`International, Inc.
`
`2015 J.P. Morgan Healthcare Conference
`
`
`Howard Schiller
`EVP and Chief Financial Officer
`
`Dr. Ari Kellen
`EVP and Company Group Chairman
`
`January 13, 2015
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1608
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`Page 1 of 29
`
`
`
`Forward-looking Statements
`
`Forward-looking Statements
`Certain statements made in this presentation may constitute forward-looking statements, including, but not limited to, statements
`regarding guidance with respect to expected revenues, non-GAAP cash earnings per share, adjusted cash flows from operations and organic
`product sales growth, future disclosures, patent exclusivity, launches and approvals of products, business development activities, share buybacks,
`and the 2015 strategic initiatives of Valeant Pharmaceuticals International, Inc. (the “Company”). Forward-looking statements may be identified by
`the use of the words “anticipates,” “expects,” “intends,” “plans,” “could,” “should,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or
`“continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are
`subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.
`These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly
`report filed with the Securities and Exchange Commission ("SEC") and other risks and uncertainties detailed from time to time in the Company's
`filings with the SEC and the Canadian Securities Administrators ("CSA"), which factors are incorporated herein by reference. Readers are cautioned
`not to place undue reliance on any of these forward-looking statements. The Company undertakes no obligation to update any of these forward-
`looking statements to reflect events or circumstances after the date of this presentation or to reflect actual outcomes.
`
`
`Non-GAAP Information
`To supplement the financial measures prepared in accordance with generally accepted accounting principles (GAAP), the Company uses non-
`GAAP financial measures that exclude certain items. Management uses non-GAAP financial measures internally for strategic decision making,
`forecasting future results and evaluating current performance. By disclosing non-GAAP financial measures, management intends to provide
`investors with a meaningful, consistent comparison of the Company’s core operating results and trends for the periods presented. Non-GAAP
`financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and
`should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with
`GAAP. The Company has provided preliminary results and guidance with respect to cash earnings per share, adjusted cash flows from operations
`and organic product growth rates, which are non-GAAP financial measures. The Company has not provided a reconciliation of these preliminary
`and forward-looking non-GAAP financial measures due to the difficulty in forecasting and quantifying the exact amount of the items excluded from
`the non-GAAP financial measures that will be included in the comparable GAAP financial measures. Reconciliations of historical non-GAAP
`financials can be found at www.valeant.com.
`
`
`Note 1: The guidance in this presentation is only effective as of the date given,
`January 8, 2015, and will not be updated or affirmed unless and until the Company
`publicly announces updated or affirmed guidance.
`
`2
`
`Page 2 of 29
`
`
`
`Who Is Valeant?
` Focused, multinational specialty pharmaceutical company
` $50B+ Market Cap
`
` Headquartered in Laval, Quebec, Canada (NYSE/TSX: VRX)
` Unconventional Business Model
` Decentralized operating model
`
` Geographical and product diversity
`
` Focus on faster-growing geographies and therapeutic categories
`
` Durable product portfolio with limited patent risk
`
` Significant cash pay component / low exposure to government reimbursement
`
` Financially disciplined M&A
` Ownership Culture
` Shareholder friendly executive compensation and corporate governance
` Commitment to Innovation
` Emphasis on bringing new products to the market (output), through internal R&D, acquisitions and licensing
`(input)
`
` Focus on late-stage and lower-risk development projects
`
`
`
`
`Proven track record of delivering industry leading returns to shareholders
`
`
`
`
`3
`
`Page 3 of 29
`
`
`
`Strong Growth Platforms
`
`Developed Markets
`
`Emerging Markets
`
`Derm Rx
`
`Eye Health
`
`Aesthetics
`
`Neuro & Other
`
`Dental
`
`Consumer
`
`4
`
`EMEA
`
` Russia/ CIS
` Poland
` Turkey
` Middle East
`
`Latin America
`
` Brazil
` Mexico
`
`Asia/South Africa
`
` China
` Vietnam
`
`Indonesia
` South Africa
`
`Page 4 of 29
`
`
`
`Strong Growth Platforms (3)
`Dermatology Rx (U.S.)
`Eye Health (U.S.)
`
`Consumer (U.S.)
`
`~$1.0B
`
`10%+
`
`~$1.5B
`
`25%+
`
`~$0.6B
`
`10%+
`
`Other Developed (1)
`
`Neurology/Dental/Other (2)
`
`Emerging Markets
`
`~$1.7B
`
`5%+
`
`~$2.2B
`
`15%+
`
`~$2.2B
`
`10%+
`
`(1)
`(2)
`
`Includes Japan, Canada, Australia, Western Europe
`Includes Neuro & Other, Oral Health, Aesthetics, Generics.
`Growth rate excludes facial injectable sales from 1H 14
`(3) Growth rates reflect same store organic growth projections
`
`Valeant 2015E rev
`
`2015E growth rate
`
`5
`
`Page 5 of 29
`
`
`
`Highly Diversified Business Portfolio
`
`Based on projected 2015 revenues
`
`By Geography
`
`By Business
`
`Latin
`America
`
`Canada /
`Australia
`
`Central &
`Eastern
`Europe/
`Middle East/
`Africa
`
`Asia
`
`10%
`
`5%
`6%
`
`11%
`
`9%
`
`Western
`Europe
`
`Gx/BGx
`
`12%
`
`59%
`
`United
`States
`
`Devices 1
`
`19%
`
`49%
`
`Rx
`
`20%
`
`OTC /
`Solutions
`
`Emerging Markets = ~23%
`
`1 Includes contact lens, and surgical devices
`
`
`6
`
`Page 6 of 29
`
`
`
`Highly Diversified Product Revenue
`Based on projected 2015 revenues
`
`By Number of Products
`
`By Gov’t Reimbursement
`
`22%
`
`32%
`
`50%
`
`50%
`
`Government
`Pay
`
`25%
`
`Public Pay
`75%
`25%
`75
`
`Cash/Private
` Pay
`
`Top 10
`
`Top 20
`
`No product greater than 4% of revenue
`
`42%
`
`7
`
`Page 7 of 29
`
`
`
`Limited Patent Risk
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`Products
`
`1) Xenazine
`Targretin
`2)
`
`Ziana
`1)
`Zirgan
`2)
`3) Visudyne
`
`1)
`
`Lotemax
`Gel
`2) Macugen
`
`1)
`
`Zyclara
`
`1) Acanya
`2) Solodyn
`Istalol
`3)
`
`
`Annual
`2014
`Sales
`% 2015
`Revenue
`
`Projected
`Generic
`Impact (1)
`
`% of 2015
`Revenue
`
`
`~$335 million
`
`
`~$90 million
`
`
`~$115 million
`
`
`~$300 million
`
`
`~$30 million
`
`
`~4%
`
`
`~1%
`
`
`~1%
`
`
`~4%
`
`
`<1%
`
`
`<$200 million
`
`
`<$200 million
`
`
`<$150 million
`
`
`<$200 million
`
`
`<$30 million
`
`
`~2%
`
`
`~2%
`
`
`~2%
`
`
`~2%
`
`
`<1%
`
`1)
`
`Impact to revenue in the year in which the product(s) go generic based on 2014 sales and date of loss
`of exclusivity
`
`8
`
`Page 8 of 29
`
`
`
`Ownership Culture
`
` Relentless focus on organic growth
` Business units leaders are evaluated on organic growth and cash flows
` Each employee has a duty to speak up
` Best idea in the room wins
` Executive compensation tied to long-term shareholder returns
` Front-loaded performance units tied to shareholder returns with
`minimum 10% CAGR over 3 years
` Shareholder friendly corporate governance
` ValueAct (major shareholder since 2007) has representation on the
`Board of Directors
`
` Annual executive sessions with top shareholders and Board of Directors
`
`
`
`9
`
`Page 9 of 29
`
`
`
`Financially Disciplined M&A
`
` Business Development will continue to be the priority
` Developed Markets: Focus on building out existing platforms, adding new
`platforms in fast growing markets, or acquiring tail products with extremely high
`IRR’s and/or fast payback periods
`
` Emerging Markets: Focus on Branded Generics and OTC’s and look to build out
`platforms in Asia, Middle East and Latin America
` Expect steady flow of small/medium sized deals
` Timing of large transactions difficult to predict
` Business Development criteria remain the same
` Target 20% IRR’s at local statutory tax rates
`
` Require 6 years or less payback period
` Current leverage at ~3.5 times adjusted pro forma EBITDA
`creates substantial Balance Sheet capacity
` Our deal pipeline is robust
`
`
`
`10
`
`Page 10 of 29
`
`
`
`Dr. Ari Kellen
`
`Dr. Ari Kellen
`
`
`
`
`Page 11 of 29
`
`'VALEANT
`
`Page 11 of 29
`
`
`
`
`
`
`
`Valeant’s Approach to Innovation
` Innovation critical to the industry and to Valeant
` We source innovation through our internal R&D, acquisitions, in-
`licensing
` We have acquired terrific set of capabilities and technologies over time
` Dow (dermatology)
` B&L (e.g., Ultra, Victus, Stellaris)
` Additional external collaborations (e.g., Cirle navigation)
` We run a lean R&D model focused on productivity – outputs measured
`against inputs
` Leverage industry overcapacity
` Outsource commodity services
` Focus on critical skills and capabilities needed to bring new technologies
`to market
` Spend according to promise of programs - for short and long term
` Results of this approach: 20 launches in the US in 2014; rich pipeline of
`products for the future sourced from inside, acquisitions and in-
`licensing
`
`
`
`
`
`
`
`
`
`
`12
`
`Page 12 of 29
`
`
`
`20 New U.S. Product Launches in 2014
`
`Highlights
` Dermatology: Jublia, Luzu, Retin-A Micro .08,
`Onexton (2015)
`
`
` Contact lenses: Ultra, PureVision 2 Multi Focal,
`Biotrue Multi Focal
`
`
` Surgical: Victus Lens fragmentation
`
` Consumer: Soothe XP, Peroxiclear, CeraVe Baby
`
`
`13
`
`Page 13 of 29
`
`
`
`Strong Start to Jublia Launch
`
`DTC TV
`
` Q4 2014 sales >$50 million – annualized run rate >$200
`million
`
` Continue heavy DTC advertising as long as growth rate
`continues
`
` Zero co-pay in effect as long as growth rate continues
`
`
`
`14
`
`Page 14 of 29
`
`
`
`Comprehensive Jublia Launch Campaign
`
` Extensive professional education and outreach to
`Dermatologists and Podiatrists
` Extensive print, digital and TV advertising to reach consumers
` Over 150 reps supporting launch
`
`Physician Campaign
`
`Physician Website
`
`Physician
`eBlast/Banners
`
`Physician Journal Ads
`
`Consumer Campaign
`
`
`
`asd
`
` Speaker Programs
` Webinars
` Medical Education
` Ad Boards
`
`TV
`
`DIGITAL
`
`15
`
`
`Page 15 of 29
`
`
`
`Launched Early January
`
` Extensive professional education and outreach: product theaters,
`webinars, advisory boards, journal and digital advertising
`
` Integrated digital, print and TV consumer campaign beginning Q2
`
` Over 100 sales reps supporting launch
`
`
`
`OnextonGel.com
`
`16
`
`Page 16 of 29
`
`
`
`Bausch + Lomb ULTRA® 2015 Launch Activities
`
` Doctor outreach and peer-to-peer activities: 400 speaker bureau meetings will
`reach over 7,000 doctors
`
` Patient trial driven by Digital DTC Campaign
`
` New co-branded programs with Biotrue multi-purpose solution
`
`
`
`ECP product materials
`
`ECP testimonials
`
`Journal Advertising
`
`Professional ECP Website
`
`Consumer/Patient campaign
`
`In-office materials
`
`Convenience Pack
`
`17
`
`Digital Advertising
`
`Social Media Advertising
`
`Page 17 of 29
`
`
`
`Valeant Late Stage R&D Portfolio
`
`Product
`
`EnVista Toric
`
`Brimonidine
`
`Vesneo
`
`Description
`
`Expected launch year
`
`Category
`
`Eye Health
`
`Eye Health
`
`Toric IOL
`
`OTC
`
`2016
`
`2016
`
`2016
`
`2016
`
`2016
`
`2016
`
`Eye Health
`
`Glaucoma
`
`Lotemax Gel Next Gen
`
`Eye Health
`
`Post-operative pain and
`inflammation
`
`Ultra Plus Powers
`
`Eye Health
`
`Contact lens
`
`BioTrue Toric
`
`Eye Health
`
`Contact lens
`
`IDP-118
`
`IDP-120
`
`Emerade
`
`Derm
`
`Derm
`
`Allergy
`
`Arestin LCM
`
`Oral Health
`
`Moderate to severe
`plaque psoriasis
`
`2017/2018
`
`Novel acne combination
`
`2019
`
`Anaphylaxis
`
`2016/2017
`
`Antibiotic treatment for
`periodontal (gum) disease
`
`2016
`
`18
`
`Page 18 of 29
`
`
`
`Vesneo TM (Latanoprostene bunod)
`
`
`
` Nitric Oxide Donating Prostaglandin
` Novel monotherapy Indicated for reduction of Intraocular
`Pressure in patients with Ocular Hypertension and Glaucoma
` Two mechanisms of action:
` increased uveoscleral outflow
`
`
`
` secondary mechanism via trabecular meshwork
`
`
`
` Phase 2 dose-ranging study is the first randomized, head-to-
`head study that shows superior IOP lowering > 1mmHg vs the
`standard of care Latanoprost
`
`
`19
`
`Page 19 of 29
`
`
`
`Vesneo TM Phase III Top-Line Results
`
`
`
`
`
` Primary endpoint of non-inferiority to timolol maleate 0.5%
`achieved in both Phase 3 studies
` Achieved reduction in mean IOP of 7.5 to 9.1 mmHg from baseline
`between 2 and 12 weeks of treatment in the two Phase 3 studies
` IOP effect was statistically superior (p < 0.05) to timolol in both
`studies
` Positive results on a number of secondary endpoints
` No significant safety findings in either study
` Additional data supporting efficacy – Publications under
`development
` FDA submission on track for Q2
`
`
`
`
`
`
`
`
`
`
`20
`
`Page 20 of 29
`
`
`
`Sub-Micron Loteprednol Gel 0.38%
`
` For the treatment of pain and Inflammation following ocular surgery
` Therapeutic goal is to minimize steroid exposure to the eye while
`relieving pain and inflammation
` Sub-micron loteprednol gel offers lower exposure of active drug
` .38% v .5% concentration of Lotemax gel in new sub-micron particle
`formulation
`
` Dosing reduced from qid to bid
` Program Status
` First Phase 3 study completed in 2014; no safety concerns
`
` Second Phase 3 enrolled
`
` Submission on track for late Q3/early Q4 2015
`
` Expect to launch Q3 2016
`
`21
`
`Page 21 of 29
`
`
`
`Key R&D Milestones for 2015
`
`Product
`
`EnVista Toric
`
`Brimonidine (OTC)
`
`Vesneo (glaucoma)
`
`Category
`
`Eye Health
`
`Eye Health
`
`Eye Health
`
`Action
`
`File PMA 1H 2015
`
`File NDA 1H 2015
`
`File NDA 1H 2015
`
`Lotemax Gel Next Gen
`
`Eye Health
`
`File NDA 2H 2015
`
`Ultra Multi Focal
`
`Ultra Toric
`
`BioTrue Toric
`
`IDP-118 (moderate to severe
`plaque psoriasis)
`IDP – 120 (novel acne
`combination )
`
`Eye Health
`
`Eye Health
`
`Eye Health
`
`Derm
`
`Derm
`
`File PMA 1H 2015
`
`File PMA 2H 2015
`
`File PMA 2H 2015
`
`Initiate Phase III 1H 2015
`
`Initiate Phase II 2H 2015
`
`Arestin LCM
`
`Oral Health
`
`File NDA 2H 2015
`
`22
`
`Page 22 of 29
`
`
`
`Howard Schiller
`
`January 13, 2015
`
`Page 23 of 29
`
`
`
`Q4 Operational Highlights
`
` Strong organic growth across almost all business units
` Expect >12% same store organic growth for total company Q4 and >10% for full year
`
` Expect Bausch + Lomb organic growth >10% for full year
`
` Expect continued strong performance from Jublia and other recent product launches
` Continued progress with key programs in R&D pipeline
` Strong Vesneo (glaucoma) Phase III data – expect to file NDA 1H 2015
`
` Successful IDP – 118 (moderate to severe plaque psoriasis) Phase IIb data – move
`into phase III 1H 2015
`
` Successful IDP – 120 (novel acne combination) data – move into Phase II 2H 2015
`
` Received FDA approval for Onexton (Nov 25) – fourth U.S. approval in 2014
`
` We believe first time any company has received 4 dermatology approvals in one
`year
` Meaningful Business Development activities completed at 2-3 times sales
` Nicox Diagnostics: Acquisition of U.S. Ophthalmic Diagnostics platform
`
` Croma: Global rights to IOLs and Viscoelastics
`
` Marathon (2015): Established specialty hospital portfolio
`
`
`
`
`
`
`
`24
`
`Page 24 of 29
`
`
`
`Q4 Guidance
`
`
`Revenue
`
`
`Cash EPS
`
`
`Adjusted Cash Flow from
`Operations
`
`Guidance
`7/31/14
`
`$2.1 – 2.3 billion
`
`
`$2.35 - $2.45
`
`
`N/A
`
`Guidance
`10/21/14
`
`$2.1 – 2.3 billion
`
`
`$2.45 - $2.55
`
`
`~$600 million
`
`Guidance
`1/8/15
`
`$2.1 – 2.3 billion
`
`
`$2.55+
`
`
`~$600 million
`
` Absorbed additional negative Fx impact of ~$40 million to revenue and ~$0.10 to
`Cash EPS
` Excludes gain from Allergan transaction
` Net proceeds ~$300 million (gain less deal related out-of-pocket expenses)
` Restructuring charges
` <$50 million
` Net leverage ratio reduced to ~3.5 times adjusted pro forma EBITDA by year end
` Strength of balance sheet provides opportunities to make acquisitions and
`opportunistically buyback shares and/or pay down debt
`
`
`
`See Note 1 regarding guidance
`
`25
`
`Page 25 of 29
`
`
`
`New 2015 Strategic Initiatives
`
`1. Deliver strong (10% - 12%) organic growth and a cash conversion rate of
`
`>90%
`
`2. Continue to over-deliver on the Bausch + Lomb acquisition through our
`
`decentralized operating model
`
`3.
`
`Achieve $500+ million revenues, in aggregate, for key launch programs –
`
`Jublia, Ultra (Toric and Multi Focal), Luzu, Retin-A Micro 0.08%, Onexton
`
`4. Continue to progress key development programs and prepare for launches
`
`e.g. Vesneo, Ultra, IDP-118
`
`5. Deliver industry leading returns to shareholders through strong organic
`
`growth and financially disciplined business development
`
`6. Develop / build the best management team in the industry
`
`
`
`26
`
`Page 26 of 29
`
`
`
`Financial Guidance for 2015
`
`2015
`
`
`2014 (1)
`
`Outlook
`10/21/14 (2)
`
`Guidance
`1/8/15 (2)
`
`
`% over 2014
`
`
`~$8.1 billion
`
`
`~$9.1 billion
`
`
`$9.2 - $9.3 billion
`
`
`~14-15%
`
`
`~$8.32+
`
`
`~$10.00
`
`
`$10.10 - $10.40
`
`
`~21-25%
`
`
`~$2.5+ billion
`
`
`~$3.1 billion
`
`
`>$3.1 billion
`(at least 90% cash
`conversion)
`
`
`~25+%
`
`
`Revenue
`
`
`
`Cash EPS
`
`
`Adjusted Cash
`Flow from
`Operations
`
`1) Three quarters of actuals plus fourth quarter guidance
`2) 2015 outlook assumed benefit of debt paydown (approximately $0.10 per share) while 2015 guidance does not factor in any benefit from
`the use of free cash flow
`
`See Note 1 regarding guidance
`
`Page 27 of 29
`
`
`
`2015 - Validation of Valeant’s Business Model
`
` Robust organic growth profile
` Double-digit organic growth expected in 2014, 2015 and beyond
`
` Geographical and product diversification creates lower-risk profile
`
` Durable product portfolio limits patent expiry exposure
` Rich pipeline of low-risk R&D programs
` Internal development – e.g. IDP-118, IDP-120, Onexton
`
` Acquisitions – e.g. Vesneo, Brimonidine, Ultra
`
` Product acquisitions/licenses – e.g. Emerade, Croma
` Strong cash flows and balance sheet
` Operating cash flows of over $3 billion expected in 2015
`
` Absent large transactions, restructuring charges trending to zero
`
` Convergence of GAAP to non-GAAP cash flows
`
` Enhanced capacity to continue acquisition activity as well as opportunistically
`paydown debt and/or buy back shares
` Disciplined approach to business development
` Continue to be disciplined with capital deployment to generate above average
`returns for shareholders
`
`
`
`28
`
`Page 28 of 29
`
`
`
`Valeant Pharmaceutical
`International, Inc.
`
`2015 J.P. Morgan Healthcare Conference
`
`
`Howard Schiller
`EVP and Chief Financial Officer
`
`Dr. Ari Kellen
`EVP and Company Group Chairman
`
`January 13, 2015
`
`Page 29 of 29
`
`