21 years later…one Group, two strategies
`Separation scheduled for Q4 2016
`
`April 2016
`
`The Galenica Group - Excellence in the healthcare market
`
`Pharmacosmos, Exh. 1059, p. 1
`
`
`Separation scheduled for Q4 2016
`
`April 2016
`
`The Galenica Group - Excellence in the healthcare market
`
`Pharmacosmos, Exh. 1059, p. 1
`
`
`
`Galenica Group
`Overview
`
`April 2016
`
`− © Galenica Group
`
`2
`
`Pharmacosmos, Exh. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, p. 7
`
`
`
`Vifor Pharma
`“Vifor Pharma will become a successful, stand-
`alone global speciality pharma company”
`
`April 2016
`
`− © Galenica Group
`
`8
`
`Pharmacosmos, Exh. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, p. 31
`
`
`
`Galenica Santé
`Organisation and management structure
`
`April 2016
`
`− © Galenica Group
`
`32
`
`Pharmacosmos, Exh. 1059, 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. 1059, p. 33
`
`̶
`̶
`̶
`̶
`
`
`Galenica Santé
`The vision for Galenica Santé
`
`Products & Brands
`
`Retail
`
`Services
`
`Synergies
`
`Synergies
`
`April 2016
`
`− © Galenica Group
`
`34
`
`Pharmacosmos, Exh. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, p. 39
`
`
`
`Financials
`
`April 2016
`
`− © Galenica Group
`
`40
`
`Pharmacosmos, Exh. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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. 1059, 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
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