Valeant: An Enduring Engine for Growth - Bausch Health/media/Files/V/Valeant-IR/...Higher charges in...
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Valeant: An Enduring
Engine for Growth
December 16, 2015
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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, launches and approvals of products,
business development activities, and the 2016 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,” “seeks,” “potential,” or “continue” and variations or similar
expressions. These statements are based upon the current expectations and beliefs of
management, and depend on assumptions, data or methods that may be incorrect or
imprecise 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.
Note 1: The guidance in this presentation is only effective as of the date given,
December 15, 2015, and will not be updated or affirmed unless and until the Company
publicly announces updated or affirmed guidance.
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J. Michael Pearson
Chairman and CEO
<portrait>
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Drivers of Valeant’s success
Our decentralized model and talented people, which give
us a competitive edge (speed of decision making and in-
depth customer knowledge)
Our collection of great healthcare brands around the
world
Our innovative strategies (often disruptive), which have
challenged industry convention
Our relentless focus on providing easy and affordable
access for physicians and patients
Our exceptionally productive approach to R&D
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A collection of great brands in a breadth of
therapeutic areas
Valeant 2016 forecast revenues
19%
21% Gastrointestinal (GI)
17%
Emerging markets (including Ophthalmology, Dermatology, and GI sales)
22%
Ophthalmology and Eye Care (B+L)
Dermatology and Skin Care 22%
Oncology, Dentistry, Women’s Health, Neuro and Other
Total: $12.5 – 12.7 B
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Dermatology
▪ Great brands in attractive segments
▪ Importance of trust-based physician relationships
▪ Concentrated, specialist prescriber base
▪ Attractive from a payor standpoint
– High component of cash pay
– Reasonably priced products
▪ Lower-cost, lower risk R&D
4-year mkt CAGR: ~5%
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▪ Strong underlying global growth
drivers (e.g., demographics)
▪ Attractive specialty Rx and OTC segments
▪ Importance of trust-based physician relationships
▪ Concentrated, specialist prescriber base
▪ Significant unmet medical needs
▪ Opportunity for lower-risk innovation
▪ Low exposure to reimbursement pressure;
significant cash pay
▪ Durable products
4-year mkt CAGR: ~6%
Ophthalmology (B+L)
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Gastrointestinal
▪ Concentrated, specialist prescriber population
▪ Importance of trust-based physician relationships
▪ Concentrated, specialist prescriber base
▪ Less of a priority for many larger pharma companies
▪ Favorable reimbursement
▪ Opportunity for low-risk, incremental innovation
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Emerging markets
▪ 1,000+ brands with sales in emerging markets
▪ High growth markets (e.g., Mexico, China, Middle East / North Africa)
▪ Rich pipeline of upcoming launches
▪ Decentralized operating model
▪ Products not dependent on reimbursement
▪ Local R&D capabilities
4-year mkt CAGR: ~7%
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Valeant Access Program with Walgreens –
Physician/Pharmacist/Patient-led experience
▪ Direct distribution to patients through
Walgreens
▪ All products in Walgreens on
consignment; Walgreens never takes title
▪ Walgreens paid a distribution and
pharmacy fulfillment fee
▪ Valeant sets prices to the patient
▪ Ensures affordable, immediate access to
all Valeant brands in program that
physicians prescribe (for eligible patients)
Branded Access
Program
Branded Generic
Access Program
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Our innovative strategies – the early years
▪ Dramatically
reduced OPEX
(e.g., to focus
predominantly on
customer-facing
areas)
▪ Shifted from high-
risk/high-spend
R&D (e.g.
neurology,
virology) to lower
cost “singles and
doubles”
▪ Built unrivaled
M&A capabilities
(e.g., requiring
returns in excess of
cost of capital)
▪ Began building
undervalued
BGx and OTC
businesses
(e.g., in
emerging
markets)
▪ Initiated new
R&D capability
and operating
model (e.g.,
Dow)
▪ Executed
merger of
equals with
Biovail (strong
strategic fit,
improved tax
rate)
2008 2009 2010
▪ ~$600M in revenue
▪ 8% operating margin and 1% growth
▪ Imminent Effudex generics
▪ Bloated cost base and infrastructure
▪ High risk, high spend R&D
▪ Demotivated organization
Then
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Our innovative strategies – recent years
▪ Gained critical
mass in
ophthalmology
with acquisition
of B+L
▪ New R&D model
beginning to
pay dividends
▪ Created
attractive
access program
in dermatology
initially through
partnership with
Philidor
▪ Built a leading
US market
position in
dermatology,
with a series
of focused
acquisitions
(e.g., Medicis,
Obagi,
Dermik/Ortho)
▪ Secured entry into
attractive GI space with
acquisition of Salix
▪ Created even better,
branded access
program with Walgreens
▪ Launched with
Walgreens the first
branded generics
program in the US
2011
/12
2013
/14 2015
▪ $12.5-12.7B in revenue
▪ Double-digit organic growth
▪ Great brands around the world
▪ Attractive geographies and TA platforms
▪ Energized and committed talent base
Now
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Our R&D model
Rx R&D spend as a % of branded Rx sales
8%
▪ 6 NDAs approved in last 3 years
▪ 200+ active US programs
▪ Dermatology Phase II and
Phase III success rates 3-5x
better than industry averages
▪ Highest 5 year output1 on R&D
spend in the industry
1 Number of NMEs/BLAs approved 2009-'14 for each $1 billion spent; peer set is 15 companies with the highest number of NME/BLA approvals
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Our decentralized model
▪ Empowers local leaders to make decisions that are right for their business
▪ Allows us to move with speed and agility
▪ Aligns with our customers’ needs
▪ Ensures strong centralization and controls in key functions/ activities, e.g.,
– Finance
– Compliance
– Audit
– Pharmacovigilance
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How you can measure our progress in 2016
▪ Retained all key management talent and added new key hires
▪ Dermatology returned to growth
▪ Maximized Xifaxan – created our first $1B brand
▪ Got approval and successfully launched
– Brodalumab
– Latanoprostene Bunod
– Relistor Oral
▪ Delivered $100-150M in addyi sales in 2016
▪ Brought leverage to ~4.0x by end of 2016
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Who you will hear from – Our business leaders
Yang Yang BU Director,
Vision Care China & Japan
Fernando Zarate GM, Mexico, Andean region,
Central America and
Caribbean
Joe Gordon SVP and GM,
Consumer Health Care
Deb Jorn EVP, Dermatology and GI
Dr. Tage Ramakrishna Chief Medical Officer, Head of
R&D and Quality
Robert Rosiello EVP, CFO
Tracy Valorie SVP and GM, Women’s Health
and Bausch + Lomb
Pharmaceutical Division
Mark McKenna VP and GM,
Bausch + Lomb
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Robert Rosiello
Executive VP, CFO
<portrait>
Financial guidance
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* Non-GAAP (see Appendix)
Previous Q4
2015 Guidance
Revised Q4
2015 Guidance
~$3.25 - $3.45B
~$2.7 - $2.8B
~$4.00 - $4.20
per share
~$2.55 - $2.65
per share
>$1.0B
>$600M
Revenue
Adjusted EPS*
Adj. Cash
Flow from
Operations*
Revised Q4 2015 and full-year 2015 guidance
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Midpoint of previous guidance
Midpoint of revised guidance
~$3,350M ~$4.10
Revenue Adjusted EPS*
Philidor separation
Estimated one-time revenue impact from Walgreens transition
Pricing and volume-related changes (e.g., non-promoted products)
~($250M)
~($150M)
~($200M)
~($0.65)
~($0.40)
~($0.45)
~$2,750M ~$2.60
* Non-GAAP (see Appendix)
Bridge from previous Q4 2015 guidance
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Estimated Q4 Revenue Impact: (~$250M)
Announced Philidor separation October 30
Provided free scripts from October 31 to November 8
Dispensed refills without seeking reimbursement from payors
from November 9 to present
Average cash pay price declined from $67 to $23
Lost ~20% of scripts from business disruption in Q4, virtually all Philidor covered scripts
Philidor separation
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Transition to consignment model at Walgreens for
current inventory on hand
Under this arrangement, Valeant will hold title to products sold under this program until dispensed to a patient
Valeant will credit Walgreens for any inventory on hand in its stores or distribution centers as part of transition
Estimated reduction in traditional channel
inventories for the products included in Walgreens
program
One-time revenue impact from Walgreens transition
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2016 Guidance
~$12.5B – 12.7B
~$13.25 – 13.75
per share
~$6.9 – 7.1B
Revenue
Adj. EPS*
Adj. EBITDA*
* Non-GAAP (see Appendix)
2016 guidance
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Previous 2016 Adj. EBITDA* Outlook
2016 Adj. EBITDA* Guidance (Mid-point)
>$7.50B
Dermatology Patient Access Program ramp-up ~($225M)
~$7.0B
Changes in pricing assumptions ~($125M)
Employee retention bonuses ~($75M)
Incremental legal fees ~($75M)
* Non-GAAP (see Appendix)
Bridge from previous 2016 EBITDA outlook
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Revised 2015
Guidance
2016
Guidance
2016
Guidance %
over Updated
2015
Guidance
$10.4B – 10.5B ~$12.5B – 12.7B ~21%
Double-Digit Double-Digit NA
$10.23 – 10.33
per share
~$13.25 – 13.75
per share
~31%
>$5.4B $6.9 – 7.1B ~30%
Revenue
Organic Growth*
Adj. EPS*
Adj. EBITDA*
* Non-GAAP (see Appendix)
2016 guidance vs. revised 2015 guidance
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Exchange rates based on current spot rates
No use of balance sheet/acquisitions
Planned impact from generics expected ~($140M) in revenues
Glumetza (Q1); Zegerid (Q3); Nitropress (Q4); Virazole (Q4)
No use of balance sheet/acquisitions
U.S. branded drugs (excluding drugs in the Walgreens program) consistent with PBM, managed care contracts
Other U.S. businesses (e.g., contact lenses, consumer) typically no more than CPI
Ex-U.S. driven by volume, pricing impact is immaterial
Negotiated price discounts for hospital-administered drugs of ~30% (e.g., Nitropress, Isuprel, Virazole, Ammunol)
COGS* ~20-21%
SG&A* ~23-24%
R&D spend ~$400-500M
* Non-GAAP (see Appendix)
2016 guidance assumptions (1/2)
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Restructuring charges expected <$200M
Higher charges in Q1 and Q2 due to completion of restructuring and integration programs for Salix, Sprout, Synergetics, Amoun, trending downward in Q3 and Q4
Cash tax rate expected to be ~5%
Interest expense ~$1.6B
Sequential quarters for Revenue and Adjusted EPS* are expected to be higher than the previous quarter
2H will be substantially higher than 1H due to ramp up in Walgreen’s programs
Cash Flow Items
Cap Ex - ~$350M
Depreciation - ~$200M
Stock Based Comp - ~$200M (includes impact of employee retention plan)
2016 guidance assumptions (2/2)
* Non-GAAP (see Appendix)
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Q1 2016
Guidance
$2.8 - $3.1B
$2.35 - $2.55
per share
Dermatology Patient Access Program ramp-up
Continued impact of reduction in channel inventories
Revenue
Adj. EPS*
Q1 2016 guidance
* Non-GAAP (see Appendix)
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Majority of 2016 free cash flow used for debt pay down
Committed to minimum debt pay down in 2016 of >$2.25B including $562M term loan amortization and $260M maturities
Remain in clear compliance with credit agreement financial maintenance covenants
Senior secured leverage covenant: 2.5x (secured debt to pro forma adjusted EBITDA*)
Interest coverage covenant: 2.25x though March 31, 2016, then 3.0x (pro forma adjusted EBITDA* to pro forma interest coverage)
Net leverage to pro forma adjusted EBITDA* expected to be ~4x by year end
Minimal amortization and maturities until 2018
2016: $822M
2017: $631M
2018: $2,923M + $1,500M (Revolver)
* Non-GAAP (see Appendix)
Balance sheet update
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Cash flow
“Adjusted cash flow from operations” and “Cash conversion” will no
longer be reported each quarter
Only GAAP Cash Flow will be reported going forward
We will continue to report integration expenses by acquisition on quarterly basis so investors can continue to calculate adjusted cash
flow, if desired
Adjusted EBITDA* will be reported on a quarterly basis
“Cash EPS” to be labeled “Adjusted EPS* (non-GAAP)”
Top 30 global brands
Volume and Price/Mix for total company and U.S. branded Rx business
* Non-GAAP (see Appendix)
Changes to planned quarterly disclosures
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Deb Jorn: EVP, Dermatology and GI
Background
▪ 30+ years in Pharma industry ▪ Bausch + Lomb; VP and CMO (3 years) ▪ Schering-Plough (5+ years)
– VP for Women’s Healthcare and Fertility – VP for Allergy, Respiratory, and Urology
▪ J&J (2 years) – VP for Internal Medicine
▪ Pharmacia Corporation (2 years) – VP for Detrol / Detrusitol and Urology
▪ Merck (20 years) – Executive Director, Worldwide Human Health Marketing;
Respiratory Products; senior marketing roles
Education
▪ M.B.A., NYU Stern Graduate School of Business Administration
▪ B.A., Rutgers University
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Jublia
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Onexton
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Key Takeaways
• Valeant is the #1 Medical Dermatology Company1 in the U.S.
• Internal R&D efforts resulted in approval of 4 new products in 2014 (Jublia, Onexton, RAM .08, Luzu)
• Strong near-term pipeline expected to sustain organic growth
• Deep, trust-based relationships with dermatologists and podiatrists
• New Valeant Access Program, in partnership with Walgreens, launching in January 2016
Source: Symphony Monthly PHAST Audit MAT October 2015
1. Excluding biologics and oral antibiotics
*Dermatology Rx refers to entire USC2 37000 (Dermatological, Ethical)
**Sales are based on MBS Dollar Sales (MBS represents a standardized dollar
metric based on manufacturer’s published catalog or list prices to wholesalers
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Oct 30th 2015 – Nov 8th 2015
No submission of claims to
payors after October 30th
All prescriptions filled at no
cost to patient
Commercial insured and
uninsured only – no
government plans
3 phase transition plan
Phase I:
Initial Transition
Rapidly developed new
access program
Entered into agreement
with Walgreens
Prepared for execution
with excellence
Nov 9th 2015 until new
program in place (before
Jan 30th 2016 Philidor
closing)
$35 cash pay option for
all new and refill
prescriptions sent to
Philidor
Refills already in Philidor
prior to Nov 9th filled for
$0 if previous refill was
that copay or $35
Commercial insured and
uninsured only – no
government plans
Phase II:
Full Transition
Phase III:
Relaunch
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Key recent actions
Customer outreach
20 cities covered in 6 weeks by senior management and sales & marketing team
Reaffirmed commitment to Dermatology / Podiatry specialty
Retention
Retained all sales & marketing leaders
Retained all but two sales representatives out of field force of over 350
Maintained historic vacancy rate of 5% (lower than industry norms)
New Access Program
Gathered input regarding key elements of new access program
Established new relationship with leading consumer retailer (Walgreens), streamlining prescription process for patients and physicians
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We have retained 81% of dermatology prescriptions
-
20,000
40,000
60,000
80,000
100,000
120,000
140,000
Pre Post
CoveredUncoveredCashRetail
1 October average pre Philidor
2 November average, excluding Thanksgiving week post Philidor
1 2
# of weekly TRx
▪ Retail prescriptions grew by 17% to 66,000, mitigating overall drop in total prescriptions
~116,000
~94,000
+17%
Ph
ilid
or
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Valeant’s new access program
▪ Ensures affordable, convenient patient access
to medicines prescribed by their physician1
▪ Some products as low as $0
▪ Allows physicians, NPs and PAs to focus their
efforts on patient care
▪ Sales force will start providing physicians with
program overview as of Dec 21st
▪ Goal: fully operational January 15th
1 Commercial insured and uninsured only – no government plans
2
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New access program is simpler for patients and
physicians New Approach
HCP sends Rx to Walgreens
Patient picks up
Rx at Walgreens same day
Old Approach
HCP sends Rx to Philidor
Patient calls Philidor with insurance, credit card
2-3 days later Rx arrives at home
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9/14 YTD 9/15 YTDQ3 YTD 2014
Q3 YTD 2015
Strong Organic Growth in Dermatology
Valeant Dermatology Revenues
1 Brands launched 2014+: Luzu (Q2 14), Jublia (Q3 14), Ram08 (Q3 14), and Onexton (Q1 15)
$1,266M
$718M
0
20
40
60
80
100
120
140
160
Q2
2014
Q3
2014
Q4
2014
Q1
2015
Q2
2015
Q3
2015
New Product Revenue1
$150M/quarter
76%
In-line brand Launch brand1
Total Revenue
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39
Exciting Late-stage Dermatology Pipeline
2017+
IDP – 121 (acne vulgaris)
2016
Brodalumab (plaque
psoriasis)
IDP – 122 (plaque psoriasis)
IDP – 118 (plaque psoriasis)
IDP – 120 (acne vulgaris)
Select pipeline products
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40
Gastrointestinal health
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Gut GuyTM
Hepatic Encephalopathy (HE) Irritable Bowl Syndrome – diarrhea (IBS-D)
Xifaxan 550mg
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42
TV
DIGITAL
75
55
80
65
50
85
70
60
Oct-15
Oct-14
Jul-14
Apr-15
Jan-15
Jul-15
IBS-D indication Drives Xifaxan TRx Growth
*Note: TRx’s are Unit-adjusted each month based on the different Pack Sizes of 42 and 60
Source: Symphony PHAST 2.0
IBS-D
Indication
Retail + Hospital TRx’s*
DTC
Launch
Thousands of Xifaxan scripts
(US)
+27% TRx
81K Rx / month
64K Rx / month
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43
Up to 8M in US at risk for Chronic Liver Disease1, including those
with Overt HE
Only 2 products are approved for Overt HE: lactulose and Xifaxan
2014 AASLD/EASL Guidelines recommended the addition of Xifaxan to lactulose to maintain Overt HE remission, which has
been shown to reduce risk of Overt HE recurrence by 58% and
hospitalizations by 50%2
Today only 45% of NRx for Lactulose are written with Xifaxan,
creating a large untapped opportunity for Xifaxan to help HE
patients
Xifaxan continues to have substantial growth potential
in hepatic encephalopathy (HE)
1 Includes patients with HepB, HepC, NAFLD, NSH, and OHE; source: National Institute of Diabetes and Digestive and Kidney Disease.
Digestive Diseases Statistics for the United States. Assessed September 7, 2010
2 Bass NM, Mullen KD, Sanyal A, et al. Rifaxamin treatment in hepatic encephalopathy. N Engl Med. 2010;362(12):1071-1081
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Increase sales force by a further 100 representatives to
support Xifaxan growth in HE
Expand the GI team in high density areas
Increase continuity of care between sales teams working in
hospitals and out-patient settings
Key actions to accelerate Xifaxan growth
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45
Strong growth of in-line brands
Source: Symphony PHAST 2.0 + VA Procurement, Non-Retail TRx’s are unit-adjusted each month based on the different Pack Sizes of 42 and 60
* Since Ruconest Launched in Dec 2014, Growth Rates are 5 vs. 5 months (instead of 12 vs. 12 months).
Brand
% TRx
Growth
YOY October
Apriso 8%
Uceris 30%
Relistor 33%
Ruconest* 140%
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46
An estimated 3% of the adults in the US are receiving long-
term opioid therapy
41% of those patients, or approximately 3.7 million patients,
develop Opioid Induced Constipation (OIC)
The prescription market for OIC is growing rapidly now that
there is an oral option
In our phase III program, Relistor oral significantly increased the
percentage of patients with a rescue-free bowel movement
(RFBM) within 4 hours
Relistor Oral (April 19, 2016 PDUFA)
Source: Spencer Dorn, et al. American Journal of GASTROENTEROLOGY 2014
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47
Strong Late-stage GI Pipeline
2017+ 2015
Xifaxan
IBS-D
SAL-023
Chronic cirrhosis of liver
2016
Relistor Oral
Opiod induced constipation
SAL-024
Crohn's
SAL-022
Diabetes
SAL -021
Rheumatoid arthritis
SAL-020
Hereditary angioedema
Select pipeline products and launches
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48
Tracy Valorie: SVP and GM, Women’s Health and B+L
Pharmaceutical Ophthalmology
Background
Education
▪ 20+ years in Pharma industry
▪ Bausch + Lomb
– Vice President of Pharmaceutical Marketing
– Former Global Head of Glaucoma
▪ Pfizer
– Global Commercial Lead of Ophthalmology (Xalabrands and Macugen), mid-stage development portfolio, and long-range planning
▪ Experience in discovery, clinical development, commercial assessment, marketing and strategic planning
▪ Previous board membership The Glaucoma Foundation and ARVO Foundation for Eye Research (AFER)
▪ M.B.A., Rensselaer Polytechnic Institute ▪ B.S. Molecular Biology, University of Connecticut
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49
addyi is a breakthrough product with great potential
▪ addyi is the first FDA approved product for Hypoactive Sexual Dysfunction Disorder (HSDD) in premenopausal women and is not the “Female Viagra”
▪ Hypoactive Sexual Dysfunction Disorder effects many premenopausal women
– ~15M premenopausal women have HSDD
– Only 10% diagnosed
– Opportunity to educate on the disease state and expand the diagnosed population
▪ Physician and Patient Education, and managing expectations is critical to success, including:
– Education on disease state
– Physician and patient education on features, benefits, and risks of addyi
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Challenge ahead of us: TRx’s are not being filled
Source: McKesson
0
1000
2000
3000
4000
5000
6000
7000
8000
Oct-23 Oct-30 Nov-06 Nov-13 Nov-20 Nov-27 Dec-04 Dec-11
addyi TRx (# TRx cumulative)
TRx filled
Total TRx
-82%
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Physician sentiment is positive
“
”
Physicians are optimistic
about addyi as an FDA
approved treatment
option
”
It is fantastic that we have an FDA-approved medication for a woman with a sexual health concern… I did not think this
was possible prior to this day and age
“ ”
We discuss and write scripts for multiple patients in our clinic every day
Physicians who have
experience with addyi are
enthusiastic about its
potential
Physicians caution that
managing expectations is
crucial “ Physicians need to be educated on the
disease state and the product so they can appropriately counsel patients on how the product works and what they can expect
Source: Symphony, RelayHealth as of Dec. 2015, physician outreach
“
”
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We have a strong assessment of the issues
▪ Limited physician education /
awareness of HSDD and addyi
▪ Confusion around REMS certification
process (physicians and pharmacies)
▪ Sales force targeting not optimal
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Go forward plan
▪ Remove barriers to REMS certification
▪ Physician and patient outreach, MSL recruiting
and training
▪ Build an integrated Valeant team (Commercial,
Medical, Sales, etc.)
▪ Improve field force effectiveness
– Revisit targeting and call plan
– Improve reach and frequency on key targets
– Retrain our sales force
– Enhance performance management
▪ Improve patient access (thru Walgreens Access
Program as of Jan. 15th)
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54
Market Access: Continuing to improve
▪ 50% of US lives are covered to date
▪ >1/3 of all US lives have unrestricted coverage
▪ Managed Markets team is working diligently
with our payor stakeholders to improve access Unrestricted coverage
Restricted coverage
50%
U.S. lives covered
Seeking coverage / under negotiation
35%
15%
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addyi: 2016 Expectations
USD 100-150M+ net revenue
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Mark McKenna: Vice President and General Manager,
Bausch + Lomb
Background
▪ 13+ Years of diverse experience in the eye health category in leadership roles across sales, marketing, operations and strategy
▪ Led the reinvigoration of the U.S. contact lens product portfolio, making Bausch + Lomb the fastest growing contact lens company in the U.S.
▪ Held positions of increasing responsibility in Bausch + Lomb’s sales and marketing division, most recently as Head of Sales and Operations
▪ Global Marketing experience leading new product development projects for Bausch + Lomb from ideation through commercialization
▪ Joined Bausch + Lomb in 2006 after spending several years with Johnson & Johnson Vision Care
▪ Speaker at the 5th Annual Life Science Executive Leadership forum
Education
▪ MBA from Azusa Pacific University
▪ BA in Marketing from Arizona State University
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Biotrue lens
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The resurgence of an iconic eye care brand
▪ Valeant has transformed the underperforming Bausch + Lomb
(B+L) company into a $1.2B+ diversified vision care business
▪ Products are outgrowing category averages through commercial investments in the US and a decentralized model
▪ Global roll out of contact lens pipeline, which will build on US and Asia success
▪ One of the fastest growing contact lens solution brands in the world
▪ Strong pipeline, with >20 product launches and extensions
planned for next 3 years globally
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59
B+L contact lens business turnaround under Valeant
US B+L contact lens revenue and
growth in millions
▪ Innovation and Organic Growth: Our
investments in R&D, DTC marketing
and manufacturing have allowed us
to drive organic growth in vision care
▪ Distinctive Commercial Model: Our
physician oriented approach has
enabled us to transform Biotrue®
ONEday into one of the fastest
growing daily disposable brands
20% lens CAGR under Valeant
ownership vs 5% lens category CAGR1
$-
$50
$100
$150
$200
$250
$300
2009 2010 2011 2012 2013 2014 2015 2016
-1% -7% -2%
-8% -8%
+16%
+26%
+26%
Source: Management estimates, 3rd party data
1 Category CAGR over same time period
Annual growth
E
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60
B+L is growing rapidly relative to competitors
Source: 3rd party data, Company filings
Lens sales growth 2013-’15
6%
Market
Average1 5%
-3%
22%
7%
1 B+L and top market competitors 2 Excludes private label sales
Solutions sales growth 2013-’15
-1%
-5%
0%
7%
All others2 2%
Market
Average1
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Winning Strategies for Contact Lenses
• Expanded Sales Force by 50% to increase frequency and reach
• Signed multi-year partnership agreements with leading optical
retailers; Vision Source (#2) and NVI (#4)
• Accelerated Bausch + Lomb ULTRA Multifocal & Toric launches
by 12 months
20%+ Annual Growth Next
3 Years
• Upgraded organization with top industry talent
• Formed Professional Strategy group to enhance peer-to-peer
outreach
• Innovative launch strategies to maximize launch trajectory
Forge Higher Performance Leadership Team
Enhance Operational Effectiveness
Strengthen Customer Partnerships
Launch Excellence
Accelerate the Pipeline
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62
Bausch + Lomb ULTRA® is Fastest Growing
Frequent Replacement Contact Lens
Sales: Forecasted to more than double from $45M in 2015 to $100M+ in 2016
Share: Unprecedented 7.9 share within 18 months of launch
Distribution: Gained +13k doorways in 2015 resulting in 22k total ECP’s1 with diagnostic fitting sets
DTC Campaign: Delivered over 1B impressions via Digital, Social, and Paid Search in 2015, and TV spots planned for first half of 2016
0
1
2
3
4
5
6
7
8
9ULTRA share of dollars in FRP category
1 Eye care professionals
Source: 3rd party data, Management Estimates
Ma
rke
t sh
are
(%
)
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Bausch + Lomb ULTRA®
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Bausch + Lomb ULTRA, a CLEAR standout in recent
Eye Care Professional poll
Cleveland Research Company, Nov 2015
34%
22%
19%
15%
7%
3% 0%
10%
20%
30%
40%
ULTRA Clariti
Freshday
MOIST for
Presbyopia
Acuvue
OASYS One
Day
Air Optix
Colors
MyDay
When ECP’s Were Asked: Which recently launched lens has gained
the most traction in your practice?
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Bausch + Lomb ULTRA® 2016 Launch Activities
Launching Bausch + Lomb ULTRA® for Presbyopia and Astigmatism in 2016
Expand Bausch + Lomb ULTRA® reach by 35% of the market (multifocal and toric)
Halo effect on Spherical business
Investing Multi-Million Dollar in DTC campaign
TV, Digital, Social Media, Search
In-office Digital Displays to create 360 campaign
Targeted Professional Outreach
Largest Eye Care Professional Share of Voice within contact lens industry
High impact launch events to generate awareness and request of new products
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66
Biotrue® ONEday is one of the fastest growing daily disposable brands through a change in go-to-market strategy
US Biotrue ONEday net sales since acquisition
0
1
2
3
4
5
6
7
8
9
Q3 '13 Q4 '13 Q1 '14 Q2 '14 Q3 '14 Q4 '14 Q1 '15 Q2 '15 Q3 '15
Base trend
Biotrue
ONEday is
on track to
achieve a
60% YOY
growth rate
in 2015
Sa
les
($M
)
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67
New Product Launches Planned Over the Next
Years Across Lens and Lens Care
13 3
2015 2016
Q2 Q3 Q4 Q1
2017 - 2020
BLC-009
(Astigmatism)
Biotrue Multifocal
BLC-007 (Multifocal)
BLC-008
(Astigmatism)
BLO-030
(Disinfectant)
▪ BLC-003 (single vision spherical /
multifocal / astigmatism)
▪ BLC-005 (single vision
spherical / multifocal)
▪ BLC-001 (single vision
spherical)
▪ BLC-006 (single vision spherical)
▪ BLC-002 (cosmetic single vision
spherical)
▪ BLC-004 (Novel Astigmatism)
▪ BLO-027 (Lubricant)
▪ BLO-028 (Lubricant)
▪ BLO-029 (Disinfectant)
Select product pipeline and launches
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Yang Yang: Business Unit Director, Vision Care China & Japan
Background
▪ 15+ years China and overseas consumer marketing & sales
experience. Born and raised in Beijing, China
▪ Bausch + Lomb / Valeant (China & Japan)
- Business Unit Director – Vision Care
- Marketing Director – Vision Care
▪ L'Oréal (China)
- Director of e-commerce – L'Oréal Paris, Maybelline, & Garnier
- Marketing Director – Garnier
▪ Johnson & Johnson Consumer Products
- Marketing Manager – Listerine, Carefree, & o.b. (China)
- Brand Manager – Reach & Visine (USA)
▪ Citigroup CitiCards – New Product Development (USA)
▪ Procter & Gamble (China)
- Category Management Manager
- Key Account Manager & Unit Manager
Education
▪ MBA, University of Michigan, Ross School of Business
▪ BA English Language & Literature, Peking University
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Valeant China
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70
Vision care is growing strongly in Asia
Japan
Korea
Thailand Hong Kong
Singapore
India
China
Taiwan
Malaysia
Vision care sales $491 million (2015)
+6% annual growth
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Valeant China business overview
15% Rx Vision Care 45%
25% Surgical
15%
OTC eye drop
▪ 1st contact lens
company to enter China; the brand
name has been used as synonym for contact lens
▪ B+L is the #1
recognized brand in China and preferred by consumers
▪ B+L is also the #1
vision care brand in China, with fastest growth
Valeant China business by franchise 2015
Total China sales: $ 277M
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2014 China lens market by modality revenue & % growth: ~$284M, +3%
2014 China vision care market revenue & % growth: ~$438M, +2%
44%
21%
35%
Lens care
24%
22%
54%
Clear lens Daily Half yearly / Yearly Monthly Cosmetic lens
+4%
+1%
+1%
+2%
-3%
+15%
China Market – All companies
NOTE: USD at constant dollars Source: CLI, credit report and trade intelligence
China is a half yearly / yearly lens market;
cosmetic lens is 1/3 of total lens market
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B+L is the #1 and the fastest growing vision care
brand in China
Source: CLI, credit report, and trade intelligence
2013-’14 growth rate
%
Revenue 2014
$M
$125
$105
$57
$49
$8
$438
Market Share 2014
%
28%
24%
13%
11%
2%
100%
16
9
8
-6
-26
2 Total
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2012 $M
2015 $M
Growth %
Clear lens 46 63 +37%
Cosmetic lens 12 28 +131%
Lens care 21 35 +61%
Total vision care 79 125 +58%
Growth is driven by all three segments
China vision care business
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75
46 49
54
63
-
10
20
30
40
50
60
70
2012 2013 2014 2015
Clear lens revenue
Clear lens portfolio
▪ Diverse full modality portfolio (daily to yearly), different materials (hema /sihy /hypergel), spherical and toric
Drivers of growth
▪ Introducing innovative premium products while continuing to grow user base of long modality lenses
▪ Professional training to ECPs on toric and multifocal
$
$
$
$
$
$
$
M
M
M
M
M
M
M
CAGR: 11%
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▪ Segment market with multiple offerings and pack sizes
Lens care portfolio
21
24
28
35
-
5
10
15
20
25
30
35
40
2012 2013 2014 2015
Lens care revenue Drivers of growth
▪ Cross-sell with lens to maximize B+L strong brand equity
$
$
$
$
$
$
$
M
M
M
M
M
M
M
$ M
CAGR: 17%
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77
Cosmetic lens portfolio
12
19
23
28
-
5
10
15
20
25
30
2012 2013 2014 2015
Cosmetic lens revenue
▪ Positioning cosmetic lens as beauty necessity, and B+L as trend setter
Drivers of growth
▪ Variety of patterns and colors, along with full modality offerings CAGR:
32% $
$
$
$
$
M
M
M
M
M
$ M
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▪ Best-in-class team and talent pipeline for future growth
▪ Stable, passionate sales force committed to growing with
customers and consistently delivering results, which exceed
expectations
▪ Robust local portfolio to meet the diverse consumer needs
▪ Insights into customer needs, values, and behavior drive the
development of successful local marketing campaigns
▪ Content-based digital social media model is proven to be
effective and cost efficient
Valeant’s decentralized model has enabled
China business to grow faster than competition
We have a distinctive commercial model
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Our pipeline in China is set up to fuel further growth
2015 2016 2017-2019
XUV-005 (Lubricant)
XUV-011 (Multifocal)
XUV-002 (Color)
XUV-014 (Multifocal)
XUV-004 (Single vision
spherical)
XUV-008 (Lubricant)
XUV-007 (Multifocal)
XUV-001 (Cosmetic)
Biotrue ONEday
PureVision2 Toric
Bescon half yearly
cosmetic lens
Bescon half yearly
clear lens
2017-2019 NPD Pipeline
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Joseph Gordon: General Manager, Consumer Health
Care
Background
▪ 28 years in OTC Health Care
▪ Valeant / B+L (5 years)
▪ Wyeth (19 years)
– VP, Sales
– VP, Marketing, Advil
– GM, Nutritionals Business Unit
▪ GSK (5 years)
Education
▪ B.A. Economics, Rutgers University
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Valeant Consumer Healthcare drivers of growth
▪ Strong and diverse portfolio of products
▪ Exceptional retailer relationships
▪ Consumer marketing expertise and effectiveness
▪ Drive recommendations through detailing of: dermatologists, ophthalmologists, and optometrists
▪ Physicians’ intimate involvement in our product development process
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-2.0-1.6
-0.4
1.01.41.5
2.8
4.55.3
5.7
6.6
7.67.77.9
9.8
Valeant is one of the fastest growing US consumer
healthcare companies
Source: IRI Market Advantage
Fastest growing US consumer healthcare companies (3-year CAGR)1, %
1 CAGR calculation based on retail sales; Total US 3 year CAGR for latest 52 weeks ending 11-29-2015. Based on biggest manufacturers in Healthcare. Excludes
private Label.
2 Alcon growth figures have been disaggregated from Novartis
2
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Valeant has a strong portfolio of consumer products
Skin Care
Eye Care
Eye Vitamins
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Important relationships with key leading retailers
Strong account management
Effective customer marketing
Private label
Eye Care category captain
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Comprehensive marketing approach
Print Digital / social media
Professional Television
Integrated and diverse consumer marketing
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Consumer Marketing: PreserVision
▪ 88% share of the AREDS vitamin market
▪ First to market with AREDS 2 formula
▪ AREDS clinically proven
▪ Estimated 7M+ diagnosed non-users (growth opportunity)
Net sales
Source: IRI data, NEI incidence and prevalence data
15
$100M
$80M
14
$72M
$113M
2012 2016E
$140M
2013
+8% +15% +17% +20%
AREDS 2
Launch
Q4 TV
Campaign
Launch Consumer
TV
Campaign
(continued)
Retail consumption growth
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PreserVision
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Biotrue is the fastest growing multipurpose contact
solution brand
Biotrue net sales
2013
$63M
$41M
2015
$46M
$76M
2016 E 2012 2014
$88M
Source: IRI data
Biotrue Challenge
re-launched
CAGR (2012 – 2015)
▪ Biotrue: 23%
▪ Category: 1%
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Biotrue fast facts
New users who took the Biotrue Challenge
Doctors’ primary recommendation
1 Million
1/3
#1 Contact lens solution at Walmart
Biotrue contact lens solution works like your own eyes – 20 hours of moisture
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Biotrue solution
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Focusing on the professional
▪ Over 600 sales reps selling to dermatologists, optometrists, and ophthalmologists
▪ Reps have reached 10,000 dermatologists, distributing 15 million samples
▪ CeraVe #1 dermatologist recommended moisturizing brand
Source: Valeant sales force productivity, Symphony Health Survey of Dermatologists
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92
CeraVe has been the fastest growing skincare brand
for four straight years
2016 E
$88M
2015
$114M
2014
$135M
12
$50M
2013
$69M
CeraVe core products
CeraVe new products
Net Sales Competitive Trends (2013-2015 CAGR)
24%
8%
3%
▪ Professional support and involvement has driven commercial success
▪ Growth sustained in both core and new products
Category 1%
Source: IRI data
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CeraVe has generated a digital buzz on Facebook,
boosting viral impressions by 600%
“The CeraVe Moisturizing
Lotion and Hydrating
Cleanser are just the best
products out there”
- Kathy M.
“I love your Foaming Facial
Cleanser but have recently
fallen in love with your Baby
Wash & Shampoo to clean my
face during the Winter!”
- Diana D.
“My allergist insisted I use
CeraVe…I had no idea they
had so many products!”
- Christie C.
“My dermatologist
recommended CeraVe Skincare
to me yesterday…I’m really
looking forward to trying it out!”
- Emily M.
“Seriously, CeraVe is the best
product ever. Totally obsessed
and refuse to use anything else. I
use the lotion, the wash, all of it.
Great stuff.”
- Melissa M.
“Just bought the am/pm
lotion today and I love it,
my face is so soft and
smooth…”
- April M.
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Creating long-term growth
Recent 2016 2017 2018
Healing
ointment1
Skin
Care
Eye
Care
Eye
Vita-
mins
CeraVe
Baby
CeraVe Sun
CeraVe anti-
aging
CeraVe
cleansing bar
Peroxiclear
SootheXP
AREDS 2
Body wash
Anti-itch
AREDS 2
multivitamin
Targeted
therapies
Project
‘lightbulb’
Dry Eye
extension
Core
upgrades /
claims
Product
upgrade
Project
‘moisture’
AREDS 2
advanced
Note: Position of star in box does not reflect anticipated launch timing within a given year
1 All pipeline skin care products planned as part of the CeraVe family
Product
upgrade
Select product pipeline and launches
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Valeant consumer healthcare company is poised to
continue its strong growth trajectory
~$540M
2013 2015
~$625M
2014
~$590M
Valeant US consumer healthcare revenues High single-
digit growth
expected in
2016
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Fernando Zarate
General Manager, Valeant Mexico, Andean region,
Central America and Caribbean (CAC)
Background
Education
▪ 24 years in Pharma industry ▪ Valeant-Mexico; General Manager (8 years) ▪ Teva (3+ years)
– OTC-Consumer Business Director ▪ Schering Plough (3+ years)
– Pharma Division Director ▪ SmithKline Beecham (7+ years)
– Consumer business Commercial Director (Venezuela-Andean)
– Commercial Director (Mexico)
▪ M.B.A., IPADE Business School Administration ▪ B.A., Iberoamericana University (Mexico City)
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Mexico, Central America, Andean Revenue (Constant US$)
Strong growth across all businesses
$17M
$20M
Generics (Branded Generics)1
$228M
Innovative (Rx)
20152 2014
$199M
$14M
$56M
Device
OTC
$23M
$109M
$64M
$124M
2 2015 data actual through Oct., on track to outperform forecast for Nov. and Dec.
18%
16%
14%
15%
Growth’14-’15
1 ~90% of generics in Mexico & Andean region sold as Branded Generics
15% growth overall
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Branded generics success in region depends on four
defining features
Well-known local brands with strong reputation for quality
▪ Trusted company names: Atlantis,
Tecnofarma, Grossman
Local manufacturing skill and agility
▪ Two local manufacturing facilities
with internal capability to produce
injectables, oral solids, topical, liquids
▪ ~800 manufacturing employees
producing 30M units/year (30% YOY
growth)
Proven commercial model with direct distribution
▪ ~600 sales employees drive
distinctive level of geographic
coverage (92%)
▪ ~45% of sales through direct
distribution channels
First-to-market advantage driven by local R&D
▪ Mexico R&D team: 32 professionals
▪ 9 mo. for Valeant vs. 2-3 years for
competitors to launch new BGx
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Mexico, Andean region, Central America and
Caribbean branded generics pipeline
We have plans to release many new branded generics in the
next few years to supplement strong growth in existing offerings
2017 2015
Spagnosan
(osteoporosis)
Ciscotan
(glaucoma)
Sotoldor
(glaucoma)
XUG-002 (glaucoma)
2016
XUG-012 (vaginal infections)
XUG-011 (anti-inflammatory)
XUG-001 (joint pain, RA)
XUG-003 (antifungal)
XUG-004 (oral inflammatory
disorders)
XUG-010 (ocular lubricant) XUG-013 (vaginal infections)
Select product pipeline and launches
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Dr. Tage Ramakrishna
Chief Medical Officer, Head of R&D and Quality
Background
Education
▪ Valeant Pharmaceuticals (4 years)
– Chief Medical officer, Head of R&D and Quality
▪ Progenics Pharmaceuticals (4 years)
– VP Clinical Research
▪ Nycomed (formerly Altana) (5 years)
– Corporate VP International Drug Safety
▪ Insmed, Inc.
– Medical Director
▪ Degge Group
– Pharmacovigilance Consultant
▪ M.D., Karol Marcinkowski University of Medicine
▪ Medical College of Virginia
▪ B.A. in Biology, Rutgers University
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R&D team
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Valeant R&D at a glance
200 + active
US programs
+
+
6 NDAs approved in last three years
43 R&D facilities 13
510K and PMA approvals in last three years 100
MD, PHD, PharmD, JD and DMD degrees
1,000 R&D and quality
employees
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R&D: Key messages
Our robust pipeline positions us well for future
growth
We are excited about our numerous upcoming
launches
We have a strong track record of launching products
We are the most productive R&D organization in the
industry
We have a distinctive R&D model with high quality people
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Our R&D activities look similar to
other Pharma companies…
▪ Study design leveraging TA expertise
▪ Input from KOLs and customers throughout the
development process
▪ Collaboration between R&D and commercial
▪ Outsourcing rather than fixed infrastructure
▪ Internal expertise in regulatory,
pharmacovigilance, quality, and medical
affairs
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Our execution of R&D makes our model distinctive
Eliminate non-value added
bureaucracy
Partner with third parties to leverage capabilities
Empower individuals and regions to make
their own decisions
Terminate non-promising assets
early, based on data
Take actions when needed,
rather than waiting for
committees
Embrace incremental
as well as transformative
innovation
Outside experts participate in key decision meetings
(e.g., portfolio reviews)
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Our productivity is higher than peers
Source: Evaluate Pharma, FDA, Capital IQ, Annual reports, Press search
0.1
0.2
0.2
0.2
0.2
0.2
0.2
0.3
0.3
0.3
0.3
0.5
1.2
2.1
Top 15 average
3.02
1 Refers to New Molecular Entity and Biologic License Application 2 Does not include Contact lenses and surgical devices. Does not include B+L and Salix approved products (Fulyzaq, Bepreve and Besivance) that
were not developed under the Valeant model; all other companies include acquired brands, which overstates their productivity
“
”
Innovation has nothing to
do with how many R&D
dollars you have. When
Apple came up with the
Mac, IBM was spending at
least 100 times more on
R&D. It's not about money.
It's about the people you
have, how you're led, and
how much you get it
- Steve Jobs
R&D Productivity for 15 PharmaCos with most approvals - 2009-’14 # of NMEs/BLAs1 per $B R&D spend
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107
We believe we are significantly more successful at
developing products than the industry
Source: Pharmaprojects 2014, Management Estimates
1 Average of all competitors from 2010-2014 2 2011-2015
Valeant’s success rate in dermatology2
20%18%
55%
100%
56%
69%
Ph. II Ph. III Ph. I
Valeant2
Industry1
Success rates in dermatology
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Global product launches
Source: Management estimates
32
131 218+ 32
Product launches1, 2014-’15
1 Includes global line products launched in Ex-US markets
76
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109
How our R&D pipeline was built
We continue to invest in TAs with attractive assets
We have acquired new platforms and capabilities in attractive TAs
In Dermatology, we have built capabilities from discovery to commercialization
Our selection and portfolio de-risking give us an advantage
Post-acquisition, we have supplemented the pipeline where required and de-risked where possible
We are building similar capabilities in Ophthalmology and GI
Internal Inherited In-licensed / purchased
Brodalumab
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110
We have dramatically expanded our significant US
R&D programs
1 US programs only; Includes generics; excludes 90+ programs related to post marketing commitments and other small programs 2 Prior to acquisitions in TA (e.g., B+L in 2013 and Salix in 2015) 3 Includes aesthetics, women’s health, and generics
Dec. 20151 Dec. 2010
Surgical 32 N/A2
17 Consumer 26
Dermatology 9 15
Contact lenses 9 N/A2
Ophthalmology 1 7
GI 6 N/A2
Others3 5 17
Total 32 112
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111
We have good depth of early and late
assets across TAs
1 Prior to Phase III for Pharma, 2018+ expected launch for others 2 Includes Phase III and FDA submitted products 3 Includes aesthetics, women’s health, and generics
8
4
12
6
4
5
7
22
6
20
3
2
12
1Opthalmology 7
Contact lenses 9
GI 6
Others3 17
Surgical
Dermatology 15
26 Consumer
32
40
early
72
late
112
total
Early1 Late2
Significant active US programs as of Dec. 2015
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US prescription and generic drugs pipeline Ophthalmology Generics Dermatology
GI In-house development Women’s health
Early stage (Pre Ph. III)
Late stage (Ph. III - submission)
Latanoprostene Bunod:
OAG
IDP-118: Psoriasis SAL-020: HAE IDP-120: Acne
IDP-121: Acne SAL-021: RA IDP-125: Actinic
keratosis
Relistor Oral: Opioid induced constipation
IDP-124: Atopic dermatitis
IDP-131: Psoriasis SAL-022: Diabetes
IDP-126: Acne IDP-122: Psoriasis
SAL-024: Crohn’s
SAL-023: Cirrhosis
BLG023: Anti-infective
IDP-127: Anti-fungal IDP-123: Acne
Brinzolamide Gx: OAG
BLO-020: Inflammation
IDP-128: Actinic keratosis
VAL-BRO-03: Psoriatic arthritis
SPT-201: HSDD
BLG020: Disclosing agent
IDP-129: Acne Brodalumab: Psoriasis
BLG021: Anti-infective
IDP-130: Acne BLO-021: Cystoid
Macular edema
BLG022: Anesthetic
EGP-437: Anterior uveitis
BLO-022: Post-operative
inflammation
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US OTC pipeline
CER-008: Lotion
CER-007: Lotion
CER-006: Wash
CER-009: Lotion
CER-005: Wash
CER-004: Ointment
CER-003: Oil
CER-002: Cream
CER-001: Oil
PUR-004: Bar
PUR-003: Wash
PUR-002: Wash
PUR-006: Cream
PUR-005: Cream
PUR-001: Wash
STS-001: Spray
CAL-001: Spray
ACF-002: Device
ACF-001: Lotion
BLO-026: Dry eye
OBG-006: Kit
BLO-024: Nutritional
BLO-023: Nutritional
BLO-025: Nutritional
OBG-005: Cleanser
OBG-004: Reformulation
OBG-003: Sunscreen
OBG-002: Skin lightener
OBG-001: Cleanser
BLO-029: Disinfectant
BLO-030: Disinfectant
BLO-028: Lubricant
BLO-027: Lubricant
Early stage Late stage
Aesthetics
Dermatology
Lens Care
Ophthalmology In-house development
Nutritionals
BLO-031: Eye whitener
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114
US Devices pipeline Aesthetics Contact lenses
Surgical In-house development
Late stage Early stage
BLS-021: Retina
BLS-023: Retina
BLS-022: Retina
BLS-024: Retina
BLS-026: Retina
BLS-027: Retina
BLS-028: Retina
BLS-029: Retina
BLS-030: Retina
BLS-031: Retina
BLS-025: Retina
BLS-032: OEM
SOF-010: Skin resurfacing
SOT-010: Fine Lines & wrinkles
SOT-011: Fine Lines & wrinkles
BLS-002: Cataract
BLS-003: Cataract
BLS-004: Cataract
BLS-005: Retina
BLS-006: Cataract
BLS-007: Cataract
BLS-001: Cataract
SOM-010 Vascular Lesions
BLC-008: Astigmatism
BLC-007: MF
BLC-009: Astigmatism
BLS-015: Cataract
BLS-016: Cataract
BLS-017: Therapeutics
BLS-018: Retina
BLS-019: Retina
BLS-020: Retina
BLS-014: Refractive
BLC-001: SVS
BLC-003: SVS/MF/fA
BLC-002: SVS
BLC-004: Toric
BLC-006: SVS
BLS-012: Retina
BLS-008: Cataract
BLS-009: Retina
BLS-010: Cataract
BLS-011: Cataract
BLC-005: SVS/MF
BLS-013: Retina
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Ex-US pipeline Dermatology In-house development Ophthalmology
Nutritionals Generics Women’s health Contact lenses
1 Excludes EU Generics (listed on the next page)
Aesthetics
Lens Care
Surgical
GI
Early stage1 Late stage1
XUN-004: Nutritional
XUN-003: Magnesium caps XUO-017: Lubricant XUV-001: Cosmetic
XUN-002: Vitamins XUO-016: Lubricant
XUV-006: Lubricant
XUN-001: Nutitional XUO-015: Dry eye XUD-008: Second degree burns
XUN-005: Nutritional
XUO-018: Lubricant XUV-002: Cosmetic
XUW-002: Osteoarthritis
XUV-003: Aphakia
XUG-002: OAG XUO-002: Glaucoma XUO-009: Glaucoma XUD-002: Sunscreen
XUG-003: Anti-fungal XUO-003: Dry eye XUO-010: Conjunctivitis XUD-003: Lotion
XUG-004: Oral Inflamatory Disorders
XUO-004: Glaucoma XUO-011: Inflammation XUD-004: Device
XUG-009: Hypertension
XUO-005: Lubricant XUO-012: Corneal lesions XUD-005: Cosmetic
XUG-001: RA XUO-001: Inflammation XUO-008: Dry eye XUD-001: cleanser
XUO-006: Decongestant XUO-013: Conjunctivitis XUD-006: Onychomycosis
XUO-014: Dry eye XUD-007: Cosmetics XUO-007: Decongestant
XUV-004: SVS
XUW-001: HSDD
XUV-005: Lubricant XUA-001: Hair removal
LAV-006: Lubricant
LAV-001: Aphakia
XUI-001: IBS-D
XUD-009: Emollient
XUN-006: Nutitional
XUN-007: Nutritional
XUV-007: MF
XUV-011: MF
XUV-008: Lubricant
XUV-009: SVS
XUV-010: Astigmatism
XUV-012: SVS
XUV-013: Astigmatism
XUV-014: Presbyopia
XUV-015: MF
XUG-006: Diabetes
XUG-007: Hypertension
XUG-008: Hypertension
XUG-005: Cholestrol
XUG-013: Vaginal Infections
XUG-010: Ocular lubricant
XUG-011: Anti-Inflammatory
XUG-012: Vaginal Infections
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EU generics pipeline In-house development
Early stage Late stage
EUG-012: Glaucoma EUG-044: 0 EUG-070: Copd EUG-095: Glaucoma EUG-026: Local hemostasis
EUG-013: Glaucoma EUG-045: Benign prostatic hyperplasia
EUG-071: Asthma EUG-096: Glaucoma EUG-027: Prevention of deep vein thrombosis
EUG-046: Benign prostatic hyperplasia
EUG-079: Allergy EUG-097: Glaucoma EUG-028: Chronic nevous insufficiency
EUG-047: Rheumatoid arthritis
EUG-080: Allergy EUG-098: Eye infections EUG-029: Chronic nevous insufficiency
EUG-048: Osteoporosis EUG-081: Pain EUG-099: Glaucoma EUG-030: Hypertension
EUG-051: Bacterial infections
EUG-082: Eye vitamins EUG-100: Glaucoma EUG-031: Hypertension
EUG-052: Cell lung cancer EUG-083: Allergy EUG-101: Glaucoma EUG-032: Hypertension, heart failure
EUG-057: Mlaignant melanoma
EUG-033: Hypertension, heart failure
EUG-001: Hypertension EUG-034: Hypertension EUG-059: Lung and pancreatic cancer
EUG-086: Adrenocortical insufficiency
EUG-014: Antispasmotic
EUG-002: Acne vulgaris EUG-035: Angina pectoris EUG-060: Pain EUG-087: Dry eye EUG-015: Hypertension
EUG-003: Atopic dermatitis EUG-036: Hypercholesterolemia
EUG-061: Pain EUG-088: Eye inflamation EUG-016: Dermtitis
EUG-004: Acne vulgaris EUG-037: Hypercholesterolemia
EUG-064: Schisofrenia EUG-089: Eye inflamation EUG-017: Antiseptic
EUG-005: Acne vulgaris EUG-038: Prevention of blod clots
EUG-065: Schisofrenia EUG-090: Dry eye EUG-018: Cough and cold
EUG-006: Hypertension EUG-039: Whitenning cream
EUG-066: Pain EUG-091: Eye infections EUG-019: Eye inflamation
EUG-009: Dermatitis EUG-040: Cosmetics EUG-067: Pain EUG-092: Eye inflammation EUG-020: Chemotherapy induced nauzea
EUG-010: Severe acne EUG-041: Atopic dermatitis EUG-068: Cough and cold EUG-093: Allergy EUG-021: Type II diabetes
EUG-011: Hyperuricemia EUG-042: Bacterial skin lesions
EUG-069: Asthma, copd EUG-094: Dry eye EUG-022: Haemorrhoids - early stage
EUG-084: Glaucoma
EUG-058: Myeloma EUG-085: Allergic conjuctivitis
Generics
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Select pipeline opportunities
Brodalumab
Relistor Oral
Latanoprostene Bunod (LBN)
Drug1 Indication Expected launch
US Prevalence
Opioid induced constipation (OIC) with chronic non-cancer pain
2017/18 IDP118 Moderate to severe plaque psoriasis
Reduction of Intraocular pressure in patients with Open Angle Glaucoma (OAG) and Ocular hypertension
2016
2016
2016
~9.5M
~3.7M
~3.0M
Source: Decision Resources, BioMed Tracker
Moderate to severe plaque psoriasis
~9.5M
1 Product candidates, not yet approved by the FDA
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Relistor Oral could be a new option for patients
suffering from opioid induced constipation (OIC) with
chronic non-cancer pain
Source: Digestive Disease Week, 2012 (R. Rauck, J.Peppin, R.Israel, J. Carpentino, J.Cohn, S.Huang, E.Bortley, C.Paterson, W.Forbes)
1 Peripherally acting, selective μ-opioid receptor antagonist with restricted CNS penetration 2 Product candidate, not yet approved by the FDA 3 Rescue-free bowel movement - defined as a bowel movement that occurred without laxative use (i.e., no laxative use within 24 hrs prior to the
bowel movement); tested for within 4 hours of dosing during daily dosing period 4 Severe adverse events
27.424.618.1
MNTX 450 mg MNTX 300 mg Placebo
28.9
9.4
Placebo 12 mg QD
MNTX 3201 Oral formulation Primary Efficacy Endpoint (% of
respondents1)
MNTX 3356 SC Formulation Co-Primary Efficacy Endpoint
▪ Subcutaneous injection currently approved for OIC in patients with advanced illness and chronic non-cancer pain
▪ Oral methylnaltrexone2 300 mg and 450 mg significantly increased the percentage of patients with a RFBM3 within 4 hours
▪ Incidence of SAEs4 was 3% in the all tested groups versus 4% in the placebo group
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Latanoprostene Bunod (LBN) ophthalmic solution
(0.024%) combines Latanoprost and Nitric Oxide in a
single molecule to lower Intraocular pressure (IOP)
LBN will be the first novel OAG monotherapy approved in 20 years:
▪ Nitric oxide plays a key role in numerous functions throughout the body including many well documented functions in the healthy eye1
▪ Glaucoma patients have lower levels of ocular nitric oxide than those observed in normal eyes2,3
▪ LBN4 lowers IOP by increasing outflow through both the uveoscleral and trabecular meshwork pathways
▪ PDUFA date – July 21st 2016
1 Culotta E, et al. Science. 1992;258:1862-5 2 Nathanson JA, et al. Invest Ophthalmol Vis Sci. 1995;36:1774-84 3 Galassi F, et al. Br J Ophthalmol. 2004;88:757-760 4 Product candidate, not yet approved by the FDA
Source: Mayo Clinic
Open Angle Glaucoma (OAG)
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Clinical Studies Support Viability of LBN (1/2)
Summary of Phase II results Reduction in mean diurnal IOP on day 7, 14 and 28
9.08.9
8.3
7.87.7
7.3
Day 14 Day 28 Day 7
Latanoprostene bunod 0.024%
Latanoprost 0.005%
P = 0.033 P = 0.015 P = 0.005
In a Phase II dose-ranging study, LBN3 showed positive results including consistently better control of IOP over 28 days as well as a statistically significant greater percentage of responders vs. latanoprost 0.005%1,2
1 Defined as patients achieving an IOP ≤18 mm Hg 2 Weinreb RH, et al. Br J Ophthalmology. 2015;99:738-45 3 Product candidate, not yet approved by the FDA
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Clinical Studies Support Viability of LBN (2/2)
Summary of results of two phase III pivotal studies
▪ In two phase III studies LBN provided a mean IOP reduction of 7.5-9.1 mm Hg over three months of treatment (statistically superior to timolol between 2 and 12 weeks)1
▪ LBN3 was safe and well tolerated with no significant adverse events.1,2 Rates for hyperemia were comparable to latanoprost2
1 Data on file 2 Weinreb RH, et al. Br J Ophthalmology. 2015;99:738-45 3 Product candidate, not yet approved by the FDA
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R. Todd Plott, MD Dermatologist
Background
▪ 16 years in the pharmaceutical drug development
including at Medicis Pharmaceuticals
▪ Led the development of Solodyn, Vanos, Ziana,
Loprox Shampoo and Ammunol while at Medicis
▪ Over the past 5 years, in solo dermatology practice
in Ft Worth, TX
▪ Unpaid (expenses only paid) Valeant R&D
consultant; holds no Valeant stock
Education
▪ University of Texas Medical Branch Galveston, M.D.
▪ University of Arkansas Heath Sciences - Intern and
Dermatology Residency
▪ National Cancer Institute - Fellowship
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• Patients have a medical need for the unique
dermatology drug products that manufacturers provide
• Access to these drugs can be a problem
• Many manufacturers offer drug assistance programs for
patients
• Drug assistance programs have been very helpful to
patients
• Patients do better when they get the medications that
they need
My observations
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IDP118 – Topical Treatment of Psoriasis
▪ A combination topical drug product1 containing and
retinoid and a steroid
▪ Phase II clinical results suggest the combination is
superior to the individual components
▪ Expected completion Phase III Studies - Q4 2016
1 Product candidate; not yet approved by the FDA
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Brodalumab is an anti–interleukin-17 receptor-A
mAB that could address moderate-to-severe psoriasis
▪ Brodalumab 210 mg was superior to placebo and to ustekinumab1 in treatment of moderate-to-severe psoriasis
▪ Symptoms of psoriasis reduced ~2x faster than the median response time with ustekinumab (4.1 weeks vs. 8.1 weeks)2
▪ Results for Brodalumab3 210 mg were confirmed in two phase III studies
Source: New England Journal of Medicine (M. Lebwohl, B. Strober, A. Menter)
1 At week 12, PASI 75 response rates were significantly higher with brodalumab at a dose of 210 mg and at a dose of 140 mg than with placebo 2 Tested median time to a PASI 75 response for patient arm given 210 mg of brodalumab every 2 week 3 Product candidate, not yet approved by the FDA
PASI 75 response
PASI 100
response
0
50
100
69%
09
6%
12 05
85%
10
Week
69%
Response rate (%)
11 07 06 08 04 02 03 1
0
50
100
03 10 04 08 07 05
0.3% 19%
02 09 06 11 1
Response rate (%)
Week
12
37% 27%
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Looking forward
▪ We have a history of successes
across key therapeutic areas
▪ We have intelligently invested in
R&D to build a deep and exciting
pipeline
▪ I am passionate about our R&D
model and strategy, and confident
about the future
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Drivers of Valeant’s success
Our decentralized model and talented people, which give
us a competitive edge (speed of decision making and in-
depth customer knowledge)
Our collection of great healthcare brands around the
world
Our innovative strategies (often disruptive), which have
challenged industry convention
Our relentless focus on providing easy and affordable
access for physicians and patients
Our exceptionally productive approach to R&D
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EMT
J. Michael Pearson Chairman of the Board and Chief Executive Officer
Robert Chai-Onn Executive Vice President, General Counsel and Chief Legal Officer
Robert Rosiello Executive Vice President and Chief Financial Officer
Dr. Pavel Mirovsky President and General Manager, Europe
Dr. Ari Kellen Executive Vice President/Company Group Chairman
Anne Whitaker Executive Vice President/Company Group Chairman
Deb Jorn Executive Vice President Dermatology and GI
Tom Appio Sr. Vice President - Asia Pacific, Managing Director, China
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Senior Management Team Panel
J. Michael Pearson
Chairman of the Board
and Chief Executive Officer
Robert Rosiello
Executive Vice President
and Chief Financial Officer
Dr. Pavel Mirovsky
President and General
Manager, Europe
Dr. Ari Kellen
Executive Vice
President/Company Group
Chairman
Anne Whitaker
Executive Vice
President/Company Group
Chairman
Deb Jorn
Executive Vice President
Dermatology and GI
Tanya Carro
Senior Vice President,
Finance and
Corporate Controller
Dr. Tage Ramakrishna
Chief Medical Officer,
Head of R&D and Quality
Tracy Valorie
Senior Vice President and
General Manager,
Women’s Health and
Bausch + Lomb
Pharmaceutical Division
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Financial guidance appendix
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To supplement the financial measures prepared in accordance with U.S. generally accepted accounting
principles (GAAP), the company uses the following non-GAAP financial measures: Adjusted EPS, non-GAAP
revenue, non-GAAP cost of goods, non-GAAP selling, general and administrative expenses, Adjusted Cash flow from Operations. Reconciliations of these non-GAAP financial measures to their most directly comparable
GAAP financial measure can be found in our earnings release and Form 8-K on Tables 2 through 2b, Table 3,
Table 4 and Table 5.2, respectively. A copy of the earnings release, including financial schedules, is posted on
the “Investors” section of the Valeant.com website. In addition, Adjusted EBITDA is a non-GAAP financial measure that will be provided in our earnings releases and Form 8-K going forward.
The Company does not provide guidance with respect to GAAP financial measures other than revenues or
provide reconciliations to GAAP of its forward-looking [non-GAAP financial measures] due to the inherent
difficulty in quantifying certain amounts that would be required to be included in the GAAP measure of
earnings per share due to their unknown effect, timing and potential significance. Examples of these items
include impairments of assets, gains and losses from the extinguishment of debt, legal settlements, purchases of
in-process research and development assets, and gains and losses from asset sales. Accordingly, the GAAP
calculation of projected net income (loss) is not available for Valeant without unreasonable efforts.
By disclosing the non-GAAP financial measures referenced above, management intends to provide investors
with a meaningful, consistent comparison of the company’s baseline operating results and trends for the periods presented by excluding items that are considered by the company not to be reflective of the
company’s ongoing results. Management uses all of the above named non-GAAP financial measures internally
for strategic decision making, forecasting future results and evaluating current performance. [For example: to
set internal budgets, evaluating company performance, setting incentive compensation targets and planning
and forecasting of future periods] 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.
Definition of terms
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Adjusted EPS* (non-GAAP) multiplied by Shares Outstanding
Add:
Taxes
Interest
Share Based Compensation
Depreciation
Adjusted EBITDA*
Note: Adjusted EBITDA as defined in our Credit Agreement excludes certain charges and
includes certain pro forma adjustments for acquisitions and divestitures. Details of the
Adjusted EBITDA calculations per our Credit Agreement can be found in our Credit
Agreement, which is filed as an exhibit to our 10-K and can be found in the investor relations
section of the Valeant website.
* See Page * Non-GAAP
Adjusted EBITDA calculation