need it<br> >950,000<br>tests<br>performed<br> >205,000<br>deficient<br>patients found<br> >16,000<br>severe patients<br>diagnosed<br>1 Return On Investment (ROI)<br>2 Chronic Obstructive Pulmonary Disease (COPD)<br>Validated, Convenient and Efficient Diagnostic Solution<br>COPD2 patients<br>ROI<br>231%<br>U.S. market<br>(2013 to 2024)<br>(figures since 2006) | |
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| 87<br>Our Journey to an Innovative Program…<br>2017 2021 2018 2019 2020 2022<br>Spanish launch<br>Successful with<br>extremely positive<br>feedback<br>LATAM launch<br>Main countries<br>(Argentina, Brazil,<br>Chile and Colombia)<br>U.S. Launch<br>AlphaID™<br>buccal swab<br>German launch<br>Alphakit<br>Dry Blood Spot<br>(DBS)<br>Clinical trial U.S. population<br> • AlphaID™ saliva collection kit - 350<br>individuals<br> • Genetic result report - 500 individuals<br> • > 90% Understanding Score Developments<br>A1AT1 Genotyping Test<br>Robust genetic assay<br>A1AT Genotyping test<br>FDA clearance<br>for saliva samples<br>Testing programs<br>German launch<br>AlphaID™<br>buccal swab<br>A1AT Genotyping Test<br>CE Mark for saliva<br>samples<br>1 Alpha-1-Antitrypsin (A1AT) | |
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| 88<br>Over The Counter innovative solution to expand the U.S. screening program<br>Over The Counter 510(k) Filing Submitted to FDA: AlphaID™ at Home<br> … To Achieve a New Milestone<br>May 2022<br>FDA<br>SUBMISSION<br>The program is<br>ready to launch<br>once cleared | |
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| 89<br>Beyond<br>hATd3/ATIII4 patients<br>While Embracing Future Initiatives Including Biotest Projects<br>Expanding the Model to Support Biopharma Growth<br>Pharma programs<br>Alpha-1 patients<br>Basis for innovative<br>testing strategies<br>PI1/SID2 patients<br>1 Primary Immunodeficiency (PI)<br>2 Secondary Immunodeficiency (SID)<br>3 Inherited AT deficiency (hATd)<br>4 Antithrombin III (ATIII)<br>(<br>and others) | |
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| 90<br>Promonitor Quick IFX<br>one of the first near-patient testing devices approved under the IVDR<br>Grifols, Already Compliance With New In Vitro Diagnostics<br>Medical Devices European Regulation (IVDR)<br>Grifols will ensure on-time delivery of IVDR certification for all relevant products<br>First Certifications for the New IVDR Received in December 2021<br>Grifols on track with the initial IVDR timing<br>Additional transition period (until May 2024) not needed | |
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| 91<br>Advanced Software Solutions and a New Customer Portal<br>Digital Transformation Promotes Higher Performance<br>Key strategic solutions to streamline customer operations<br>1 2<br>New middleware solution connecting blood typing data across<br>laboratory network system to improve patient care, enhance<br>operational efficiency and minimize risks<br>New Bloodstream software as a single point management<br>system for the NAT testing laboratory<br> • All information, one site<br> • Quick and easy access<br> • Granted up-to-date documentation<br> • Digital safety environment<br>Digital platform for technical<br>documentation of our products:<br>Going Green<br>91 | |
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| 92<br>Key Takeaways<br>Evolving Business Model to Strengthen Competitiveness<br>Strengthened leadership to<br>increase effectiveness and drive<br>efficiencies<br>Broad portfolio of platforms,<br>assets and global presence to<br>outperform competition and<br>grow value<br>Secured U.S. key large customer<br>while poised to increase<br>penetration to fast-growing<br>Chinese market through<br>strategic alliance with SRAAS<br>Enhanced field digitalization to<br>support further growth<br>Grifols Alpha-1 OTC breakthrough<br>testing to achieve FDA regulatory<br>remarkable milestone<br>Unique diagnostic capabilities<br>to expand Grifols’ Biopharma<br>core markets and beyond | |
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| June 30, 2022 | |
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| 94 | |
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| 95<br>Accelerating Innovation Through 3 Key Objectives<br>Gaining focus and<br>speed in our pipeline<br>(from past to present)<br>2<br>Building new<br>innovation models<br>(paving the future)<br>3<br>Further evolving our<br>innovation organization 1 | |
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| 96<br>Focus on Scientific Areas While Elevating Controlling and PMO1<br>Gaining focus and<br>speed in our pipeline<br>(from past to present)<br>2<br>Building new<br>innovation models<br>(paving the future)<br>3<br>Further evolving our<br>innovation organization 1<br>1 Project Management Office<br>Greater discipline in accountability & execution…<br>Scientific Areas<br>Support Areas<br>Albert Grifols Coma-Cros<br>Chief Scientific Innovation Officer Advisor<br>Sci. Business<br>Develop. Global IP Controlling PMO & Strategy<br>Discovery Plasma R&D Discovery,<br>Recombinant Ab<br>Drug<br>Develop. Scouting Scientific &<br>Med. Affairs | |
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| 97<br>Rationalizing Portfolio & Establishing Result-Oriented Processes<br>Building new<br>innovation models<br>(paving the future)<br>3<br>Further evolving our<br>innovation organization 1<br>Gaining focus and<br>speed in our pipeline<br>(from past to present)<br>2<br>+<br>Clear direction with a 2030 Ambition target<br>Stronger business-weight (i.e., commercial, financial return) into<br>project approval and prioritization processes<br>Increased weight of milestones achievement into bonus scheme<br>8 projects discontinued<br>Non-strategic divestments<br>(e.g., VCN)<br>Optimizing and re-prioritizing our R&D portfolio…<br> … while adopting a result-oriented governance<br>2<br>Key projects launched<br>(internal)<br>3<br>(Biotest) | |
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| 98<br>New Approaches: Developing a 360-Degree Innovation Ecosystem<br>Gaining focus and<br>speed in our pipeline<br>(from past to present)<br>2<br>Further evolving our<br>innovation organization 1<br>Building new<br>innovation models<br>(paving the future)<br>3<br>Driving growth…<br>Digital & Data China Strategic Alliances<br> & Initiatives<br>Bioinformatics<br>platform<br>Digitalization of R&D<br>organization<br>R&D collaboration<br>agreement<br>Precision medicine<br>(ATIII in sepsis collaborations)<br>Plasma innovation<br>outlicensed<br>(new projects)<br>ETHICON<br>Scouting for synergistic<br>collaborations<br>(increased efforts) | |
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| 99<br>Balanced Risk-Value Pipeline<br>Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Phase 4 / Regulatory LCM<br>Immunology ++<br>recIG<br>Spike in PdIG with enriched<br>recombinant libraries (PI)<br>IVIG-PEG Xembify®<br>Europe Xembify®<br>Prefilled syringes IVIgG Next Gen PI Xembify®<br>Bi-weekly dose Xembify® in CLL<br>Hepatology/<br>Intensive Care ++<br>PRECIOSA D.Cirrhosis (Alb.20%) FlexBag®<br>US, EUR APACHE ACLF (Alb 5%)<br>Pulmonology<br>Alpha-1 AT<br>Non-cystic fibrosis<br>bronchiectasis<br>Alpha-1 AT<br>15% (SC)<br>AAT deficiency<br>SPARTA - Prolastin-C®<br>EUR<br>Prolastin®<br>EU 4-5gr vials<br>Hematology + ATIII in Sepsis***<br>Fibrinogen<br>Cong. Deficiency & severe hypofibrinogen Fostamatinib**<br>ITP – Refractory patients Fibrinogen<br>Acquired Deficiency<br>IVIgG Next Gen - ITP<br>Others ++<br>GIGA 564<br>Anti-CTLA-4<br>mAb Oncology<br>GIGA 2328<br>Anti-CTLA-4<br>mAb Oncology<br>AKST4290<br>nAMD & DR<br>AKST1210<br>ESRD-CI<br>Fibrin Sealant<br>Biosurgery Pediatric Use<br>Infectious<br>Diseases +++<br>GIGA 2339<br>HBV<br>Recombinant hyperimmune Ig<br>Trimodulin<br>sCAP<br>Cytotec® Pregnancy<br>(CMV infection)<br>Neurology +++ AKST 1220<br>CADASIL<br>GRF6019<br>AD<br>ABvac40<br>AD<br>AMBAR-Next AKST4290<br>PD<br>GRF6021<br>PD with<br>Dementia<br> …<br>Biotest projects Non-plasma projects Plasma projects Detailed next<br>* Project of AlbaJuna (Grifols’ invested company); ** Licensed rights from Rigel Pharmaceuticals in EU and other countries; *** Partnership with Endpoint Health | |
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| 100<br>Notable Progresses in 4 Core Projects<br>AMBAR-Next<br>in Alzheimer's<br>1<br>Xembify®<br>in CLL<br>2<br>ATIII<br>in sepsis<br>3<br>GigaGen<br> & HBV1<br>4<br>1 Hepatitis B Virus (HBV)<br>Disease background R&D | |
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| 101<br>5th Leading Cause of Death Worldwide<br>Alzheimer’s Disease Therapy: An Urgent Unmet Need<br>Worldwide Prevalence % of Dementia Cases By Age Mortality<br> >65y/o<br>Majority are<br>leading cause<br>of mortality<br>5th<br>dementia cases<br>60-70%<br>accounts for<br>200,000<br> <65 y/o have<br>younger-onset<br>Alzheimer's disease<br>but…<br>Progressive disease in which dementia symptoms gradually worsen over several years<br>No cure to date but research continues, and treatments are available to alleviate symptoms<br> >35 million<br>AMBAR-Next<br>in Alzheimer's<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>Sources: Alzheimer's Disease International, Worlds Alzheimer's Report 2015, https://www.alz.org/Alzheimers-dementia/what-is-dementia<br>patients | |
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| 102<br>Innovation Strategy in Neurogenerative Diseases (ND)<br>R&D Efforts Encompass the Entire Development Path<br>Understanding of plasma at the<br>molecular level in healthy and<br>disease states<br>Pipeline expansion of therapeutic<br>plasma fractions, small molecules,<br>antibodies<br>Explore therapeutic benefit of<br>plasma proteins in a wide range of<br>CNS1 disorders<br>Discovery of chronokines<br>proteins with biological impact<br>that changes with age<br>vaccine against Ab40<br>Placebo-controlled AB1601<br>trial in 120 very early AD and<br>MCI4 patients in phase II Remove toxic moieties from<br>systemic and brain compartments<br>Restore pharmacological<br>properties of Albumin<br>AMBAR<br>-Next<br>Immunomodulatory effects on AD<br>pathological mediators<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>1 Central Nervous System (CNS); 2 Alzheimer's Disease (AD); 1 Parkinson Disease (PD); 4 Mild Cognitive Impairment (MCI)<br>Plasma Proteome Chronokines<br>Discovery<br>Plasma Fractions<br> & Small Molecules<br>Clinical Development Programs<br>Active Immunotherapy<br>GRF-6019<br>GRF-6021<br>Proprietary plasma fraction<br>inducing neurogenesis<br>2 clinical programs<br>in AD2 and PD3 patients<br>with dementia in phase II<br>Abvac40<br>Two-Pronged<br>Strategy<br>Plasma exchange<br>Albumin replacement<br>+<br>AMBAR-Next<br>in Alzheimer's | |
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| 103<br>Confirmatory Albumin and Plasma Exchange to Treat Alzheimer’s<br>AMBAR-Next: Slowing Clinical Decline of Mild-to-Moderate AD<br>Phase 3 1:1 randomized<br>Double-blinded<br>U.S., Canada,<br>Spain and other<br>EU countries<br>AMBAR-<br>Next<br>~600 subjects with<br>mild-to-moderate AD<br>18-month follow-up<br>Plasma exchange<br>treatment group<br>Sham-control<br>group<br>Protocol<br>Development<br>Centers and countries<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>Canada<br>Spain<br>Other countries in<br>West and East EU U.S.<br>Status (as of June ‘22)<br>1 First Patient First Visit (FPFV)<br>Q2’22 Q3’22 Q4’22 Q1’23<br>Type B<br>(pre-IND) Meeting FPFV1 expected<br>AMBAR-Next<br>in Alzheimer's | |
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| 104<br>Chronic Lymphocytic Leukemia (CLL)<br>Targeting the Fastest-Growing Patient Segment for IG Therapy<br>Leukemia<br>Prevalence By Age Morbidity<br>and Mortality<br>CLL IG<br>Market Potential<br>30-50%<br>between<br>avg. at time<br>of diagnosis<br>72 years<br>Accumulation of monoclonal, mature CD5+B cells in the peripheral blood, bone marrow, and secondary organs1<br>No definitive cause has been established; targeted therapy regimens proven as efficacious treatments<br> >376,500<br>patients<br>1 Burger JA. 2 Secondary Immunodeficiencies (SID); 3 Hypogammaglobulinemia (HGG); 4 Wintrobe MM, Hasenbush LL.; 5 Hansen MM.; 6 Morra E, Nosari<br>A, Montillo M.; 7 Hamblin AD, Hamblin TJ. 8 Morrison VA.; 9 Dhalla F, Lucas M, Schuh A, Bhole M, Jain R, Patel SY, et al.<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>38%<br>SID2<br>Others ~260M<br> >1Bn<br>2021 2031<br>(in EUR)<br>x4<br>caused by an increased<br>risk for infections and<br>recurrent or severe<br>infections4,5,6,7,8,9<br>of deaths<br>with...<br>25% HGG3 presented in<br>newly diagnosed B-cell CLL<br>AMBAR-Next<br>in Alzheimer's | |
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| 105<br>Treating Patients with Concomitant HGG and Recurrent or Severe Infections<br>Xembify® to Prevent Infections in CLL Patients<br>Phase 3 1:1 randomized<br>Double-blinded U.S. only,<br>multi-center<br>~375 subjects<br>Xembify® + standard<br>medical treatment<br>Placebo + standard<br>medical treatment<br>FDA provided approval<br>to continue with<br>protocol development<br>Centers and countries Status (as of June ‘22)<br>1 First Patient First Visit (FPFV)<br>Q2’22 Q3’22 Q4’22<br>Final protocol<br>due incorporating<br>FDA feedback<br>FPFV1 expected<br>~88 to 100<br>sites in<br>the U.S.<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>AMBAR-Next<br>in Alzheimer's | |
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| 106<br>Outlook for U.S. Potential if Treatment Proven<br>ATIII in Sepsis: Very High Burden of Healthcare Costs<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>Patient population: septic shock with disseminated<br>intravascular coagulopathy (DIC) targeted with<br>endpoint versus “C” signature<br>Presumed dose: 30k IU<br>Portion of total sepsis patients: 6.6%<br>Treatment location: ICU<br>5M ICU admissions (in the U.S.)<br>1 in 5 deaths (globally)<br>40%<br>mortality rate<br>No approved<br>targeted therapy<br>Sepsis<br>2.1M cases/year<br>Shock<br>397k cases/year<br>ATIII Responders<br>139k cases/year<br>United States<br>AMBAR-Next<br>in Alzheimer's | |
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| 107<br>Global Collaboration Agreement and Solid Partnership With Endpoint Health<br>Disruptive Diagnostic to Identify Thrombate III Responders<br>Gene expression array<br>(Biocartis device)<br> • IVD test using small<br>blood sample<br> • 15 marker array<br>developed and<br>validated in over 900<br>sepsis patients<br> • Gene expression array<br>evaluating innate and<br>adaptive immune<br>response, complement,<br>adaptive suppression<br>and coagulation<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>Draw blood and<br>send to in-<br>hospital lab<br>RT -qPCR assay on<br>rapid IVD system<br>14 Gene mRNA<br>expression data<br>Avoid immune<br>suppressants<br>Use anti-inflammatories<br>Use immune stimulants<br>Use anticoagulant<br>targeted<br>Biologically<br>validated subtypes<br>90-minute rapid test + algorithm<br> • Developed by Endpoint Health<br> • Distributed/sold by Endpoint Health + IVD partner<br> • Novel assay, system and algorithms / IP protected<br> • FDA authorized system and sample collection device<br>Develop and<br>commercialize ATIII<br>for severe sepsis<br>AMBAR-Next<br>in Alzheimer's | |
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| 108<br>Solid partnership with Endpoint Health (EPH)<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>Building the Future to Treat Severe Sepsis<br>Next Steps<br>Evaluate the feasibility of the Phase III study design with regards to<br>endpoints and mortality event rates<br>So far<br> • Supplying ATIII to conduct clinical trials<br> • Manufacturing capacity<br> • Advice on clinical development and regulatory activities (led by EPH)<br>EPH is waiting results of an observational study, which results will… Currently<br> • Guide the pre-IND package submission to the FDA<br> • Help inform the design of the upcoming Phase II study<br>Moving<br>forward<br>AMBAR-Next<br>in Alzheimer's | |
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| 109<br>Recombinant polyclonal antibodies<br>World-Leading Immune Genomics Technology for Drug Discovery<br>GigaGen Captures & Recreates Complex Antibody Repertories<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>Capture Re-create Immune repertoire:<br>Human or<br>Humanized Animal<br>Exceptional monoclonal<br>antibodies<br>AMBAR-Next<br>in Alzheimer's | |
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| 110<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>Despite Currently Available Therapies and Vaccines<br>Chronic HBV1: Widespread Disease With Significant Morbidity<br>1 Hepatitis B Virus (HBV)<br>2 Global Data report: Hepatitis B Virus Infection – Global Drug Forecast and Market Analysis to 2029<br>3 WHO (https://www.who.int/news-room/fact-sheets/detail/hepatitis-b)<br>4 Hepatitis B Foundation (hepb.org)<br>newly infected<br>patients per year3<br>1.5M 296M people<br>living with<br>chronic HBV<br>USD 3.8Bn2 worldwide market<br>go on to develop cirrhosis &<br>hepatocellular carcinoma<br>20% of patients<br>deaths per year4<br>~820,000<br>Nucleotide<br>analogues<br>pegylated<br>interferon<br>(PEG-IFN)<br>HBV sales in the U.S. (2019)<br>~USD 615M<br>AMBAR-Next<br>in Alzheimer's | |
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| 111<br>Anti-HBV Recombinant Polyclonal<br>0.0001<br>0.001<br>0.01<br>0.1 1 10<br>100<br>1000<br>10000<br>100000<br>0<br>50<br>100<br>Concentration [ug/mL]<br>%<br><br>i<br>n<br>f<br>e<br>c<br>t<br>e<br>d<br>(<br>n<br>o<br>r<br>m<br>a<br>l<br>i<br>z<br>e<br>d<br><br>t<br>o<br><br>n<br>o<br><br>A<br>b<br><br>c<br>o<br>n<br>t<br>r<br>o<br>l<br>)<br>IVIG<br>HBV hyperimmune<br>rHBIG<br>3rd party mAb in dev<br>Live Virus Neutralization (In Vitro)<br>Humanized Liver HBV Challenge Mouse<br>Model (In Vivo)<br>0 20 40 60 80<br>104<br>105<br>106<br>107<br>108<br>109<br>1010<br>Days post challenge<br>V<br>i<br>r<br>a<br>l<br><br>l<br>o<br>a<br>d<br><br>(<br>H<br>B<br>V<br><br>c<br>o<br>p<br>i<br>e<br>s<br>/<br>m<br>L<br>)<br>Vehicle<br>HBV hyperimmune (2 mg/kg)<br>rHBIG (0.02 mg/kg)<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>rHBIG<br> • Recombinant polyclonal antibody therapy<br>(rHBIG) targeting HBV surface antigens<br> • Composed of >1,000 antibodies<br> • Derived from antibody sequences from human<br>donors following HBV vaccine booster<br> • Polyclonal therapy ensures retained targeting<br>of the many genotypes present and the large<br>number of escape mutant variants that arise<br>Potency<br>Neutralizing potency of > 1,000x that of<br>plasma-derived HBV hyperimmune therapy<br>In vitro and in vivo models demonstrate efficacy<br>potential GMP manufacturing initiation planned<br>for Q4 2022<br>AMBAR-Next<br>in Alzheimer's | |
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| 112<br>rHBIG1: the First Chapter<br>GigaGen’s Antibody Platform Potential<br> • Completely new class of therapeutics uniquely enabled by the GigaGen platform<br> • Capability that Grifols alone possesses<br> • Additional recombinant polyclonal therapeutics for infectious disease, immunology,<br>transplant and other areas will be enabled with rHBIG’s success<br>Xembify®<br>in CLL<br>ATIII in<br>sepsis<br>GigaGen<br> & HBV<br>AMBAR-Next<br>in Alzheimer's<br>1 Recombinant Hepatitis B Virus Immunoglobulin (rHBVIG)<br>Recombinant<br>Polyclonal<br>Antibody<br>Therapies<br> • Some indications are best addressed with monoclonal antibody treatments<br> • GigaGen’s platform rapidly identifies rare, highly potent antibodies with unique<br>activities from natural immune systems<br>Monoclonal<br>Antibodies | |
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| 113<br>Key Takeaways<br>Accelerating Innovation: Gaining Focus & Speed in Our Pipeline<br>Gaining focus and speed in our<br>pipeline by rationalizing our<br>portfolio and adopting a more<br>result-oriented governance<br>Building new innovation models<br>in digital and data, China and<br>precision medicine<br>Seeking U.S. indication for<br>Xembify® in CLL, the fastest<br>growing patient segment for<br>IG therapy<br>GigaGen's novel technology to<br>create recombinant polyclonal<br>antibody drugs for a wide range<br>of infectious diseases<br>Partnering with Endpoint Health<br>to treat severe sepsis with ATIII,<br>an innovative precision<br>medicine approach<br>Leading the mild-to-moderate<br>Alzheimer's space with AMBAR-<br>Next, a confirmatory trial for our<br>AMBAR program | |
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| 115<br>Grifols and Biotest: A Transformational Transaction<br>Maximizing Opportunities for Both Companies…<br>Geographic fit<br>U.S.<br>64%<br>Europe<br>61%<br>Scalability Broader<br>commercial reach<br>U.S. market knowledge<br>and penetration<br>Plasma collection and<br>manufacturing capacity<br>Pipeline<br>acceleration of key<br>novel products | |
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| 116<br>Bringing in Precision Therapies, Fibrinogen and Trimodulin, and Cytotect®<br> … Accelerating Grifols’ Innovation Pipeline<br>* Project of AlbaJuna (Grifols’ invested company); ** Licensed rights from Rigel Pharmaceuticals in EU and other countries; *** Partnership with Endpoint Health<br> …<br>Biotest projects Non-plasma projects Plasma projects<br>Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Phase 4 / Regulatory LCM<br>Immunology ++<br>recIG<br>Spike in PdIG with enriched<br>recombinant libraries (PID)<br>IVIG-PEG Xembify®<br>Europe Xembify®<br>Prefilled syringes IVIgG Next Gen PID Xembify®<br>Bi-weekly dose Xembify® in CLL<br>Hepatology/<br>Intensive Care ++<br>PRECIOSA D.Cirrhosis (Alb.20%) FlexBag®<br>US, EUR APACHE ACLF (Alb 5%)<br>Pulmonology<br>Alpha-1 AT<br>Non-cystic fibrosis<br>bronchiectasis<br>Alpha-1 AT<br>15% (SC)<br>AAT deficiency<br>SPARTA - Prolastin-C®<br>EUR<br>Prolastin®<br>EU 4-5gr vials<br>Hematology + ATIII in Sepsis***<br>Fibrinogen<br>Cong. Deficiency & severe hypofibrinogen Fostamatinib**<br>ITP – Refractory patients Fibrinogen<br>Acquired Deficiency<br>IVIgG Next Gen - ITP<br>Others ++<br>GIGA 564<br>Anti-CTLA-4<br>mAb Oncology<br>GIGA 2328<br>Anti-CTLA-4<br>mAb Oncology<br>AKST4290<br>nAMD & DR<br>AKST1210<br>ESRD-CI<br>Fibrin Sealant<br>Biosurgery Pediatric Use<br>Infectious<br>Diseases +++<br>GIGA 2339<br>HBV<br>Recombinant hyperimmune Ig<br>IgM<br>sCAP<br>Cytotect Pregnancy<br>(CMV infection)<br>Neurology +++ AKST 1220<br>CADASIL<br>GRF6019<br>AD<br>ABvac40<br>AD<br>AMBAR-Next AKST4290<br>PD<br>GRF6021<br>PD with<br>Dementia<br>Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Phase 4 / Regulatory LCM<br>++<br>recIG<br>Spike in PdIG with enriched<br>recombinant libraries (PI)<br>IVIG-PEG Xembify®<br>Europe Xembify®<br>Prefilled syringes IVIgG Next Gen PI Xembify®<br>Bi-weekly dose Xembify® in CLL<br>++<br>PRECIOSA D.Cirrhosis (Alb.20%) FlexBag®<br>US, EUR APACHE ACLF (Alb 5%)<br>Alpha-1 AT<br>Non-cystic fibrosis<br>bronchiectasis<br>Alpha-1 AT<br>15% (SC)<br>AAT deficiency<br>SPARTA - Prolastin-C®<br>EUR<br>Prolastin®<br>EU 4-5gr vials<br>+ ATIII in Sepsis***<br>Fibrinogen<br>Cong. Deficiency & severe hypofibrinogen Fostamatinib**<br>ITP – Refractory patients Fibrinogen<br>Acquired Deficiency<br>IVIgG Next Gen - ITP<br>++<br>GIGA 564<br>Anti-CTLA-4<br>mAb Oncology<br>GIGA 2328<br>Anti-CTLA-4<br>mAb Oncology<br>AKST4290<br>nAMD & DR<br>AKST1210<br>ESRD-CI<br>Fibrin Sealant<br>Biosurgery Pediatric Use<br>+++<br>GIGA 2339<br>HBV<br>Recombinant hyperimmune Ig<br>Trimodulin<br>sCAP<br>Cytotect® Pregnancy<br>(CMV infection)<br>+++ AKST 1220<br>CADASIL<br>GRF6019<br>AD<br>ABvac40<br>AD<br>AMBAR-Next AKST4290<br>PD<br>GRF6021<br>PD with<br>Dementia | |
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| 117<br>Fibrinogen concentrate is a highly pure preparation of human fibrinogen<br>that can be used to safely replace the absence or deficit of fibrinogen<br>safer, much faster and with greater efficiency and precision than the<br>current options of fresh frozen plasma or cryoprecipitates<br>Fibrinogen: An Unparalleled Opportunity to Boost Revenue<br>per Liter and Expand Margins<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>Fibrinogen is an abundant, large, and complex protein, which makes it<br>ideally suited to be isolated from human plasma. It accounts for 95% of all<br>coagulation factors in the blood<br>Fibrinogen promotes platelet aggregation. It is converted to fibrin which<br>forms the connecting glue in blood clots | |
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| 118<br> • Very rare, inherited bleeding disorder<br>in which the body’s ability to form<br>blood clots is impaired<br> • Fibrinogen is used for treatment and<br>prophylaxis of bleeding episodes in<br>these patients<br>Playing an Essential Role in Blood Clotting and Hemostasis<br>Treating Acquired and Congenital Fibrinogen Deficiency<br>Source: IMS Data 2-2017, Internal Critical bleeding market research, LEK Critical Bleeding market assessment 2017, and Biotest market research<br> • Body’s own fibrinogen lost due to major bleeding during<br>elective surgical procedures or unexpected trauma events<br> • Fibrinogen is the first coagulation factor missing in<br>major blood loss<br> • Replacement of lost fibrinogen is critical to restore<br>effective hemostasis<br>Normal levels<br>2 -4 g/L<br>Deficiency<br> <2 g/L<br>Congenital deficiency Acquired deficiency<br>Disease background Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>Deficiency<br>0-1 g/L<br>Massive bleeding<br> • Major surgeries<br> • Postpartum hemorrhage<br> • Trauma | |
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| 119<br>Monitoring Patient Coagulation Status Allows Administering Precise Therapies<br>Most widely-used devices… TEG® ROTEM®<br>Clotting Assessment: Critical to Monitor Deficiency<br>Point-of-Care (PoC) diagnostic…… bringing in positive market implications<br>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<br>Prediction of massive transfusion requirement<br>Creation of goal-directed and individualized coagulation<br>algorithms that may improve patient outcome<br>Distinguish the most important coagulation<br>deficiencies (including fibrinogen)<br>Grifols is uniquely positioned to leverage<br>its deep Diagnostic expertise<br>PoC Precision<br>therapy Fibrinogen<br> • Goal-oriented treatment protocols proposed for<br>bleeding management in surgery and trauma patients<br> • Rapidly developing field of acute medicine<br>Disease background Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 120<br>Promising Results in Both Clinical Trials<br>Congenital<br>FD1<br>Phase I/III study: Largest clinical trial in congenital fibrinogen deficiency worldwide<br>Treatment of adults and children<br>Results confirm high expectations regarding efficacy and safety…<br> • Expected pharmaco-kinetics and -dynamics (Phase I), excellent efficacy and safety (Phase III)<br> • 175 bleeding events (BEs) treated in 36 patients of all age groups<br> • Overall hemostatic response assessments of 175 BEs demonstrated a treatment success in nearly all cases<br> • Study completed<br>Acquired<br>FD1<br>Phase III study in severe spinal surgery and<br>pseudomyxoma peritonei (tumor) surgery<br> • Non-inferiority study compared to standard of care<br>(fresh frozen plasma or cryoprecipitate)<br> • Interim analysis with 120 subjects (June ’22)<br>confirms planned patient number<br> • Recruitment ongoing – 150 of 200 patients recruited<br> • Other interim analysis to define final sample size<br>expected in December ’22<br>major<br>blood<br>loss<br>decision<br>to treat<br>Fibrinogen<br>Fresh frozen plasma<br>Fibrinogen<br>Cryoprecipitate<br>Spinal surgery<br>Tumor surgery<br>1 FD: Fibrinogen deficiency<br>Clinical development status Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 121<br>Acquired Fibrinogen Deficiency Indication: Broader Adoption<br>and Opportunity<br>No indication for Acquired<br>Fibrinogen Deficiency, only<br>congenital use<br>Currently using cryoprecipitate or FFP1<br>Indication for Acquired<br>Fibrinogen Deficiency<br>Additional evidence would<br>drive broader adoption<br>Fibrinogen consumption per capita (g/1000 inhab.)<br>Source: MRB<br>1 FFP: Fresh-frozen plasma<br>Market opportunity Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>3,070<br>2,823<br>1,036 1,002<br>0,846<br>0,494<br>0,350<br>0,225<br>0,071 0,021 0,005<br>GERMANY AUSTRIA CANADA FRANCE SPAIN CHINA CANADA USA BRAZIL AUSTRALIA UK U.S.<br>x3 once acquired<br>indication was obtained | |
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| 122<br>+5.9%<br>Improved Point-of-Care diagnostics<br> • Increasing knowledge, availability and<br>reimbursement worldwide<br>Increased awareness<br> • European and Canadian guidelines<br> • Diagnostic companies and plasma-<br>derived medicines companies increasing<br>education on Precision Therapy<br>Change of market dynamics<br> • Shortage of cryoprecipitate during<br>pandemic driving fibrinogen concentrate<br>usage with improved customer<br>experience in the U.S.<br>Current Trends Underscore Its Potential While Further Benefiting Patients<br>Seizing Fibrinogen’s Large Market Opportunity<br>Not considering potential<br>Acquired Deficiency indication<br>+13.5%<br>Source: MRB, November 2021<br>Expected CAGRs 19-27<br>(volume)<br>Precision Therapy<br>Market opportunity Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>+200%<br>If Acquired Deficiency indication is<br>obtained (based on Canada example) | |
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| 123<br>Unique Polyvalent IG Composition<br>Trimodulin: A Potential Blockbuster<br> • Recognizes pathogens, also part of innate immune system<br> • IgM and IgA can be secreted and are present directly on the<br>pulmonary surface<br> • Strong anti-inflammatory effects by acting through<br>cellular receptors<br> • Scavenge virulence factors, such as lipopolysaccharides<br>which lead to inflammation<br> • Binds and modulates activated coagulation factors,<br>complement factors, and cytokines<br>Important functions Trimodulin IVIG<br>IgM ~23% -<br>IgA ~21% -<br>IgG ~56% ≥95%<br>Patient<br>target<br>Clinical<br>development in<br>severe COVID-19<br>and sCAP1<br>e.g., patients with<br>immunodeficiency<br>1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU)<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 124<br>A High Unmet Medical Need<br>sCAP1: A Leading Cause of Illness and Death Worldwide2<br>1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU)<br>2 Wunderink 2014, N Engl J Med 370;6.<br>3 Chest Journal (CHEST) (chestnet.org)<br>4 Woodhead, 2006, Critical Care 10:S1, p3.<br>5 Sirvent et al. 2013, Med. Intensiva 37:308e 15.<br>Pneumonia requiring supportive therapy<br>within a critical care environment<br> >350k patients3<br>suffer sCAP each year<br>23-58%4,5<br>mortality range<br>no significant changes over the past decades despite the<br>availability of improved broad-spectrum antibiotics<br>COVID-19 is a subtype of sCAP<br>Caused by all kinds of<br>pathogens (viruses,<br>bacteria, fungi)<br>Caused by<br>SARS-CoV2<br>virus<br>Disease background Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 125<br>Trimodulin Improves Patient Response With Further Decrease in Mortality<br>Changing the sCAP1 Treatment Paradigm<br>+<br>Antibiotics/Antivirals Ventilation, hydration,<br>vasopressors…<br>Causal<br>therapy Trimodulin Supportive<br>therapy<br>No comparable adjuvant<br>therapy available<br>Standard Medical Treatment<br>+<br> ✓ overshooting immune-mediated tissue damage<br> ✓ risk for lung inflammation, severe sepsis, septic shock, respiratory and multi-organ failure<br> ✓ Prevention of secondary infections<br>Mortality<br>Disease background Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU) | |
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| 126<br>Patient Groups and Disease Stages for Optimal Therapy Identified in Phase II Studies<br>Extensive Development Program in Severe Pneumonia<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>CIGMA Phase II Completed ESsCOVID Phase II Completed<br> ✓ Very positive feedback from FDA1, EMA2, PEI3 and clinical experts ✓ Positive feedback from PEI<br> ✓ EUR 29M funding from German government<br> ✓ Guidance from EMA on expedited pathway for registration<br>Placebo Trimodulin<br>Deterioration and mortality<br>rate<br>Significant reduction in deterioration<br>and mortality in stratified subset with<br>early systemic inflammation<br>Phase III Start 2022 Phase III Start 2022<br>Severe Community Acquired Pneumonia (sCAP) Severe COVID-19<br>Clinical development status<br>1 U.S: Food Drug and Administration; 2 European Medicines Agency; 3 Paul-Ehrlich-Institute; | |
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| 127<br>COVID-19 patients sCAP patients<br>(Start 2022) (Start 2022)<br>Leveraging on Phase II Results to Start Phase III Trials in 2022<br>Randomized, placebo-controlled, double-blind, multi-center, phase III trials investigating<br>the efficacy and safety of Trimodulin in adult hospitalized subjects<br> • Subjects on invasive mechanical ventilation (within <12h)<br> • Subjects with inflammation (CRP >70 mg/L)<br> • SARS-CoV-2 negative<br>480-780 subjects<br> • Subjects on low-flow oxygen, high-flow oxygen, NIV<br> • Subjects with early systemic inflammation<br>334 subjects<br>Clinical development status Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 128<br>Potential Addressable Markets<br>Grifols’ Capacities Help Address the Opportunity<br>sCAP<br>Adjunctive treatment of patients<br>with severe Community Acquired<br>Pneumonia (sCAP) who require<br>invasive mechanical ventilation<br>and have CRP1 >70 mg/L<br>COVID-19<br>Source: Biotest market research<br>1 C-reactive protein (CRP)<br>Market opportunity<br>Potential treatment OPPORTUNITY<br>Add-on therapy to standard of care<br>in adult patients with severe<br>COVID-19 and CRP ≥50 mg/L<br> • Early approval will be beneficial for faster sCAP approval<br> • Development risk covered by public funding<br> • Even with vaccination, >20,000 patients/year in EU are<br>expected over the next three years<br> • Significant upside due to higher price depends on clinical<br>trials’ data<br> >80,000 patients/year<br>initial target population<br>~350,000<br>sCAP market size<br>patients<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 129<br>Harnessing the Opportunity to Address a Critical Medical Need<br>No Direct Competitors for Trimodulin in sCAP1<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>No direct competitors: no IgM enriched immunoglobulins on the market or in clinical trials<br>High medical need: high mortality rate despite antibiotics or antivirals<br>Commercial advantageous pricing opportunity<br>Trimodulin<br>home hospital ICU2<br>Broad spectrum<br>monotherapy Broad spectrum<br>combination therapy<br>Avycaz<br>Mono or combination<br>antibiotics/antivirals for<br>intolerant patients<br>Xigris (withdrawn)<br>Corticosteroids<br>Filters<br>Zerbaxa<br>1 Severe community acquired pneumonia: Severe CAP (sCAP) is usually defined as CAP that requires admission to the intensive care unit (ICU)<br>2 Intensive Care Unit (ICU)<br>Market opportunity | |
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| 130<br>No Approved Treatment for This Disease<br>CMV1 Infection: A Disease With Large Unmet Medical Need<br>81% – 95%<br> >95% 66% – 80%<br>51% – 65%<br>No data 35% – 50%<br> <35%<br>1 Cytomegalovirus (CMV)<br>CMV prevalence The most common congenital infection in<br>developed countries<br>0.3-2.4% prevalence in newborns<br>Infected women<br>may transmit the<br>virus to the fetus<br>CMV-related disorders<br> • Hearing loss<br> • Intellectual disabilities<br> • Premature birth<br> • Development delays<br> • Death<br>Higher rates Lower rates<br>Disease background Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 131<br>Potential Effective Treatment to Increase Awareness and Diagnosis<br>Very Low Awareness of CMV Infection in Pregnancy<br>Disease background<br>Fig: National CMV Foundation; (www.nationalCMV.org) (adapted)<br>CMV disease<br>awareness<br>100%<br>awareness<br>U.S. children<br>affected per<br>year<br>CMV<br>30%<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 132<br>First Treatment to Prevent Transmission from the Mother to the Unborn Child<br>Cytotect®: Tackling CMV1 With a High-Potential Specialty Protein<br>It binds to CMV and avoids infections of host cells and presents CMV<br>particles for phagocytosis<br>Modulates and interacts with immune cells (dendritic cells, monocytes, B- and T-cells), exerting<br>a positive immunological balance<br>Anti-CMV antibodies in Cytotect® are actively shuttled through the placenta<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br>These CMV-specific antibodies block the infection from all CMV genotypes and<br>from virus variants that are resistant to virostatics<br>1 Cytomegalovirus (CMV) | |
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| 133<br>Significant Transmission Reduction When CMVIG1 Is Administered<br>Clinical Experience Suggests Good Efficacy of Cytotect®<br>Clinical development status<br>Previous prospective, observational study has described<br>success of study protocol 35,2%<br>6,5%<br>No intervention CMVIG 2 3<br>1 CMVIG: Cytomegalovirus Immunoglobulin<br>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<br>3 Treatment group (n=153), Maternal-fetal transmission at gw20: 6,5% (10/153). Kagan et al. Ultrasound Obstet Gynecol 2021; 57: 560-567<br>Adequate criteria for Phase III leveraging on previous experience:<br> • Inclusion and diagnosis criteria revised<br> • Accelerating treatment start<br> • Adjusting the dose<br> • Establishing right intervals<br>Transmission<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy<br> >5x less | |
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| 134<br>Following Primary Maternal Infection With Gestational Age ≤ 14 Weeks<br>PreCyssion Trial: Prevention of Maternal-Fetal CMV Transmission<br>Objective:<br>Demonstrate efficacy and safety of Cytotect® in preventing maternal-fetal transmission of CMV<br>Study Design<br> • Pivotal, clinical Phase III<br> • Open-label<br> • Single-arm<br> • Prospective<br> • Multicenter<br> • With historical control group<br> • 80 subjects – 13 of 80 patients recruited (as of June 15, 2022).<br>Recruitment dependent on the course of the pandemic (hygiene measures reduce CMV transmissions).<br>Clinical development status Trimodulin Fibrinogen Cytotect®<br>Pregnancy | |
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| 135<br>Success of Cytotect® Represents an Important Opportunity<br>Experts Unveil the Uniqueness of Anti-CMV<br>Number of births per year<br>3 M<br>3.6 M<br>EU51<br>Market opportunity<br>Source: Centers for Disease Control and Prevention (CDC): Congenital CMV Infection | CDC<br>1 Includes France, Germany, Italy, Spain and United Kingdom<br>Pediatric infectious disease experts acknowledge Hyper anti-CMV and antivirals are the only therapeutic<br>alternatives to treat these cases<br>Important opportunity behind phase III success<br>Diagnostic tools could be developed, leveraging on Grifols’ expertise, to accelerate treatment adoption<br>(0.5% - 1.0% of all newborns)<br>Neonates with congenital CMV infection<br>15,000 - 30,000<br>18,000 - 36,000<br>EU51<br>Trimodulin Fibrinogen Cytotect®<br>Pregnancy |
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| 136<br>Grifols’ Scale and Commercial Strength: Key to Unfold the Full<br>Value of a New Generation of Plasma Medicines<br>Expected<br>market<br>approval<br>Fibrinogen Trimodulin Cytotect® Pregnancy<br>Market opportunity<br>Key<br>considerations<br> • As for now, only European<br>market approval is considered<br> • Intention in the mid-term to seek<br>U.S. market opportunity<br>2024-2025 2024-2025<br> • Results of AdFIrst study for acquired<br>FD1 (interim results June ’22) and<br>completed phase I/III trial in<br>congenital FD will serve as the basis<br>for the combined approval in Europe<br> • FDA meeting in H2’22 to provide<br>guidance on acceptance of clinical<br>data for BLA<br> • Study duration dependent on<br>interim analysis results<br> • Approval timelines assuming<br>earlier TRICOVID trial success<br>(combined approval:<br>acquired & congenital deficiency)<br>2024-2025<br>1 FD: Fibrinogen deficiency | |
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| 137<br>Grifols’ Scale and Commercial Strength: Key to Unfold the Full<br>Value of a New Generation of Plasma Medicines<br>Revenues/<br>Margins<br>Fibrinogen<br>USD 30-50M<br>USD 400-800M<br> • Greater commercial reach<br> • Complementary presence in<br>important markets (US)<br> • Ability to develop new markets<br>Trimodulin Cytotect® Pregnancy<br>USD ~300M<br>USD 1-2 Bn<br> • Scalability of production volumes<br> • Full market potential of the main<br>indications becomes addressable<br>USD ~30M<br>TBD<br> • Commercial reach and promotion<br> • Diagnostic capabilities<br>Peritonitis/lymphopenic sepsis: USD >1Bn<br>each<br>Transplant: USD >30M<br>Pediatric sepsis: USD 80M<br>Multi-drug-resistance: USD 0.2Bn<br>Potential upside from U.S. Potential<br>upsides USD >200M<br>Market opportunity<br>opportunity<br>combined<br>opportunity<br>increased<br>capabilities<br>Leveraging on Diagnostic capabilities<br>Expanding into other geographies<br>(e.g., China)<br>Significantly improving revenue per liter and margins | |
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| 138<br>Grifols and Biotest: A Transformational Transaction to<br>Maximize Both Opportunities<br>Acquisition enhancing Grifols and<br>Biotest opportunities while<br>accelerating pipeline<br>Expanding and diversifying<br>plasma sourcing by adding 31<br>European centers and increasing<br>revenue footprint in EMEA<br>Shared values and culture based<br>on strong family heritage<br>Contributing to increase fibrinogen<br>opportunity up to USD 400-800M<br>and trimodulin to USD 1-2Bn<br>Unique opportunity to boost<br>revenue per liter and<br>expand margins<br>Two precision therapies<br>(fibrinogen and trimodulin) and a<br>new indication for Cytotect®<br>with an expected market approval<br>by 2024-2025 | |
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| 139 | |
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| 140<br>Committed to Long-Term Growth<br>Strong Underlying Fundamentals<br>4.318 4.487 5.099 5.340 4.933<br>2017 2018 2019 2020 2021<br> • Global player in the attractive plasma market<br>(7.2%1 CAGR2017-2020 for the industry) with strong position in<br>the U.S.<br> • Leaders in diagnostic solutions to screen whole-blood and<br>plasma<br> • Strengthening global presence in China through SRAAS<br>strategic alliance, Europe, Middle East and Africa, and<br>Canada (operations in 100+ countries and subsidiaries in 30+)<br> • Largest plasma-center network (400+) and industrial<br>capacity (22mL+) to support underlying demand<br> • Reinforced pipeline to deliver a balanced risk-value<br>portfolio<br>Grifols revenues<br>(EUR in millions)<br>CAGR: +8.1%<br>1 The Worldwide Plasma Proteins Market, MRB, February 2022<br>Note: CAFR at constant currency (cc), which excludes exchange rate fluctuations vs. PY | |
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| 141<br>Doubling-Down Efforts to Increase Performance in the<br>Past 2 Years<br>Reinforced plasma capabilities<br>and capacities, supporting<br>acceleration of plasma<br>collections<br>Biotest investment bolstering<br>innovation, adding two unused<br>plasma proteins<br>Global footprint while<br>strengthening presence in Europe,<br>China, Canada and Egypt<br>Divested non-strategic assets<br>while executing on structural<br>cost savings<br>Commitment to achieve<br>deleverage<br>CAPEX and R&D investments to<br>support future growth | |
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| 142<br>The decline in plasma volumes<br>caused by COVID-19 was the<br>primary driver of extraordinary<br>financial impacts<br> • Lower collections and higher cost per liter<br>impacted revenues and margins<br>particularly in H2 2021<br> • Strong underlying demand backed by<br>price increases<br> • Higher R&D and SG&A due to the<br>integration of new companies, transaction<br>and restructuring costs, and inflationary<br>pressures<br>2021 Key Financials<br>Full Year Performance Marked by COVID-19<br>Revenue 2,537 2,397 4,933<br>% Growth +2.3% (9.8%) (3.7%)<br>Gross Margin 1,114 849 1,963<br>% Margin 43.9% 35.4% 39.8%<br>R&D 159 196 355<br>SG&A 507 555 1,062<br>EBITDA 635 327 962<br>% Margin 25.0% 13.6% 19.5%<br>EBITDA Adjusted 637 377 1,014<br>% Margin 25.1% 15.8% 20.6%<br>Group Profit 267 (78) 189<br>H1’21 H2’21 2021 (EUR in millions)<br>Note: all growths at constant currency (cc), which excludes exchange rate fluctuations vs. PY | |
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| 143<br>Bioscience Constrained by Plasma Supply While the Other<br>Divisions Grew in 2021<br>Bioscience Diagnostic Bio Supplies Hospital<br> • Underlying demand strong of key<br>proteins<br> • Plasma supply constrained IG<br>volume growth, especially in the<br>U.S.<br> • Strong performance of new<br>product launches: Xembify®<br>gaining traction, VISTASEALTM and<br>TAVLESSE®<br> • Growth driven by COVID-19 test<br>sales in Spain and Hungary (+34%<br>vs. 2020)<br> • Underlying NAT donor screening<br>impacted by Zika testing mandate<br>termination; whole-blood donations<br>strong in the U.S. and Japan<br> • Blood Typing Solutions strong<br>growth also contributed due to<br>higher volume in the U.S.<br> • Bio Supplies Commercial,<br>declined due to lower sales of blood<br>cells and serum triggered by lower<br>donations<br> • Plasma sales to third-parties<br>increased based on pre-existing<br>supply agreements<br> • Strong growth following<br>normalization of hospital<br>pharmacy investments<br> • Noteworthy sales of Pharmatech,<br>and IV therapy<br> • Contract manufacturing growth<br>stemmed from albumin bags and<br>third-party sales<br>Note: all growths at constant currency (cc), which excludes exchange rate fluctuations vs. PY | |
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| 144<br>1.219 1.223 1.434 1.324<br>961<br>106<br>220<br>503<br>28,2% 27,3% 28,1% 28,1% 27,6%<br>-7,0% 0<br>1.000<br>2.000<br>2017 2018 2019 2020 2021<br>COVID Impact<br>Transaction, restructuring, one-offs and Fx<br>EBITDA Reported<br>Reported / Underlying EBITDA Margin<br>Underlying EBITDA Margin Revealed Strong Fundamentals<br>68<br>Sales volume<br>150 Donor compensation<br>NAT Covid<br>238<br>183 Cost under absorption<br>COVID impact on 2021 EBITDA<br>(EUR in millions)<br>1<br>1 Reported EBITDA for 2017-2019, and Underlying EBITDA for 2020 as per FY21 Results Presentation<br> €420M volume-related<br>Expected to resolve<br>as plasma volumes<br>normalize<br>1,570 1,544 | |
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| 145<br>Investments in plasma<br>and innovation<br>pipeline…<br> … to accelerate growth<br>and profitability<br>145 | |
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| 146<br>~1,000M in the past 2 years<br>Strategically Invested to Support and Accelerate Growth<br>Enhancing industrial capacities<br>332 308 281<br>2019 2020 2021<br>EUR 900+ million CAPEX in 3 years<br> • New 6ML plasma fractionation plant in Clayton, North Carolina<br> • World’s largest sterile purification and filling plant in Clayton<br> • New albumin purification and sterile filling plant for flexible containers in Dublin<br> • Expansion of fibrin adhesive and topical thrombin production plant in Barcelona<br> • Upgrade Grifols’ facilities in Canada<br>(EUR in millions)<br>Strengthening plasma and innovation<br>107<br>389 394<br>12<br>17<br>126<br>120<br>406<br>520<br>0<br>100<br>200<br>300<br>400<br>500<br>600<br>2019 2020 2021<br>Innovation<br>Plasma<br>(EUR in millions; figures as per the Balance Sheet)<br>PLASMA INNOVATION<br>Strengthening<br>innovation ecosystem<br>+43 +1<br>Expanding and diversifying<br>plasma assets<br>+ manufacturing site<br>centers | |
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| 147<br>Complementary Business to Boost Performance<br>Biotest: A Transformational Investment<br>378 400 419 484 516<br>2017 2018 2019 2020 2021<br>Revenues<br>(EUR in millions)<br>CAGR: +8.1%<br>Adjusted EBITDA2<br>75 92 100 108 101<br>19,8% 23,0% 23,9% 22,3% 19,5%<br>-15%<br>-10%<br>-5%<br>0%<br>5%<br>10%<br>15%<br>20%<br>25%<br>30%<br>0<br>2017 2018 2019 2020 2021<br>Adjusted EBITDA Adjusted EBITDA margin<br>Financial KPIs<br> • Family business founded in 1946, HQ in Dreieich (Germany)<br> • Specialized on immunology and hematology<br> • Broad plasma pipeline to be launched in the short-term<br> • Direct commercial presence in 10 countries, marketed in 90+<br> • Manufacturing sites reaching 3mL plasma production capacity<br> • Strong presence in Europe: 31 plasma centers*<br>1 As of June 30, 2022<br>Excludes mainly Next Level Project costs (production and R&D costs)<br>Closing<br>April 25, 2022<br>Investment<br>EUR 1.5Bn<br>Capital: 70%<br>Voting rights: 96%<br>Preferred shares: 43% | |
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| 148<br>Investments in plasma<br>and innovation<br>pipeline…<br> … to accelerate growth<br>and profitability<br>148 | |
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| 149<br>Outlook H1 2022<br>Improving Performance in the First Half of 2022<br> • Accelerated plasma collections - already reached pre-COVID<br>weekly levels<br> • Price increases on key proteins<br> • Robust underlying demand<br> • Product mix driven by subcutaneous immunoglobulin (SCIG)<br> • Higher alpha-1 patient base and strong albumin demand<br> • Partially impacted by albumin positive temporary effect in<br>H1’21 due to commercial integration with SRAAS<br> • Higher plasma volumes, price increases, product and country mix<br> • Financial discipline: cost savings and R&D prioritization<br> • Inflationary labor costs persist<br> • Donor compensation still high<br> • Fixed plasma costs decline as volume recovers<br>EBITDA Margin<br>20-22% Significant sequential<br>improvement vs. H2 2021<br>Reported<br>1 Constant currency (cc), which excludes exchange rate fluctuations vs. PY<br>Performance leveraging on:<br>c.+5%<br>Revenues<br>c.-1% at cc1<br> … driven by<br>Biopharma<br>c.+9%<br>c.+2%<br>Growths vs. PY<br>c.+5% at cc1 at cc1<br>c.+11%<br>Biopharma excluding<br>albumin phasing in H1’21 | |
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| 150<br>Positive Performance for 2022 and Beyond<br>Plasma<br>Collections expected to continue<br>accelerating throughout 2022 driven by:<br>Revenues<br>Sound revenue growth stemming<br>from Biopharma, supported by:<br> • Strong underlying demand<br> • Global price improvements<br> • Product and geo mix<br> • New and recently-acquired centers<br> • Larger volumes from regular centers<br> • Plasma collections upside if B1/B2 visa<br>restrictions in the U.S. southern border are lifted<br> • Technological, digital and operational<br>enhancements<br>Margins<br>Sequential gradual expansion<br> • Triggering plasma volume<br> • Cost savings<br> • Still high donor compensation;<br>inflationary pressures including wages<br>-<br>+<br>+ | |
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| 151<br>Despite Short-Term Challenges, Commitment to Deleveraging<br>Remains Firm<br>Deleveraging path supported by…<br>Reinforcing our<br>financial discipline 2<br>Business optimization Structural cost plan and R&D prioritization EUR 100M<br>savings<br>Cash dividends No cash dividends until leverage ratio <4x<br>CAPEX Lowering CAPEX in 2022 and 2023 as already well-invested<br>M&A Not pursuing any meaningful M&A<br>Divestments<br> • Hemostasis technology line (USD 25M) (Oct’21)<br> • Sale of VCN Biosciences (USD 75M1) (Oct’21)<br> • Closure of the production of blood bags (Nov’21)<br> • Sale of Hospital Software BU (USD 100M) (already agreed)<br>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<br>in payments, contingent upon the achievement of clinical-development and regulatory milestones over the next six years<br>Gradual<br>sequential EBITDA<br>improvement<br>1<br> • Plasma collection momentum<br> • Strong underlying demand<br> • Global price improvements<br> • Product mix<br> • Lower cost per liter | |
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| 152<br>Prepared to Respond to the Current Macro-economic Context<br>Interest rates Optimized financial structure. Low exposure to interest rate hikes,<br>since c.65% of debt tied to a fixed interest rate<br>Inflation<br>Inflationary pressures driving higher incentive to donate<br>Impact on labor costs<br>No significant impact on energy costs (<1% of cost per liter)<br>Supply chain Cross-licensing of our industrial facilities supporting efficient supply chain<br>management<br>Exchange rate<br>EUR/USD FX tailwind in 2022<br>Ukraine-Russia No direct commercial or industrial presence in Ukraine/Russia<br>Representing <0.3% of total sales | |
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| 153<br>Low Exposure to Interest Rates Hike: 65% Fixed<br>Note: RCF not included and Euribor considered as fixed interest<br>35%<br>65%<br>Floating<br>Fixed<br>Total debt<br>Interest structure<br>EUR floating debt<br>13%<br>of total debt outstanding<br>USD floating debt<br>22%<br>of total debt outstanding<br>153 | |
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| 154<br>Investments in Plasma and Innovation Pipeline to Accelerate<br>Growth and Profitability<br>During 2020 and 2021, Grifols<br>invested to drive further revenue<br>growth and margin expansion<br>Plasma collection momentum<br>supports sequential performance<br>improvement<br>Delivered on commitments:<br>divestments and cost<br>optimization<br>Prepared to respond to the current<br>macro-economic context<br>Deleveraging remains a key<br>priority, levering on EBITDA<br>improvement and cash flow<br>generation<br>Focus on value creation assets<br>to fuel cash flow and margins | |
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| 155 | |
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| 156<br>Our Commitments<br>Accelerating innovation and<br>optimizing our portfolio<br>Gaining focus on<br>Biopharma, Plasma<br>Procurement, Diagnostics<br>and Bio Supplies<br>Optimizing our business:<br>Divestments and cost<br>optimization<br>Streamlined our<br>organizational model<br>Core Business Innovation Organization<br>+<br>Leveraging sustainability leadership to enhance financial and non-Financial performance | |
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| 157<br>Accelerated and focus on<br>priority projects<br>Accelerating Innovation and Optimizing Our Portfolio…<br>Re-prioritized R&D projects<br>R&D collaboration agreement<br>+<br>8<br>projects discontinued<br>~€30M<br>savings<br>Reinforced by Biotest R&D pipeline<br>+<br>Expanding our innovation footprint…<br>RTP, NC<br>Biopharma<br>Düdingen, Switzerland<br>Diagnostic<br>Andorra<br>Immunology<br>Dublin<br>Biopharma<br>Hub SF Area, CA<br>Emeryville,<br>San Carlos<br>LA, San Diego<br> & South San<br>Francisco, CA<br>Biopharma<br>and Diagnostic<br>Hub RTP, NC Hub Europe<br>Barcelona, Bilbao and<br>Zaragoza, Spain<br>Biopharma and Diagnostic<br>Dreieich, Germany<br>Biopharma<br>R&D sites<br>Innovation Hub<br> … while prioritizing on our R&D portfolio<br>Innovation<br>13 R&D sites and +1,100 employees | |
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| 158<br> … With Strong Pipeline Enhanced by Grifols’ Scalability<br>and Broader Commercial Reach<br> …strengthened with Biotest acquisition + Accelerated priority projects…<br>Market potential<br>Fibrinogen®<br>Trimodulin<br>USD 400-800M<br>USD 1Bn+<br>CMV IG Hyper USD 200-300M<br>Market potential<br>Xembify® in SID (CLL)<br>ATIII in Sepsis<br>~USD 1Bn<br>~ USD 1Bn<br>AMBAR-Next USD 1Bn+<br>GigaGen Platform USD 1Bn+<br>Additional proteins to boost revenue per<br>liter and expand margins<br>Innovation | |
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| 159<br>Biopharma | Strong Business Fundamentals Support<br>Biotest Acquisition<br>1 North America Europe<br>MEA<br>313 donor centers<br>3 manufacturing sites<br>89 donor centers<br>3 manufacturing sites<br>1 donor center<br>(+19 planned for 2022 & 2023)<br>1 manufacturing site<br>Note: number of plasma centers as of June 30, 2022<br>+31 donor centers<br>+1 manuf. site<br>Manufacturing site<br>U.S.<br>64%<br>Europe<br>61%<br>400+ donor centers and<br>7 manufacturing sites<br>Strengthening core<br>Diversified donor center and manufacturing footprint Geographic fit<br>+ |
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| 160<br>Distribution agreement through SRAAS + CTS agreement<br>Long-term agreement:<br> • CTS will operate Grifols testing labs<br> • Grifols will supply NAT instrumentation and testing<br>Diagnostic | Securing U.S. NAT Business While Untapping<br>China Opportunity Through SRAAS Agreement<br> •Integrated commercial model combining<br>Grifols’ heritage with SRAAS commercial<br>expertise and broad reach<br> • Leverage SRAAS branding<br> • Fastest IVD market worldwide with untapped<br>market potential<br> • Value chain consolidation with the streamlining<br>of all operations from importation to distribution<br> ✓ Long-term NAT supply agreement<br> ✓ Increasing efficiency of Grifols labs<br>leveraging on CTS expertise<br> ✓ Building a long-term partnership with largest<br>lab in the world<br>Strengthening core<br>Fuel immunohematology (IH) business line to achieve leadership position |
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| 161<br>Bio Supplies | High Growth and Profitability Business With<br>the Full Integration of Access Biologicals<br>Key customers: Biotechnology research & manufacturing and Diagnostic industries<br>Vertical integration to obtain<br>higher margin from Grifols<br>products<br>Commercial knowledge to grow<br>in cell culture market<br>Enhanced Bio Supplies portfolio<br> • Leverages discarded<br>products from<br>Biopharma<br> • Finds niche markets<br>Strengthening core<br>Bio Supplies + Access Biologicals High growth engine for the future<br>2018 2021<br>Bio Supplies Commercial1<br>1 Bio Supplies Commercial includes sales of biological products for non-therapeutic use<br>EBIT 35-40%<br>Including<br>Access Biologicals<br>pro-forma<br>2.0x<br>2.6x |
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| 162<br>Optimizing Our Business | Focusing On Value-Creation<br>Businesses While Achieving Structural Cost Savings<br>Divestments Cost optimization<br>Structural Cost reduction<br>R&D prioritization<br>+€100M annualized savings<br>Optimizing business<br>+<br>Hemostasis Oct’21<br>Blood Bags Nov’21<br>Hospital Software BU Already<br>agreed<br>VCN Oct’21 |
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| 163<br>Evolving Our Organization to Reinforce Competitiveness<br>Biopharma Plasma<br>Procurement Diagnostic Bio<br>Supplies<br>Others<br>(Healthcare<br>Solutions)<br>Operations<br>Co-CEOs<br>New organization<br>Full-fledged Business Units 1<br>Streamlined value-driven organization 2<br>End-to-end business ownership 3<br>Streamlined Value-Driven Business Units to Increase Effectiveness and Efficiencies<br>Enhanced effectiveness and operational efficiencies<br>Stronger governance model<br>Accountability over execution<br>Cutting down on the complexity<br>Key support functions provide speed & agility<br>Reduce time-to-market reaction<br>One Grifols Building Principles<br>Scientific<br>Innovation<br>Corporate<br>Quality Finance Human<br>Resources<br>Industrial<br>Services<br>Former Bioscience Division<br>split into Biopharma and<br>Plasma Procurement<br>Services<br>Corporate<br>Comms.<br>Corporate<br>Affairs Digital Corp. Dev.<br>Legal & DP | |
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| 164<br>Key Takeaways<br>Delivering on Commitments Outlined in 2020 and 2021<br>CAGR: +8.1% (at cc)<br>Stable Cost per Liter<br>while increasing plasma supply<br>EBITDA: 28%<br>2017<br>Continuous growth<br>and value creation<br>Supported by strong underlying demand, pricing<br>environment and product/geographical mix coupled<br>with plasma volume efficiencies and cost savings<br>Build on robust core: 7 manufacturing plants<br>400+ plasma centers<br>Sound business revenue growth &<br>sequential gradual margin expansion<br>Harvest innovation efforts<br>New plasma proteins and indications<br>as well as therapies beyond plasma<br>Further performance fueled by delivering on<br>innovation backed by strong fundamentals<br>Business value Delivered on our<br>commitments:<br> • Prioritized & reinforced our<br>innovation pipeline<br> • Strengthened the core:<br> • Gained focus on Biopharma,<br>Plasma Procurement,<br>Diagnostics & Bio Supplies<br> • Divestments & Cost<br>Optimization<br> • Streamlined organization<br>Feb ‘20 Jun ‘22 COVID<br>Outbreak | |
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| 167<br>Glossary<br> • 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<br>liver, reaches other organs (such as the lungs), after being released into the blood stream, enabling its normal function<br> • 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<br>maintaining the oncotic pressure of the blood compartment<br> • Alzheimer’s disease: This is the most common form of dementia. This incurable, degenerative, and terminal disease was first described by German psychiatrist<br>and neuropathologist Alois Alzheimer in 1906 and was named after him<br> • 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<br>destroy T cells and decrease the risk of graft-versus-host disease<br> • ASFA: American Society for Apheresis An organization of physicians, scientists, and allied health professionals whose mission is to advance apheresis medicine<br>for patients, donors, and professionals through education, evidence-based practice, research, and advocacy<br> • Autoimmune disease: Condition in which the immune system mistakenly attacks healthy cells<br> • Babesiosis/Babesia virus: Disease caused by microscopic parasites that infect red blood cells<br> • 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<br>Alzheimer’s disease<br> • Bullous pemphigoid: is an autoimmune disease that appears when the immune system attacks the skin and causes blisters, more common in the elderly<br> • CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) Neurological disorder which causes gradual weakness, numbness, pain in arms and legs and<br>difficulty in walking<br> • 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<br>regenerative nodules (lumps that occur due to attempted repair of damaged tissue)<br> • Cognitive impairment: Alterations in thinking, learning, memory, judgment, and decision making<br> • COVID-19: Infectious disease caused by a new strain of coronavirus. ‘CO’ stands for corona, ‘VI’ for virus, and ‘D’ for disease<br> • ELISA: Enzyme-linked immunosorbent assay<br> • EMA: European Medicines Agency | |
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| 168<br>Glossary<br> • 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<br>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<br>alternatively recombinant FVIII, or rFVIII can be given to hemophiliacs to restore hemostasis<br> • 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<br>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<br>predominantly in males<br> • FDA: Food and Drug Administration. U.S. Health Authority<br> • Fibrin sealant: Surgical adhesive material derived from plasma<br> • Fibrinogen: Coagulation factor found in human plasma crucial for blood clot formation<br> • Fractionation: Process of separating plasma into its component parts, such as albumin, immunoglobulin, alpha-1 antitrypsin and coagulation factors<br> • GMP: Good manufacturing practice<br> • GPO: Group Purchasing Organization<br> • HAE (Hereditary Angioedema): Rare but serious genetic disorder characterized by recurrent episodes of severe swelling (angioedema), particularly of the face<br>and airways, and abdominal cramping. It is caused by low levels or improper function of the C1- esterase inhibitor protein<br> • HBV: Hepatitis B Virus<br> • HCV: Hepatitis C Virus<br> • Hematocrit: value that is defined by the amount of blood volume occupied by red blood cells, with respect to that occupied by total blood<br> • Hematology: The study of blood, blood forming organs, and blood diseases<br> • Hemoderivative: Proteins obtained by fractionation of human blood plasma. See plasma derived proteins<br> • Hemophilia: Genetic deficiency characterized by the lack of one of the clotting factors. It has two main variants:<br>- Hemophilia A: genetic deficiency of coagulation Factor VIII, which causes increased bleeding (usually affects males)<br>- Hemophilia B: genetic deficiency of coagulation Factor IX | |
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| 169<br>Glossary<br> • Hemotherapy: Treatment of a disease using blood, blood components and its derivatives<br> • HIV: Human Immunodeficiency Virus<br> • Hyperimmune globulins: type of immunoglobulins prepared in a manner similar to human normal immunoglobulin, except that the donor has high titers of<br>antibodies against an organism or antigen in their plasma<br> • IA: Immunoassays. These are systems available in several formats that may be used to detect antibodies, recombinant proteins or a combination of the two<br> • Intravenous: Administration of drugs or fluids directly into a vein<br> • Immunohematology: A branch of hematology related to the study of recombinant proteins and antibodies and their effects on blood and the relationships<br>between blood disorders and the immune system. Also referred to as Transfusional Medicine – blood bank, its main activities include blood typing, compatibility<br>tests and crossmatching and antibody identification<br> • 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<br>functioning of the immune system in states of both health and disease; malfunctions (autoimmune diseases, hypersensitivities, immune deficiency, transplant<br>rejection) and the physical, chemical and physiological characteristics of the components of the immune system in vitro, in situ, and in vivo<br> • Immunoglobulin (IgG): Also known as antibodies, are proteins derived from plasma. They control de body’s immune response. They have multiple indications<br>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<br>administered intravenously that contains IgG (immunoglobulin (antibody)G)<br> • ITP (Chronic immune thrombocytopenia): Autoimmune disorder in which patients produce antiplatelet autoantibodies and specialized white blood cells that<br>destroy their blood platelets. This results in a low blood platelet count (thrombocytopenia) that may produce bruising or excessive bleeding<br> • IVD: In vitro Diagnostic<br> • IV solutions/Intravenous solution: Medicine or homogeneous mixture of a substance in liquid, enabling it to be infusedinto the circulatory system through a<br>needle<br> • Lipemic plasma: plasma with a cloudy and/or milky appearance, caused by excess lipids (hyperlipidemia) mainly cholesterol and/or triglycerides in the blood,<br>which in some cases becomes evident<br> • MRB: Marketing Research Bureau | |
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| 170<br>Glossary<br> • Molecular Diagnostic: Discipline that studies genomic (DNA) and proteomic (proteins)expression patterns and uses the information to distinguish between<br>normal, precancerous, and canceroustissues at the molecular level<br> • Monoclonal antibody (mAb): Antibody produced by a single clone of cells typically used in immunotherapy (such as in the treatment of autoimmune or<br>inflammatory disorders and cancer), diagnostic testing and cell identification and tracking. Monoclonal antibodies are a cornerstone of immunology and are<br>increasingly coming into use as therapeutic agents<br> • Myasthenia Gravis (MG): Chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles that worsens after periods of activity and<br>improves after periods of rest. These muscles are responsible for functions involving breathing and moving parts of the body<br> • NAT: Nucleic Acid Amplification Testing<br> • Neurology: Science that deals with the anatomy, functions and organic disorders of nerves and the nervous system<br> • Northamerica: includes the U.S. and Canada<br> • Ophthalmology: branch of medicine and surgery that deals with the diagnosis and treatment of eye diseases<br> • Pandemic: The worldwide spread of a new disease<br> • Parkinson’s Disease: complex neurodegenerative disorder in which each patient experiences a different combination of motor and non-motor symptoms<br> • 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<br>small sample of DNA and amplify it to a large enough amount to study in detail<br> • pdFVIII: Plasma-derived Factor VIII<br> • Pharmacovigilance: Practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate<br>previously unreported adverse reactions<br> • Plasma: Yellow-coloured liquid part of the blood, consisting of a mix of a large number of proteins in solution<br> • Plasma-derived proteins: Purified plasma proteins with therapeutic properties that are obtained through the fractionation of human plasma. Albumin,<br>immunoglobulins, factor VIII and alpha-1 antitrypsin are the main plasma proteins<br> • Plasma proteomic: describes the high throughput analysis of plasma biomarkers using very powerful, sensitive and specific instruments | |
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| 171<br>Glossary<br> • Plasmapheresis: Plasmapheresis is a technique which separates plasma from other blood components, such as red blood cells, platelets and other cells. These<br>unused blood components are suspended in saline solution and immediately reinjected back into the donor. Because the donor is only providing plasma and not<br>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<br>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<br>different plasma protein therapies<br> • Pneumology: is the specialty that takes care of the diagnosis and treatment of respiratory diseases Pulmunologists treat everything related to the respiratory<br>system from asthma to tuberculosis<br> • PPTA: Plasma Protein Therapeutics Association<br> • Primary arthroplasty: Surgery performed to replace damaged joints for various reasons, such as hip fractures, osteoarthritis or other rheumatic diseases, by<br>artificial joints called prostheses<br> • Primary immunodeficiency (PI): Inherited condition where there is an impaired immune response, weakening the immune system and allowing infections and<br>other health problems to occur more easily. It may be in one or more aspects of the immune system<br> • ProlastinR/ProlastinR -C: This is a concentrated form of alpha-1 antitrypsin (AAT), derived from human plasma and approved only for chronic, or ongoing,<br>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<br>may help reduce the damage to the lungs caused by destructive enzymes<br> • 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<br>organisms are like, how their bodies work and how they behave<br> • Recombinant: Protein prepared by recombinant technology, coded by the manipulated gene. Procedures are used to join together segments in a cell-free<br>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<br>develop than small molecules<br> • Recovered plasma: plasma derived from whole blood collected in blood donations<br> • rFVIII: Recombinant Factor VIII is the antihemophilic factor A, obtained using recombinant DNA technology. With this technology, pure factor is synthesized in the<br>laboratory instead of being extracted from blood plasma | |
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| 172<br>Glossary<br> • Rh (Rhesus) blood group system: Most important blood group system after ABO. The Rh blood group system consists of 50 defined blood-group recombinant<br>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<br>refer to the D antigen only<br> • ROW: Rest of the World<br> • SARS-CoV-2: Severe acute respiratory syndrome coronavirus 2 is the strain of coronavirus that causes coronavirus disease 2019 (COVID-19), the respiratory<br>illness responsible for the COVID-19 pandemic<br> • Secondary immunodeficiency: Occurs when the immune system is compromised due to an environmental factor. Examples of these outside forces include HIV,<br>chemotherapy, severe burns or malnutrition<br> • SCIG: subcutaneous immunoglobulin<br> • Single-cell transcriptomics: technique to characterize cell identity<br> • SCIG/SubQ: Sub-cutaneous<br> • Thrombin: Enzyme that presides over the conversion of a substance called fibrinogen to fibrin, which promotes blood clotting<br> • Transfusion medicine: Branch of medicine that encompasses among others, immunohematology, blood and plasma screening and blood typing<br> • West Nile Virus (WNV): Virus transmitted by mosquitoes. Humans are mainly infected through mosquito bites, but infection can occur through organ<br>transplantation and blood<br> • Von Willebrand Disease (vWD): This is the most common hereditary coagulation abnormality described in humans, although it can also be acquired as a result<br>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<br>adhesion<br> • Zika virus: Infectious disease spread by the bite of an infected Aedes species mosquito | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.
| Grifols, S.A. | ||
|---|---|---|
| By: | /s/ David I. Bell | |
| Name: | David I. Bell | |
| Title: | Authorized Signatory |
Date: June 30, 2022