Download as pdf or txt
Download as pdf or txt
You are on page 1of 74

Use the Passbook

With a Hologic badge, you


cannot enter another
vendor’s exhibit without
their explicit permission
The Exhibit Logistics Advisory Team
Award Winning 3D Mammography and Other
Advanced Imaging Technologies Featured at
RSNA 2012

Hologic’s Investor Meeting


November 27, 2012
Welcome

Deb Gordon, CPA


Vice President,
Investor Relations

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

Tomosynthesis: a Clinician Liane Philpotts, MD, Professor of Diagnostic


Radiology, Chief of Breast Imaging, Yale
Perspective
University School of Medicine
Tomosynthesis: a C-Suite Patrick Waring, Administrator for Washington
Radiology Associates, PC
Perspective
Closing Remarks Rob Cascella

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

• Representing more than


100 countries.
Over a Week Ago, the Work Began
New Look

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

Peter Soltani, Ph.D.


Senior Vice President and General
Manager, Breast Health

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

ARRS Annual Meeting


Yale University May 2012
School of Medicine
• To compare the recall rates from
screening mammography in women
undergoing Digital Breast
Tomosynthesis (DBT) with 2D vs. 2D
mammography alone
• Initial 7 months experience after
introduction of DBT

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

Radiological Society of North America 2012


RSNA ID: 12023567
RSNA Paper No: SSE02-04
Winner of RSNA Research Trainee Award
Yale University
November 2012
School of Medicine
Study Population
13,174 screening mammograms

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

% Reduction in Recall Rate # Tomo Exams to Prevent One Recall


60% 55.8% 100 85.8
80
40% 36.5%
26.6% 26.2% 60
36.2 37.5
14.9% 40
20%
16.7
20 7.2
0% 0
<40 40-50 50-60 60-70 >70 <40 40-50 50-60 60-70 >70
Yale University
School of Medicine
Addition of 2 view DBT to These reductions in recall
conventional 2D screening rates held across women
exams resulted in a 28% of all breast densities and
decrease in recall rates. ages. Statistical
– Finding is in keeping significance was achieved
with 30-40% for all subgroups of
reductions previously women except those with
published predominantly fatty breast
density and those aged 70
and older
Yale University
School of Medicine
The greatest reductions in There was no statistically
recall rates occurred for: significant difference in cancer
Patients aged under 50 detection although there was
years old greater cancer detection in the
Patients with dense breasts Tomo group

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

2009 – 2D 2011 – 2D 2011 – tomo slice


Yale University
School of Medicine
Thank you!

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 not only


met our expectations, it
exceeded them by
allowing us to diagnose
some early curable small
breast cancers well before
they would become
clinically apparent.”
Agnes Holland, M.D., Ph.D.
WRA Radiologist
“Tomosynthesis
completely changed the
patient’s prognosis and
treatments. That was an
incredible feeling.”
Peter Dunner, 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

“As a mammographer, I've


been waiting 30 years for
something like
tomosynthesis.”
Marketing
Tomosynthesis to
Patients
Marketing tomosynthesis to referring
physicians, other clinicians and
decision makers is critical to adoption
HOW DO WE DO WE HANDLE
REIMBURSEMENT?
ARE WE FINDING CANCERS THAT WERE
MISSED IN 2D?
Ingrid Ott, M.D.
WRA Radiologist

“So far we have found 30


percent more cancers with
3D images than with 2D.
Tomosynthesis exceeds
our expectations and
we’re really, really happy
to offer this to our
patients.”
Carole Rubin M.D.
WRA Radiologist
“What I’m seeing is on
tomosynthesis I am
finding more cancers.
Even when I go back to
the 2D images I can’t see
these cancers. And to me
as a physician, as a breast
imager, that is crucial, that
is the focus of my job.”
HAVE WE SEEN A CHANGE IN OUR
RECALL RATE?
HAVE WE SEEN AN INCREASE IN
PATIENT VOLUME SINCE WE LAUNCHED
TOMO?
DO I BELIEVE TOMO WILL BECOME THE
STANDARD OF CARE IN BREAST CANCER
SCREENING?
THANK YOU
Closing Remarks

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*

Total Diagnostic $265.1M*


•Legacy $164.0M
•Gen-Probe $101.1M* 44% Capital
$127.2M

Breast Health $230.3M 39%


Service $95.6M Consumables
$377.4

GYN Surgical $79.7M 13%

Skeletal Health $25.1M 4% Consumables/Service 79%


Capital Equipment 21%

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

• Early stage of a promising replacement cycle with technology


superior to 2D digital
• First to market with no near-term U.S. competition
• Upcoming peer-reviewed publications further support near-term
adoption

Dimensions 3D Breast Tomosynthesis

• Ability to offer class-leading automation to low- and medium-


volume labs
• Extends molecular diagnostics into hospital labs, the fastest-
growing market segment
• Menu expansion on the horizon to sustain growth for
the long-term

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

Franchise Anchored by NovaSure


• Market leader in treating abnormal uterine bleeding with
60%-plus share
• Business stabilized and resuming modest growth

Complemented by a broad portfolio of surgical


instruments addressing unmet needs in women’s health
on a global basis

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

You might also like