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1 NASDAQ: NEO How NeoGenomics is Responding to a Changing Clinical Market and New Payment Models Executive War College May 1, 2014

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Page 1: How NeoGenomics is Responding to a Changing Clinical ... › wp-content › uploads › EWC14.Post_.… · early stage increases patient survival rates 1980 – Healthcare Savings:

1 NASDAQ: NEO

How NeoGenomics is Responding to a

Changing Clinical Market and New

Payment Models

Executive War College

May 1, 2014

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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.

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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

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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

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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

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Q3 1

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Q4 1

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Q1 1

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Q3 1

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Q4 1

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Q1 1

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Q2 1

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Q3 1

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Q4 1

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Q1 1

4

Millio

ns

Th

ou

san

ds

Test Volume (000's)

Revenue

*

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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

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Strategic Approach

• Relentless Innovation “Precision Medicine”

• Process Improvements Reimbursement-pressured industry

• Flexible Business Model Dynamic market

• Segmentation Tailored customer demands

• Engaged culture Operational excellence

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Strategic Approach

• Relentless Innovation “Precision Medicine”

• Process Improvements Reimbursement-pressured industry

• Flexible Business Model Dynamic market

• Segmentation Tailored customer demands

• Engaged culture Operational excellence

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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

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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.

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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

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Strategic Approach

• Relentless Innovation “Precision Medicine”

• Process Improvements Reimbursement-pressured industry

• Flexible Business Model Dynamic market

• Segmentation Tailored customer demands

• Engaged culture Operational excellence

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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)

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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 %

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Future Process Improvements

• “Digital Lab”

• Automated platforms

• Lean Manufacturing

• Information Technology

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Strategic Approach

• Relentless Innovation “Precision Medicine”

• Process Improvements Reimbursement-pressured industry

• Flexible Business Model Dynamic market

• Segmentation Tailored customer demands

• Engaged culture Operational excellence

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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

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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.

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“Dynamic” Market Share

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Strategic Approach

• Relentless Innovation “Precision Medicine”

• Process Improvements Reimbursement-pressured industry

• Flexible Business Model Dynamic market

• Segmentation Tailored customer demands

• Engaged culture Operational excellence

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Segmentation by Customer Type

NEO

Pathologists

Large Systems

Other Clinicians

Managed Care

Academic Centers

Oncologists Hospitals

BioPharma

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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

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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

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Strategic Approach

• Relentless Innovation “Precision Medicine”

• Process Improvements Reimbursement-pressured industry

• Flexible Business Model Dynamic market

• Segmentation Tailored customer demands

• Engaged culture Operational excellence

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Values

Quality

Integrity

Accountability

Teamwork Employee Focused

Customer Focused

Results Focused

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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%

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27 NASDAQ: NEO

How NeoGenomics is Responding to

a Changing Clinical Market and New

Payment Models

Executive War College

May 1, 2014