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RSNA Hologic Presentation 2012
RSNA Hologic Presentation 2012
7
Safe Harbor
With the exception of historical information, the statements set forth in this
presentation include forward-looking statements that involve risks and
uncertainties. The Company wishes to caution that a number of important
factors could cause actual results to differ materially from those in the
forward-looking statements. These and other factors which could cause
actual results to differ materially from those in the forward-looking
statements are discussed in the Company’s filings with the Securities and
Exchange Commission, including its recent filings on Forms 10-K and 10-Q.
Hologic, APTIMA, C-View, Dimensions, Gen-Probe, MyoSure, TIGRIS, PANTHER, Selenia and associated logos are
trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other
countries.
Agenda
Welcome Deb Gordon, CPA - Vice President, Investor
Relations
What’s New at RSNA Glenn Muir, Executive Vice President and Chief
Financial Officer
What to Look for at RSNA Peter Soltani, Senior VP & GM, Breast Health
Line of Business
Q&A All
RSNA Facts
Q4 Review
Glenn Muir
Executive Vice President
and Chief Financial Officer
10
RSNA 2012 Patient’s First
• More than 60,000 people
will attend
• 27,000 medical
professionals
13
14
We expect breast
tomosynthesis will
dominate the attention of
RSNA attendees
Leadership
16
…And Growth
• Record Q4 revenues
• Growth in all four operating segments
• Welcoming Gen-Probe into the Hologic family
• Key products in early stages of introduction
• Key products with continued growth
• Recent new product approvals/clearances
17
What to Look for
from Hologic at
RSNA
18
Dimensions Clinical Applications
2D Screening
2D Diagnostic
Stereotactic Biopsy
Combo Screening
3D Diagnostic
New Capabilities
#1 Hologic C-View
– Pending FDA
approval
– Available outside
U.S.
– C-View interest is
high
#2 Contrast Enhanced 2D Imaging
CE2D is:
– Iodine contrast on the Tomo platform to provide
functional information about cancers
– A Selenia Dimensions licensed option
– CE marked for EU
– Pending FDA approval
#3 Tomo-guided Biopsy
– Targeting solution
for cancers only
visible with Tomo
– Pending FDA
approval
– CE marked for EU
#4 Dimensions 2D Screening Package
Tomo Dimensions
3D 8000
Dimensions
3D 5000
Dimensions
2D 8000
Dimensions
2D 5000
???
Digital
Selenia
Serenity
Film China Only
M-IV
Hawk
Dimensions 2D
Screening Package
China Only
New Web Sites for Patients,
Radiologists, OB-GYNs
BreastTomo.com
Hologic3D.com WebMD.com
2D
Liane E. Philpotts, MD
Professor
Diagnostic Radiology
Chief of Breast Imaging
Yale University 3D
School of Medicine
Screening Mammogram:
Heterogeneously Dense
Yale University
School of Medicine
Melissa Durand, MD, Brian Haas, MD, Madhavi
Raghu, MD, Liva Andrejeva, MD, Reni Butler, MD,
Jaime Geisel, MD, Regina Hooley, MD, Laura Horvath,
MD, Reena Vashi, MD,
Liane E. Philpotts, MD
Yale University
School of Medicine
Study Population
7,578 Screening Mammograms
1,925
DBT + 2D
5,653 2D
alone
Yale University
School of Medicine
Recalls Reduced by 40% (p<.001)
12%
10% 11.1%
DBT + 2D 6.6%
8%
2D Alone 11.1%
6% 6.6%
Overall Recall Rate 10.0%
4%
2%
0%
DBT + 2D 2D alone
Yale University
School of Medicine
Mammographic Finding
Triggering Recall
Finding DBT + 2D 2D alone p value
Calcs 36 (1.8%) 175 (3.1%) 0.0048
Asym 53 (2.8%) 400 (7.1%) <0.0001
Mass 45 (2.3%) 119 (2.1%) 0.367
Arch Dist 2 (0.1%) 32 (0.6%) 0.008
Yale University
School of Medicine
• DBT+2D • The greatest reduction
mammography is was found in the recall
shown to of asymmetries,
significantly reduce suggesting that the
recall rates of majority of such
screening findings can be
mammography confidently assessed as
• This effect can be normal tissue on the
seen immediately DBT images and
upon introduction of reducing the need for
the new technology recall
Yale University
School of Medicine
Brian M Haas, MD, Vivek Kalra, MD, Jaime Geisel, MD,
Madhavi Raghu, MD, Liane E Philpotts, MD
2D+3D
2D
6,116
7,058
46%
54%
Yale University
School of Medicine
Breast Density of Study Patients
60%
50%
40%
30% 3D+2D
2D
20%
1-Predominantly Fatty
10% 2-Scattered Fibroglandular
3-Heterogeneously Dense
0%
4-Extremely Dense
1 2 3 4
Breast Density
Yale University
School of Medicine
Recall Rate
• 28% reduction in recall rate
• One recall is prevented for every 30.8 women screened
Recall Rate
12.0%
10.0%
8.0%
6.0% 11.7%
4.0% 8.4%
2.0%
0.0%
2D+3D 2D
Yale University
School of Medicine p-value for comparison: <0.01
Recall Rate by Breast Density
Breast Density 2D+3D Recall 2D Recall Rate p value
Rate
(1) Predominantly Fatty 5.0% 7.1% 0.12
(2) Scattered Fibroglandular 7.9% 10.4% <0.01
(3) Heterogeneously Dense 10.1% 16.3% <0.01
(4) Extremely Dense 6.4% 15.1% <0.01
60% % Reduction in Recall Rate 58% #r Tomo Exams to Prevent One Recall
38% 60
40% 48.4
50 41.5
29%
23% 40
30
20%
20 16.3
11.5
10
0% 0
1 2 3 4 1 2 3 4
Breast Density Breast Density
Yale University
School of Medicine
Results:
Recall Rates by Age
Age 2D+3D Recall 2D Recall Rate p value
Rate
< 40 11.0% 24.8% <0.01
40 – 50 10.4% 16.4% <0.01
50 – 60 7.6% 10.4% <0.01
60 – 70 7.5% 10.2% 0.01
> 70 6.7% 7.8% 0.44
Yale University
School of Medicine
B enefits of 3D
• Reduction of false positives
(recalls)
• Facilitation of lesion margin
analysis
• Precise lesion location
• Enhanced cancer detection
Yale University
School of Medicine
Tomo only cancer
Yale University
School of Medicine
Screening Mammogram: True Positive
Yale University
School of Medicine
Tomosynthesis as a
Field of Dreams
If You Build It,
They Will Come
Patrick Waring, MHSA, MBA, FACHE
Administrator
Washington Radiology Associates, PC
Maryland, District of Columbia & Northern Virginia
Washington Radiology Associates
• A large private imaging
practice in the
Washington DC
Metropolitan area
• Twenty-seven
radiologists
• 85,000 mammograms
annually
• Six clinical offices
The WRA Path to 100% Tomo
(15 Selenia Dimensions systems)
Jul – Sep 2011
Replaced 15 Hologic Selenia 2D systems with
Dimensions 2D/3D systems
August 2011
Upgraded one site to Tomo. No one was charged. Only
“in office” marketing
Jan - Mar 2012
We upgraded 11 more Hologic Dimensions systems to
Tomo
June 2012
We upgraded our final 2 systems
Spring 2012 – We Launched
• Washington Radiology
Associates…first in DC
Metro Area to Offer
Cutting Edge 3D
Mammography
Technology
• WRA is the largest Tomo
provider in the world
The Clinical Value of Breast
Tomosynthesis
Julianne Greenberg, M.D.
WRA Radiologist
“Tomosynthesis provides
more information and
gives us more of a
certainty of what we are
looking at, as well as
detecting cancer that may
be unsuspected.”
Edward R. Lipsit, M.D.,
Radiologist and WRA President
Rob Cascella
President and Chief Executive Officer
64
Hologic Today
• Well-positioned to drive growth
and shareholder value through
– Three business units possessing strong
growth profiles
– Strong development portfolio with
critical new product cycles emerging NEW
PRODUCTS
– Near- and mid-term cost
synergies from acquisition of
Gen-Probe to enhance profitability
– Strong cash flows and
focus on de-leveraging
65
Total Revenues by Business Segment
Consolidated Non-GAAP Adjusted Q4’12 Revenues of $600M*
66
* See the definition of non-GAAP financial measures on slide 3 and the reconciliation of GAAP to non-GAAP on slide 31.
Diversity & Innovation
67
Driving Growth…
68
Two Exciting New Product Cycles are Just Beginning
PANTHER System
69
Substantial
3D Dimensions Opportunity
Leading Share of U.S. Installed Base and a Growing Replacement Cycle
Installed Base - Analog Installed Base - Digital Replacement Potential
14000
12000
10000
8000
6000
4000
2000
0
2004 2005 2006 2007 2008 2009 2010 2011 2012E 2013E 2014E 2015E 2016E 2017E
70
Source for historical information: MQSA Registry Data, Oct. 2012.
Flagship Brand in STD Testing
• APTIMA Combo 2 assay remains a growth driver
– < 40% of sexually active women aged 25 and under are
screened for chlamydia and gonorrhea
– Improved compliance and international expansion opportunities
• APTIMA Trichomonas experiencing rapid adoption
– Trichomonas vaginalis is the most common curable STD
– First FDA-cleared nucleic acid amplified test
• Menu expansion on the PANTHER is key
– Trichomonas, HPV and genotyping expected by calendar
year-end 2013/early 2014
• All APTIMA assays able to test from ThinPrep vial
71
MyoSure a Growth Driver
in GYN Surgical
MyoSure Hysteroscopic Tissue Removal System
• Minimally-invasive technology to remove fibroids and polyps
• Dynamic technology in early stages of adoption
• $300-400 million annual opportunity in the U.S.
• Product line extensions offer flexibility to spur further adoption
72
Summary
• Prepared to deliver on the promise of 3D Tomo
• Leading diagnostics franchise materially
strengthened with acquisition of Gen-Probe
• Well-positioned for sustained growth with new
product cycles and a global infrastructure
• Poised for earnings growth, strong cash flow and
de-leveraging the balance sheet
73
Q&A
Hologic’s Investor Meeting
November 27, 2012