jnj earnings presentation 4q2015

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$JNJ Earnings 4Q 2015

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  • 1

    4th Quarter 2015

    Earnings Call Presentation

    January 26, 2016

  • 2

    Louise Mehrotra

    Vice President

    Investor Relations

  • 3

    Note on Forward-Looking Statements These presentations contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, future operating and financial performance, product development, market position, business strategy and restructuring plans. The viewer is

    cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying

    assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and

    projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to, economic factors, such as interest rate and currency exchange

    rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges and uncertainties inherent

    in new product development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and

    existing products; impact of business combinations and divestitures; challenges to patents; the impact of patent expirations; the ability of the company to

    successfully execute strategic plans, including on-going restructuring plans; any required consultation procedures relating to restructuring workforce

    actions, the potential that the expected benefits and opportunities related to the restructuring may not be realized or may take longer to realize than

    expected; market conditions and the possibility that the share repurchase program may be suspended or discontinued; significant adverse litigation or

    government action, including related to product liability claims; changes to applicable laws and regulations, including global health care reforms; trends

    toward health care cost containment; changes in behavior and spending patterns or financial distress of purchasers of health care products and services;

    financial instability of international economies and legal systems and sovereign risk; manufacturing difficulties or delays, internally or within the supply

    chain; product efficacy or safety concerns resulting in product recalls or regulatory action; increased scrutiny of the health care industry by government

    agencies; and the potential failure to meet obligations in compliance agreements with government bodies. A further list and description of these risks,

    uncertainties and other factors can be found in Johnson & Johnsons Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including Exhibit 99 thereto, and the companys subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.investor.jnj.com, or on request from Johnson & Johnson. Any forward-looking statement made in these presentations speaks only as

    of the date of these presentations. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or

    future events or developments.

    Note on Non-GAAP Financial Measures These presentations refer to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered replacements for, and

    should be read together with, the most comparable GAAP financial measures.

    A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying

    financial schedules of the earnings release and the Investor Relations section of the Companys website at www.investor.jnj.com.

  • 4

    Strategic Partnerships, Collaborations and Licensing Arrangements During the course of this mornings presentations, we will discuss a number of products and compounds developed in collaboration with strategic partners or licensed from other companies. Following is an acknowledgement of those relationships.

    Neuroscience: INVEGA SUSTENNA/XEPLION includes technology licensed from Alkermes, Inc.; RISPERDAL CONSTA developed in collaboration with Alkermes

    Cardiovascular/Metabolism: XARELTO co-developed with Bayer HealthCare; INVOKANA/INVOKAMET licensed from Mitsubishi Tanabe Pharma Corporation

    Immunology: REMICADE and SIMPONI marketing partners are Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. and Mitsubishi Tanabe Pharma Corporation; sirukumab developed in collaboration with GlaxoSmithKline PLC

    Infectious Diseases & Virology: OLYSIO in US, GALEXOS in Canada and SOVRIAD in Japan developed in collaboration with Medivir AB; PREZCOBIX / REZOLSTA fixed-dose combination and Rilpivirine +F/TAF FDC developed in collaboration with Gilead Sciences, Inc.

    Oncology: VELCADE developed in collaboration with Millennium: The Takeda Oncology Company; IMBRUVICA developed in collaboration with Pharmacyclics, Inc.; DARZALEX licensed from Genmab A/S; ZYTIGA licensed from BTG International Ltd.; YONDELIS developed in collaboration with Pharma Mar S.A.

    Orthopaedics: MONOVISC/ORTHOVISC licensed from Anika Therapeutics, Inc.

  • 5

    4th Quarter 2015 Sales by Geographic Area

    % Change

    TOTAL COMPANY 4Q 2015 4Q 2014 Reported Operational*

    U.S. $9.3 $8.6 8.0 8.0

    Europe 4.0 4.6 (12.2) 0.8

    Western Hemisphere

    (ex U.S.) 1.4 1.8 (19.1) 2.8

    Asia-Pacific, Africa 3.1 3.3 (7.1) 0.9

    International 8.5 9.7 (11.7) 1.2

    Worldwide (WW) $17.8 $18.3 (2.4) 4.4

    * Excludes impact of translational currency

    $ U.S. Billions, except EPS

  • 6

    4th Quarter 2015 Financial Highlights

    * Excludes impact of translational currency

    ** Non-GAAP measure; excludes intangible amortization expense and special items; see reconciliation

    $ U.S. Billions, except EPS

    4Q 2015 4Q 2014 % Change

    Sales $17.8 $18.3 (2.4) Total

    4.4 Ops*

    GAAP Earnings 3.2 2.5 27.5

    GAAP EPS 1.15 0.89 29.2

    Adjusted Earnings** 4.0 3.9 4.0

    Adjusted EPS** 1.44 1.37 5.1 Total

    12.4 Ops*

  • 7

    2015 2014 % Change

    Sales $70.1 $74.3 (5.7) Total

    1.8 Ops*

    GAAP Earnings 15.4 16.3 (5.6)

    GAAP EPS 5.48 5.70 (3.9)

    Adjusted Earnings** 17.4 18.3 (4.8)

    Adjusted EPS** 6.20 6.39 (3.0) Total

    5.8 Ops*

    Free Cash Flow*** 15.9 14.8 7.4

    Full Year 2015 Financial Highlights

    * Excludes impact of translational currency

    ** Non-GAAP measure; excludes special items; see reconciliation

    *** Non-GAAP measure; defined as operating cash flow less capital spending; estimated as of 1/26/16

    $ US Billions, except EPS

  • 8

    Consumer Highlights 4th Quarter 2015

    Key Drivers of Operational Performance*

    Skin Care

    U.S. negatively impacted by timing of shipments and

    inventory builds

    OUS new products partially offset by soft sales in China

    Women's Health

    OUS new products & sales momentum

    Wound Care/Other

    Excluding divestitures +~6.5%

    Total Consumer

    Excl. net impact of Acq./Div.**, WW growth +4.7%, U.S.

    +1.7%, OUS +6.3%

    Additional shipping days contributed ~4% to J&J WW

    growth

    Baby Care

    New product launches partially offset by soft sales in China

    Oral Care

    LISTERINE successful marketing campaigns &

    geographic expansion

    OTC

    U.S. ZYRTEC strong consumption & re-launched

    digestive health products

    U.S. analgesics +3% share growth partially offset by slow

    start to flu season U.S. adult $ share ~13.5%

    U.S. pediatric $ share ~45.5%

    OUS growth driven by upper respiratory including inventory

    build & anti-smoking product

    re-launches

    Sales: $3.3B Ops Change*: WW 1.8%, U.S. (4.9%), Intl 5.5%

    CONSUMER

    SEGMENT

    TOTAL WW

    SALES $MM

    REPORTED

    % GROWTH

    OPERATIONAL

    % GROWTH*

    Baby Care $484 (7.6%) 3.7%

    Oral Care 408 (1.4) 8.2

    OTC 1,045 (2.6) 8.2

    Skin Care 871 (8.9) (1.1)

    Womens Health

    283 (8.1) 7.4

    Wound

    Care/Other 229 (30.8) (26.7)

    Total

    Consumer $3,320 (7.9%) 1.8%

    * Excludes impact of translational currency ** Non-GAAP measure; see reconciliation

  • 9

    Pharmaceutical Highlights 4th Quarter 2015

    Key Drivers of Operational Performance*

    Oncology (cont.)

    Strong launch of DARZALEX

    ZYTIGA strong U.S. market growth

    partially offset by share decline

    OUS - strong sales in Asia

    Pac/Africa; Canada and LA partially

    offset by lower sales in Europe due to

    increased competition

    Cardiovascular / Metabolism /

    Other**

    INVOKANA/INVOKAMET achieved

    6.5% TRx share in defined U.S. T2D

    market and ~13%TRx share with

    endocrinologists

    XARELTO continued novel oral

    anticoagulant U.S. market leadership;

    16.1% TRx share of broader oral

    anticoagulant market

    Total Pharmaceutical

    Excl. net impact of Acq/Div and Hep C

    sales***, WW growth +11.1%, U.S.

    +21.0% and OUS -0.2%

    Additional shipping days contributed

    ~4% to J&J WW growth

    Immunology

    Strong U.S. immunology market

    growth and increased penetration

    of SIMPONI ARIA

    OUS - Strong results for STELARA

    due to increased penetration of PsA

    indication partially offset by lower

    sales to distribution partner for

    REMICADE and SIMPONI

    Infectious Diseases

    Lower sales of hepatitis C products

    due to competitive launches

    Increased sales of HIV products with

    introduction of PREZCOBIX

    Neuroscience

    Long-acting injectable products

    growth of +13% WW ;+30% U.S.;

    uptake of INVEGA TRINZA

    CONCERTA positive impact of

    reclassification of generic competitor

    products in U.S.

    Oncology

    Sales of IMBRUVICA due to

    strong patient uptake, additional

    country launches; US share leader

    2nd line CLL & MCL

    Sales: $8.1B Ops Change*: WW 6.5%, U.S. 12.7%, Intl (0.9%)

    PHARMACEUTICAL

    SEGMENT

    TOTAL WW

    SALES $MM

    REPORTED

    % GROWTH

    OPERATIONAL

    % GROWTH*

    Immunology $2,771 7.5% 11.7%

    Infectious Diseases 801 (25.6) (20.4)

    Neuroscience 1,601 (3.0) 3.9

    Oncology 1,273 5.0 14.8

    Cardiovascular/

    Metabolism/ Other ** 1,618 9.2 13.0

    Total Pharma $8,064 0.8% 6.5%

    * Excludes impact of translational currency

    ** Previously referred to as Other *** Non-GAAP measure; see reconciliation

  • 10

    Medical Devices Highlights 4th Quarter 2015

    Key Drivers of Operational Performance*

    Orthopaedics (cont.)

    Results OUS were negatively impacted by softer demand and a reduction in

    inventory levels primarily in China

    Pricing pressure across major categories partially offset by mix for Trauma & Spine

    Surgery

    Advanced endocutters +15%, biosurgicals +9%, energy +5%

    General Lower sales of womens health & urology partially offset by growth in

    sutures & topical adhesives

    Specialty growth driven by ASP & Mentor products

    Vision Care

    Strong growth in U.S. due to new product introductions & trade inventory build

    Total Medical Devices

    Excl. net impact of Acq./Div.**, WW growth +5.8%, U.S. +8.0%, OUS +3.9%

    Additional shipping days contributed ~4% to J&J WW growth

    Cardiovascular

    WW electrophysiology +19%; driven by strong growth of THERMOCOOL

    SMARTTOUCH Contact Force

    Sensing Catheter

    Impacted by divestiture of Cordis business in 4Q 2015

    Diabetes

    ANIMAS VIBE strong double digit growth & SMBG volume growth

    partially offset by lower price

    Diagnostics

    Divestiture of Ortho-Clinical Diagnostics in June 2014

    Orthopaedics

    Hips - driven by primary stem platform

    Knees - strong sales of ATTUNE Knee System

    Trauma global launch of TFNA nail

    Spine & Other - ORTHOVISC

    /MONOVISC strong contributor to

    growth; WW Spine (2%), U.S. +3%,

    OUS (9%),

    Sales: $6.4B Ops Change*: WW 3.4%, U.S. 6.7%, Intl 0.6%

    MEDICAL DEVICES

    SEGMENT

    TOTAL WW

    SALES $MM

    REPORTED

    % GROWTH

    OPERATIONAL

    % GROWTH*

    Cardiovascular $439 (21.3%) (16.4%)

    Diabetes 480 (6.6) 2.2

    Diagnostics 24 71.4 N/M

    Orthopaedics 2,423 (0.7) 4.5

    Hips 354 1.1 6.4

    Knees 405 1.0 5.5

    Trauma 644 0.8 6.3

    Spine & Other 1,020 (2.9) 2.4

    Surgery 2,413 (2.5) 4.7

    Advanced 870 2.5 9.7

    General 1,147 (8.5) (1.0)

    Specialty 396 5.9 12.4

    Vision Care 648 0.3 8.4

    Total Med Dev $6,427 (3.3%) 3.4%

    * Excludes impact of translational currency ** Non-GAAP measure; see reconciliation

  • 11

    Important Developments in 4th Quarter 2015 Pharmaceutical:

    U.S. Food and Drug Administration (FDA) approval of DARZALEX (daratumumab) for the treatment of double refractory multiple myeloma

    U.S. FDA approval of YONDELIS (trabectedin) for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma

    European Commission approval of EDURANT (rilpiravine) in combination with other anti-retroviral agents, for treatment-nave adolescent patients aged 12 to 18 years with human immunodeficiency virus-1 (HIV-1) infection

    U.S. FDA New Drug Application (NDA) submitted for INVOKAMET XR, a once-daily therapy combining fixed doses of canagliflozin and metformin hydrochloride extended release for the treatment of adults with type 2 diabetes

    U.S. FDA and European Medicines Agency (EMA) submissions for STELARA (ustekinumab) for the treatment of adult patients with moderately to severely active Crohn's disease

    U.S. FDA and EMA submissions for IMBRUVICA (ibrutinib) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma in combination with bendamustine and rituximab; EMA submission for patients with relapsed/refractory mantle cell lymphoma

    European Extension Marketing Authorization Application submitted for IMBRUVICA (ibrutinib) for treatment-nave chronic lymphocytic leukemia

    Completion of the acquisition of Novira Therapeutics, Inc.

    Medical Devices:

    U.S. FDA approved the pediatric indication for the Animas Vibe insulin pump

    Completion of the acquisition of Coherex Medical, Inc.

    The company announced the restructuring of certain Medical Devices businesses

  • 12

    Alex Gorsky

    Chairman of the Board

    &

    Chief Executive Officer

  • 13

  • 14

    Our Responsibility to Help Lead

    the Way to A Better Future

    Growing Global Challenge:

    Aging population

    Rising costs in health care

    Growing middle classes in emerging economies

    Access to quality health care

  • 15

    BROAD GLOBAL

    FOOTPRINT

    PARTNER OF

    CHOICE

    ENTERPRISE

    CAPABILITIES &

    EFFICIENCIES

    BREAKTHROUGH

    INNOVATION

    STRONG

    FINANCIAL

    PERFORMANCE

    Our Broad-Base Advantage

  • 16

    Creating Value Through Global Reach

    & Local Focus

    New operating models

    Strong relationships with local governments/health systems;

    medical communities

    Robust investments in market appropriate portfolios

    and R&D centers

    Strategic acquisitions and partnerships with local players

    to further accelerate growth

    to reach more consumers and patients

    Building on a strong position

    2015 Sales: $70.1B

    80% Developed

    20% Emerging

    51% US

    49% OUS

    BROAD GLOBAL

    FOOTPRINT

  • 17

    Johnson & Johnson as the Partner of Choice

    Johnson & Johnson

    Differentiators:

    Scale and depth

    Financial flexibility

    Breadth of business and health care expertise

    Hospital Systems

    Early-Stage Innovators

    Information Technology Companies

    CUSTOMER

    SOLUTIONS

    Public Health

    Organizations

  • 18

    Insulin Glucagon

    Somatostatin DAPI

    Cell Therapy

    for Diabetes

    Developing a

    combination biologic-

    device product with

    insulin producing cells

    encapsulated in an

    immune-isolation device

    Obesity / Diabetes

    Leveraging innovative

    device, pharma and

    consumer capabilities

    to treat and / or

    prevent obesity and

    diabetes

    Eye Health

    Bringing together novel

    pharma / surgical / cell

    based therapies and

    vision care insights

    and technologies for

    a comprehensive

    approach

    Cell Therapy for AMD

    Bringing together

    novel pharma / vision

    technologies for an

    innovative therapy

    treatment for age-

    related macular

    degeneration

    Driving Innovation with Cross-Segment Collaborations

    PHARMACEUTICAL MEDICAL DEVICES CONSUMER

    China Lung

    Cancer Center

    Developing a holistic

    approach to treat lung

    cancer in China

    BREAKTHROUGH

    INNOVATION

  • 19

    Enterprise Capabilities to Enable

    Our Business ENTERPRISE

    CAPABILITIES &

    EFFICIENCIES

    Our Strategy

    Enable business growth through supply chain

    innovation

    Make quality a competitive advantage, focused on

    prevention

    Set new benchmarks for medical safety

    Leverage Enterprise Standards

    and Productivity to drive

    business growth

    Our Actions and Results

    One Johnson & Johnson Supply Chain

    Implemented the Johnson & Johnson Quality Policy and

    quality standards across our

    Family of Companies

    Clinical research transparency: Johnson & Johnson / Yale Open

    Data Access agreement

    Achieving operational savings to support our growth: Targeting $1B

    by 2018

  • 20

    A Strong, Consistent, Sustainable Business STRONG FINANCIAL

    PERFORMANCE

    * Non-GAAP measure; excludes intangible amortization expense, special items and the impact of translational currency

    ** Inclusive of the April 2015 dividend declaration

    *** Non-GAAP measure; defined as operating cash flow less capital spending; estimated as of 1/22/16

  • 21

    Performance Driven Strategy

    GROW SALES

    FASTER

    THAN THE

    MARKET

    GROW EARNINGS

    FASTER THAN

    SALES

    CREATE VALUE

    THROUGH

    STRATEGIC

    ACQUISITIONS &

    PARTNERSHIPS

    COMPELLING

    LONG-TERM

    TOTAL

    SHAREHOLDER

    RETURNS

    GENERATE

    STRONG

    DIVIDEND YIELD

  • 22

    Our Near-Term Priorities

    ENTERPRISE Delivering on our financial and quality commitments

    PHARMACEUTICAL Continuing to build on our launch excellence

    and robust pipeline

    MEDICAL DEVICES Accelerating growth through innovation and transforming

    our go-to-market models

    CONSUMER Expanding market leadership in key segments within OTCs,

    Oral Care, Baby and Beauty

  • 23

    A Market Leader Across All Segments

    Market Leadership

    One of the largest and fastest growing Pharmaceutical companies in

    the world

    Most comprehensive Medical Devices business in the world

    Market-leading Consumer Health Care company, with trusted brands

    endorsed by professionals globally

    2015 Sales: $70.1B*

    Pharma

    Medical

    Devices

    $28.5B

    $28.1B

    $14.7B

    Consumer

    $25.1B

    $31.4B

    $13.5B

    * The sum of the segments do not equal the total due to rounding

  • 24

    Our Strategy

    Focus innovation on

    five therapeutic areas

    Deliver continued growth with

    our current core billion-dollar-

    plus products

    Maximize our existing

    in-market portfolio, which

    includes seven products

    launched since 2009 that have

    multi-billion dollar potential

    Invest in our future with 10

    new products we plan to file by

    2019, each with billion-dollar-

    plus potential

    Our Actions and Results

    16 new product launches

    since 2009, driving cumulative

    sales of ~$41B

    6 new products1 achieved

    >$1B in sales in last 12 months

    U.S. approval for DARZALEX,

    the first human monoclonal

    antibody, 4 months ahead

    of schedule

    More than 70 novel compounds

    in early development and

    approximately 150 ongoing

    discovery projects

    Pharmaceutical

    Industry-Leading Pipeline and Commercial Excellence

    1 Products launched since 2009

  • 25

    Pharmaceutical

    Key Pipeline Events for 2016 Potential Approvals*

    DARZALEXTM Double Refractory Multiple Myeloma (EU)

    IMBRUVICA CLL Frontline (US/ EU)

    MCL Relapsed (EU)

    CLL 2nd Line No prior Bendamustine (US/ EU)

    INVOKAMET Initial Therapy Fixed Dose with Metformin (US)

    INVOKAMET XR Fixed Dose Combo with Metformin XR (US)

    3-Month Paliperidone

    Palmitate Schizophrenia (EU)

    STELARA Crohns Disease (US)

    EDURANT STR Single tablet regimen for HIV (US/ EU) (Rilpivirine + F/TAF FDC)

    Planned Submissions

    Sirukumab Rheumatoid Arthritis (US/ EU)

    Guselkumab Psoriasis (US/ EU)

    DARZALEXTM Relapsed/Refractory Multiple

    Myeloma (US/EU)

    Potential Clinical Data Presentations

    Phase 3

    DARZALEXTM Relapsed/Refractory Multiple Myeloma

    Guselkumab Psoriasis

    SIMPONI /

    SIMPONI ARIA AS, PsA and UC

    Sirukumab Rheumatoid Arthritis

    STELARA Crohns Disease

    INVEGA TRINZA Schizophrenia

    ZYTIGA Prostate cancer

    Phase 2

    3DAA FDC (AL-335 + odalasvir + simeprevir) Hepatitis C

    IMBRUVICA Refractory Follicular Lymphoma

    * Based on submissions in 2015

  • 26

    Our Strategy

    Focus on key consumer need states

    and 12 megabrands

    Leverage new marketing models and brand-building

    competitive advantage

    Develop insight-led innovation grounded in

    science, endorsed by

    professionals

    Improve margins by reducing costs and

    complexity

    Our Actions and Results

    Delivered double-digit growth in key emerging

    markets like Russia, India and

    Brazil*

    Exceeded market share in Oral Care, Feminine Care

    and US OTC

    Nearly all OTC products returned to shelves with

    additional sizes and flavors

    to be introduced during 2016

    FDA notification that all of our US OTC manufacturing

    facilities are in conformity

    Consumer

    Iconic Brands and Unparalleled Consumer Insights

    * Operational growth vs. full year 2014

  • 27

    Our Strategy

    Drive growth in priority platforms through innovation

    and launch excellence

    Sustain our leadership in foundation platforms

    Leverage our breadth and scale through novel

    commercial models

    Invest in areas of significant unmet need

    Our Actions and Results

    Strong sales performance in endocutters, biosurgicals and

    electrophysiology*

    Shifting more resources to priority platforms and key markets

    Ethicon and DePuy Synthes Joint Reconstruction and Spine, now

    co-selling in over 1200 accounts

    Acquisition of Coherex Medical in the area of atrial fibrillation and

    surgical robotics collaboration

    with Verily

    Medical Devices

    Comprehensive Portfolio and Accelerated Growth Strategy

    * Operational growth vs. full year 2014

  • 28

    Key Takeaways

    Focusing on near-term priorities

    Delivering on our financial and quality commitments

    Building on pharmaceutical launch excellence

    & robust pipeline

    Accelerating our growth in Medical Devices

    through innovation and by transforming our

    go-to-market models

    Expanding our market leadership in key consumer

    segments: OTC, Oral Care, Baby and Beauty

    Positioned well for the future

    Broad base in health care a competitive advantage

    Optimistic about opportunities in

    health care

  • 29

    Dominic Caruso

    Vice President, Finance

    &

    Chief Financial Officer

  • 30

    Full Year 2015 Condensed Consolidated Statement of Earnings (Unaudited; Dollars and Shares in Millions Except Per Share Figures)

  • 31

    4th Quarter 2015 Condensed Consolidated Statement of Earnings (Unaudited; Dollars and Shares in Millions Except Per Share Figures)

  • 32

    2015** 2014

    Adjusted Income Before Tax by Segment*

    * Non-GAAP measure; excludes amortization expense and special items; see reconciliation at www.investor.jnj.com

    ** Estimated as of 1/26/16.

    $22.0B $22.8B

    Pharmaceutical

    Medical Devices

    Consumer

    Expenses Not Allocated

    to Segments

    2015 2014

    Pharmaceutical 39.1% 39.6%

    Medical Devices 35.6% 32.0%

    Consumer 14.3% 15.4%

    Total 31.4% 30.7%

    % to Sales

    $12.8

    $8.8

    $2.2 $1.9

    $8.9

    $12.3

    ($1.1) ($1.0)

  • 33

    Save the Date

    Consumer and Medical Device Business Review

    Wednesday, May 18, 2016

    Hyatt Regency, New Brunswick