Professional Documents
Culture Documents
Aun CFF 12 Final
Aun CFF 12 Final
Contents
1. Executive Summary 3
2. General Overview 5
3. HD Machines 20
4. Dialysers 24
5. Acute and Therapeutic Apheresis Products 27
6. Provider Business 28
7. Market Shares, Regional Coverage 33
8. Quality Issues and Litigations 36
9. History and News 39
1. Executive Summary:
B.Braun is a privately held company headquartered in Melsungen, Germany and owned by the Braun family.
In April 2011, Ludwig Georg Braun retired as CEO and for the first time a non-family member, Heinz-Walter
Große, took over this position. Still, the Braun family will continue to operate the company as a closed family
business. Ludwig Georg Braun’s son, Otto-Philipp Braun, joined the management board when his father
retired. He is responsible for the regions Iberian Peninsula and Latin America.
In 2011, B.Braun had a total group revenue of EUR 4.6bn and an EBITDA margin of 14.9%. Overall, profit
and income expectations were not met as sales increased only 4.2% and the EBITDA margin fell by 0.9%-
points. Consequently in the second half of 2011, cost reduction measures were implemented to limit an
increase in general, administrative, and selling expenses and improve the EBITDA margin. B.Braun’s
strategic goal is to reach EUR 6bn of revenue and an EBITDA margin of 17-18% in 2015. Latin America and
Asia are considered its major growth markets.
Avitum, the fully integrated dialysis products and provider business of B.Braun, is the smallest business
segment with 2011 revenues of EUR 501m (+5.5%) contributing 10.9% (2010: 10.7%) to total group
revenues. Further business segments in the B.Braun group are Hospital Care (47% of group revenues),
Aesculap and OPM (Out Patient Market).
According to FME’s Market and Competitor Survey 2011, the sale of new HD machines declined by 4.5% to
5,000 units. This represents a 2011 global market share of 7% and a market share decline of 0.6 percent
points. Dialyzer sales increased by 8.7% to total 6.6m which increased the market share by 0.1%-points to
3.1%.
In May 2012, two strong earthquakes in Northern Italy had an effect on B.Braun’s plant in Mirandola.
H.E.L.P. Plasmat Futura- and Diapact CRRT kits were affected. For one month production was temporarily
relocated.
1. Executive Summary:
B.Braun’s dialysis provider business is continuing its strong international expansion. In 2011, about 11,300
dialysis patients were treated in 185 B.Braun dialysis clinics (2010: 10,800 patients, 180 clinics). B.Braun
owns clinics in 23 countries including Europe, Asia, Africa and Latin America. In 2011, provider business was
established in Russia, Singapore and Germany. In April 2012, B.Braun entered Paraguay by acquiring the
majority shares of a distributor, forming B.Braun Medical SA Paraguay. In Q2 2012, B.Braun bought a third
clinic in Colombia, in addition to the purchase two small independent local providers.
Since 2008, two investment programs were set up for international business expansion:
The first program (2008-2011), was announced to be EUR 1.4bn large and included the expansion of
B.Braun's manufacturing capacities for dialysers to 9m units annually and HD machines to 15,000 units
annually, besides its ambition to achieve and maintain cost and market leadership in the infusion therapies
market.
In 2010, B.Braun announced a new worldwide EUR 1.6bn investment program for the period 2011- 2014
which will largely be financed from operating cash flow. It focuses on emerging and developing countries,
including the renewal of the location in Malaysia, expansion of its sites in Brazil and Argentina and the
construction of a new infusion solutions factory in Indonesia. The program also includes the construction of a
third L.I.F.E. factory (dialysis and apheresis machines, infusion pumps and infusion solutions) in Melsungen.
In April 2011, the investment amount was further increased to a total of EUR 2-2.5bn
At EDTA 2012 in Paris, B.Braun presents itself together with Lauer membrane water technology on a joint
booth for the first time after the forming of a partnership in February 2012.
2. General Overview:
Headquarters: Carl-Braun-Straße 1 and Pfieffewiesen Europe building,
34212 Melsungen, Germany
History: Founded in 1839
Ownership: Ludwig Georg Braun and his family
In its 2011 annual report, B.Braun reaffirmed that the company will
remain a closed family company and will not pursue a public offering
Organizational Structure:
B.Braun Melsungen AG
2. General Overview:
Major Shareholdings of B.Braun Melsungen AG – Germany and Europe:
Operations in 56 countries; 196 consolidated companies; 3 minority owned joint venture companies; 18
holdings
2. General Overview:
Major Shareholdings of B.Braun Melsungen AG – Americas, Asia, Australia, Africa & other holdings
Operations in 56 countries; 196 consolidated companies; 3 minority owned joint venture companies; 18
holdings
2. General Overview:
Executive Management – Management Board:
From left:
Source: B.Braun Annual Report 2011
Otto-Philipp Dr. rer. pol. Heinz- Dr. Annette Dr. rer. nat. Meinrad Lugan Caroll H. Neubauer Prof. Dr. med. Hanns-Peter Dr. rer. nat. Wolfgang Feller
Braun Walter Große Beller • Head of Hospital Care • Chairman and CEO of Knaebel • Head of Avitum
• Responsible for • Chairman of the • Head of and OPM B.Braun Medical North America • Head of Aesculap
the regions Management Board Finance, Tax • Chairman of the board of • Prev. position: Head of Clinical
Iberian • Successor of Ludwig & Controlling B.Braun Foundation Sciences Department
Peninsula and Georg Braun • Successor of • Chairman of the board of at Aesculap with global
Latin America • Previous position: Heinz-Walter BVMed responsibility for
Head of Finance and Große marketing & sales
Human Resources
2. General Overview:
Executive Management – Supervisory Board: From left:
• Mike Schwarz, Member of the Work’s Council
• Rainer Heoke, Member of the Work’s Council
• Prof. Dr. Oliver Schnell, Managing Director of Sciarc GmbH,
Baierbrunn, Exec. Mamber of the Board of Forschergruppe
Diabetes e.V. at Helmholtz Zentrum
• Edeltraud Glänzer, Member of the Managing Board of IG BCE,
Hannover
• Prof. Dr. rer. pol. Thomas Rödder, Tax Advisor and Certified
Public Accountant, Partner, Flick Gocke Schaumburg, Bonn
• Barbara Braun-Lüdicke, Businesswoman, Melsungen
• Prof. Dr. med. habil. Dr. Ing. Dr. h. c. Michael Ungethüm,
former Vice Chairman of the Management Board of
B.Braun Melsungen AG
• Hans-Carsten Hansen, Predisent Human Resources, BASF SE,
Ludwigshafen
• Sonja Siewert, Member of the Work’s Council
• Dr. h.c. August Oetker, Partner, Dr. August Oetker KG
• Dr. H.C. Ludwig Georg Braun, Chairman, Former Chairman of
the Management Board of B.Braun Melsungen AG
Source: B.Braun Annual Report 2011 • Ekkehard Rist, Vice Chairman of the Work’s Council of B.Braun
Germany and Aesculap AG , Tuttlingen
• Peter Hohmann, Vice Chairman/Chairman of the Workers’
Council of B.Braun Meldungen AG, Melsungen
• Dr. Rer. Pol. Antonius Engberding, Member of the Executive
Board of IG Metall, Frankfurt/Main
• Manfred Herres, Production Director, B.Braun Avitum
• Dr. Joachim Rauhut, Member of the Managing Board of Wacker
Chemie AG, Munich
2. General Overview:
Key Figures:
Euro m 2007 2008 2009 2010 2011 2010/2011
%-change
Total Revenues 3,573 3,786 4,028 4,423 4,609 + 4.2
2. General Overview:
Key Figures:
29% 7%
Aesculap 91% LA 20%
Products Germany
2. General Overview:
Group Strategy:
• After the “retirement” of Ludwig Georg Braun in April 2011, continuation as closed family business
• Equity ratio of ~42 % in 2011 (target: 45%) to maintain the independence and foundation for long-term success
• Group Targtes for 2015:
• EUR 6bn revenue
• EBITDA margin of 17 – 18 percent of sales
• Global development of Avitum as fully integrated dialysis products and service provider
• Increasing centralization of functions (lean and cost-optimized organization) with divisional organization structured
in Centers of Excellence
• Organic growth through international investment programs (2007-2015) for business and manufacturing capacity
expansion, totaling ~ EUR 4.6bn (more information on pages 16-17)
• Asia and Latin America are major growth markets; Asia-Pacific region is expected to contribute more than EUR
1.2bn ~ 20% to group revenues in 2015; North America and Europe moderate growth expected
• In 2012, B.Braun became more active in India, acquiring a controlling stake in Oyster Medisafe, a medical devices
manufacturer in the state of Andhra Pradesh where B.Braun is operating a PPP since 2010; in addition it entered
into a share purchase agreement with Ahlcon Parenterals; this strengthens B.Braun’s market presence and is in line
with its strategy to become the first choice in infusion therapy in India
• With the acquisition of its previous OEM manufacturer for enteral nutrition, Nutrichem in Germany, B.Braun
underlines efforts to expand its business areas into the area of clinical and enteral nutrition
• “Sharing Expertise” as guiding principle; open innovation strategy for the creation of sustainable value
2. General Overview:
Avitum Strategy:
• Doubling of production capacities for polysulfone dialysers to 9m and dialysis machines to 15,000 finished
in 2011; dialysis concentrates production expansion to a capacity of 37m bags in Glandorf begun 2011,
expected completion in 2013
• Internationalization of dialysis provider business through acquisition and opening of new clinics
• Public private partnerships as means of provider expansion in India (Andhra Pradesh) and in Germany
with GTZ to train nurses in the use of modern medical equipment and products in Kenya
• India, South Africa, and Russia are considered major growth markets in provider business; growth rates
were reported as “satisfying” in these countries in 2011 (internal sources estimate B.Braun patient growth
rates to be above market growth in these three countries)
• HD business is secured through regional co-operations and agreements with other market participants
(e.g. agreement with Baxter in Eastern Europe, where 30% of all new patients in B.Braun centers are
targeted for starting on PD with Baxter equipment)
2. General Overview:
Key Partnerships:
• 2012, cooperation with Lauer membrane water technology; B.Braun takes over sale for Lauer’s dialysis
water technology worldwide
• LDIAMON delivers online clearance measurement tool Adimea for Dialog+
• AM2PAT manufactures pre-filled heparin and saline flush syringes under the B.Braun Medical Inc. label
• Heparin supplied by Wisconsin-based Scientific Protein Laboratories, which operates a manufacturing plant
in Changzhou, China
• Supply agreement with NxStage for the delivery of blood tubing sets by NxStage’s in-center business
Medisystems for B.Braun‘s Dialog hemodialysis systems; B.Braun provides sales, marketing and clinical
support to its customers in the US; in Jan. 2012 agreement was extended through 2014
• Distribution of B.Braun HD solutions by Renamed in Romania
• Since 2007, partnership with Nipro, which acquired exclusive distribution rights for B.Braun‘s
cardiovascular disease products (stents, PTCA catheters) in Japan
2. General Overview:
Product Overview:
HD products:
• Machines
• Dialysers
• Needles, catheters,
cannulas
• Bloodlines
• Concentrates
• Disinfectants
Dialog+ Xevonta & Solcart B Bloodline Systems HD Concentrates
Diacap
Dialysers
2. General Overview:
Production Sites:
2. General Overview:
Initially communicated investment program: EUR 1.4bn, 2008 – 2011
• B.Braun invested EUR 1.4bn across all business areas; half of the amount invested in Germany
2. General Overview:
Initially communicated investment program: EUR 1.6bn, 2011-2014
• B.Braun invests an additional EUR 1.6bn for the construction of new and the expansion of existing
production sites after the termination of the 2008-2011 investment program
• Production expansion in developing and emerging markets
• Renewal of the location in Malaysia
• Construction of a new factory for infusion solutions in Indonesia
• Expansion of production sites in Brazil and Argentina
• Financed from the company’s operating cash flow
• Construction of a third L.I.F.E infusion factory at Pfieffewiesen location, Melsungen, Germany
2. General Overview:
B.Braun communication after earthquakes in Northern in May 2012
Two major earthquakes struck the Emilia-Romagna region in Northern Italy within less than 10 days on May
20th and 29th. The epicenter were in in Modena and Mirandola, with magnitudes of 6.0 and 5.8 respectively,
destroying major infrastructure and various medical device manufacturing plants.
Jun. 1, B.Braun plant in Mirandola was effected by the earthquake on May 20 th; none of the 200 staff
was injured; longtime delivery problems are not expected, except for concentrates in bags
Jun. 12, Parts of the production site in Mirandola were affected by both earthquakes and by
severe aftershocks; production suspension of H.E.L.P. Plasmat Futura- and Diapact CRRT Kits; ban to enter
the production building; relocation of production to a site in the area; products affected by
delivery problems: H.E.L.P. Plasmat Futura Kits, small stock of Diapact CRRT Kits, dialysis
concentrates in bags not deliverable (alternative, concentrate in canisters from
Glandorf offered)
Jul. 9, Production is resumed at Mirandola; sterilization processes for the H.E.L.P. Plasmat
Futura kits is working; stable supply situation for both the H.E.L.P. Plasmat Futura kits and the Diapact
CRRT kits
Eye-witness
photographs
of B.Braun
productionsite Mirandola and Medolla
in Mirandola, in the region
Italy Emilia-Romana,
Italy
3. HD Machines:
Hemodialysis Machines:
Dialog+
• Launched 2003/2004
• Adimea online clearance measurement based on UV light absorption of “urea-like”
compounds (technology delivered by LDIAMON)
• bioLogic RR Comfort biofeedback system; automatic regulation of UFR based on
periodic blood pressure measurements during dialysis
• Nexadia data management system
• Rotatable TFT monitor
• No measurement of blood temperature and volume, hematocrit and hemoglobin
• No online HDF with single needle
• In 2011, new software and modifications to electronics and hydraulics were
introduced for compliance with ISO/IEC 60601-1 standard 3rd edition
• It is rumored that a PMCFU is currently carried out with new Dialog+ version
called “Dialog+ Evolution”
3. HD Machines:
Hemodialysis Machines – History:
3. HD Machines:
Hemodialysis Machines – History:
Plasmat secura
HD105 HD Secura
3. HD Machines:
Hemodialysis Machines – Comparison of features:
4. Dialysers:
Xevonta Hi series: High-flux
Polyethersulfone (amembris)
1.0 m² 2.3 m²
Gamma sterilization
Launched at WCN 2009
4. Dialysers:
Diacap HiFlo series: High-flux
Polysulfone-PVP blend ( Polysulfone+)
1.8 m², 2.3 m²
Gamma sterilization
Launched 2008
4. Dialysers:
Membrane Source, Dialyser Production and Distribution:
6. Provider Business:
Dialysis Centers 2011:
• 185 dialysis centers with 11,300 patients
• Centers in 23 countries: Germany, U.K., Spain, France, Lithuania, Finland, Croatia, Slovakia, Czech
Republic, Poland, Turkey, Romania, Russia, Hungary, South Africa, Zimbabwe, Latvia, Colombia, South
Korea, Singapore, Malaysia, India, Philippines
6. Provider Business:
Global Patient Distribution:
Global dialysis patients in 2011: 2,164,000 (+6.8%)
Patients B.Braun centers 2011: ~ 11,300 (+4.7%)
Thereof in EMEA: ~ 9,340
Thereof in RoW: ~ 2,000
B.Braun centers 2011: 185
14,000
RoW
12,000 11,300 Europe
10,800
10,000 9,300
8,390
Patients
8,000 7,200
5,800
6,000
5,000
4,600
4,000 3,500
2,500
2,000 1,600 1,700
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Strictly Confidential For internal Use Only
International Strategic Development & Strategic Coordination Office © August, 2012 Page 29
B.Braun
6. Provider Business:
Patients and Centers Regional Distribution:
ZWE
ROM
ZWE
ROM
MYS
MYS
DEU
HUN
HUN
KOR
KOR
HRV
RUS
RUS
SGP
TUR
COL
FRA
CZE
FRA
CZE
ESP
SVK
ESP
SVK
POL
POL
GBR
GBR
HRV
PHL
ZAF
SGP
COL
FIN
FIN
TUR
IND
LTU
LVA
IND
LTU
LVA
ZAF
PHL
PD patients
HD patients
6. Provider Business:
International Expansion – Clinics in 23 Countries:
RUS
DEU
Europe FIN Latin America
15
13 LVA
12
11 GBR, LTU
9 ROM
8
TUR, POL
6
5 FRA 1
HUN
COL
CZE,SVK,ESP,HRV
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2008 2009 2010 2011
IND (PPP)
3
2
MYS
2
ZWE
KOR 1
1
PHL ZAF
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2005 2006 2007 2008 2009 2010 2011
6. Provider Business:
Global Patient Distribution:
100%
Other
21%
Company B.Braun
Baxter 2% 2%
Public 25% 4%
33% Diaverum
DaVita 27%
7%
35% FME 44%
HCO
Private
2011
Source: MCS 2011
NA 8%
Bellco
JMS Other 12%
Toray
3%
Nipro 5% 45% EMEA
1%
6% 1%
B.Braun 35%
7%
FME AP
11%
13%
Nikkiso
9%
7% 6%
3%
Global NA EMEA AP LA
14% 8%
Gambro 5%
4% 4% 3%
Global NA EMEA AP LA
AP 3%
Bellco 3%
Other 16%
Nikkiso
Baxter 5%
2%
B.Braun
Toray 3% 3%
1%
5% FME
78%
45% EMEA
Asahi 11%
Global NA EMEA AP LA
2008 In Jan., AM2PAT, which manufactures pre-filled heparin syringes under the B.Braun Medical Inc.
label, recalls B.Braun branded pre-filled heparin and saline flush syringes in the US due to
potential contamination with Serratia marcescens identified in the course of an inspection by the
FDA
In Feb./Mar., B.Braun and German BfArM inform about failures of Dialog+
machines with DF-option (dialysis fluid filter) to trigger an alarm in case of an excess of
ultrafiltration volume (negative deviation in the fluid balance of up to 1000ml) in machines
which have been produced on October 16th, 2007, or later; 9 cases had been reported so far;
cause: leakage at conductivity sensor
In Mar., B.Braun Medical begins recalling 23 finished product lots of heparin sodium
injection solutions (US and Canada) after its heparin sodium supplier Scientific Protein
Laboratories informed about a heparin-like contaminant (oversulfated chondroitin sulfate) in one lot
In Apr./Jun., recall of H.E.L.P. LDL-apheresis heparin adsorber batches due to
several cases of allergic reactions
In May, British MHRA publishes a field safety notice concerning B.Braun‘s Dialog+ HD
machine; several incidences of negative deviation in the fluid balance were reported that did not
trigger an alarm although the ultrafiltration volume was to large
2009 In Mar., it is announced that the criminal court of San Bernardo, Chile has decided not to hold an
abbreviated trial for the five B.Braun laboratory executives charged with an “attack on public health
resulting death” in the case of 14 of the 23 people, who died after taking the dietary supplement
AND Nutricomp; the measure implies that the defendants could receive harsher punishments than
they would have through an abbreviated trial, now risking up to 15 years in prison
In Jul., German BfArM publishes a customer information letter concerning B.Braun‘s
blood tubing system AV-Set Dialog; leakage was observed between the lid and the corpus of the
arterial chamber; leakage will be detected by the machine‘s alarm system
2010 In Jun. and Aug., British MHRA and German BfArM publish urgent field safety notices concerning B.Braun's
Online Substitution Line for Dialog 7210558 and 721055A because a leakage between the non
return valve and the connector was reported in singular cases
In Sep., German BfArM, British MHRA, French Afssaps and Italian Minestero della Salute
publish field safety notices for defined series of Safety Air Detectors (SAD) for B.Braun Avitum's
Dialog+ Haemodialysis system, Diapact CRR Apheresis system and Plasmat Futura Therapeutic
plasma exchange system; in rare cases the air detection function in the venous blood line may be
impaired
In Oct., B.Braun voluntarily recalls seven lots of heparin manufactured in 2008 by its
supplier Scientific Protein Laboratories LLC (SPL); the recall is initiated by SPL because additional testing
of retained crude heparin samples indicated a trace amount of oversulfated chondroitin sulfate (OSCS)
contaminant
2012 In Jun./Jul., British MHRA and French ANSM publish Field Safety Notice concerning B.Braun Avitum‘s
Xevonta Hi 20 hemodialyers; problems during the packaging process caused sterility problems in two
batches
In Aug., the FDA issued a Class I recall for B.Braun‘s Infusomat Space Infusion System
because potential breakage of the anti free flow clip if infusion is imporperly inserted and the door shut
by force; the recall concerns all devices distributed Nov. 6, 2008 – Dec. 29, 2011
2009 In Jan., B.Braun Medical Inc., USA launches a new web site exclusively devoted to products,
support services and educational information for home infusion therapy (HIT)
(http://www.hit.bbraunusa.com)
In Jan., B.Braun announces to expand operations in Penang, Malaysia by investing
about EUR 64.5m into its manufacturing facility at the Bayan Lepas Industrial Zone
In Feb., B.Braun establishes a subsidiary in Croatia; B.Braun Adria represents a
joint venture with its long standing partner, the Dzepina family
In Feb., B.Braun announces that it has been awarded a three-year contract by
Premier Purchasing Partners, Pennsylvania, US for both hemodialysis and continuous renal
replacement therapy; B.Braun has a long-standing relationship with Premier in other product
areas; adding renal products to B.Braun’s broad offering gives Premier members a more complete
solution to improve patient care
2010 In Jan., B.Braun announces a new worldwide EUR 1.6bn investment program for the period
2011 to 2014; the company plans to construct a third L.I.F.E. factory in Melsungen, to renew
the location in Malaysia, to build a new infusion solutions factory in Indonesia and to
expand its sites in Brazil and Argentina; this investment program will be financed from the
company’s operating cash flow
In Jan., B.Braun US introduces oncology infusion therapy product WHIN Safe Huber
Needle; an implantable port access device that protects from needle stick injuries and expelled
blood and fluid (www.whinsafe.bbraunusa.com)
In Jul., B.Braun starts using Twitter to distribute company news in German language
In Jul., B.Braun expands the production of infusion bags and opens a new
production line at its existing production site in Crissier, close by Lausanne, Switzerland; a second
floor with 4,000m² allows for potential further expansion; in the future, Crissier will serve as the
central manufacturing plant for multi-chamber infusion bags
In Sep., B.Braun CEO Ludwig Georg Braun is awarded “Deutscher
Gründerpreis”; he was honored for his achievement in terms of internationalization, innovation
and establishment of a corporate culture at B.Braun
In Oct., Redsense announces B.Braun as distributor for its business in the
Netherlands
In Oct., B.Braun wins third consecutive three-year contract from Premier, Inc. For
the delivery of safety IV catheters
Strictly Confidential For internal Use Only
International Strategic Development & Strategic Coordination Office © August, 2012 Page 53
B.Braun
2011 In Feb., B.Braun officially opens a production site expansion in Timisoara, Romania; the new
facility is operational since early 2011 and was subject to a EUR 4m investment to reach a
capacity of 19m units of infusion solutions annually; it will serve as distribution hub in
South-East Europe; B.Braun intends to invest EUR 2m into upgrading production facilities and
further integration of B.Braun Pharmaceuticals SA into the B.Braun production sites network
worldwide
In Feb., B.Braun announces to spend EUR 50m to extend its production facility in
Glandorf, Germany; EUR 20m to built up a 11,000m² fully automated rack storage for 30,000
pallets; EUR 30m to build a new dialysis solution manufacturing line with a capacity of 37m
bags; current capacity amounts to 60m liter p.a.; manufacturing begin is planned in May 2011 and
completion is planned in Q1 2013
In Mar., B.Braun publishes its financials for 2010; corporate sales increased by 9.8
percent to EUR 4,422.8m; sales of dialysis division Avitum increased by 12.9 percent to EUR
474.8m