21 years later…one Group, two strategies
`Separation scheduled for Q4 2016
`
`April 2016
`
`The Galenica Group - Excellence in the healthcare market
`
`Pharmacosmos, Exh. 1069, p. 1
`
`
`Separation scheduled for Q4 2016
`
`April 2016
`
`The Galenica Group - Excellence in the healthcare market
`
`Pharmacosmos, Exh. 1069, p. 1
`
`
`
`Galenica Group
`Overview
`
`April 2016
`
`− © Galenica Group
`
`2
`
`Pharmacosmos, Exh. 1069, p. 2
`
`
`
`Galenica Group
`Financial Profile
`
`Net profit before minorities (*)
`
`EPS development
`
`(CHFm)
`
`(CHF)
`
`370
`
`312
`
`296
`
`277
`
`256
`
`232
`
`210
`
`189
`
`Swiss GAAP
`
`IFRS
`
`135
`
`104
`
`80
`
`49
`
`54
`
`42
`
`59
`
`67
`
`64
`
`21
`
`26
`
`30
`
`34
`
`'95 '96 '97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '14 '15
`Minorities
`
` 50.0
`
` 45.0
`
` 40.0
`
` 35.0
`
` 30.0
`
` 25.0
`
` 20.0
`
` 15.0
`
` 10.0
`
` 5.0
`
` -
`
`46.5
`
`43.9
`
`39.4
`
`39.8
`
`35.5
`
`34.6
`
`32.3
`
`29.1
`
`20.7
`
`15.9
`
`12.3
`
`9.9
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`Cumulative growth: +1,645%
`CAGR: +15.4%
`
`Cumulative growth: +370%
`CAGR: +15.1%
`
`(*) like-for-like (excludes non-cash one off effects of CHF39m in 2013)
`
`April 2016
`
`− © Galenica Group
`
`3
`
`Pharmacosmos, Exh. 1069, p. 3
`
`
`
`Galenica Group
`Stock market value from CHF 250M to >9BN
`
`Scaling to 100 from 1995
`
`Share Price (CHF)
`
`SMI
`
`Berkshire Hathaway CHF
`
`Swiss Life Sciences Index
`
`Galenica
`
`4'500
`
`4'000
`
`3'500
`
`3'000
`
`2'500
`
`2'000
`
`1'500
`
`1'000
`
`500
`
`0
`
`1'600
`
`1'400
`
`1'200
`
`1'000
`
`800
`
`600
`
`400
`
`200
`
`0
`
`April 2016
`
`− © Galenica Group
`
`4
`
`Cumulative growth: +3,650%; Average growth rate p.a.: 23%
`Total shareholder return p.a.: 26% (incl. dividends)
`
`Pharmacosmos, Exh. 1069, p. 4
`
`
`
`Galenica Group
`Leadership team organisation – Long-term sustainability
`
`Head Strategic Projects
`Felix Burkhard
`
`Executive Chairman
`Etienne Jornod
`
`CFO Group
`Jörg Kneubühler
`
`CEO Vifor Pharma
`Søren Tulstrup
`
`CEO Galenica Santé
`Jörg Kneubühler
`
`April 2016
`
`− © Galenica Group
`
`Deputy CEO Vifor Pharma
`Gianni Zampieri
`
`Head Retail Business sector
`Jean-Claude Clémençon
`
`5
`
`Pharmacosmos, Exh. 1069, p. 5
`
`
`
`Galenica prepares
`foundation for two
`listed independent
`companies with new
`management
`structure
`
`Galenica announced
`that separation of the
`Group into two
`independent
`companies to take
`place in Q4 2016
`
`Galenica Group
`Corporate Timeline
`
`Galenica is listed on the Swiss Stock
`Exchange
`New strategy based on a vision of
`turning the company into a player
`engaged in the entire drug value
`chain in Switzerland
`
`Corporate
`
`Acquisition of
`Sun Store
`pharmacy chain
`Acquisition of
`Globopharm
`
`Acquisition of
`Medifilm
`Acquisition of a
`49% stake in
`Bahnhof
`Apotheke Zurich
`
`Creation of
`GaleniCare
`
`Acquisition of
`MediService
`
`The pharmacies
`of GaleniCare
`appear under a
`new brand:
`Amavita
`
`Expansion of
`distribution
`activities
`Acquisition of
`Galexis and
`Amidro
`
`Partnership with
`Alliance Boots
`based on a
`contract that
`runs to this day
`
`Galenica
`
`Santé
`
`1994
`
`1996
`
`1997
`
`1999
`
`2000
`
`2001
`
`2004
`
`2005
`
`2007
`
`2008
`
`2009
`
`2010
`
`2013
`
`2014
`
`2015
`
`2016
`
`2014: Velphoro®
`receives EU marketing
`authorization
`2015: Exclusive license
`agreement for Mircera®
`(U.S. only) and for
`Veltassa® (except
`U.S./Japan)
`2015: Japan approval
`for P-TOL® (Velphoro®
`in U.S./EU)
`
`6
`
`1997: Acquisition of
`Laboratoire Golaz
`(OTC)
`
`1999: Acquisition of
`Medichemie
`(phythotherapy and
`gastro-enterology)
`
`Beginning of
`international
`expansion in the
`area of iron
`replacement
`Products redesigned
`/ positioned as
`Venofer® and
`Maltofer®
`
`2001: Venofer® is
`approved by the
`FDA
`2004: Creation of
`Vifor Pharma
`
`International
`expansion with
`Venofer® and
`Maltofer®
`First launch of
`Ferinject® in
`Germany
`
`2008: Acquisition of
`Aspreva
`Phamaceuticals
`2009: Acquisition of
`OM Pharma
`2010: Creation of
`Vifor Fresenius
`Medical Care Renal
`Pharma
`
`FDA approval of
`Injectafer®
`FDA approval for
`Velphoro®
`
`Vifor Pharma
`
`April 2016
`
`− © Galenica Group
`
`Pharmacosmos, Exh. 1069, p. 6
`
`
`
`Galenica Group
`Galenica vision for the separation: 2 listed companies in Q4 2016
`
`1 share
`Galenica
`
`1 share
`Vifor Pharma
`
`1 share
`Galenica Santé
`
`Board of
`Directors
`New
`Chairman /
`new Board
`
`Management
`
`Unchanged
`
`Holding
`structure
`To be set up
`/
`transferred
`
`Vifor
`Pharma
`
`Galenica
`Santé
`
`New
`Chairman /
`new Board
`
`April 2016
`
`− © Galenica Group
`
`Unchanged
`
`Modified
`
`7
`
`Pharmacosmos, Exh. 1069, p. 7
`
`
`
`Vifor Pharma
`“Vifor Pharma will become a successful, stand-
`alone global speciality pharma company”
`
`April 2016
`
`− © Galenica Group
`
`8
`
`Pharmacosmos, Exh. 1069, p. 8
`
`
`
`Vifor Pharma
`Executive Committee
`
`CEO Vifor Pharma
`Søren Tulstrup
`
`Finance, Administration & IT
`Alex Sigalas
`
`Legal, IP and Compliance
`(Secretary)
`Oliver Kronenberg
`
`Head Human Resources
`Michael Puri
`
`Deputy CEO Vifor Pharma
`Pharma Operations
`Gianni Zampieri
`
`Global Business Operations
`Dario Eklund
`
`CEO Vifor Fresenius Medical Care
`Renal Pharma
`Stefan Schulze
`
`Global Marketing
`Abdul Mullick
`
`Research & Development
`Chief Medical Officer
`Stefan Wohlfeil
`
`April 2016
`
`− © Galenica Group
`
`9
`
`Pharmacosmos, Exh. 1069, p. 9
`
`
`
`Vifor Pharma
`Excellent progress made in 2015
`
`Solid Results
`
`Impressive top line growth (+36.9%) and EBIT growth (+25.7%), offsetting the planned
`decline of other revenue (CHF 92.6M)
`
`Ferinject® /
`Injectafer®
`
`Strong growth in value of 33% (42% excluding FX impact) and in volume (+49%)
`Ferinject® is now available in 65 countries
`
`Mircera®
`
`Veltassa®
`
`Exclusive license agreement with Roche for the commercialization of the long-acting ESA
`Mircera® in the U.S.
`Significant sales already generated in 2015 (CHF 206.8M)
`
`Exclusive partnership with Relypsa to commercialize Veltassa® worldwide (except
`U.S./Japan) for the treatment of hyperkalemia
`EMA filing in Spring 2016
`
`April 2016
`
`− © Galenica Group
`
`10
`
`Pharmacosmos, Exh. 1069, p. 10
`
`̶
`̶
`̶
`̶
`̶
`̶
`̶
`
`
`Vifor Pharma
`Summary of marketed products
`
`2015 Net Sales
`(CHFm)
`
`Indication
`
`Ferinject®
`
`Injectafer®
`
`212.3
`
`38.5
`
` ID (general)
` Anemia in CKD (dialysis/non-dialysis)
` Chronic heart failure
` Inflammatory bowel diseases
` Chemotherapy-induced anemia
`
`Venofer®
`
`108.9
`
` ID (general)
` Anemia in CKD (dialysis/non-dialysis)
`
`Maltofer®
`
`Velphoro®
`
`53.2
`
`43.2
`
` Iron-deficiency anemia
` Mineral deficiency
`
` Hyperphosphatemia
`
`Mircera®
`
`206.8
`
` Anemia in CKD (dialysis)
`
`OTX(1)
`
`122.0
`
` Infectious diseases / OTX franchise (e.g.
`respiratory/urinary infections)
`
`Infectious Disease / OTX(1)
`Diversified portfolio of prescribed non-prescription
`medicines
`
`Iron
`Franchise
`Iron
`replacement
`products for
`the treatment
`of ID
`
`Other
`Nephrology
`Products
`
`Infectious
`Disease /
`OTX(1)
`
`(1) Select key products only.
`April 2016
`− © Galenica Group
`
`11
`
`Pharmacosmos, Exh. 1069, p. 11
`
`
`
`Vifor Pharma
`Fully exploit potential of Ferinject®/Injectafer®
`
`Ferinject® sales
`
`FY 2014
`
`FY 2015
`
`in MCHF
`
`188.3
`
`250.9
`
`±% prior year
`
`+19.0%
`
`+33.2%
`
`Ferinject® numbers of units (100mg) sold
`FY 2014
`FY 2015
`
`±% prior year
`
`+28.0%
`
`+49.0%
`
`Launched: 65 countries
`
`Approved, not yet in the market: 7 countries
`
`Expected approval in 2016: 5 countries
`
`April 2016
`
`− © Galenica Group
`
`12
`
`Pharmacosmos, Exh. 1069, p. 12
`
`
`
`Vifor Pharma
`Ferinject® / Injectafer®
`Patients treated: >3 million
`First, high-dose, non-dextran IV iron
` Ferinject®: Single dose up to 1,000mg
` Injectafer® (branded name in the U.S.): Single dose up to 750mg
` Short administration time:
` 200mg in fast push injection
` 1,000mg / 750mg (U.S.) in 15-minute infusion/injection
`Total repletion in few visits
`Lower medical care costs
` Worldwide clinical trials have established a large base of clinical evidence
` Approved in 72 countries, launched in 65 countries
` FDA approval for the treatment of iron deficiency anaemia (25 July 2013)
` Licensed to Zeria Pharmaceutical in Japan. Phase 3 study started in 2016
`
`Net sales 2015:
`CHF 250.9M (+33% PY)
`
`Unit (100mg) Sold 2015:
`+49% PY
`
`April 2016
`
`− © Galenica Group
`
`13
`
`Pharmacosmos, Exh. 1069, p. 13
`
`
`
`Vifor Pharma
`Injectafer® - Market leader in “high-dose” segment
`
`Net Sales
`
`Launch Progress
`
`Injectafer® high dose segment sales leader
`
`̶ High dose segment represents 23.1% of
`total IV iron market volume
`
`Injectafer® value share December YTD of
`47% (+19 pts vs. prior YTD) in High Dose
`segment
`
`Injectafer® driving high dose segment
`growth +19.4% versus prior YTD
`
`Injectafer® contributing 100% of the High
`Dose growth
`
`18
`16
`14
`12
`10
`
`02468
`
`($m)
`
`Feraheme
`
`®
`
`Injectafer
`
`®
`
`Infed
`
`®
`
`Sales
`
`Volume
`
`467.1
`
`138.9
`
`185.2
`
`143.0
`
`391.3
`
`58.1
`
`186.9
`
`146.4
`
`Kg Volume
`
`YTD December 2015 Sales Share High Dose
`Segment
`
`Injectafer®
`47%
`(+19.2 pts)
`
`Feraheme®
`38%
`(‐12.7 pts)
`
`INFeD®
`15%
`(‐6.3 pts)
`
`April 2016
`
`− © Galenica Group
`
`YTD Dec ‐14
`
`YTD Dec ‐15
`
`14
`
`Pharmacosmos, Exh. 1069, p. 14
`
`̶
`̶
`̶
`̶
`
`
`Vifor Pharma
`Venofer® & Iron Sucrose Similars
`
`̶ Positioning of Venofer® as drug of choice in HD with a distinct safety and efficacy
`profile compared to ISS preparations
`In addition to clinical data on differences in efficacy, new clinical observation
`reports increased adverse event rate of ISS
`̶ Major authorities recognize the complexity of the product and discuss the limitation of the approval of ISS
`preparations through the generic pathway
`̶ Venofer® has 85 marketing authorizations worldwide
`
`Net sales 2015:
`CHF 108.9M (-4% PY)
`
`ROTTEMBOURG STUDY DEMONSTRATES SUPERIORITY OF VENOFER® vs ISS
`̶ Patients with anemia and iron deficiency treated successfully with erythropoiesis-stimulating agents (ESA)
`and Venofer® switched to FerMylan®
`̶ Outcome to regain control of hemoglobin: + 35% IV iron, + 14% ESA, + 12% costs
`̶ A recent study conducted in Spain confirmed the Rottembourg study: «The treatment with generic IV iron
`needs a higher dose of iron and ESA to keep hemoglobin stable»
`
`April 2016
`
`− © Galenica Group
`
`15
`
`Pharmacosmos, Exh. 1069, p. 15
`
`̶
`
`
`Vifor Pharma
`Global Market Leader in IV and Oral Iron
`
`Iron Franchise Products
`Outside Dialysis
`
`Ferinject®: >3m patients per year
`
`Dialysis & Hospital
`Chronic Use
`
`Pediatric/
`Pregnancy
`
`Global Iron Market (2015)
`
`Global Iron
`CHF 2,539m
`
`37%
`Vifor
`Pharma
`
`Iron deficiency is the most
`common nutrient
`deficiency in the world1
`
`Up to 4 to 5 billion people may
`suffer from iron deficiency.2
`
`Intravenous Iron
`CHF 1,177m
`
`Oral Iron
`CHF 1,362m
`
`Venofer®: >20m patients per year
`
`66%
`Vifor
`Pharma
`
`10%
`Vifor
`Pharma
`
`Iron deficiency anemia
`affects approximately 15%
`of the world population.3
`
`(1) World Health Organization (WHO) Micronutrient deficiencies: Iron deficiency anaemia. Available at http://www.who.int/nutrition/topics/ida/en/. Last accessed: 10 November 2014.
`(2) Unicef http://www.unicef.org/nutrition/23964_iron.html Last accessed: 10 November 2014.
`(3) Vos T Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010 Lancet. 2012 Dec 15;380(9859):2163-96.
`
`April 2016
`
`− © Galenica Group
`
`16
`
`Pharmacosmos, Exh. 1069, p. 16
`
`
`
`Vifor Pharma
`Health economic outcomes of Ferinject® vs other i.v. iron
`
`Savings of €90-110
`per 1,000mg per patient
`
`€430
`
`€413
`
`€410
`
`Admin costs
`p/1,000mg
`
`€320
`
`Costs of IV iron
`p/1,000mg
`
`Therapeutics
`areas
`
`Required average
`iron need (mg)
`
`Infusions prior
`to Ferinject®
`
`Infusions with
`Ferinject®
`
`ND-CKD
`
`Cardiology
`
`Oncology
`
`Gastro
`
`PBM* / Surgery
`
`1,200 – 1,800
`
`1,500
`
`750 – 1,200
`
`1,450
`
`> 1,000
`
`6 – 28
`
`6 – 18
`
`4 – 19
`
`8 – 23
`
`5 – 16
`
`5 – 24
`
`2
`
`2
`
`1 – 2
`
`2
`
`1 – 2
`
`1 – 2
`
`Ferrlecit®
`
`Cosmofer®
`
`Venofer®
`
`Ferinject®
`
`Ob/Gyn
`
`960 – 1,500
`
`NBbrs Admin
`
`Admin time in min
`(standard for 1,000mg)
`
`16x
`
`320
`
`1x
`
`352
`
`5x
`
`161
`
`1x
`
`15
`
`* Patient Blood Management
`
`Higher-generation i.v. products provide real cost savings with a significant reduction in admin time
`
`April 2016
`
`− © Galenica Group
`
`Source: Szucs et al 2009, University of Zurich, ASH HE.
`
`17
`
`Pharmacosmos, Exh. 1069, p. 17
`
`
`
`Vifor Pharma
`i.v. Iron Market - Large potential outside dialysis
`
`Worldwide market
`
`Swiss market
`
`30%
`
`70%
`
`Nephrology
`segment
`
`9%
`
`38%
`
`12%
`
`8%
`
`4%
`
`25%
`
`Gynaecology
`Internal Medicine
`Nephrology
`Cardiology
`Oncology/Hematology
`Geriatry
`Gastroenterology
`Other TA's
`
` 70% of the worldwide i.v. market is in Nephrology (CKD 3-5) vs 9% in Switzerland
` 2015 Swiss Sales in i.v. iron amounted to CHF 53.7 million
` Still large potential in Switzerland in women’s health (fatigue) & elderly people
` Focused therapeutic areas (TAs): Nephrology (ND-CKD), Gastroenterology, Cardiology
`
`April 2016
`
`− © Galenica Group
`
`18
`
`Pharmacosmos, Exh. 1069, p. 18
`
`
`
`Vifor Pharma
`Swiss market: Venofer® and Ferinject® sales history
`
`Ferinject
`
`Venofer
`
`MAT 12/2015
`53.7 Mio. CHF
`
`1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
`
`50
`
`40
`
`30
`
`20
`
`10
`
`00
`
`April 2016
`
`− © Galenica Group
`
`Source: IMS
`
`19
`
`Pharmacosmos, Exh. 1069, p. 19
`
`
`
`Vifor Pharma
`Worldwide i.v. iron market
` Vifor Pharma owns 2/3 of the worldwide i.v. iron market with 66% market share (70% USA, 80% Europe)
` Venofer® remains the «gold» standard product in dialysis patients
` Ferinject® offers significant opportunities outside dialysis (higher dosing / faster infusion time)
`
`World i.v. iron market (sales)
`
`World i.v. iron market share (value)
`
`in million CHF
`
` 1'200
`
` 1'000
`
` 800
`
` 600
`
` 400
`
` 200
`
` -
`
`915
`65
`61
`91
`68
`
`567
`
`905
`69
`54
`83
`74
`
`879
`
`79
`57
`79
`90
`
`537
`
`438
`
`63
`2010
`
`88
`2011
`
`136
`
`2012
`
`914
`
`90
`74
`71
`101
`
`399
`
`179
`
`2013
`
`1'177
`
`107
`102
`67
`135
`
`399
`
`368
`
`2015
`
`1'043
`
`93
`93
`66
`118
`
`416
`
`256
`
`2014
`
`Ferinject
`
`Venofer
`
`ISS
`
`Gluconate
`
`Feraheme
`
`Other
`
`April 2016
`
`− © Galenica Group
`
`62%
`
`59%
`
`7%
`
`10%
`
`50%
`
`15%
`
`44%
`
`20%
`
`40%
`
`25%
`
`34%
`
`31%
`
`Venofer®
`Ferinject®
`
`ISS®
`Feraheme®
`Gluconate®
`
`11%
`
`9%
`
`6%
`
`2015
`
`Source: IMS
`
`20
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`Pharmacosmos, Exh. 1069, p. 20
`
`
`
`Vifor Pharma
`European i.v. iron market
` The European market represents 27% of the worldwide i.v. iron market
` Vifor Pharma has increased its market share to +80% in a doubled market since 2008
` Market growth driven by Ferinject® (mostly outside dialysis)
`
`European i.v. iron market (sales)
`
`European i.v. iron market share (value)
`
`in million CHF
`
` 300
`
` 250
`
` 200
`
` 150
`
` 100
`
` 50
`
` -
`
`207
`9
`18
`27
`
`89
`
`63
`
`2010
`
`308
`19
`13
`29
`
`56
`
`289
`17
`15
`27
`
`58
`
`170
`
`189
`
`312
`20
`12
`29
`
`43
`
`208
`
`43%
`
`30%
`
`40%
`37%
`
`13%
`
`11%
`
`52%
`
`26%
`
`10%
`
`258
`12
`15
`27
`
`67
`
`134
`
`220
`8
`16
`24
`
`81
`
`88
`
`59%
`
`61%
`
`67%
`
`Ferinject®
`
`20%
`
`9%
`
`18%
`
`9%
`
`14%
`
`9%
`6%
`
`Venofer®
`ISS
`Pharma
`cosmos
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`Ferinject
`
`Venofer
`
`ISS
`
`Gluconate
`
`Pharmacosmos
`
`Other
`
`April 2016
`
`− © Galenica Group
`
`Source IMS
`
`21
`
`Pharmacosmos, Exh. 1069, p. 21
`
`
`
`Vifor Pharma
`North american i.v. iron market
` The North American market represents >50% of the worldwide i.v. iron market
` Venofer® leads the USA iron market with 50% market share
` The USA market is mostly a «nephrology» market, leaving significant opportunities for Injectafer® in other
`therapeutic areas (TAs)
`
`USA i.v. iron market (sales)
`
`USA i.v. iron market share (value)
`
`In million CHF
`
` 700
`
` 600
`
` 500
`
` 400
`
` 300
`
` 200
`
` 100
`
` -
`
`611
`37
`60
`
`72
`
`573
`36
`54
`65
`
`442
`
`418
`
`488
`39
`57
`63
`
`329
`
`471
`44
`74
`
`55
`
`296
`
`2010
`
`2011
`
`2012
`
`2013
`
`640
`40
`
`102
`
`53
`
`321
`
`125
`
`2015
`
`546
`39
`
`92
`
`52
`
`313
`
`50
`2014
`
`Injectafer
`
`Venofer
`
`Gluconate
`
`Feraheme
`
`Other
`
`April 2016
`
`− © Galenica Group
`
`72%
`
`73%
`
`67%
`
`63%
`
`12%
`
`2010
`
`11%
`
`9%
`
`2011
`
`13%
`
`12%
`
`2012
`
`57%
`
`17%
`
`9%
`
`Venofer®
`
`50%
`
`20%
`
`16%
`
`Injectafer®
`Feraheme®
`
`8%
`
`Gluconate®
`
`12%
`16%
`
`2013
`
`2014
`
`2015
`
`Source IMS
`
`22
`
`Pharmacosmos, Exh. 1069, p. 22
`
`
`
`Vifor Pharma
`Main clinical studies for key brands
`
`CONFIRM-HF: Delivered excellent results in CHF
`− Primary endpoint: Significant improvement in 6-min-walk-test (6MWT) at Week 24
`− Sustainable improvement in: Exercise capacity, symptoms, quality of life
`Meta-analysis results in CHF presented on 31 August at ESC Congress 2015,
`combining 4 studies (including FAIR-HF and CONFIRM-HF), demonstrating a 41%
`reduction in cardiovascular hospitalization and mortality outcomes.
`EFFECT-HF: Objective endpoint measurement in 2015
`− Primary endpoint: Change in exercise capacity (peak VO2) from baseline to
`Week 24.
`FER-ASAP: Expansion into women’s health therapeutic areas
`− Open-label RCT comparing Ferinject with oral iron in 252 pregnant women
`between second and third trimester with iron deficiency anaemia
`
`− Paediatric trial to fulfill our regulatory commitment
`− Two non-interventional studies to assess adherence
`
`April 2016
`
`− © Galenica Group
`
`23
`
`Pharmacosmos, Exh. 1069, p. 23
`
`
`
`Net sales 2015:
`CHF 122M
`
`Vifor Pharma
`Infectious Disease/OTX
`
` Respiratory immuno enhancer
` #1 Broncho-Vaxom® marketed in 65 countries
`
` Urinary immuno enhancer
` Marketed in 56 countries worldwide
`
` Micro-vascular complications
` Doxium® presence in 47 countries worldwide
`
` Antihemorragic
` Worldwide presence in 42 countries
`
`April 2016
`
`− © Galenica Group
`
`24
`
`Pharmacosmos, Exh. 1069, p. 24
`
`
`
`Vifor Fresenius Medical Care Renal Pharma
`Structure, scope & objectives
`
`Structure
`Minority profits
`(45% net profit)
`
`Payment for minority
`stake
`
`100% consolidated
`
`55% stake
`
`Key objectives
`
`Allows Vifor Pharma focus “scope for growth” strategy on
`Ferinject® outside the field of nephrology
`
`45% stake
`
`Access to FMC’s large pool of patients (over 290k
`dialysis patients worldwide)
`
`Distribution partners incl. FMC & Vifor
`Scope of operations
`− The common company holds the global nephrology (dialysis &
`pre-dialysis) commercialization rights for Ferinject®, Venofer®
`and Velphoro®(1)
`− Exclusive agreement for the commercialization of Roche’s
`drug Mircera® in the US and Puerto Rico.
`− Partnership agreement with Relypsa for the commercialization
`of Veltassa® worldwide (except USA/Japan) for the treatment
`of hyperkalaemia.
`Most importantly, patients benefit most from faster access to high-quality care
`(1) Velphoro IP rights owned by Vifor FMC Renal Pharma.
`
`April 2016
`
`− © Galenica Group
`
`25
`
`Maximizes sales forces synergies between Vifor Pharma
`and Fresenius
`
`Optimizes commercial success of Velphoro® through
`access to patients and a single field force that has a
`complete nephrology portfolio
`
`Potential to build a world-leading nephrology specialty care
`pharma company
`
`Pharmacosmos, Exh. 1069, p. 25
`
`
`
`Vifor Fresenius Medical Care Renal Pharma
`From Strong Brands to Therapeutic Area Portfolios
`
`Anaemia
`Management
`
`Mineral & Bone
`Management
`
`Cardio-Renal
`Management
`
`GROW – Licensing & Acquisition Targets
`
`TRANSFORM – Integrated Solutions
`
`to
`
`OUTCOMESOUTCOMES
`
`April 2016
`
`− © Galenica Group
`
`26
`
`Pharmacosmos, Exh. 1069, p. 26
`
`
`
`Vifor Fresenius Medical Care Renal Pharma
`Velphoro® - Oral Iron Phosphate Binder
`
`Net sales 2015:
`CHF 43.2M
`
`̶ Velphoro® is a novel iron-based (non-calcium) phosphate binder with
`good phosphate binding capacity
`̶ Velphoro® is is a calcium-free iron-based phosphate binder offering safety, efficacy, simplicity
`and high acceptance with low pill burden (3 pills per day)
`̶ Pivotal phase III study (> 1,000 patients) met primary and secondary endpoints, with fewer pills
`than sevelamer carbonate (3.3 pills per day after 52 weeks)
`̶ Strong commercial partners with Fresenius Medical Care in U.S. and Europe
`̶ U.S: Approved by FDA (27 November 2013) and launched in March 2014
`̶ EU: Approved by EMA (26 August 2014) and first launch in Germany in October 2014, launch in
`U.K. on 04 January 2015
`Japan: Launch of P-TOL® by the local partner (Kissei) on 27 November 2015
`̶ Velphoro® is approved in 37 countries, launched in 17 countries
`
`April 2016
`
`− © Galenica Group
`
`27
`
`Pharmacosmos, Exh. 1069, p. 27
`
`̶
`
`
`Vifor Fresenius Medical Care Renal Pharma
`Mircera®
`
` Mircera®: A long-acting* erythropoiesis-stimulating agent (ESA)
`
` Long-acting ESAs expected to reach significant market shares
`
`Net sales 2015:
`CHF 206.8M
`
` Used by Fresenius Medical Care in the USA since December 2014 (pilot phase)
`
` Excellent feedback from physicians and clinic staff
`
` Provides opportunities to strengthen our existing partnerships aiming at leadership in anemia
`treatment in ND-CKD and dialysis
`
`* for bi-weekly or monthly treatment
`
`April 2016
`
`− © Galenica Group
`
`28
`
`Pharmacosmos, Exh. 1069, p. 28
`
`
`
`Vifor Fresenius Medical Care Renal Pharma
`Veltassa™
`
`• Veltassa™ addresses a large unmet medical need – elevated potassium levels are leading
`to increased mortality
`
`• Veltassa™ is the first hyperkalemia drug with tolerability and efficacy profile enabling
`chronic daily administration
`
`• Exclusive license to commercialize Veltassa® outside the U.S. and Japan
`• VFMCRP intends to file with EMA in Spring 2016
`• Veltassa™ approved by FDA on 21 October 2015
`• Great opportunity for VFMCRP to expanding nephrology portfolio and jointly with Vifor to
`leverage opportunities in cardio-renal
`• Highly effective and well tolerated
`
`April 2016
`
`− © Galenica Group
`
`29
`
`Pharmacosmos, Exh. 1069, p. 29
`
`
`
`Vifor Pharma
`Global Network & Footprint
`
`Affiliates
` Australia
` Austria
` Belgium
` France
` Germany
`Italy
`
` Netherlands
` Peru
` Portugal
` Romania
` Singapore
` Spain
` Sweden/Nordics
` Switzerland
` United Arab Emirates
` United Kingdom/
`Ireland
`
`Offices
` Argentina
` Canada
` China
` Russia
` United States
`
`Russia, CIS, Italy
`
`Eastern, Europe
`CIS, Russia
`
`Worldwide Partnerships
`
`April 2016
`
`− © Galenica Group
`
`Mexico, Brazil,
`Argentina, South Africa
`
`30
`
`Pharmacosmos, Exh. 1069, p. 30
`
`
`
`Galenica Santé
`“Galenica Santé aims to be the first choice in
`Switzerland for health, beauty and well-being!”
`
`April 2016
`
`− © Galenica Group
`
`31
`
`Pharmacosmos, Exh. 1069, p. 31
`
`
`
`Galenica Santé
`Organisation and management structure
`
`April 2016
`
`− © Galenica Group
`
`32
`
`Pharmacosmos, Exh. 1069, p. 32
`
`
`
`Galenica Santé
`Highlights 2015
`
`Galenica Santé
`
`Solid top line growth (+3.9%) and EBIT growth (+21.7%), supported by Vifor Consumer
`Health transferred to Galenica Santé as of 01 July 2015 (+14.4% EBIT growth on a
`comparable basis)
`̶ New organisation and management structure since September 2015
`
`Products & Brands
`
`̶ OTC products in Switzerland clearly outperformed the market
`Successful transfer of Vifor Consumer Health to Galenica Santé
`̶ Galenica Santé established overarching product and category teams
`
`Retail
`
`Services
`
`Significant improvement in profitability
`̶ Unified management of Amavita & Sun Store
`
`̶ Niederbipp expansion on track
`Further improvement in profitability
`
`April 2016
`
`− © Galenica Group
`
`33
`
`Pharmacosmos, Exh. 1069, p. 33
`
`̶
`̶
`̶
`̶
`
`
`Galenica Santé
`The vision for Galenica Santé
`
`Products & Brands
`
`Retail
`
`Services
`
`Synergies
`
`Synergies
`
`April 2016
`
`− © Galenica Group
`
`34
`
`Pharmacosmos, Exh. 1069, p. 34
`
`
`
`Galenica Santé
`Health & Beauty segment - Number 1 in Switzerland
`
`145
`
`102
`
`64 (3)
`
`1
`
`Others
`6
`
`pharmacies
`318 Own
`
`− Network of 318 own pharmacies and 173 independent partners
`− Approx. 100,000 customers daily
`− Network: No. 1 with 491 pharmacies in the best locations
`− MediService: No. 1 as Specialty Pharmacy
`− Objective of 500 pharmacies
`
`# of pharmacies, as of 2014, total = 1,764 (1)
`
`15
`
`& Drugstores
`Pill Pharmacies
`
`17
`
`Genéve
`Populaires
`Pharmacies
`
`6.0x # of pharmacies
`
`33
`
`Topwell
`
`51
`
`Dr. Bähler
`
`Dropa
`
`88
`
`(Phoenix)
`
`BENU
`
`(2)
`
`491
`
`173
`
`318
`
`Galenica
`
`− # 3 player in Swiss OTC market
`− Preferred OTC partners for Swiss pharmacists
`− Largest OTC sales force in Switzerland
`− Over 60 brands with focus areas: Pain & Cough-Cold-
`Respiratory
`− exclusively in pharmacies and drugstores
`− G-Pharma: 180 references for own brands from our pharmacies
`and from Galexis
`
`Swiss Retail Market
`
`Products & Brands
`
`April 2016
`
`− © Galenica Group
`
`1.) Source: PharmaSuisse – Annual report 2014
`2.) 318 own pharmacies (Amavita and Sun Store) and 178 independent partners (under Winconcept partnerships).
`3.) Galenica holds 49% of Coop Vitality. Consolidated at equity.
`
`35
`
`Pharmacosmos, Exh. 1069, p. 35
`
`
`
`Galenica Santé
`Retail - Challenges and focus
`
`100%
`
`80%
`
`60%
`
`40%
`
`20%
`
`0%
`
`46%
`
`54%
`
`58%
`
`42%
`
`ø Swiss Market
`
`Net sales 2015:
`CHF 1’307.6M
`
`in CHF million
`5
`
`4.3m
`
`47%
`
`53%
`
`2.9m
`
`4
`
`3
`
`2
`
`1
`
`0
`
`April 2016
`
`− © Galenica Group
`
`Source: PharmaSuisse – Annual report 2014
`
`36
`
`Rx part
`
`Non Rx part
`
`Average Revenue / Pharmacy
`
`Pharmacosmos, Exh. 1069, p. 36
`
`
`
`Galenica Santé
`Products & Brands – A strong OTC partner in Switzerland
`
` A full range of consumer health products…
`
`Net sales 2015:
`CHF 113M
`
`Perskindol®
`
`Algifor®
`
`Triofan®
`
`Anti-Brumm®
`
` …and leading brands in Switzerland
`
`Magnesium
`Vital®
`
`Sanadermil®
`
`Ginsana®
`
`Formoline®
`
`Dermaplast®
`
`Oral-B®
`
`Clearblue®
`
`April 2016
`
`− © Galenica Group
`
`37
`
`Pharmacosmos, Exh. 1069, p. 37
`
`
`
`Net sales 2015:
`CHF 2.2 billion
`
`Wholesale
`&
`Pre-
`wholesale
`
`− Network on pharmaceutical products and
`laboratory equipment wholesale suppliers and
`pre-wholesalers across Switzerland
`− Handling of the purchase, sale, warehousing and
`distribution of products for third parties
`
`Healthcare
`Information
`
`− Digital editions of Swiss drug compendium
`(online and smartphone app)
`− Master database for all stakeholders in Swiss
`health market
`− IT software solutions TriaMed® and TriaPharm®
`− about 1,300 doctors offices
`− about 300 pharmacies Sun Store and
`Amavita
`
`Galenica Santé
`Services - Positioning in markets
`
`Market
`Share:
`
`~55%
`
`30%
`
`10%
`
`Market Leader
`+6000 customers
`
`Acquired by
`Phoenix in 2007
`
`Covers German-
`speaking part of
`Switzerland
`
`Content & process management
`
`Wholesale Market
`
`HealthCare Information
`
`April 2016
`
`− © Galenica Group
`
`38
`
`Pharmacosmos, Exh. 1069, p. 38
`
`
`
`Galenica Santé
`Services - Wholesale & pre-wholesale
`
`Overview of divisions
`
`− Over 1,100 suppliers
`− 80,000 products, 42,000 always in stock including
`Pharmaceutical, non-pharmaceutical, practice
`laboratory equipment, and medical equipment
`Over 6,000 customers
`
`1,000
`Pharmacies
`
`4,000
`Doctor Practices
`
`450
`Drugstores
`
`580
`Hospitals/
`Aged Care
`
`− Largest Swiss pre-wholesaler, offers specialised
`logistics services with distribution centre in Burgdorf
`− 14,000 products in stock
`− 80 partners
`
`− Handles and coordinates the purchase, sale,
`warehousing and distribution of products for third
`parties
`− Medifilm: Specializes in the field of unit dose
`packaging for patients in care homes.
`
`Wholesale
`
`wholesale
`
`Pre-
`
`Services
`
`Logistic network
`
`Basel
`
`Niederbipp
`
`Zurich
`
`Neuenberg
`
`Burgdorf
`Luzern
`
`Bern
`
`Chur
`
`Lausanne
`
`Genf
`
`Sitten
`
`Wholesale
`Pre-wholesale
`
`Barbengo-Lugano
`
`Niederbipp
`- 21‘000 m2 storage space
`- 2‘800 containers/hr.
`- 100‘000 lines/day
`- 70 delivery vehicles
`- 500 employees
`
`Lausanne
`- 8‘200 m2 storage space
`- 900 containers/hr.
`- 30‘000 lines/day
`- 40 delivery vehicles
`- 190 employees
`
`April 2016
`
`− © Galenica Group
`
`39
`
`Pharmacosmos, Exh. 1069, p. 39
`
`
`
`Financials
`
`April 2016
`
`− © Galenica Group
`
`40
`
`Pharmacosmos, Exh. 1069, p. 40
`
`
`
`Galenica Group
`Key Financials
`
`in million CHF
`Net Sales – Vifor Pharma
`Net Sales – Galenica Santé
`Consolidation Group
`Net Sales – Galenica Group
`Other operating income
`Operating revenue
`COGS
`OPEX
`EBITDA
`EBIT
`ROS (%)
`Net profit (before minorities)
`Non-controlling interests
`Net profit (after minorities)
`EPS (in CHF)
`
`2014
`706.2
`2,781.9
`-71.8
`3,416.2
`254.7
`3,671.0
`-2,185.4
`-1,038.7
`446.8
`370.2
`10.8%
`312.0
`-27.5
`284.5
`43.9
`
`2015
`967.0
`2,891.3
`-66.8
`3,791.6
`137.5
`3,945.2
`-2,333.6
`-1,074.2
`537.4
`450.8
`11.9%
`370.0
`-68.9
`301.1
`46.5
`
`∆ %
`+36.9%
`+3.9%
`
`+11.0%
`-39.7%
`+7.5%
`+6.8%
`+3.4%
`+20.3%
`+21.8%
`
`+18.6%
`+150.4%
`+5.8%
`
`April 2016
`
`− © Galenica Group
`
`41
`
`Pharmacosmos, Exh. 1069, p. 41
`
`
`
`Galenica Group
`Free cash flow & investments
`
`In million CHF
`
`Cash flow from operating activities
`+ Proceeds from property, plant and equipment, investment properties,
`intangible assets, financial assets and securities
`- Investments in property, plant and equipment, investment properties
`and intangible assets
`
`- Investments in financial assets, associates & subsidiaries
`
`Free cash flow
`
`in million CHF
`600
`
`Investment
`
`300
`
`0
`
`71.7
`14.4
`57.3
`2013
`
`70.0
`10.1
`60.0
`2014
`
`April 2016
`
`− © Galenica Group
`
`368.6
`
`300.0
`
`68.6
`2015
`
`Actual
`2013
`329.0
`
`Actual
`2014
`355.8
`
`Actual
`2015
`522.2
`
`12.7
`
`12.9
`
`52.2
`
`(71.6)
`
`(49.4)
`
`220.7
`
`(69.9)
`
`(164.9)
`
`(102.0)
`
`196.9
`
`(49.4)
`
`360.1
`
`Investment intangible assets
`Investment tangible assets
`
`42
`
`Pharmacosmos, Exh. 1069, p. 42
`
`
`
`Galenica Group
`Balance sheet – key figures
`
`in million CHF / %
`
`Interest coverage
`Debt coverage
`Gearing
`Operating net working capital1)
`
`in million CHF
`4'000
`
`2'000
`
`0
`
`-2'000
`
`Equity
`51%
`1'555
`
`437
`
`14%
`
`55%
`1'750
`
`341
`
`11%
`
`2013
`
`2014
`
`Actual
`2013
`14.9
`0.94
`28.1%
`521
`
`Actual
`2014
`17.1
`0.76
`19.5%
`536
`
`Actual
`2015
`26.4
`0.30
`8.1%
`563
`
`Equity
`Net Debt
`
`54%
`1'976
`
`159
`
`4%
`
`Net debt
`
`2015
`
`April 2016
`
`− © Galenica Group
`
`% of Total liabilities and shareholders' equity
`
`43
`
`Pharmacosmos, Exh. 1069, p. 43
`
`
`
`Galenica Group
`Key financials - EBIT in 2015: +21.8%
`EBITDA
`
`in million CHF
`466.2
`23
`
`4431)
`
`+0.8%
`447
`
`305
`
`138
`
`255
`
`192
`
`2013
`
`2014
`
`+20.3%
`537.4
`
`154
`
`393
`
`-9
`2015
`
`+22.3%
`5461)
`
`in million CHF
`390.6
`23
`
`EBIT
`
`+0.7%
`370
`
`+21.8%
`450.8
`
`154
`
`+24.2%
`4591)
`
`3671)
`
`305
`
`63
`
`255
`
`116
`
`2013
`
`2014
`
`306
`
`-9
`
`2015
`
`IAS19
`Other income
`EBIT w/o other income
`1) w/o IAS19 effect
`
`in million CHF
`
`Net Profit before minorities
`
`in million CHF
`
`Net Profit after minorities
`
`334.8
`38.6
`
`296.2
`
`IAS19 &
`CRA
`
`-6.8%
`+5.3%1)
`312.0
`
`2013
`
`2014
`
`April 2016
`
`− © Galenica Group
`
`+18.6%
`370.0
`
`+21.1%1)
`377.8
`
`IAS19
`
`-7.8
`2015
`
`296.2
`38.6
`
`257.6
`
`IAS19 &
`CRA
`
`-4.0%
`+10.4%1)
`284.5
`
`2013
`
`2014
`
`+5.8%
`301.1
`
`+8.6%1)
`308.9
`
`-7.8
`2015
`
`44
`
`Pharmacosmos, Exh. 1069, p. 44
`
`
`
`Vifor Pharma
`Net sales in 2015: +36.9%
`
`in million CHF
`
`Total other revenue
`
`112.9
`
`(-93)
`
`252.6
`
`662.7
`
`205.9
`
`(-47)
`
`+6.6%
`706.2
`
`+36.9%
`967.0
`
`2013
`
`2014
`
`2015
`
`Other income
`Net sales
`
`April 2016
`
`− © Galenica Group
`
`in million CHF
`
`600
`
`300
`
`0
`
`ROS1)
`
`304.7
`
`269.3
`
`2013
`29.6%
`
`-1.2%
`301.0
`
`265.0
`-1.6%
`
`2014
`29.2%
`
`+25.7%
`378.4
`
`333.0
`+25.7%
`
`2015
`30.8%
`
`1) EBIT in % net sales & other operating income
`
`EBITDA
`EBIT
`
`45
`
`Pharmacosmos, Exh. 1069, p. 45
`
`
`
`Galenica Santé
`Substantial EBIT/ROS progress
`
`Galenica Santé
`
`in million CHF
`300
`
`150
`
`0
`
`ROS
`
`139.2
`
`99.3
`
`2013
`3.6%
`
`+2.9%
`143.3
`
`102.9
`+3.6%
`
`2014
`3.7%
`
`(+10.6%)1)
`+16.0%
`166.2
`
`125.2
`+21.7%
`(+14.4%)1)
`
`2015
`4.3%
`
`EBITDA
`EBIT
`1) L4L w/o VCH
`
`Health & Beauty
`
`Services
`
`in million CHF
`150
`
`75
`
`0
`
`ROS
`− © Galenica Group
`
`April 2016
`
`90.1
`
`66.6
`
`2014
`5.1%
`
`+19.6%
`107.7
`
`(+11.0%)1)
`
`84.5
`+26.9%
`
`(+15.5%)1)
`
`2015
`6.1%
`
`in million CHF
`100
`
`50
`
`0
`
`ROS
`
`53.6
`
`34.9
`
`2014
`1.6%
`
`+5.1%
`56.4
`
`37.1
`+6.4%
`
`2015
`1.7%
`
`46
`
`Pharmacosmos, Exh. 1069, p. 46
`
`
`
`Galenica Group
`Contact information
`
` Jörg Kneubühler
`CEO Galenica Santé & CFO Galenica Group
`Tel.: +41 58 852 81 11
`Mail: kneubuehler@galenica.com
`
` Søren Tulstrup
`CEO Vifor Pharma
`Tel.: +41 58 851 80 87
`Mail: soren.tulstrup@viforpharma.com
`
` Investor Relations:
`Julien Vignot
`Head Investor Relations
`Tel.: +41 58 852 85 29
`Mail: investors@galenica.com
`
`Media:
`Christina Hertig
`Head Corporate Communication
`Tel.: +41 58 852 85 17
`Mail: media@galenica.com
`
`April 2016
`
`− © Galenica Group
`
`47
`
`Pharmacosmos, Exh. 1069, p. 47
`
`
`
`Disclaimer
`
`Certain statements, beliefs and opinions in this presentation are forward-looking, which reflect the Company’s
`or, as appropriate, the Company’s directors’ current expectations and projections about future events. By their
`nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause
`actual results or events to differ materially from those expressed or implied by the forward-looking statements.
`These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the
`plans and events described herein. A multitude of factors including, but not limited to, changes in demand,
`competition and technology, can cause actual events, performance or results to differ significantly from any
`anticipated development. Forward-looking statements contained in this presentation regarding past trends or
`activities should not be taken as a representation that such trends or activities will continue in the future. As a
`result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to
`any forward-looking statements in this presentation as a result of any change in expectations or any change in
`events, conditions, assumptions or circumstances on which these forward-looking statements are based.
`Neither the Company nor its advisers or representatives nor any of its of their parent or subsidiary undertakings
`or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking
`statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-
`looking statem
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
