ZACKS initiating CBMX with OUTPERFORM PT 3.50

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masti...@gmail.com

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Jul 8, 2014, 9:27:55 AM7/8/14
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Molecular diagnostics company CBMX has offered a
variety of genetic tests for various indications but just
recently shifted the majority of its focus for growth on
chromosomal microarray analysis (CMA) in the prenatal
setting. A relatively novel genetic testing method, CMA
has gained more attention due to two recent NEJMpublished
studies and a recommendation from an
influential trade association supporting its use in prenatal
analysis. CBMX is positioning itself to exploit an industry
shift away from the current standard testing method
towards CMA by expanding distribution, entering into key
partnerships and leveraging competitive advantages.
Early indications are that this plan is already bearing fruit.
We are initiating coverage of CBMX with an Outperform
rating.

masti...@gmail.com

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Jul 8, 2014, 9:55:28 AM7/8/14
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SNAPSHOT
CombiMatrix Corporation (CBMX), founded in 1995 and currently headquartered in Irvine, CA, is involved in
the field of molecular diagnostics with a primary focus on prenatal and postnatal genetic testing,
miscarriage/stillbirth management and the diagnosis of developmental disorders (and to a lesser extent
hematology/oncology genetic testing). The company performs a variety of methods of genetic testing out of
its CLIA and CAP-certified lab including chromosomal microarray analysis (CMA).
While the company also offers other types of genetic tests for areas outside of prenatal disorders, including
fluorescence in situ hybridization (FISH) for genetic abnormalities associated with cancer and hematological
diseases, and traditional karyotyping, CBMX has recently shifted the majority of its focus for growth on CMA
in the prenatal setting and simultaneously de-emphasized their oncology/hematology platform. The strategy
appears to be paying off, with prenatal microarray testing volumes growing 126% in 2013 and 60% in Q1
2014 and accounting for almost the entire 19% and 13% revenue growth in those respective periods.
CMA looks to have several key advantages to karyotyping, the current standard genetic testing method for
prenatal disorders. These include that CMA can identify extremely small chromosomal abnormalities, can be
used on non-living tissue (while karyotyping can not), it produces a successful test result more often than
karyotyping and also has a faster sampling-to-results turnaround time. CMA has recently gained attention as
a result of National Institute of Health (NIH) studies published in late 2012 in the New England Journal of
Medicine and a December 2013 recommendation from the American College of Obstetricians, both of which
support use of CMA in addition to or in lieu of karyotyping for miscarriage management and prenatal testing of
at-risk pregnancies. Anecdotal evidence indicates that, since the publications and positive opinion from
ACOG, that there has been an ongoing shift from use of karyotyping to CMA by maternity specialists for
miscarriage management.
The recent endorsements for the use of CMA along with rapid growth of the overall molecular diagnostics
market should provide a tailwind to CombiMatrix's recently implemented and ongoing efforts to expand
awareness of the technology, ramp sales and further their quest to become the preeminent diagnostic
services laboratory for prenatal microarray testing. Their strategy to do so includes direct sales to OB/GYNs,
pathologists (i.e. - the hospital/clinic-level decision-makers in terms of which lab/test to utilize) and maternalfetal
medicine (MFM) specialists with a recently beefed up sales force, cultivation of relationships with
pathology partners including other lab service providers, broadening reimbursement and entering into
complementary industry alliances, all of which are aimed at expanding distribution and growing revenue.
Recent headway in implementation of this strategy has already borne fruit, evidenced in part by
consummation of an alliance with Sequenom, Inc. in late 2013, recently entered partnerships with certain
pathology labs, a doubling of the sales force, an increase in the number of third-party payers that reimburse
for the company's services, a rapid increase in prenatal microarray testing volumes and consistent doubledigit
sales growth.
We view the low-hanging fruit for CBMX as the market for miscarriage/stillbirth testing, also known as
products of conception (POC) - the U.S. market for which the company estimates at approximately $250M
and only ~10% penetrated and which we think may be ripe for a relatively rapid transition from karyotyping to
CMA. Prenatal testing for developmental disorders is another attractive market, although penetration of CMA
in this segment may be much more measured as CMA can provide results with uncertain clinical significance
- potentially offering a challenge to clinicians in counseling patients and causing patient anxiety. As more
clinical data becomes available and more is known about certain copy number variants with currently
unknown clinical significance, we think use of CMA in prenatal testing could become much more widespread.
CBMX believes that it differentiates itself from competing and larger laboratories that also offer CMA by
offering a higher level of genetic counseling services and providing an overall superior customer relations
experience. As CMA is a relatively new and highly complex technology that requires specific expertise in
interpreting and relaying results, the company's on-staff genetic counselors offer clinicians and patients a
readily available and knowledgeable source of information on testing results. Finally, in terms of competitive
positioning, while the prenatal microarray testing markets are relatively large and attractive for a company of
CBMX's small size, the opportunity may not appear nearly as enticing for much larger competitors. This is
because to exploit these prenatal microarray markets (which are relatively small for large labs) requires a

masti...@gmail.com

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Jul 8, 2014, 10:16:21 AM7/8/14
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The final piece of CBMX's sales/distribution plan includes alliances with strategic industry partners. In
August 2013 the company announced a collaboration with Sequenom Inc. (SQNM) whereby the companies
will jointly market CBMX's CMA testing services. We view this collaboration as not only beneficial in terms of
expanding CBMX's distribution but, perhaps just as important, as validation of the company's CMA testing
services as SQNM is a leader in NIPT testing with MaterniT21 PLUS being one of the largest selling NIPT
tests on the market. The collaboration appears to be a good fit for both parties; providing CBMX with
significantly expanded distribution and SQNM a low-cost ancillary revenue source as CMA can be offered as
an adjunct to their MaterniT21 PLUS test.
> Expect Expanded Distribution To Make Meaningful Impact in Near-Term
CBMX's recent shift to de-emphasize their oncology/hematology platform and turn their majority focus on
prenatal and POC chromosomal microarray analysis already appears to be paying off. This is evidenced by

prenatal microarray testing volumes growing 126% in 2013 and 60% in Q1 2014 and accounting for almost
the entire 19% and 13% revenue growth in those respective periods. The company expects to pursue this
strategy with even greater vigor as it continues the implementation of its more aggressive distribution plan.
As noted, with recent doubling of the sales force and an expected 6 - 9 month breaking-in period, we think
direct sales-related revenue may show a more pronounced rate of acceleration in the second half of 2014.
The pathology partnerships, while providing incremental distribution, are unlikely to result in significant volume
in our opinion, particularly over the near-term.
We believe the alliance with Sequenom is more significant given that SQNM's MaterniT21 PLUS test is one of
the largest selling NIPT tests (at ~150k annually) which instantly and meaningfully expands CBMX's footprint.
Sequenom's endorsement of CBMX's services also, in our opinion adds validation to the CMA technology as
well as CBMX's abilities to service SQNM's customer base. As such, we think this partnership, as well as
potential future similar alliances, has the potential to provide revenue contribution beginning in the near-term
as well as helping to broaden awareness of prenatal chromosomal microarray analysis and CBMX's position
as the only pure-play prenatal-focused CMA provider.

masti...@gmail.com

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Jul 9, 2014, 9:34:07 AM7/9/14
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they have release this initiation tonight
CBMX starting now

masti...@gmail.com

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Jul 9, 2014, 9:56:41 AM7/9/14
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BACKGROUND
Rapid Growth of Molecular Diagnostics
Molecular diagnostics (i.e. - genetic testing) refers to analysis of a person's individual DNA. Genetic testing is
used for a variety of purposes including the determination of biological heritage, for criminal forensics, to
predict an individual's response to a particular drug, to establish potential vulnerability to inherited diseases
and in prenatal diagnosis to determine risk of a baby being born with a chromosomal or genetic disorder.
Molecular diagnostics has been around since the 1970s and in the early years made up a relatively miniscule
portion of the overall diagnostics market. Initially it was mostly focused on prenatal testing to determine, for
example, whether an unborn fetus is carrying gene mutations associated with certain diseases. Since then
the field of molecular diagnostics has rapidly expanded, interest in and growth of which was particularly fueled
by the completion of the Human Genome Project in 2003 which sequenced the entire human genome.
Molecular diagnostics now makes up approximately 11% of the total worldwide in-vitro diagnostics market
and, per Frost and Sullivan, is expected to grow at about 12% over the next five years, about 70% faster than
the 7% growth predicted for the entire diagnostics market. While much of the recent and near-term
anticipated growth in molecular diagnostics is being driven by applications in infectious diseases and
oncology, the recent emergence and increasing adoption of newer DNA testing methods and overall improved
accuracy and utility of molecular analysis has spurred growth across a spectrum of applications, including
prenatal testing.
Traditional Prenatal and POC Testing Done by Karyotyping
Prenatal diagnosis is done in order to determine the health and condition (as well as sex) of the fetus prior to
being born. Initially this is typically done with relatively non-invasive screening techniques such as ultrasound
and maternal blood tests. Maternal blood tests, called non-invasive prenatal testing (NIPT), examine fetal
DNA that is circulating in the mother's blood stream. NIPT is generally used to determine if the baby is at risk
of Down Syndrome (i.e. - trisomy 21), although it can also identify risk of certain other abnormalities and
conditions including Edwards syndrome (trisomy 18) and Patau syndrome (trisomy 13). For other conditions,
however, a more invasive test must be used.
CombiMatrix recently entered into a marketing and distribution agreement with Sequenom, Inc., a
manufacturer of an NIPT test, whereby Sequenom will market CBMX's CMA prenatal testing services.
Sequenom s MaterniT21 PLUS is one of the largest selling NIPT tests on the market.

masti...@gmail.com

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Jul 9, 2014, 10:56:08 AM7/9/14
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INVESTMENT CONSIDERATIONS
> Focus is Prenatal / POC
While CBMX has historically generated the majority of revenue from microarray analysis of postnatal genetic
disorders and for certain hematological and oncological applications, these are now being treated as more
legacy segments as management focuses on the prenatal / POC segments to drive future growth of the
company.
This shift is already well underway. In 2012 prenatal microarray tests accounted for 27% of microarray
volume and 37% of microarray revenue, in 2013 prenatal microarray tests accounted for 49% of microarray
volume and 61% of microarray revenue.
> Niche Markets: Attractive for CBMX, Maybe Not So Much for Larger Labs - We See CBMX as Very
Competitive
CBMX estimates the prenatal and miscarriage markets at approximately 100k and 140k patients annually.
With 26k stillbirths each year, this would put CBMX's total potential annual market at about 260k patients.
However, we note that this 260k patient number may actually be somewhat conservative as, depending on
the source, there are between 200k and 400k invasive (i.e. - amnio and CVS) procedures done every year.
And while demand for NIPT is increasing at the expense of invasive procedures, a 200k patient potential
prenatal market size (360k patient potential total market size) would not be an unreasonable estimate in our
opinion.
The company received $1.6k on average per prenatal test in all of 2013 - this fell to slightly better than $1.5k
in Q1 2014. If we assume $1.5k per test going forward and a 260k patient market size, the company's
potential prenatal and POC markets aggregate to roughly $150M and $250M, respectively.
Total markets worth about $400M are significant for a company of CBMX's relatively small size, even if the
company captures just low double-digit market share. However, for the other chromosomal microarray
providers targeting the prenatal and POC spaces, which mostly consists of relatively large diagnostic testing
companies with various different lines of products and services, several thousands of employees and billions
of dollars in annual revenue, $400M market size is not likely to be considered high priority. We think this is
particularly true given that this niche segment requires a relatively high level of support and counseling
services which do not lend itself well to a more automated-oriented functioning and perhaps rigid structure of
large diagnostic companies. CBMX expects to differentiate themselves from competing providers via
providing superior customer relations with a particular focus on counseling services.
Competitors in Microarray Analysis Market
Company 2013 Revenue (M) Market Cap (M) Employees
Quest Diagnostics $7,146 $8,550 41,000
PerkinElmer Inc $2,166 $5,320 7,600
LabCorp $5,808 $8,700 34,000
And while CBMX does still offer other types of tests and for applications in postnatal and oncology indications,
the company has transitioned to largely being a pure-play provider of chromosomal microarray analysis tests
for the prenatal and POC segments. Management estimates that the POC market alone is only
approximately 10% penetrated, leaving the vast majority up for grabs among just a small handful of
participants. If CBMX can prove more competitive in terms of service and sales model, we think it is
reasonable to expect that the company can capture meaningful share of the ~$400M markets that they are
focused on exploiting.

masti...@gmail.com

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Jul 9, 2014, 2:25:37 PM7/9/14
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CBMX running

masti...@gmail.com

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Jul 15, 2014, 8:04:15 AM7/15/14
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Calif., July 15, 2014 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (Nasdaq:CBMX), a
molecular diagnostics company performing DNA-based testing services for developmental disorders
and cancer diagnostics, today announced that its chromosomal microarray analysis (CMA) test to
identify development disorders in pediatric patients, the CombiSNP Array for Pediatric Analysis,
has received conditional approval from the New York Department of Health for testing on patient
samples. In 2013, the New York Department of Health granted CombiMatrix approval to market its
CombiSNP CMA test for miscarriage analysis.

CMA testing for pediatric development disorders, such as the company's CombiSNP CMA test, is
recommended by the American College of Medical Genetics for individuals with developmental delays,
birth defects, physical deformities or autism or autism spectrum disorder. Such tests enable
parents and physicians to determine whether the child's abnormality is caused by a genetic defect.
If so, the condition can be addressed in a number of ways including watching for health conditions
associated with the abnormality, providing eligibility for services such as speech or physical
therapy and to evaluate the risk to future pregnancies.

"Gaining the conditional license enables us to market and sell the CombiSNP Array throughout New
York State for pediatric development disorders," said Mark McDonough, chief executive officer of
CombiMatrix. "We have focused our market development activities on our miscarriage analysis test
over the past year and now we plan to expand our activity to address pediatric disorders. Since
last year, we have been selling directly to customers as well as through distribution
partnerships. In the meantime, we look forward to working with the New York Department of Health
to obtain full approval for this important test to assist patients and their physicians."

Under conditional approval, CombiMatrix will be able to market the test in New York while the test
is under Clinical Laboratory Reference System review. Upon completion of the review, either the
test will receive full marketing approval or additional information will be required in order to
achieve final approval.

masti...@gmail.com

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Jul 15, 2014, 9:22:24 AM7/15/14
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Significance: High
Topic(s): Products


 

CombiMatrix Corp:Says its chromosomal microarray analysis (CMA) test to identify development disorders in pediatric patients, the CombiSNP Array for Pediatric Analysis, has received conditional approval from the New York Department of Health for testing on patient samples.CMA testing for pediatric development disorders, such as its CombiSNP CMA test, is recommended by the American College of Medical Genetics for individuals with developmental delays, birth defects, physical deformities or autism or autism spectrum disorder.Under conditional approval, CombiMatrix will be able to market the test in New York while the test is under Clinical Laboratory Reference System review.Upon completion of the review, either the test will receive full marketing approval or additional information will be required in order to achieve final approval.

per reuters

btomm...@aol.com

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Jul 15, 2014, 3:20:05 PM7/15/14
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On Tuesday, July 15, 2014 9:22:24 AM UTC-4, masti...@gmail.com wrote:
> Significance: High
>
>
> Topic(s): Products
>
>
> up 4 cents.

masti...@gmail.com

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Jul 22, 2014, 8:19:49 AM7/22/14
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CBMX flying on news

IRVINE, Calif., July 22, 2014 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has entered into a contractual agreement with Stratose for coverage of CombiMatrix's diagnostic laboratory services.

Stratose, based in Atlanta, GA, maintains one of the largest and growing directly managed PPO networks in the U.S., including more than 850,000 direct and affiliate medical, dental and workers' compensation provider contract. These members will now have access to CombiMatrix's suite of molecular diagnostic solutions and comprehensive clinical support specializing in prenatal, miscarriage and pediatric healthcare.

Mark McDonough, president and chief executive officer of CombiMatrix, says, "Our partnership with Stratose is another example of the value our health plan customers place on our service-oriented testing model. Through this agreement, millions of Stratose PPO members will now have access to our entire portfolio of testing services, including our CombiSNP(TM) chromosomal microarray test (CMA). We look forward to providing them this service."

About Stratose

Stratose is a marketplace leader, providing comprehensive solutions for managing healthcare costs. Stratose utilizes proprietary technology and a suite of products and services to deliver industry leading discounts on medical, dental and workers' compensation billings by accessing direct provider contracts, PPO networks, provider negotiations, proprietary re-pricing including Medicare, to achieve industry leading savings for its national client base. Learn more at www.stratose.com.


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