Grifols, S.a. Class A · BME:GRF
Grifols, S.a. Class A — Investor Day (June 2012)
188 slides from Grifols, S.a. Class A's investor day presentation, Jun 14, 2012
Slide 1: Investors' & Analysts' Meeting in North Carolina
Investors’ & Analysts’ Meeting in North Carolina Thursday 14th and Friday 15th June 2012
Slide 2: Thursday, June 14th, 2012: Raleigh / Clayton (North Carolina)
Thursday, June 14th, 2012: Raleigh / Clayton (North Carolina) Time Topic Speakers 8:45 • Reception of participants at Raleigh Convention Center 9:00 • Welcome and Introduction N. Pascual / T.Glanzmann • Manufacturing Bioscience overview 9:15 Understanding manufacturing cycle Víctor Grifols 10:00 Bio
Slide 3: Friday, June 15th, 2012: Raleigh (North Carolina)
Friday, June 15th, 2012: Raleigh (North Carolina) Time Topic Speakers 8:45 • Reception of participants at Raleigh Convention Center 9:00 • Integration / Achievements Greg Rich • Sales & Marketing 10:00 Global Markets Ramón Riera 10:30 North American Markets Joel Abelson 11:00 • Coffee break 11:30 •
Slide 4: Grifols Management Team (speakers' order)
Grifols Management Team (speakers’ order) Name Víctor Grifols President & CEO Thomas Glanzmann Chairman Grifols Inc. Mary Kuhn EVP & President NA Manufacturing Op. Grifols Inc. Sergi Roura President Grifols Therapeutics Inc. Juan Ignacio Jorquera VP R&D Instituto Grifols Greg Rich President & CEO Gr
Slide 5: Disclaimer
Disclaimer This document has been prepared by GRIFOLS, S.A. (GRIFOLS or the “Company”) exclusively for use during the Investor Day Presentation dated June 14th – 15th, 2012. Therefore it cannot be disclosed or made public by any person or entity with an aim other than the one expressed above, withou
Slide 6: Thomas Glanzmann
Thomas Glanzmann - Chairman Grifols Inc.-
Slide 7: Understanding the Manufacturing cycle and some Fractionation Concepts
Understanding the Manufacturing cycle and some Fractionation Concepts - Víctor Grifols -
Slide 8: Fractionation / Product Manufacturing Process
Fractionation / Product Manufacturing Process Plasma procurement Plasma fractionation Protein purification COLLECTION 2 POOLING 3 FRACTIONATION 4 PURIFICATION 5 FORMULATION PURIFIED VARIOUS FINAL BULK FORMULATION CRYOPRECIPITATE FRACTION V PASTE
Slide 9: Review of some concepts
Review of some concepts • Plasma fractionation capacity ? • Plasma fractionation throughput ? • Protein purification capacity ? • Protein purification throughput ? • Paste or Fractions exchange ? • Protein yields ? • Plasma procurement ? • Plasma testing ? Analysts and Investors meeting. North Carol
Slide 10: Plasma fractionation capacity
Plasma fractionation capacity • For Grifols, “the plasma fractionation capacity” of a given plant is one that is validated and approved by either FDA or EMA or both. • It is not easy to substantially increase the capacity of a given plasma fractionation plant. Such an increase would necessarily need
Slide 11: Plasma fractionation capacity
Plasma fractionation capacity Grifols has the following fractionation capacities in 2012 : • Barcelona plant : • Los Angeles plant : • Clayton plant : • Melville plant : Total 2,200,000 liters/year 2,300,000 liters/year 2,500,000 liters/year 1,500,000 liters/year 8,500,000 liters/year
Slide 12: Plasma fractionation capacity
Plasma fractionation capacity By the 2015 horizon, Grifols intends to have a fractionation capacity per year of : • Barcelona plant : 4,200,000 liters/year • Los Angeles plant : 2,300,000 liters/year • Clayton plant : 6,000,000 liters/year • Melville plant : 0 liters/year Total 12,500,000 liters/yea
Slide 13: Plasma fractionation capacity
Plasma fractionation capacity Given the complexity of plasma fractionation plants, any and all capacity increase requires, under our experience and know how, a seven years period between decision day to completion day, including approval of FDA, or EMA or both. We believe it is a must to master long
Slide 14: Plasma fractionation throughput
Plasma fractionation throughput The plasma fractionation throughput is the plasma sent to the facilities to be fractionated and converted into either fractions or finished goods. The throughput combined for both companies in the past two years has been (million liters) : • 2010 : 3.2 Grifols + 3.8 T
Slide 15: Plasma fractionation capacity and throughput
Plasma fractionation capacity and throughput It is a widely common mistake among specialized and non specialized forums (media, health institutions, politicians, and even analysts) to mix these two concepts, capacity and throughput. Please, help us in making this very clearly understandable in trans
Slide 16: Protein purification capacity
Protein purification capacity The definition is very similar to that of the plasma fractionation capacity. That is, a capacity approved by either FDA, or EMA or both. However, it should be noted that each protein to be obtained needs its own facility. Depending on the protein, that facility can be e
Slide 17: Protein purification capacity
Protein purification capacity Therefore, and consistent with the previous comments certain purification capacity increases require also the same seven-year period applicable to the fractionation plant itself. It is also necessary in protein purification to excel in long term industrial planning.
Slide 18: Protein purification capacity
Protein purification capacity As a consequence of its R & D achievements Grifols is in the process of adding two new purification plants to the existing ones : • A plant for Fibrin Glue in Barcelona (constructed, not yet approved) • A plant for Plasmin in Clayton, (details on construction pending).
Slide 19: Protein purification throughput
Protein purification throughput It has always been Grifols philosophy to obtain and sell 100% of at least three of the proteins that can be fractionated from one liter of plasma. Consequently : Liters of plasma Kg of paste Vials of finished goods
Slide 20: Paste or Fractions exchange
Paste or Fractions exchange • A plasma fractionation facility produces fractions or pastes, but not finished goods. These are obtained as explained before during this presentation, in each of the protein purification facilities. • Grifols operates today four fractionation facilities (Barcelona, Los
Slide 21: Paste or Fractions exchange
Paste or Fractions exchange • It is most important in order to achieve the best efficiency that these Fractions and pastes are exchangeable between all fractionation and purification plants. That is, – a Fraction II+III obtained in Los Angeles can be used as raw material to produce Gamunex® in Clayt
Slide 22: Paste or Fractions exchange
Paste or Fractions exchange Simple and logical as it may seem, this process is not an easy one, it requires industrial adjustments, changes in some specifications, new licenses in different countries, … in short, a constant follow-up and update. Some day, not far from today , we will attain a total
Slide 23: Protein yields
Protein yields Case study : IVIG 10 gr INITIAL Av. SAMPLES VIALS IN FILLED VIALS SAMPLES BATCH QC SAMPLES INSPECTION US/EU FINISH (10gr.) LIBRARY VOLUME (L) REJECTS RELEASE GOODS INV. 3.000 1.260 25 14 5 6 1.210 YIELD (gr/L) 4,2 4,0 INITIAL Av. SAMPLES VIALS IN FILLED VIALS SAMPLES BATCH QC SAMPLES
Slide 24: Plasma procurement
Plasma procurement • Grifols has today 147 plasma centers all over the US and is probably the biggest organization in the world in the plasma procurement activity. • In 2011 the two companies combined would have obtained 5,940,000 liters of plasma. • We are concerned about the manner in which data a
Slide 25: Plasma procurement
Plasma procurement • The important figure in plasma procurement is the amount of liters obtained, regardless the number of centers. • In our experience, bigger center does not necessarily entail higher efficiency. It can happen, due to different reasons, that a small center delivers better costs tha
Slide 26: Plasma procurement
Plasma procurement We strongly believe in training and educating all the staff involved in the plasma procurement activity. This is why the Grifols Academy of Plasmapheresis was established back in 2009 (Phoenix, AZ). The Academy has been expanded in the US with a second campus in Indianapolis, IN,
Slide 27: Plasma testing
Plasma testing LITERS TOTAL DONATIONS TESTS PER OBTAINED * DONATIONS PER DAY DAY 5.500.000 6.626.506 23.666 189.329 LITERS PER DONATION : WORKING DAYS: TEST PER DONATION: 0,830 280 8 In 2010 both companies combined (Grifols + Talecris) performed 190,000 tests per day. What if our analysis lab had an
Slide 28: Plasma testing
Plasma testing • If such an event happened the company would be stuck until the situation was remediated. With these samples per day it is impossible to identify a third party who could accept such a workload with a short notice. • This is why the company decided in 2009 to build a second lab in Aus
Slide 29: Plasma testing
Plasma testing • Today, Grifols has completed the construction of and obtained the FDA license for the second central lab in San Marcos, TX, fully automated and with capacity to absorb any further testing increase. • Also, the former Austin testing lab has been totally upgraded with new equipment an
Slide 30: Bio science Manufacturing and Investments
Bio science Manufacturing and Investments Mary Kuhn - EVP & President NA Manufacturing Op. Grifols Inc -
Slide 31: Grifols Bioscience Manufacturing
Grifols Bioscience Manufacturing CLAYTON, NC LOS ANGELES, CA BARCELONA, SPAIN YEAR: 1974 YEAR: 1950 YEAR: 1972 BUILDINGS: 800,000 Sq. Feet BUILDINGS: 350,000 Sq. Feet BUILDINGS: 420,000 Sq. Feet EMPLOYEES: 1,400 EMPLOYEES: 510 EMPLOYEES: 850
Slide 32: Fractionation / Product Manufacturing Process
Fractionation / Product Manufacturing Process Plasma procurement Plasma fractionation Protein purification 1 COLLECTION 2 POOLING 3 FRACTIONATION 4 PURIFICATION 5 FORMULATION PURIFIED VARIOUS FINAL BULK FORMULATION CRYOPRECIPITATE INACTIVATED PROTEINS AND STERILE FILLING Donor FACTOR VIII II + III P
Slide 33: Capacity, throughput and utilization definitions
CAPACITY = Maximum possible output THROUGHPUT = Actual output UTILIZATION = Measured based on number of available hours (capacity) against the number of hours actually used (throughput)
Slide 34: Long Investment Cycle-time for a New Facility
Long Investment Cycle-time for a New Facility YEARS 1 2 3 4 5 6 7 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Engineer Conceptual Engineering Selection Basic Engineering Feasibility Study Detailed Design Procurement Construction Commission/Qualification Valida
Slide 35: Fractionation Capacity
Fractionation Capacity 12.5 8.5 Barcelona; 4.2 9 UTILIZATION LITERS Barcelona; 2.2 UTILIZATION Los Angeles; 2.3 M 6 M Los Angeles; 2.3 3 Clayton; 2.5 Clayton; 6.0 Melville; 1.5 2012 2016 *Melville sold to Kedrion Fractionation investments pace future growth
Slide 36: Purification Capacity / Utilization—Current
Purification Capacity / Utilization—Current 8.9 9 8.5 7.2 6.6 iters 6 L MM 3.6 Fractionation Cryo IVIG Alpha-I Frac V *Capacities not yet fully balanced Utilization Capacity *Utilization close to capacity for some proteins
Slide 37: Purification Capacity / Utilization – 2016 Forecast
Purification Capacity / Utilization – 2016 Forecast 12.5 12.4 12.3 12 11.7 5.8 Fractionation Cryo IVIG Alpha-I Frac V • Purification investments align capacity with fractionation Utilization Capacity • Investments provide for future growth • Production is more balanced across all fractions
Slide 38: Fractionated Paste
Fractionated Paste For efficient utilization of a liter of plasma, purification capacity for all fractions needs to be balanced with fractionation through investment and paste qualification eins IVIG Prot Alpha-1 Fractionation Site Available Paste Available Purification Capacity Analysts and Investo
Slide 39: Fractionated Paste
Fractionated Paste For efficient utilization of a liter of plasma, purification capacity for all fractions needs to be balanced with fractionation through investment and paste qualification eins IVIG Prot Alpha-1 Fractionation Site Available Paste Qualification done Available Purification Capacity Q
Slide 40: Demonstrated Excellence in Regulatory Compliance
Demonstrated Excellence in Regulatory Compliance No critical observations No outstanding regulatory commitments FDA INSPECTION EU INSPECTION HISTORY HISTORY NUMBER OF MINOR NUMBER OF MINOR YEAR YEAR OBSERVATIONS OBSERVATIONS 2007 5 2008 11 Clayton, NC 2009 8 2009 4 2011 10 2012 1 2008 15 2007 12 Los
Slide 41: Demonstrated Excellence in New Facility Compliance
Demonstrated Excellence in New Facility Compliance Recent PRE-APPROVAL INSPECTIONS (PAIs) FDA EU observations # minor # minor observations Clayton, NC Prolastin-C® 0 Westphalia BSH-30 Pilot 0 Syringe Filling Suite 3 Los Angeles, CA Albutein ® (new process) 8 CytoGamA* 1 Melville, NY Hemin 15 IVIG ne
Slide 42: Fractionation Sites / Investments
Fractionation Sites / Investments LA: New bottle opening/thawing facility approved (2012) - Higher Yields - More efficient BCN: New fractionation facility under construction (2014) - 2mmL capacity - Commissioning to start second half of 2012 NC: New fractionation facility under construction (2015) -
Slide 43: IVIG Purification Sites / Investments
IVIG Purification Sites / Investments BCN : Increase of Flebogamma DIF® capacities in existing facilities (2013) LA: Conversion of B330 to manufacture Gamunex C ® (2015) - Original facility complete - Minimal utility modification - Identical column size to NC facility - Significant yield improvement
Slide 44: Plasma Liters Required to Produce 10MM IVIG
Plasma Liters Required to Produce 10MM IVIG Million Grams - Synergies - Higher Yields 2.9 Savings of 0.4 Liters ma of plasma 2,500,000 Plas of 2.5 Liters MM B330 (Flebogamma) IVIG B330 (Converted to Gamunex)
Slide 45: Plasma Liters Required to Produce 10MM IVIG
Plasma Liters Required to Produce 10MM IVIG Million Grams - Synergies - Higher Yields 2.9 Savings of 0.4 Liters ma of plasma 2,500,000 Plas of 2.5 Liters MM B330 (Flebogamma)® IVIG B330 (Converted to Gamunex)®
Slide 46: Factor VIII/Factor IX Sites / Investments
Factor VIII/Factor IX Sites / Investments LA: Modernization of purification for Factor VIII & Factor IX (2012) - More automation, CIP systems - Allows for old building to be closed BCN: Start up of new capacity for filling/lyophilization (2013) - Allows full utilization of purification capacity NC:
Slide 47: AT-III Sites / Investments
AT-III Sites / Investments NC: FDA approved new facility in March 2012 for Thrombate III® (2012) - Only plasma-derived antithrombin concentrate approved in the U.S. - Significantly increases capacity to meet future market growth - Eliminates costly contract manufacture - Thrombate III® has had doubl
Slide 48: Alpha-1 Sites / Investments
Alpha-1 Sites / Investments BCN: Modification of existing area to begin producing Prolastin® for the European market ( 2013) NC: Investments in UF process and other equipment for Prolastin-C® (2016) - With discontinuation of Prolastin®, Prolastin C ® capacity increases (2013) - Launch of liquid form
Slide 49: Albumin Sites / Investments
Albumin Sites / Investments BCN: New purification area start up (2013) NC:—New purification area using Albutein® process (first train 2014; second train 2016) Higher yields Eliminates use of acetone Allows use of Fraction V paste (shorter process than Albumin paste) - Expansion of NFF to include Fra
Slide 50: North Fractionation Facility Objectives
North Fractionation Facility Objectives • increases Fractionation to 6mm capacity liters • Same techno process logy with updated • Closed minimal processing operator intervention and to optimize compliance • Increased automated; batch minimal sizes; clean highly 12%) and cold to optimize room space
Slide 51: Protein Separation: Same Process, New Technology
Protein Separation: Same Process, New Technology • Closed processing • Minimal equipment in clean room space • Enhanced temperature control • Maximized solid and effluent recovery • Steam sanitizable The new Westphalia BSH30 in NFF The old Sharples
Slide 52: NFF Start up Progress
NFF Start up Progress Mechanical completion: 177 complete of 204 (87%) Start up: 91 in operation of 116 (89%) 50 completed of 116 (43%) Commissioning: (Test Cases) 22 in progress of 64 (34%) 13 completed of 64 (20%) Precipitation Vessels
Slide 53: NFF Master Schedule
NFF Master Schedule Permits, Engineering & Procurement Pre-plan 4/09 2010 10/11 Automation software delivered Construction Sitework started 3/10 2011 5/12 Certificate of Occupancy issued Commissioning / ETP / OQ Initiate Commission process 10/11 2012 4/13 OQ Post ETP EM / PQ / CV / PV Process runs b
Slide 54: Plasma Testing Laboratories / Investments
Plasma Testing Laboratories / Investments New Austin, Texas San Marcos, Texas 25,000 Sq. Ft. 75,000 Sq. Ft. Combined capacity 15 million donations (32 million samples). Close proximity provides efficient use of staff and resources plus risk mitigation.
Slide 55: Future Plasma Logistics Center in Clayton
Future Plasma Logistics Center in Clayton Warehouse capacity 2.5 mm liters plasma (5,200 pallets) at -30° C. In closer proximity to Clayton and Barcelona increases efficiency of logistics. Centralized Release provides more reliable freezer storage.
Slide 56: Conclusions
Conclusions Fractionation and testing investments ready to support future growth. Purification capacities become balanced and aligned with fractionation. Paste cross qualifications are on track to drive more efficient liter utilization. Plans on track to capture synergies of implementing processes t
Slide 57: Engineering Overview and Expertise
Engineering Overview and Expertise Sergi Roura - President Grifols Therapeutics Inc.-
Slide 58: Grifols Engineering Expertise
Grifols Engineering Expertise • What is Grifols Engineering S.A. ? • Engineering model at Grifols: - Differentiating factors. - What does this approach provide to the company? • Engineering Innovation examples • Summary and conclusions Analysts and Investors meeting. North Carolina. June 14-15, 2012
Slide 59: What is Grifols Engineering S.A.
What is Grifols Engineering S.A. • Grifols Engineering S.A. was incorporated in 2001, and started from a team of engineers and other professionals working in the Grifols group to help designing facilities and equipments. It was created from the vast knowledge and understanding accumulated since the
Slide 60: Engineering model at Grifols: A unique approach
Engineering model at Grifols: A unique approach Differentiating factors: - Internal expertise, internal project management - Capability of designing, developing and fabricating machinery and equipment. - Fully embedded in the Grifols organization - Learning from the experience - Continuous feedback
Slide 61: What does this approach provide to the company?
• What does this approach provide to the company? - Innovation capacity - Cost effective CAPEX management - Shorter delivery times in projects - Simple and straight-forward designs to fulfill production requirements - Sense of internal ownership of the projects across the organizations. - Quick resp
Slide 62: Engineering Innovation examples (I)
Engineering Innovation examples (I) Sterile Filling • Sterile Filling is one of the most critical steps in biological products process. • Today in Grifols we are filling around 16 million vials/year, • Grifols Engineering has a unique and patented system for sterile filling products. This concept wa
Slide 63: Engineering Innovation examples (II)
Engineering Innovation examples (II) ABO: Automated Bottle Opener • Today in Grifols we are processing more than 7.6 Million Plasmapheresis plasma bottles/year. • Internal development of an innovative process to handle the plasma bottles thawing, cutting and pooling in the plasma fractionation facil
Slide 64: Engineering Expertise: Summary
Engineering Expertise :Summary • Today this internal engineering expertise and organization gives us clearly competitive advantages for the growth of the business • Grifols Engineering S.A. provides the group with business with third parties, which also brings additional know-how and expertise. • Gr
Slide 65: R&D Overview
R&D Overview Juan Ignacio Jorquera - VP R&D Instituto Grifols-
Slide 66: R&D—Main activity fields
R&D—Main activity fields • Different scope of R&D activities: – Clinical Investigation for current proteins. “Quick and easy” opportunities, known products, no full preclinical development or additional manufacturing plants required. – Full Development of new proteins, including proof of concept, pr
Slide 67: R&D—Main activity fields
R&D—Main activity fields Current Protenis New indications Albumin Alzheimer Cirrhosis Liver failure A1-PI Type 1 Diabetes Cystic Fibrosis IVIG POST POLIO SYNDROME PEDIATRIC PID USA ITP 10% ANITITHROMBIN CARDIAC SURGERY SEVERE Burns Analystsand Investors meeting. North Carolina. June 14-15, 2012 67
Slide 68: Alzheimer's Management By Amyloid Removal AMBAR
Alzheimer’s Management By Amyloid Removal AMBAR Medical study with Haemopheresis, Albutein® & Flebogamma® DIF
Slide 69: Alzheimer's study project development
Alzheimer’s study project development • The study combining plasma exchange, plasmapheresis and infusion of Albutein® and Flebogamma® DIF is ongoing. • Three different dosages of Albutein® and Flebogamma® DIF, combined with plasma exchange and plasmapheresis will be studied in 350 patients. • The st
Slide 70: Albutein in Cirrhosis and Liver Failure
Albutein® in Cirrhosis and Liver Failure • Pilot clinical study of long term administration of Albutein® in advanced cirrhosis with ascites. • Pilot clinical research program of Plasma Exchange combined with Albutein® in acute on chronic liver failure.
Slide 71: Alpha-1 PI projects
Alpha-1 PI projects Analysts and Investors meeting. North Carolina. June 14-15, 2012 71
Slide 72: Prolastin C in Type 1 Diabetes Mellitus (T1DM)
Prolastin® C in Type 1 Diabetes Mellitus (T1DM) T1DM, formerly termed juvenile diabetes, results from an autoimmune destruction of the insulin-producing beta cells in the pancreatic Langerhans’ islets. Clinical management of T1D (insulin administration) requires daily uncomfortable, time-consuming a
Slide 73: Prolastin C in Type 1 Diabetes Mellitus (T1DM)
Prolastin® C in Type 1 Diabetes Mellitus (T1DM) Preclinical data show a consistent benefit of A1PI in the protection of islets and modification of the immune system across multiple models of diabetes. 44% 34% • Multicenter Phase II study under design: randomized, double blind treatment with Prolasti
Slide 74: A1PI in Cystic Fibrosis: US Orphan Drug Designation
A1PI in Cystic Fibrosis: US Orphan Drug Designation • CF is the most common fatal hereditary disorder that affects individuals of European descent. • Preclinical evidence indicates that proteinase activity may play a central role in the pathophysiology of CF. • A1PI may have the potential to slow th
Slide 75: IVIG Projects
IVIG Projects Analysts and Investors meeting. North Carolina. June 14-15, 2012 75
Slide 76: IVIG Projects
IVIG Projects • A pre IND meeting with the FDA for the Post Polio Syndrome (Orphan Drug Designation) to be held in the 2nd half of 2012. • Pediatric PID trial finished, submission to FDA during 2nd half 2012. • ITP submission to FDA during 2013.
Slide 77: Antithrombin Projects
Antithrombin Projects Analystsand Investors meeting. North Carolina. June 14-15, 2012 77
Slide 78: Cardiac surgery with cardiopulmonary by-pass; Severe burns
Cardiac surgery with cardiopulmonary by-pass; Severe burns The clinical study where Anbinex® was administered (versus untreated controls) before cardiac surgery with cardiopulmonary by-pass (extracorporeal circulation) is finished. The results are under evaluation. A trial in severe burns is current
Slide 79: R&D—Main activity fields
R&D—Main activity fields • Different scope of R&D activities: – Clinical Investigation for current proteins. “Quick and easy” opportunities, known products, no full preclinical development or additional manufacturing plants required. – Full Development of new proteins, including proof of concept, pr
Slide 80: R&D—Main activity fields
R&D—Main activity fields NEW PROTEINS NEW INDICATIONS FIBRIN GLUE BASULAR SURGERY SOLID ORGAN SURGERY SOFT TISSUE SURGERY TOPICAL THROMBIN ANTI-HAEMOTHAGE IN SURGERY ENDOVENOUS FIBRINOGEN ACQUIRED AND CONGENITAL DEFICIT PLASMIN(PLASMATIC) Analysts and Investors meeting. North Carolina. June 14-15, 2
Slide 81: New production and purification facilities
New production and purification facilities These projects involve construction of new production plants once the results support the investment. That was already the case for Fibrin Sealant, topical Thrombin and intravenous Fibrinogen. Analysts and Investors meeting. North Carolina. June 14-15, 2012
Slide 82: Plasmin
Plasmin • Enzyme that naturally “dissolves” clots in humans, therefore, the ideal candidate to resolve pathological thrombus formation. • The enzyme has been successfully isolated from human plasma, stabilized and shown to be active in humans.
Slide 83: Plasmin (plasma-derived)
Plasmin (plasma-derived) • Delivery of the protein in this case is critical. • A balloon catheter has been developed (CE mark granted) that will further improve delivery of the product enhancing its efficacy in the ongoing Peripheral Arterial Occlusion Phase II study.
Slide 84: Plasmin (recombinant)
Plasmin (recombinant) • Proof of concept trial for Ischemic Stroke ongoing with pdPlasmin. • Deletion mutant recombinant plasmin may provide an improved pharmacological profile for ischemic stroke, with smaller doses and shorter infusion time. Analysts and Investors meeting. North Carolina. June 14-
Slide 85: Recombinant A1PI
Recombinant A1PI • With indications such as Congenital deficiency and potentially Type I Diabetes and Cystic Fibrosis, sources of A1PI additional to plasma may be required. • Recombinant A1PI development is a safeguard for the company as main world supplier of this protein. Analystsand Investors mee
Slide 86: Additional Core Related Research
Additional Core Related Research Analysts and Investors meeting. North Carolina. June 14-15, 2012 86
Slide 87: Additional Core related research
Additional Core related research Development stage • Liquid Alpha 1 Antitrypsin (advanced) • Supplement for cell culture (advanced) • Reversal of Oral Anticoagulation therapy Feasibility stage • High concentration Factor VIII/VWF • Longer acting coagulation factors Analysts and Investors meeting. No
Slide 88: R&D—Main activity fields
R&D—Main activity fields • Different scope of R&D activities: – Clinical Investigation for current proteins. “Quick and easy” opportunities, known products, no full preclinical development or additional manufacturing plants required. – Full Development of new proteins, including proof of concept, pr
Slide 89: Gri-Cel, S.A.: New Biological Research Fields
Gri-Cel, S.A.: New Biological Research Fields • Gri-Cel is Grifols legal entity to take part in non-core, long term R&D related to biological pharmaceutical activities. • Provides the industrial capabilities, regulatory expertise and resources from Grifols, with the goal of promoting the development
Slide 90: R&D—Main activity fields
R&D—Main activity fields Diagnostic kit Vaccine Inflammatory Diseases
Slide 91: Alzheimer's Disease Comprehensive approach
Alzheimer’s Disease Comprehensive approach • In March Grifols acquired a 51% participation of Araclon, a Spanish company involved in Alzheimer’s Disease. • The Grifols and Araclon projects deliver a comprehensive and complementary approach to Alzheimer’s Disease.
Slide 92: AD Comprehensive Approach
AD Comprehensive Approach Early Diagnosis Vaccine Haemopheresis Albumin & IVIG – ABvac40 – ABvac42
Slide 93: Alzheimer's Diagnosis
Alzheimer’s Diagnosis Araclon’s technology for measuring the Apool in sampled blood can deliver an improved tool, compared to lumbar puncture dependent cerebrospinal fluid analysis, or to imaging technologies, for early prediction of Alzheimer’s disease, facilitating earlier interventions to treat t
Slide 94: ABvac40/42 immunotherapy
ABvac40/42 immunotherapy Araclon’s specific vaccines treat specific isoforms of A (40 & 42) targeting AC-terminus. C-terminal targeting may avoid toxicities seen with therapies directed to other regions of the A molecule that lead to inflammatory response. Difficulty of chemistry around targeting th
Slide 95: ABvac40/42 immunotherapy
ABvac40/42 immunotherapy Araclon Biotech has developed and patented a series of vaccines with promising results in animal models, all experiments showing high levels of safety and efficacy. We plan to enter into clinical trials in 2012.
Slide 96: Nanotherapix
Nanotherapix Analystsand Investors meeting. North Carolina. June 14-15, 2012 96
Slide 97: Nanotherapix: overview
Nanotherapix: overview • Start-up from 2 academic institutions, founded in 2009 by 4 researchers • Q2 2010, Grifols acquired a 51% participation • Focusing on development of patented gene transfer technology and products. • Nanotherapix facilities @ Grifols headquarters: 500 m2 including a P2 area w
Slide 98: Summary: Research and Development status
Summary: Research and Development status Feasibility Research Preclinical/Development Clinical (Ph I; II) Phase III Fibrin Sealant Plasmin aPAO Alzheimer’s Disease (Albutein® / Flebogamma® DIF) Antithrombin Cardiac Surgery Albutein® Liver Cirrhosis Plasmin Ischemic Stroke Antithrombin Severe Burns A
Slide 99: Integration / Achievements
Integration / Achievements Greg Rich - President & CEO Grifols Inc-
Slide 100: Integration Executive Summary
Integration Executive Summary • Company integration completed in record time • No major issues encountered • Corporate culture continued evolution • Now focused on creating sustainable long term value of “New Grifols” • Synergies above targets Analysts and Investors meeting. North Carolina. June 14-
Slide 101: Integration Goals
Integration Goals • Create a sustainable industry leader. • Establish an integrated company operating as one. • Deliver financial commitments and targeted synergies.
Slide 102: Integration Guiding Principles
Integration Guiding Principles • Integration process transparent to our customers. • Capture the best of both worlds. • Integration process to be collaborative with decisions designed for long term value creation. • Deliver mechanical integration in 100 days.
Slide 103: Integration Top Priorities
Integration Top Priorities • Create one customer interface. • Establish one global operating company. • Leverage products (IVIG) and manufacturing opportunities. • Establish one plasma sourcing organization and structure. • Align financials and reporting. • Verify and pursue identified synergies.
Slide 104: Create "One" Customer Interface
Create “One” Customer Interface • Global market organizations integrated with “one” Grifols interface • In the US we have a customer facing organization merged and set up in 3 business units - Immunology/Neurology - Pulmonary - Hematology • US key accounts management aligned • In all markets custome
Slide 105: Establish "One" Global Operating Company
Establish “One” Global Operating Company • All management aligned and operating as one Grifols • Functions globally merged • Grifols name change complete • Legal entities consolidated • HR and Operating policies and systems aligned …. “One Grifols” fully operational….
Slide 106: Leverage products (IVIG) and manufacturing opportunities
Leverage products (IVIG) and manufacturing opportunities • Licensed LA Fraction II+III for manufacturing of additional Gamunex • FDA approval received in July 2011 • First lots were available for sale end of 2011 • Registration of BCN II+III paste in process • Global product portfolios are being ali
Slide 107: Establish ONE Plasma Sourcing Organization and Structure
Establish ONE Plasma Sourcing Organization and Structure • Plasma organizations merged under one leadership structure • Grifols will maintain three separate plasma entities at the donor center level • One Management Strategy for all centers that is Field Driven • 147 centers aligned in 8 regions • C
Slide 108: Originally Defined Financial Strategic Goals
Originally Defined Financial Strategic Goals • The integration of both companies will create significant synergies with a run rate of $230 million from 2015 onwards. • Quick deleverage due to the strong cash flow generation derived from the business and related synergies.
Slide 109: Financial Synergies Above Target
Financial Synergies Above Target Annual run rate 2015 in $ millions Preliminary Current Target Assessment Manufacturing Leverage—= and Optimization Plasma Collections—= Plasma Costs—+ OPEX—+ 230 <300 Analystsand Investors meeting. North Carolina. June 14-15, 2012 109
Slide 110: Strategic Value Creators Going Forward
Strategic Value Creators Going Forward • NFF completion (6 million liters of capacity operational 2015) • Decision to convert new Los Angeles IVIG manufacturing facility to Gamunex® production (operational end of 2014) • Creation of “one” Albumin platform • Investment in new Albumin facility in Clay
Slide 111: Achievement Summary
Achievement Summary • Merger concluded ? • Key talent retained ? • Operating as “one” Grifols globally ? • Taking an industry leadership role ?—products—capacity—investments • Focused on future value creation ? • Exceeding financial commitments ? Analystsand Investors meeting. North Carolina. June 1
Slide 112: Sales & Marketing Global Markets
Sales & Marketing Global Markets Ramón Riera - EVP & President Global Commercial Division - Analystsand Investors meeting. North Carolina. June 14-15, 2012 112
Slide 113: Executive Summary
Executive Summary Grifols delivered during 2011 consistent sales growth through all products and geographies Q1 2012 represented a very solid start of the year Geographical distribution of increased product availability focused on the markets that can offer better services and faster collection days
Slide 114: General Sales evolution by divisions 2011 (proforma)
General Sales evolution by divisions 2011 (proforma) The global growth of sales in 2011 reached up to 7,7% at c.c. overcoming the Bioscience Division 6%. All divisions delivered a positive growth despite the price and consumption restrictions of the environment in certain markets Total 4.6% Total 2.
Slide 115: Analysis by Division – sales Q1 2012
Analysis by Division – sales Q1 2012 Strong growth of sales in the first quarter for all divisions. Without the effects of the exchange rate, sales grew by 16%. 17.7% Total 666.7 MM € Total 566.4 12.4% 16.1% Bioscience 600 Diagnostic Hospital 400 16.4% RM & Others Q1 2011 Proforma Q1 2012 Analystsan
Slide 116: Sales by geographic area 2011 (proforma)
Sales by geographic area 2011 (proforma) Positive growth in all regions in spite of the integration process and the economic situation. In the “New Grifols” sales in Spain, Portugal and Italy represent now only 14% versus 30% of “old Grifols” in 2010 Total Sales: 2.302,7 MM € 2011 vs 2010 EU 1,4% NA
Slide 117: Group activity by regions in Q1 2012
Group activity by regions in Q1 2012 Sales growth in Q1 was higher in markets with better prices and lower collection days. Spain’s relative weight reduced to 9%. This percentage compares with 24% that the same sales represented in 2011 (this percentage refers to Grifols before the Talecris acquisit
Slide 118: International footprints
International footprints In 2010 Grifols continued with its international expansion by opening 3 new subsidiaries and also adding Grifols Canada in 2011 as a result of the Talecris acquisition. We have now direct commercial presence in 24 countries. Canada Sweeden Germany France Poland United Kingdo
Slide 119: Bioscience Division
Bioscience Division Bioscience Division specializes in the research, development, production and marketing of high quality plasma derivatives Plasma derivatives are purified proteins with therapeutic properties that are obtained from fractionated human plasma. Grifols purifies these proteins from pl
Slide 120: Relevant market facts occurred in the last six months
Relevant market facts occurred in the last six months Start AMBAR study (Grifols in Alzheimer) Octapharma has come back to the US market Kedrion’s products launch in the US market Baxter announced the construction of a new fractionation plant in the US Baxter plans to initiate a second, confirmatory
Slide 121: Future growth drivers for the plasma proteins market
Future growth drivers for the plasma proteins market New indications for proteins already in use Current indications for undertreated diseases Healthcare improvements in developing / emerging markets Aging population New proteins with therapeutic application Analysts 121 and Investors meeting. North
Slide 122: Grifols Bioscience Division overall commercial strategy
Grifols Bioscience Division overall commercial strategy Increase the “Average revenue per liter of Plasma” Consolidate Grifols global and US leadership position in IG’s Strengthen global pd Factor VIII position Expand global usage of Prolastin® Drive geographic expansion Convert sales of intermediat
Slide 123: Grifols global growth strategies by product—I
Grifols global growth strategies by product—I Maintain global leadership position in the IVIG market Focus on CIDP in neurology with Orphan Drug status Geographical expansion of Gamunex® Alzheimer’s trial Clinical development of new indications Hyperimmunes Unique combined catalogue of Hyperimmunes
Slide 124: Grifols global growth strategies by product—II
Grifols global growth strategies by product—II Antithrombin US market development of congenital deficiency Increased use in acquired deficiencies Clinical development of new indications (such as cardiac surgery, burns) Albumin Clinical development of new indications (Alzheimer, liver related disease
Slide 125: Grifols global growth strategies by product—III
Grifols global growth strategies by product—III Coagulation Factors Growth market share in developing countries with increased consumption Development of VW indication Treatment of haemophilia A inhibitor patients Expansion of the Alpha1 Augmentation therapy markets in US and Europe with Prolastin®
Slide 126: Hospital Division
HOSPITAL DIVISION Ramon Riera
Slide 127: Hospital Division
Hospital Division The Hospital Division specialises in manufacturing and marketing i.v. medication for hospitals as well as enteral and parenteral clinical nutrition Oncotools: Introducing new concepts in hospital pharmacy procedures: modular clean rooms, compounding systems, oncology management sof
Slide 128: Product range and market presence: I.V. Solutions
Product range and market presence: I.V. Solutions Beginning of a major Supply Agreement of IV solutions in glass bottles to the Italian Company Eurospital. This Agreement together with the volume sales growth in our traditional markets will allow us to increase the production volume of glass bottles
Slide 129: Product range and market presence: Hospital logistics
Product range and market presence: Hospital logistics Development of the automated system Stockey® for the optimization of sanitary material replacement in hospitals. The product started its path in Spain in 2011 with 4 pilot installations. In 2012 besides Spain it will be launched in Latin America.
Slide 130: Hospital Division: commercial activity
Hospital Division: commercial activity The Blispack® system, pioneer in the automation of unit dose blister pack medicine preparation, was launched in Spain in 2010 In 2011 installations have been made in France, Portugal and Brazil Successful implementation of automatic i.v. mixtures preparation in
Slide 131: Hospital Business overview
Hospital Business overview Hospital Division sales evolution during last decade 100 95 89 86 82 80 74 The Division ‘s continuous growth 63 during the last decade together with € 60 54 51 its internationalization makes it a MM 43 40 great platform to contribute to future company sales 2001 2002 2003
Slide 132: Hospital Division: drivers for future growth
Hospital Division: drivers for future growth Grifols Partnership: Continuous development of Contract Manufacturing Agreements with relevant Pharmaceutical Companies of injectables in plastic or glass Blispack®: Continuous international development through Grifols subsidiaries and CareFusion Agreemen
Slide 133: Diagnostic Division
DIAGNOSTIC DIVISION Ramon Riera
Slide 134: Diagnostic Division
Diagnostic Division Focuses on research, development, manufacturing and marketing of in vitro diagnostics products for clinical laboratory analysis Diagnostic systems composed of auto analyzers, reagents and software Diagnostic division main areas: Transfusion medicine Clinical Analysis Haemostasis
Slide 135: Transfusional Medicine – Product range: Immunohematology
Transfusional Medicine – Product range: Immunohematology The most complete immunohematology product line available combining different complementary technologies (CAT, Lateral Flow, Molecular Biology) and the world leading automation for Gel-cards
Slide 136: Transfusional Medicine Product Range: Blood Bank
Transfusional Medicine Product Range: Blood Bank Blood collecting bags and methods for blood components inactivation, complete the range of Grifols products for Transfusional Medicine.
Slide 137: Immunohematology Market Presence
Immunohematology Market Presence The size of the worldwide IH market in 2010 is estimated at US $1.174 million (1*) Size of the Market by Geography IH Market Overview by Company * 25% *6% Ortho US Immucor EU BioRad Japan Grifols ROW Others (*) Grifols market share within the ROW market, company data
Slide 138: Clinical Analysis – Product Range
Clinical Analysis – Product Range Immunology + Microbiology Automated Analyzer + ELISA Reagents Complemented with: Fully automated immunofluorescence system for autoimmunity testing Single-test random access system Rapid microbiology tests Sample-in results-out molecular tests for infectious disease
Slide 139: Clinical Analysis – Market Presence
Clinical Analysis – Market Presence Global distribution of Analyzer Preferred ELISA automation platform in many reference laboratories in the US • Presence in several markets of Europe & Asia • Approx. 1.200 units installed worldwide Recognized key player in Spain, Portugal, UK, Italy, US and Chile
Slide 140: Hemostasis—Product Range
Hemostasis—Product Range Grifols develops and sells a broad catalogue of top quality reagents to study potential hemostasis disorders. Our hemostasis reagents cover the needs of all kinds of laboratories: from routine screening to specialized hemostasis laboratories (thrombosis & hemophilia). Grifol
Slide 141: Hemostasis—Market Presence
Hemostasis—Market Presence 2012 Q Installations Evaluation / Registration Analysts and Investors meeting. North Carolina. June 14-15, 2012
Slide 142: Diagnostic Business overview
Diagnostic Business overview Diagnostic Division sales evolution during the last decade 117 120 109 103 100 85 80 74 80 Strong sales increase due to the € 62 development of own products by 60 58 MM 49 our R&D department and the 42 geographic expansion 2001 2002 2003 2004 2005 2006 2007 2008 2009 201
Slide 143: Diagnostic Division growth strategies
Diagnostic Division growth strategies Increase immunohematology market share in Europe, Latin America and Asia by focusing on introduction of automation Development of the molecular biology blood genotyping market with BloodChip® Expansion of blood bags manufacturing and sales into Latin America Foc
Slide 144: The Market Today
The Market Today Continued growth of the demand in markets with stable or dynamic economies Slight recovery of prices Grifols playing a leading role in several market segments Grifols Global Commercial Results for 2012 look positive and promising Analysts and Investors meeting. North Carolina. June
Slide 145: Sales & Marketing North American Markets
Sales & Marketing North American Markets Joel Abelson - President NA Commercial Division Grifols Inc.-
Slide 146: North American Commercial Operations
North American Commercial Operations
Slide 147: Executive Summary
Executive Summary #1 Plasma-Derived Company in North America (1) US continues to be a growth market 11% sales 7-yr CAGR Successful implementation of NA commercial business unit structure. Focused commercial business units designed to optimize sales potential and maximize balance of liter #1 US marke
Slide 148: Plasma Protein Therapies: Industry background
Plasma Protein Therapies: Industry background U.S. Plasma derivative sales ($Bn) Strong growth: $5.3Bn(1) sales – Under-diagnosed and under-treated indications $5.3 $4.8 $4.5 – 11% sales 7-yr CAGR $4.0 $3.5 – Long-term anticipated 5 – 8% growth $3.1 $2.4 2005 2006 2007 2008 2009 2010 2011 Note: Shar
Slide 149: Business Units With Dedicated Sales Forces & Marketing Teams Support Specific Therapies
Business Units With Dedicated Sales Forces & Marketing Teams Support Specific Therapies Focused business units Immunology / Critical Care Pulmonary Hematology / Diagnostics/ Hospital Analysts and Investors meeting. North Carolina. June 14-15, 2012 149
Slide 150: Leading products for under-treated diseases
Leading products for under-treated diseases Orphan drug Unit Share Primary indication population Immunology IVIG (1) #1 unit share(2) in Primary Immune R United States & Canada deficiency (PI), CIDP, ITP Alpha-1 Antitrypsin #1 unit Pulmonary (2) Alpha-1 Antitrypsin R share in United States & deficie
Slide 151: Leading products for under-treated diseases
Leading products for under-treated diseases 2011 IVIG U.S. 2011 A1PI U.S. 2011 pdFVIII U.S. 2011 ATc U.S. unit share unit share unit share unit share (% of units) (% of units) (% of units) (% of units) 34% 56% 50% 1% 1% 88% 1% 7% 12% 29% 12% 21% 5% 34% 23% 38% Grifols CSL Baxter Kedrion Octapharma B
Slide 152: US Immunology Business Unit
US Immunology Business Unit GRIFOLS pioneering spirit
Slide 153: US Immunology Portfolio Market Share
US Immunology Portfolio Market Share (1) 2011 IG Market 2011 Albumin Market Grifols Grifols 34% 23% All Others 29% 41% CSL 3% CSL Octapharma 7% 2% Kedrion 34% 27% Baxter Baxter 2011 Rabies IG Market Grifols Sanofi 16% 84% 1MRB 2011, unit volume
Slide 154: IVIG portfolio profile and dedicated sales force drive competitive advantage
IVIG portfolio profile and dedicated sales force drive competitive advantage U.S. IVIG use by volume (%) CIDP indication for Gamunex-C® 17% makes Grifols only(1) leading company GRIFOLS(2) 61% Licensed with access to neurology 22% Neurology accounts 50% of IVIG usage 29% CIDP is over half of neurolo
Slide 155: Neurologist response to recent Gamunex-C promotion
Neurologist response to recent Gamunex-C® promotion Unaided Awareness Intent to Prescribe for Next CIDP Actual Rx Patient 89% 66% 61% 25% 19% 12% MAY JAN MAY JAN MAY JAN 2009 2012 2009 2012 2009 2012 Neurologists respond to Gamunex-C® promotion — Dedicated Neurology/Immunology sales force is expandi
Slide 156: Key takeaways for Immunology business unit
Key takeaways for Immunology business unit Leading IVIG DIF market portfolio share with combined Gamunex-C ® and Flebogamma ® in Double dicatio U n.s S . market access versus competitors for licensed Exclusive indication call (CIDP) point for into Gamunex neurology -C and largest neurological ® Two
Slide 157: US Pulmonary Business Unit
US Pulmonary Business Unit GRIFOLS pioneering spirit
Slide 158: Pulmonary—Performance
Pulmonary—Performance Grifols is driving growth in the US Alpha 1 market and maintains a leading market share • The US alpha 1 market grew 10% in 2011 (1) • Prolastin-C ® grew 11% in 2011 in line with the overall market (1) Grifols • Dedicated Pulmonary marketing and sales 56% team. The Prolastin-C
Slide 159: Pulmonary—Opportunity
Pulmonary—Opportunity There is significant opportunity to improve the diagnosis and expand the market for Alpha 1 • There are an estimated 100,000 alpha 1 patients in the US (approximately 75,000 are likely to be symptomatic) Alpha 1 Patient Population (US) • Approximately 4,500 alpha 1 patients are
Slide 160: US Hematology Business Unit
US Hematology Business Unit GRIFOLS pioneering spirit
Slide 161: Alphanate – The leading pdFVIII product for Hemophilia A
Alphanate® – The leading pdFVIII product for Hemophilia A Alphanate®: leadership position #1 unit share in U.S. (43%) (1) Usage has grown at 13% CAGR over last 6 years (2) Focused on increasing brand awareness through dedicated sales force Product attributes Four convenient vial sizes with low recon
Slide 162: AlphaNine SD – pdFIX product for Hemophilia B
AlphaNine SD® – pdFIX product for Hemophilia B • AlphaNine SD® leadership position #1 unit share in U.S. (51%) (1) Usage has grown at 8% CAGR over last 6 years (2) Dedicated sales force • Product attributes Indicated for prevention and control of bleeding in patients with FIX deficiency due to Haemo
Slide 163: Thrombate III: The leading Antithrombin concentrate product
Thrombate III® :The leading Antithrombin concentrate product for Hereditary Antithrombin Deficiency • Thrombate III® leadership position #1 market share in U.S. (88%) (1) US sales share(1) of ATc products Demand continues to growth with 15% CAGR in (% of revenue) US Sales The only antithrombin conce
Slide 164: Grifols
GRIFOLS pioneering spirit
Slide 165: Grifols is the Majority Supplier to the Canadian Blood System
Grifols is the Majority Supplier to the Canadian Blood System • Grifols (Bayer/Talecris) has been awarded primary supplier status in successive national tenders since 1988 • Primary fractionator for Canadian plasma for Canadian Blood Services (CBS) • Majority supplier of plasma products and primary
Slide 166: Financials
Financials Alfredo Arroyo - CFO -
Slide 167: Q1 2012 Results
Q1 2012 Results Analysts and Investors meeting. North Carolina. June 14-15, 2012 167
Slide 168: Q1 2012 – Q1 2011 Proforma Sales by Division
Q1 2012 – Q1 2011 Proforma Sales by Division € Million % % Growth at 2011 % 2012 % Growth constant rate Bioscience 504.6 89.1% 587.2 88.1% 16.4% 14.5% Hospital 24.1 4.3% 27.1 4.0% 12.4% 12.4% Diagnostic 29.9 5.2% 34.7 5.2% 16.1% 15.9% Raw Materials & Others 7.9 1.4% 17.7 2.7% 125.2% 121.1% TOTAL 566
Slide 169: Q1 2012 – Q1 2011 Proforma Sales by Region
Q1 2012 – Q1 2011 Proforma Sales by Region € Million % % Growth at 2011 % 2012 % Growth constant rate USA + CANADA 338.7 60% 416.8 62% 23.1% 20.4% IBERIA + LATAM 105.2 18% 100.4 15% -4.5% -3.8% EU (excluding Iberia) 83.3 15% 84.2 13% 1.2% 1.2% ROW 38.5 7% 57.6 9% 49.3% 45.8% Subtotal 565.7 100% 659.
Slide 170: Q1 2012 – Q1 2011 Proforma Performance
Q1 2012 – Q1 2011 Proforma Performance € Million Revenues Adjusted EBITDA 32.0% 666.7 213.1 26.6% 150.9 566.5 Q1 2011 Q1 2012 Q1 2011 Q1 2012 Financial Result Adjusted Net Profit Q1 2011 Q1 2012 -121 .0 2 14.5% 11.9% 81.9 79.2 Q1 2011 Q1 2012 -68.3 % on Sales
Slide 171: Q1 2012 Reported Performance
Q1 2012 Reported Performance € Million Revenues 666.7 EBITDA 30.4% 202.6 24.8% 261.4 64.8 Q1 2011 Q1 2012 Q1 2011 Q1 2012 Financial Result Net Profit 10.1% Q1 2011 Q1 2012 -4.9 67.5 12.9% 33.6 -68.3 Q1 2011 Q1 2012 % on Sales
Slide 172: Q1 2012 Cash Flow—Reported
Q1 2012 Cash Flow—Reported € Million Sources Uses —Net Operating Cash Flow 147.1—CAPEX 50.1 - Interest / Fee Payments 97.5 —Cash Variance 175.6—Net Debt Decrease 171.6 - FX and Others 3.5 Total 322.7 Total 322.7 ====== ======
Slide 173: Improved conditions for Financing
Improved conditions for Financing ?Reduction of interest rates and retranching. ?Only two financial covenants in place, relating to leverage ratio and interest coverage. ?Elimination of covenants relating to limitations in fixed assets investment and the debt service coverage ratio. ?Amendment to th
Slide 174: The majority of the debt will mature starting in 2017
The majority of the debt will mature starting in 2017 $ Million 1,837 Average Maturity 5.4 years 1,100 108 119 157 169 2012 2013 2014 2015 2016 2017 2018 Analysts and Investors meeting. North Carolina. June 14-15, 2012 174
Slide 175: Q1 2012 Results Summary
Q1 2012 Results Summary ?Strong growth in comparable revenues +17.7% (1). ?Significant increase of adjusted EBITDA +41.3% (1). ?The reported Profit doubled, reaching € 67.5 million. ?Leverage ratio reduction to 3.8x. ?Synergies achieved in all operational areas. ?Important improvement of financing t
Slide 176: Synergies
Synergies Analysts 176 and Investors meeting. North Carolina. June 14-15, 2012 176
Slide 177: Improved operational synergies
Improved operational synergies % of total cost synergies Annual synergies of ~ $300M beyond 2015 <300M p.a. ~15% 2012 2013 2014 2015 80 ~ 45% ~ 70% ~ 90% ~ 100% 70 ~40% 60 ~100% Estimated phase out synergies achievement ~45% Optimized SG&A Plasma Total Manufacturing R&D Collections Analysts 177 and
Slide 178: Adjusted LTM EBITDA evolution
Adjusted LTM EBITDA evolution € Million 693.0 0 630.8 592.8 602.0 June 2011 Sept. 2011 Dec. 2011 March 2012
Slide 179: Quarterly Debt Ratio: Net Debt / Adjusted LTM EBITDA
Quarterly Debt Ratio: Net Debt / Adjusted LTM EBITDA 6.0 6.0 6.0 6.0 Covenant 4.6 4.4 4.3 3.8 June 2011 Dec. 2011 Sept. 2011 March 2012 Analysts and Investors meeting. North Carolina. June 14-15, 2012 179
Slide 180: Capex "heavy" spending already happened
Capex “heavy” spending already happened € Million 768.3 226.0 Legacy Grifols Legacy Talecris 202.1 161.3 Grifols 181.5 114.0 58.1 158.7 414.5(*) Talecris 54.2 125.0 115.3 Grifols 123.4 94.3 104.5 79.9 88.1 64.7 2008 2009 2010 2011 2012 2013 2014 2015 (*) Based on existing projects and planned capaci
Slide 181: Quick deleverage path based on operational performance improvement
Quick deleverage path based on operational performance improvement 6.0 6.0 6.0 4.65 4.4 4.3 3.8 3.6 3.0 Financial covenants Estimate Proforma Actual Proforma Actual Proforma Actual 2012E 2013E 2014E LTM June 2011 LTM Dec. 2011 LTM March 2012
Slide 182: Stock Performance
Stock Performance Analysts 182 and Investors meeting. North Carolina. June 14-15, 2012 182
Slide 183: Grifols Class A: Stock price change Jan 1st 2011 to May 31st 2012
Grifols Class A: Stock price change Jan 1st 2011 to May 31st 2012 Base 100 Dec 2010 unadjusted closing price GRF:+80% 200 Grifols 1Q2012 earnings release 2011 2012 +27% YTD +41% Grifols1H2011 Grifols 2011 earnings release earnings release 170 160 Transaction Closing Jun 1 2011 150 140 130 120 110 CS
Slide 184: Grifols Class A, B & ADR B: price change June 2011 to May 2012
Grifols Class A, B & ADR B: price change June 2011 to May 31st 2012 Base 100 Dec 2010 unadjusted closing price GRF.P:+30% Grifols 1Q2012 earnings release GRF:+30% B Shares start Grifols 2011 trading June 2 2011 earnings release 120 110 Listing of New B GRFS:+15% Shares Dec 30 2011 Grifols Class A (G
Slide 185: Grifols Class A & B: price change June 2011 to May 31st 2012
Grifols Class A & B: price change June 2011 to May 31st 2012 20 € Base 100 Dec 2010 unadjusted closing price Grifols 1Q2012 19 € earnings release 18 € B Shares starts Listing of New B Grifols 2011 17 € trading June 2011 Shares Dec 30 earnings release 2011 Spread:25% 16 € 15 € 14 € 13 € 12 € 11 € Spr
Slide 186: Conclusions
Conclusions xQ1 strong performance resulted mainly from synergy achievement. x Updated synergies calculation above initial estimates. xSignificant improvement in acquisition financing terms and conditions. xCash Flow generation as well as EBITDA improvement will continue deleveraging the Company. xC
Slide 187: Wrap up
Wrap up Víctor Grifols - President & CEO -
Slide 188: Investors' & Analysts' Meeting in North Carolina
Investors’ & Analysts’ Meeting in North Carolina Thursday 14th and Friday 15th June 2012 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