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Presented at The Execu0ve War College
April 26, 2016
By: Gregory S. Henderson, MD, PhD, President of BRLI
BioReference Laboratories, Inc. ROOTS
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Founded in 1986 by Marc Grodman, MD, with the purchase of $300K/YR laboratory;
Announced Merger with OPKO Health, Inc. on 6/4/2015 with a value of $1.5B, based on revenues of over $900M/YR;
At the 0me of Merger, BRLI was the 3rd largest full service commercial laboratory in the US;
Growth over the 29 year period was primarily organic growth with acquisi0ons limited to strategic, synergis0c acquisi0ons designed to enhance capabili0es, not pa0ent count;
Throughout its 29 years in the laboratory industry BRLI has always been a posi0ve face of growth, innova0on and service.
3 Decades of Growth BioReference Laboratories, Inc.
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1988 Acquired Cytology Business
Began laboratory opera0ons 1986
1995 Acquired Oncology business
2000 Reported first profits -‐ $.01
2001 Resumed oncology opera0ons
2006 Acquired GeneDx Gene0cs Tes0ng 2007 Introduced cons0tu0onal array
2003 Exceeded revenues of $100M
2002 Launched CareEvolve
1997 Sold most of Oncology to Impath
2009 Introduced na0onal WH Program
2008 Introduced NGS tes0ng
2014 Interna0onal Sales Division
2015 Merger with OPKO
2015 Genomics solu0on -‐ Northwell
Future Marriage of Diagnos0cs & Therapeu0cs
2013 Whole Exome Sequencing
2011 Women’s reproduc0ve Gene0cs
A Brief Timeline BioReference Laboratories, Inc.
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$56 $56 $68 $74 $83 $95 $112 $128 $141 $155 $187
$230 $248 $250
$275 $290
$62 $75 $90 $103
$127
$153
$180
$233
$281
$337
$425
$533
$614
$715
$832
$936
'00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 '14 '15 1.4
1.7
2.1
2.1
2.5
2.9
3
3.7
4
4.6
5.6
6.7
7.8
8.5
9.6
10.6
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Revenues: 2000-‐2015 Esoteric and Rou0ne
Pa0ents: 2000-‐2015
16 Year Growth Chart BioReference Laboratories, Inc.
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$44.29
$44.12
$42.86
$49.05
$50.80
$52.76
$60.00
$62.97
$70.25
$73.26
$75.89
$79.55
$78.72
$84.12
$86.67
$88.30
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
ASP: 2000-‐2015
Inherited Cancers Introduced
NGS Panels introduced Second Women’s Health
First Women’s Health Introduced
Oncology Reintroduced
Revenue per Pa0ent over the last 16 years BioReference Laboratories, Inc.
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Pa@ent-‐Centric
Technological Innova@on
Service and Support
The Growth Drivers BioReference Laboratories, Inc.
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A legendary history of Growth and Innova0on
A Leadership Posi0on in the cri0cal issues of the Industry
A resounding voice in Washington
An insighcul vision for the future
Today BioReference Laboratories, Inc.
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Automa@on and Efficiency
Risk Based Reimbursement
Precision Medicine and Popula@on Analy@cs
Collabora@on and Partnership
Growth in the Future BioReference Laboratories, Inc.
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Declining reimbursement changes Managed Care Payers CMS / PAMA
FDA Regula0on Adapta0on to change
Obstacles to Growth BioReference Laboratories, Inc.
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OPKO Health, Inc. is a diversified healthcare company that seeks to establish industry-‐leading posi0ons in large, rapidly growing markets. It is ac0ve in Drug Discovery, Diagnos0cs, Therapeu0cs, Biologics and ancillary support services around the world.
OPKO con0nues to explore acquisi0on opportuni0es for complementary pharmaceu0cals, compounds, technologies, and businesses. It expects future growth to arise from leveraging its proprietary technology, development strengths, and pursuit of complementary and strategic acquisi0ons and investments.
BioReference Laboratories, Inc. OPKO Health, Inc: Who Are They?
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Diagnos0cs Therapeu0cs
OPKO and BRLI: The Value Proposi0on BioReference Laboratories, Inc.
BeSer Pa@ent Care
Improved Precision Medicine
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OPKO and BRLI: 4Kscore® Test A follow up test to iden0fy risk for high grade, aggressive prostate cancer
BioReference Laboratories, Inc.
+ Age, DRE, and prior biopsy status
OPKO ALGORITHM
% risk of having aggressive prostate
cancer for an individual patient
Components
OPKO {
4 kallikrein levels Total PSA Free PSA Intact PSA hK2
Results
• Commercial-‐ CLIA cer0fied laboratory developed test
• Designed to iden0fy aggressive prostate cancer-‐ Gleason ≥7 from Gleason 6 or no cancer • Intact PSA and hK2 associated with poorly differen0ated prostate cancer1-‐3
Clinical {
The 4Kscore Test as a Minimally Invasive Alterna0ve to Prostate Biopsy
BioReference Laboratories, Inc.
• The 4Kscore is the most accurate blood test for detec0ng aggressive prostate cancer
• Provides a con0nuum of risk from < 1% to > 95% of having aggressive prostate cancer on biopsy
Parekh, Eur Uro 68(2015)464–470
Suspicion of malignancy based on abnormal PSA
Low Risk: continue to follow
High Risk: additional evaluation or biopsy
Order 4Kscore to identify the patient’s individual risk of high
grade Gleason 7 or higher cancer on prostate biopsy
Na0onal Guidelines recommend 4Kscore® Test in men considering a prostate biopsy or a repeat prostate biopsy
NCCN Guidelines Version 2.2015 Prostate Cancer Early Detec0on (PROSD-‐3)
15 [Rev Urol. 2015;17(4):231-‐240 dio: 10.3909/riu0699] © 2016 MedReviews ®, LLC
Clinical U0lity of 4Kscore BioReference Laboratories, Inc.
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Overall reduc@on in prostate biopsies was 64.6% [Rev Urol. 2015;17(4):231-‐240 dio: 10.3909/riu0699] © 2016 MedReviews ®, LLC
4Kscore Test changes clinical prac0ce US As a Follow-‐up Test (611 pa0ents in academic/community sites)
BioReference Laboratories, Inc.
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! Cancer
! Maternal Fetal
! Pediatric Gene@cs
! Adult Gene@cs
Northwell Is the Model We are Seeking Other
Opportuni0es With Other Health Systems
Genomics Solu0on: Health System Collabora0ons BioReference Laboratories, Inc.
Reimbursement and Regulatory Threats are our Common Enemy.
United we stand, Divided we fall.
Compe00on cannot stand in the way of Improving our Industry, there is room for all of us to thrive and grow.
Together we can improve Pa0ent Care and Pa0ent Outcomes.
Call for Collabora0on BioReference Laboratories, Inc.
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