how neogenomics is responding to a changing clinical ... › wp-content › uploads ›...
TRANSCRIPT
1 NASDAQ: NEO
How NeoGenomics is Responding to a
Changing Clinical Market and New
Payment Models
Executive War College
May 1, 2014
2 2
Forward-looking Statements
This presentation contains statements which constitute forward-looking
statements within the meaning of Section 27A of the Securities Act, as
amended; Section 21E of the Securities Exchange Act of 1934; and the
Private Securities Litigation Reform Act of 1995. The words “may”, “would”,
“could”, “will”, “expect”, “estimate”, “anticipate”, “believe”, “intend”, “plan”,
“goal”, and similar expressions and variations thereof are intended to
specifically identify forward-looking statements. All statements that are not
statements of historical fact are forward-looking statements.
Investors and prospective investors are cautioned that any such
forward-looking statements are not guarantees of future performance and
involve risks and uncertainties, and that actual results may differ materially
from those projected in the forward-looking statements as a result of
various factors. The risks that might cause such differences are identified
in our filings with the Securities and Exchange Commission. We undertake
no obligation to publicly update or revise the forward looking statements
made in this presentation to reflect events or circumstances after the date
of this presentation or to reflect the occurrence of unanticipated events.
3 3
NeoGenomics Background
• Specialized Cancer-Genetics lab
• Serving Oncologists, Pathologists, Hospitals, BioPharma
• Strong growth in client base, test volume, & revenue
• About 350 full-time employees
• Most comprehensive cancer test menu in America
• NASDAQ listed
4 4
Quarterly Volume Has Almost Tripled since 2010
Quarterly Test Volume and Revenue ($ in millions)
* * *
* Includes impact of TC Grandfather Expiration, which resulted in $1.3 less revenue per quarter.
NeoGenomics History of Growth
0.5
0.8
1.3
1.6
2.7
3.5
3.3
3.4
4.2
4.5
5.7
6.7
6.9
8.1
8.4
9.5
10
.5
11
.3
11
.2
12
.7
14
.0
14
.5
14
.5
14
.4
15
.4 1
8.4
20
.0 22
.6
26
.9
28
.8
28
.3
30
.5
32
.1
32
.5
33
.7
39
.0
38
.7
-$1
$1
$3
$5
$7
$9
$11
$13
$15
$17
$19
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
45.0
Q1 0
5
Q2 0
5
Q3 0
5
Q4 0
5
Q1 0
6
Q2 0
6
Q3 0
6
Q4 0
6
Q1 0
7
Q2 0
7
Q3 0
7
Q4 0
7
Q1 0
8
Q2 0
8
Q3 0
8
Q4 0
8
Q1 0
9
Q2 0
9
Q3 0
9
Q4 0
9
Q1 1
0
Q2 1
0
Q3 1
0
Q4 1
0
Q1 1
1
Q2 1
1
Q3 1
1
Q4 1
1
Q1 1
2
Q2 1
2
Q3 1
2
Q4 1
2
Q1 1
3
Q2 1
3
Q3 1
3
Q4 1
3
Q1 1
4
Millio
ns
Th
ou
san
ds
Test Volume (000's)
Revenue
*
5 5
Dynamics in Oncology Testing
NEO
Demographics And Cancer
Physician consolidation
and in-sourcing
Regulatory Challenges
Managed Care
Technological and Scientific
Advances
Reimbursement Pressure ObamaCare
Precision Medicine
Barriers to
Entry
Volume
Drivers
6 6
Strategic Approach
• Relentless Innovation “Precision Medicine”
• Process Improvements Reimbursement-pressured industry
• Flexible Business Model Dynamic market
• Segmentation Tailored customer demands
• Engaged culture Operational excellence
7 7
Strategic Approach
• Relentless Innovation “Precision Medicine”
• Process Improvements Reimbursement-pressured industry
• Flexible Business Model Dynamic market
• Segmentation Tailored customer demands
• Engaged culture Operational excellence
8 8
• Enables physicians to better diagnose
diseases and predict therapeutic efficacy
– Clinical Benefits: Effective treatment at an
early stage increases patient survival rates
– Healthcare Savings: a) forego spending
on ineffective therapies and b) effective
intervention at an early stage generally
lowers overall treatment cost
– Companion diagnostics: being driven by
rising drug costs and an increase in targeted
therapeutics
16%17% 16%
18%
22%
25% 25% 26%
11%13% 12% 13%
16%
19% 20% 20%
0%
5%
10%
15%
20%
25%
30%
1980 1990 2000 2010 2020 2030 2040 2050
Perc
en
t O
f P
op
ula
tio
n
Age 60 and older Age 65 and older
Current
U.S. Population Demographics
Boomer Impact on Cancer
Market
Demand for “Precision Medicine”
Transformation driven by Molecular
diagnostics
Cancer prevalence expected to increase
77% of all cancers diagnosed are in people age 55
or older, the fastest growing segment of the US
9 9
Solid Tumor Assays* Hematopoietic Assays*
Relentless Innovation - 85+ New Assays Since Jan 2012
Molecular Assays:
1. IDH1 & IDH2 Mutation Analysis
2. c-KIT Mutation Analysis
3. PIK3CA Mutation Analysis
4. NRAS Mutation Analysis
5. TP53 Mutation Analysis
6. NeoARRAY SNP/Cytogenetic Profile
7. KRAS Mutation Analysis
8. BRAF Mutation Analysis
9. EGFR Mutation Analysis
10. Microsatellite Instability Analysis
11. NeoTYPE Breast Profile
12. NeoTYPE Colorectal Profile
13. NeoTYPE Gastric Profile
14. NeoTYPE Lung Profile
15. NeoTYPE Solid Tumor (Other) Profile
16. TPMT Genotyping
17. UGT1A1 Genotyping
18. Kit/PDGFRa Mutation Analysis
19. HRAS Mutation Analysis
20. PTEN Mutation Analysis
21. HOXB13 Genotyping
22. GNAS Mutation Analysis
23. MLH1 Promoter Methylation Analysis
24. MGMT Promoter Methylation Analysis
25. Next Gen Sequencing Solid Tumor
Profile
FISH/ISH Assays:
1. ISH – Kappa ISH
2. ISH – Lambda ISH
3. NeoSITE Barrett’s Esophagus FISH
4. ROS1 FISH
5. NeoSITE Melanoma FISH
6. 1p/19q Deletion FISH Test
Molecular Assays:
1. BCR-ABL1 Translocation, t(9;22)
2. ABL1 Kinase Domain Mutation Anal
3. IgVH Mutation Analysis
4. FLT3 Mutation Analysis
5. NPM1 Mutation Analysis
6. JAK2 V617F Mutation Analysis
7. JAK2 Exon 12-14 Mutation Anal
8. BCL2 Translocation, t(14;18)
9. BCL1 Translocation, t(11;14)
10. MPL Mutation Analysis
11. MPN Reflex Panel
12. DNMT3A Mutation Analysis
13. RUNX1-RUNX1T1 (AML1-ETO)
Translocation, t(8;21)
14. SF3B1 Mutation Analysis
15. B-Cell Gene Rearrangement
16. T-Cell Gene Rearrangement
17. CBFB/MYH11 Translocation, inv(16)
18. PML-RARA Translocation, t(15;17)
19. CEBPA Mutation Analysis
20. WT1 Mutation Analysis
21. NeoTYPE CLL Prognostic Profile
22. NeoTYPE AML Prognostic Profile
23. ETV6-RUNX1 (TEL-AML1)
Translocation, t(12;21)
24. CARD11 Mutation Analysis
25. CD79B Mutation Analysis
26. MYD88 Mutation Analysis
27. RUNX1 Mutation Analysis
31. NOTCH1 Mutation Analysis
32. EZH2 Mutation Analysis
33. Chimerism/DNA Fingerprinting
Analysis
34. TET2 Mutation Analysis
35. CBL Mutation Analysis
36. ASXL1 Mutation Analysis
37. PTPN11 Mutation Analysis
38. CSF3R Mutation Analysis
39. PTPN11 Mutation Analysis
40. STAT3 Mutation Analysis
41. ETV6 Mutation Analysis
42. NeoTYPE Lymphoma Profile
43. NeoTYPE MDS/CMML Profile
44. NeoTYPE Spliceosome Profile
45. Calreticulin Mutation Analysis
46. SETBP-1 Mutation Analysis
47. C-MET Mutation Analysis
48. Next Gen Sequencing MDS Profile
FISH/ISH Assays:
1. NHL FISH Panel (Revised)
2. MYC/IgH t(8;14)
3. CLL FISH Panel (Revised)
4. MDS FISH Panel (Revised)
5. MPN FISH Panel (Revised)
6. AML FISH Panel (Revised)
7. Eosinophilia FISH Panel
8. IGH/MAFB FISH
9. PTEN FISH
BOLD = Multi-assay tests customizable
to meet client needs (assays may also be
ordered individually).
* Certain assays may be useful in both solid
tumor and hematopoietic cancers. Each
assay listed in area of primary use.
10 10
Future Relentless Innovation
• NeoTYPE™ Next-Gen Cancer Profile (48 Genes, 54 Genes to
follow)
• NeoSCORE™ Prostate Test (Plasma Based) ―Diagnostic, Prognostic, Inform Therapy
―Based on licensed SVM technology
• Additional SVM-based NeoSCORE Tests – 2014 (Plasma
Based) ―Colon, Pancreatic
• Automated Cytogenetics Analysis System based on SVM
• Constant Stream of new Molecular Tests
11 11
Strategic Approach
• Relentless Innovation “Precision Medicine”
• Process Improvements Reimbursement-pressured industry
• Flexible Business Model Dynamic market
• Segmentation Tailored customer demands
• Engaged culture Operational excellence
12 12
Increasing Margins Despite Lower Average Unit Prices
(1) Productivity calculated as the average number of lab tests completed per month per laboratory FTE. (2) The expiration of the Medicare Technical Component (TC) Grandfather Clause took effect on 7/1/12 and resulted in an ~11% YoY Reduction in Avg Rev/Test.
47.3% 48.4% 46.1%
44.7% 44.6% 43.9% 44.5% 44.8% 45.2% 47.1% 47.2%
41.5% 43.2% 46.3% 45.9% 48.4%
50.0% 47.9%
-23.5%
50.8%
-40%
-20%
0%
20%
40%
60%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Q4
09
Q1
10
Q2
10
Q3
10
Q4
10
Q1
11
Q2
11
Q3 1
1
Q4
11
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Gross Margin % Cum Change in Avg Rev/Test(2) Cum Change in Productivity(1)
13 13
Operating Cost per Test & Adj. EBITDA Margin
Cost Management & Operating Leverage
$723
$642 $642 $671
$649 $618
$576 $565 $555
$531 $512 $526 $482 $478
$464 $466 $439 $459
-12%
-1% -2%
-5%
0% -1%
5% 6%
8%
12%
12%
6%
10% 11% 12% 13%
15%
9%
-15%
-10%
-5%
0%
5%
10%
15%
20%
$0
$100
$200
$300
$400
$500
$600
$700
$800
Q409 Q110 Q210 Q310 Q410 Q111 Q211 Q311 Q411 Q112 Q212 Q312 Q412 Q113 Q213 Q313 Q413 Q114
Cogs Cost/Test G&A Net of R&D Cost/Test S&M Cost/TestR&D Cost/Test Total Cost/Test Adj EBITDA Margin %
14 14
Future Process Improvements
• “Digital Lab”
• Automated platforms
• Lean Manufacturing
• Information Technology
15 15
Strategic Approach
• Relentless Innovation “Precision Medicine”
• Process Improvements Reimbursement-pressured industry
• Flexible Business Model Dynamic market
• Segmentation Tailored customer demands
• Engaged culture Operational excellence
16 16
Flexible Service Offering
• Cytogenetics
• Flow Cytometry --- Global or Technical Only
• Immunohistochemistry --- Global or Technical Only
• Digital Pathology --- Global or Technical Only
• FISH --- Global or Technical Only
• Molecular --- Individual genes, panels, Next Gen
• Information Technology, Informatics, Assay Development
17 17
Flexibility through Facilities and Coverage
Sales Representatives Facilities
Irvine, CA
25k sf Tampa, FL
6k sf
Nashville, TN
5k sf
Ft. Myers, FL
49k sf 27 Sales and Business
Development
Professionals covering
the U.S.
18 18
“Dynamic” Market Share
19 19
Strategic Approach
• Relentless Innovation “Precision Medicine”
• Process Improvements Reimbursement-pressured industry
• Flexible Business Model Dynamic market
• Segmentation Tailored customer demands
• Engaged culture Operational excellence
20 20
Segmentation by Customer Type
NEO
Pathologists
Large Systems
Other Clinicians
Managed Care
Academic Centers
Oncologists Hospitals
BioPharma
21 21
Segmentation by Customer Type
Pathologists & Hospital Pathology Groups
• Sophisticated tools and tests to enable community Pathologists to practice
• Web-based Lab System & Innovative technical component (“tech-only”) services
• Ability to offer one-stop-shop cost effective testing
• Extensive training programs
Oncologists & Clinician Groups
• State of the art testing menus
• Comprehensive Disease Profiles
• Electronic interface to EMR Systems
Clinical Trials for BioPharma Industry
• Exclusive partnership with Covance to offer comprehensive WW clinical trials lab testing
22 22
Future BioPharma Segment
• Leverages Pathologists expertise, Lab systems, Tech-
only model, comprehensive menus for new segment.
• Ability to expand into world-wide markets
• Potential for developing companion diagnostics
23 23
Strategic Approach
• Relentless Innovation “Precision Medicine”
• Process Improvements Reimbursement-pressured industry
• Flexible Business Model Dynamic market
• Segmentation Tailored customer demands
• Engaged culture Operational excellence
24 24
Values
Quality
Integrity
Accountability
Teamwork Employee Focused
Customer Focused
Results Focused
25 25
Employee Satisfaction
Employee Survey
Results
2010 2011 2012 2013
Total Survey
Respondents 170 253 252
Overall Satisfaction 72% 81% 82% 91%
Would recommend Neo
as a good place to work 78% 92% 87% 90%
Willing to give extra
effort to help Neo
succeed
97%
Employee Retention 66% 79% 81% 86%
26 26
27 NASDAQ: NEO
How NeoGenomics is Responding to
a Changing Clinical Market and New
Payment Models
Executive War College
May 1, 2014