EX-99.1 2 d850326dex991.htm EX-99.1 EX-99.1
©
2015 Sequenom. All rights reserved.
Interpreting the genome to improve your life
JP Morgan Healthcare Conference
January 12-15, 2015
Bill Welch, CEO
Exhibit 99.1


©
2015 Sequenom. All rights reserved.
2
Except for historical information, matters set forth in this presentation, including
statements regarding Sequenom’s plans, potential, opportunities, financial or other
expectations, projections, goals, objectives, milestones, strategies, market growth,
timelines, product pipeline, clinical studies, product development, and the potential
benefits of its products and products under development, are forward-looking
statements
within
the
meaning
of
the
“safe
harbor”
provisions
of
the
Private
Securities
Litigation Reform Act of 1995. These forward-looking statements are subject to risks
and uncertainties that may cause actual results to differ materially, including the risks
and uncertainties associated with Sequenom’s operating performance and financial
position, the market demand for and acceptance of Sequenom’s and Sequenom
Laboratories’
products and services, research, development and commercialization of
new
products,
reliance
upon
the
collaborative
efforts
of
others,
competition,
intellectual
property
rights,
government
regulation,
obtaining
or
maintaining
regulatory
approvals,
litigation, and other risks detailed in Sequenom’s SEC filings. These forward-looking
statements are based on current information that is likely to change, speak only as of
the
date
hereof,
and
Sequenom
undertakes
no
obligation
to
revise
or
update
such
statements.
Forward-looking statements


©
2015 Sequenom. All rights reserved.
3
The core of Sequenom’s culture is a
single uncompromising principle…
QUALITY OF SCIENCE
CLINICAL FOCUS
Reproductive health
Women’s health
Whole genome sequencing


©
2015 Sequenom. All rights reserved.
4
2014 Highlights
Focused leader in Noninvasive Prenatal Testing (NIPT)
Company Snapshot**
$ Millions
Revenue
*
Preliminary, unaudited.  Cash burn excludes the proceeds and payments from the Illumina, ISIS, and CUHK transactions in 2014.
**
Revenue and cash burn have been adjusted to remove discontinued operations.
***
Company received an additional $6M in January 2015 related to Illumina settlement agreement bringing the total cash to approximately $100M.
NIPT Accessioned Tests
Tests, Thousands
Financials
Approximately $94M*** in ending cash
Reduced cash burn from $107M* in FY2013 to
$37M* in FY2014
Divested Bioscience business
Leader in NIPT
Market innovator and leading test provider
Illumina Settlement and Patent Pool
Agreement
Freedom to operate
Broad capabilities to practice next generation
sequencing under Illumina supply agreement


©
2015 Sequenom. All rights reserved.
5
Sequenom and Illumina Settlement
Signed December 2014
Pooled intellectual property directed to NIPT
Settled all pending infringement disputes
Illumina
enforces
Patent
Pool
globally
1
Shared test fees from licensed laboratories
Sequenom
to
receive
royalty
on
IVD
2
sales
for
NIPT
kits
Sequenom
received
$50
million
3
in
cash
Sequenom expects to receive an additional $80M+ through 2020,
subject
to
potential
market
based
adjustments
4
Illumina gained access to Sequenom’s clinical samples
Obtained broader field of use with amended supply agreement
1.
Parties responsible for enforcement of their own existing litigation prior to December settlement.
2.
In Vitro Diagnostics
3.
Sequenom received $6M in January 2015.  Sequenom paid Chinese University of Hong Kong a one-time $6M payment in 2014.
4.
From the patent pool structure based on contractual payments, pursuant to the agreement.


©
2015 Sequenom. All rights reserved.
6
Global Licenses
21 organizations globally granted licenses to
the patent pool, including Sequenom
Laboratories and Verinata, January 2015
Patent Pool Content
Partnering for growth
Clarifying the NIPT IP landscape for broader access
The patent pool combines critical NIPT
patents and patent applications
Sequenom controlled over 225
Illumina controlled over 200
Numerous NIPT technologies represented
Methods to detect fetal DNA for prenatal
diagnosis
Methods to detect fetal aneuploidy
(random, targeted, length-based)
Methods to extract and amplify DNA
Others: digital PCR; whole fetal genome
sequencing; SNPs


©
2015 Sequenom. All rights reserved.
7
Roles and Responsibilities
Enhancing profitability
Capturing value from the patent pool
Illumina and Sequenom collect
existing party test fee for the
Patent Pool
Illumina Responsibilities
License additional parties
Enforcement of  patents globally
Collect test fees from new parties
Test fees distributed quarterly
between Sequenom and Illumina
NIPT Collection Pool
NIPT test fee
collection pool
Test fee payment
Test fee revenue
Licensees
SQNM
ILMN
SQNM Labs
& Verinata


©
2015 Sequenom. All rights reserved.
8
Sequenom Going Forward


©
2015 Sequenom. All rights reserved.
9
Circulating cell-free DNA (ccfDNA)
Foundational technology / core expertise
Cell free fetal DNA in maternal
blood
Believed to be from
placental and fetally
derived cells
1,2,3
Next generation sequencing of
ccfDNA allows for accurate
identification of fetal
chromosomal abnormalities
Placental
Cells, DNA
1.Lo YM, Corbetta N, Chamberlain PF, Rai V, et al. Presence of fetal DNA in maternal plasma and serum. Lancet. 1997 Aug 16;350(9076):485-487.
2.Finning KM, Martin PG, Soothill PW, Avent ND.
Prediction of fetal D status from maternal plasma: introduction of a new noninvasive fetal RHD
genotyping service. Transfusion.
2002 Aug;42(8):1079-1085.
3.Bianchi DW. Circulating fetal DNA: its origin and diagnostic potential-a review. Placenta. 2004 Apr;25 Suppl A:S93-S101.
DNA
sequencing
Fetal DNA
Maternal blood
Fetal DNA


©
2015 Sequenom. All rights reserved.
10
10
High risk pregnancies
traditionally required invasive
procedures
High requirement for medical
management and genetic
counseling
97% of invasive procedures
have normal results
Invasive testing costly and
introduces additional risk
Traditional prenatal testing


©
2015 Sequenom. All rights reserved.
11
11
A noninvasive laboratory-developed test (LDT) to
identify pregnancies at increased risk for fetal
chromosomal abnormalities


©
2015 Sequenom. All rights reserved.
12
Our clinical use mirrors
criteria in validation study
Guidelines established by
ACOG
1
and
SMFM
2
to
perform the test on women
at increased risk for fetal
chromosomal abnormalities
Payors’
medical policies for
NIPT is currently for high
risk pregnancies
12
MaterniT21
®
PLUS test
Indications for use, >375,000 tests accessioned
1.ACOG is the American Congress of Obstetricians and Gynecologists
2.SMFM is the Society for Maternal-Fetal Medicine


©
2015 Sequenom. All rights reserved.
13
NIPT Market: Large and relatively untapped
GLOBAL
PREGNANCIES
>210M
births
annually
2
US
AVERAGE RISK
3.5M
births
annually
1
US
HIGH RISK
750K births annually¹
$3B+ total
market
opportunity
worldwide
3
1.
Martin JA, et al. Division of Vital Statistics. Births: Final data for 2013.
National Vital Statistics Reports.
2013;62(9). Online
at
http://www.cdc.gov/nchs/births.htm. Accessed Aug 7, 2014.
2.
World Health Organization, World Health Statistics 2013.
3.
Morgan Stanley Research, NIPT Competition Evolves, December 2, 2014.


©
2015 Sequenom. All rights reserved.
14
VisibiliT
prenatal test
Common trisomy information mirrored
after content available in standard
serum screening
Reporting of risk score to complement
current medical and genetic counseling
practices for average risk
Sequenom the first to offer two NIPT
testing model
Launched internationally in Q4 2014
Expected US launch Q1 2015
Trisomies 21 and 18, fetal gender
Validation and performance data presented at International Society for Prenatal Diagnosis meeting in July 2014, Brisbane, Australia


©
2015 Sequenom. All rights reserved.
15
First and most
comprehensive
commercial 
NIPT for
high risk
pregnancies
First NIPT
utilizing
common trisomy
information
mirrored after
serum
screening
content
A carrier
screen that
analyzes the
most clinically
relevant
mutations and
variants related
to cystic
fibrosis (CF)
A noninvasive
prenatal test
that detects
fetal RhD
genotype in
RhD sensitized
mothers
A microarray
assessment of
patient sample
from a
chorionic villus
sampling
(CVS) and
amniocentesis
Sequenom test portfolio
Growing prenatal franchise


©
2015 Sequenom. All rights reserved.
16
Sequenom continues to innovate NIPT
1.
Expected product launch in 2H 2015
2.
Reported as additional findings
2011
2012
Trisomy 21
2014
2013
Trisomy 13
Trisomy 18
Sex aneuploidies
Enhanced Sequencing Series²
Enhanced Sequencing Series II²
-
Additional microdeletions
2015
Noninvasive
whole genome
karyotype¹
MaterniT21
®
PLUS -
17 conditions, 9 whole chromosome aneuploidies, 7 microdeletions


©
2015 Sequenom. All rights reserved.
17
Noninvasive karyotype
NIPT portfolio evolution
Rapidly accelerate
differentiation via our genome
wide testing capabilities
Noninvasive karyotype
Identifies fetal
chromosomal abnormalities
currently only seen with
invasive procedures
Expected launch in 2H 2015


©
2015 Sequenom. All rights reserved.
18
Universal carrier screen opportunity
Rapidly expanding market in prenatal care
Screening for genetic disorders as part
of preconception
care
1
6.6M pregnancies in the US
annually
2
Test potential mother and/or
father
Genetic disorders are among the most
common causes of admissions to
pediatric hospitals and a significant
cause of infant mortality
Pan-ethnic screening is increasingly
been incorporated into routine
OB/GYN care
1.
Such as Cystic Fibrosis, Spinal Muscular Atrophy, Fragile X, Alpha Thalassemia, Beta
Hemoglobinopathies and Tay-Sachs Disease
2.
CDC, National Vital Statistics Report, Vol. 60, No 1, 2012.


©
2015 Sequenom. All rights reserved.
19
HerediT
Universal is a carrier screen
that detects over 250 genetic diseases
>1700 disease causing mutations
Includes
all
ACMG,
ACOG
and
AJ
1
recommended mutations
Partnering with Recombine,
a leader in the in vitro
fertilization marketplace
Leverages commercial infrastructure
and complements existing HerediT
CF Carrier Screening test
Expected launch in Q1 2015
1.
American College of Medical Genetics and Genomics; American Congress of Obstetricians and
Gynecologists; Ashkenazi Jewish Screening Recommendations by ACOG and ACMG.
HerediT
Universal
Sequenom enters universal carrier screening market


©
2015 Sequenom. All rights reserved.
20
Sequenom enters Oncology
Building clinical foundation
Engaging key thought leaders from leading institutions:
Razelle Kurzrock, MD
Murray Professor of Medicine; Chief, Hematology & Oncology; Director, Center for Personalized Cancer
Therapy & Clinical Trials, Sr. Deputy Director UCSD Moores Cancer Center
Background of Key Opinion Leaders:


©
2015 Sequenom. All rights reserved.
21
Leveraging our ccfDNA expertise
From circulating cell-free fetal DNA to circulating tumor DNA (ctDNA)
In the course of performing NIPT, Sequenom has identified over
20 significant incidental findings of confirmed maternal tumor growths¹:
Circulating cell-free DNA (ccfDNA) and next-generation sequencing
have potential broad oncology applications:
1.
Presented in a Poster at the Association of Molecular Pathology meeting in November 2014, National Harbor, MD
Early Cancer
Detection
Treatment
Selection
Treatment
Monitoring
Relapse /
Surveillance
Breast cancer, colon cancer, lymphomas, etc.


©
2015 Sequenom. All rights reserved.
22
Oncology program
Test type
Laboratory-developed test that
detects and profiles ctDNA
in plasma
Target population
Advanced cancer patients with solid
tumors (stage III-IV) and metastatic
patients where (re)-biopsy of tumor
tissue is not possible or desired
Key activities
Clinical advisory board
Development program underway
Early access program for research use
only LDT, expected 2H 2015
Lead oncology product


©
2015 Sequenom. All rights reserved.
23
Highlights
Financial overview
$ Millions
Revenue*
$94M*** in cash and investments
Reduced cash burn by 66% from
$107M** in FY2013 to $37M** in
FY2014
Cash burn for Q4 was
approximately $7M**
Annual Cash Burn*
$ Millions
Note:
*
Revenue and cash burn exclude Sequenom Bioscience, a
discontinued operation.  Amounts from continuing operations
are management’s estimates subject to change upon audit.
**
Preliminary, unaudited. Cash burn is cash used in operations, for
capital expenditures, and payments on term loans and capital
leases. Cash burn excludes the proceeds and payments from
the Illumina, ISIS and CUHK transactions in 2014.
***
Company received an additional $6M in January 2015 related to
Illumina settlement agreement bringing the total  cash to
approximately $100M.


©
2015 Sequenom. All rights reserved.
24
Metrics
2015 Commentary
2014
160M covered commercial lives
162K
accessioned
MaterniT21
®
PLUS
tests;
197K
total
accessioned
tests
Q4
14
revenues
approximately
$37M
1
New
Tier
1
CPT
code
applicable
for
MaterniT21
®
PLUS
NIPT
effective
January
Test
fees
and
royalties
are
expected
to
range
between
$6M
to
$14M
2
Expect
total
accessioned
tests
to
be
>
200K,
including
impact
of
patent
pool
licensees
1.
Preliminary, unaudited.
2.
Range
considers
uncertainty
in
number
of
Pool
Participants,
timing
of
implementing
NIPT
tests,
and
the
associated
timing
of
test
fees
and
royalties.


©
2015 Sequenom. All rights reserved.
25
1.
Range
considers
uncertainty
in
number
of
Pool
Participants,
timing
of
implementing
NIPT
tests,
and
the
associated
timing
of
test
fees
and
royalties, among other factors.  Sequenom expects to have approximately $24M-$27M of non-cash expenses.
New Products
Sequenom Laboratories to launch 3 new laboratory-
developed tests
New Markets
Early access program for Liquid Biopsy RUO, 2H 2015
Operations
Total
cash
burn:
-$15M
to
+$15M
1
Corporate Goals 2015


26
CONTACT:
CAROLYN D. BEAVER, CFO
INVESTORRELATIONS@SEQUENOM.COM
WWW.SEQUENOM.COM
These laboratory-developed tests were developed and their performance characteristics determined by Sequenom Laboratories.  They have not been cleared or approved by the U.S.
Food and Drug Administration (FDA).  Although laboratory-developed tests to date have not been subject to U.S. FDA regulation, certification of the laboratory is required under CLIA
to ensure the quality and validity of the tests.  This laboratory is accredited and certified to perform high complexity clinical laboratory testing.
©2015
Sequenom,
Inc.
All
rights
reserved.
Sequenom
®
,
HerediT™,
MaterniT21
®
PLUS,
RetnaGene™,
SensiGene™,
NextView™
and
VisibiliT™,
are
trademarks
of
Sequenom,
Inc.
All other trademarks are the property of their respective owners. The information herein is for informational purposes only and represents the current view of Sequenom, Inc. as of the
date of this presentation. Sequenom cannot guarantee the accuracy of any information provided after the date of this presentation. Sequenom makes no warranties, express, implied
or statutory, as to the information in this presentation.