|
| [September 07, 2010] |
 |
Rosetta Genomics Reports Second Quarter 2010 Financial Results
PHILADELPHIA & REHOVOT, Israel --(Business Wire)--
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer of
microRNA-based molecular diagnostics, today reported financial results
for the three and six months ended June 30, 2010. Highlights of
activities since the announcement of the Company's first quarter
financial results on May 27, 2010 include:
-
Establishment of Rosetta Green as a majority-owned subsidiary with
Rosetta Genomics holding a 76% ownership position in the new company.
Rosetta Genomics has signed a license agreement with Rosetta Green
providing for the use of its microRNAs by Rosetta Green in
agricultural and clean technology applications, with a particular
focus on improving feedstocks for biofuels and crops for agriculture.
-
New, interim data from a study conducted in collaboration with
researchers from the University of Texas, M. D. Anderson Comprehensive
Cancer Center were presented at ASCO 2010. The data demonstrated
the ability of miRview™ mets to identify the most likely origin of
metastases in Cancer of Unknown Primary.
-
Clalit Health Services, Israel's largest and the world's second
largest health maintenance organization, established a reimbursement
coverage policy for Rosetta Genomics' miRview™ mets test.
-
Publication of a peer-reviewed article in the online version of the Journal
of Molecular Diagnostics demonstrated the ability of microRNAs to
accurately identify four histological types of renal tumors, namely
clear cell, papillary and chromophobe renal cell carcinoma, as well as
oncocytoma, a benign tumor.
-
Exclusive distribution agreement for three of Rosetta Genomics'
diagnostic tests signed with Genekor S.A, a leading molecular
diagnostic service provider in Greece.
Management Commentary
"We are encouraged by the commercial progress we made in the second
quarter, with the number of tests performed up more than 170% compared
with the immediately preceding quarter. This growth trend is continuing
as average weekly test unit volume in the third quarter to date is more
than double the average weekly test unit volume for the second quarter,"
said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta
Genomics.
"In addition to the significant percentage growth in sales of our
commercially available products, we expanded our global reach with the
addition of an exclusive distributor in Greece and have a reimbursement
policy in place for the miRview™ mets test by Clalit Health Services for
Israel. Initially, reimbursement will be provided to patients
participating in a clinical study being conducted at three medical
centers in Israel, with plans to expand reimbursement for the test to
all Clalit members. We expect to build on these successes in the coming
quarters to gain further commercial traction with our microRNA-based
diagnostic tests.
"We were especially pleased that a number of important clinical studies
were published in peer-reviewed journals and presented at annual medical
meetings during the quarter, as this expanding body of data continues to
validate the clinical utility of our microRNA platform in diagnostics.
"We continued to advance our robust development pipeline during the
quarter and we are delighted to announce that we are on or ahead of
schedule in preparing for the launch of the first two of these
diagnostics, namely our next generation miRview™ mets assay and miRview™
lung. Compelling clinical data validating each of these two tests will
be highlighted at the American Academy of Cancer Research's upcoming
Molecular Diagnostics in Cancer Therapeutic Development Conference,
taking place in Denver in late September. Our next generation miRview™
mets test will be launched outside the United States by the end of this
year and miRview™ lung will be ready for commercialization in the first
half of 2011, six months earlier than initially projected. In addition,
miRview™ bladder remains on track to launch in the second half of 2011.
"We are especially pleased to unveil our latest two tests under
development, namely, miRview™ kidney, which is being developed to
accurately identify four histological types of renal tumors, and
miRview™ meso prognostic, which we are developing to sub-classify
mesothelioma patients based on their prognosis. In each case these
diagnostic tests are being developed to provide valuable clinical
information that can help guide physicians in determining the most
effective treatment protocols for their patients. We look forward to
continuing our development work and to launching these promising
products in 2011. As with all of our products in development, our
projected launch dates assume no changes to the current regulations for
Laboratory Developed Tests by the U.S. Food and Drug Administration. Any
changes to those regulations could impact our launch dates.
"Biomarkers and companion diagnostics continue to enjoy heightened
interest within the clinical and medical communities. This was
particularly evident at this year's American Society for Clinical
Oncology Annual Meeting where biomarkers and companion diagnostics were
a key topic of discussion. Because of their high tissue specificity,
microRNAs are ideally suited as biomarkers and, thus, are particularly
valuable to the pharmaceutical industry. Rosetta plans to build on its
commercially available diagnostic tests for cancer and its robust and
diverse microRNA-based product pipeline, to lead the development of
clinically relevant response biomarkers that harness the power of
microRNAs to advance patient care worldwide," concluded Mr. Berlin.
Second Quarter Results
The Company recorded revenues from continuing operations of $70,000 and
$14,000 for the second quarters of 2010 and 2009, respectively.
Research and development expenses for the second quarter of 2010 were
$1.9 million, compared with $1.4 million for the second quarter of 2009,
mainly due to an increase in expenses related to compensation.
Marketing and business development expenses for the second quarter of
2010 were $1.6 million compared with $1.4 million for the second quarter
of 2009, primarily the result of an increase in expenses related to
compensation.
General and administrative expenses were $854,000 in the second quarter
of 2010 compared with $749,000 in the second quarter of 2009.
The operating loss for the second quarter of 2010 was $4.4 million,
including $898,000 of non-cash stock compensation expense, which in turn
included $700,000 in non-cash stock compensation expense associated with
the establishment of the Company's Rosetta Green subsidiary and
compensation for its chief executive officer. These expenses were
recorded as Research and Development, General and Administrative and
Business Development costs. This compares with an operating loss of $3.8
million, including $268,000 of non-cash stock compensation expense, for
the corresponding quarter of 2009.
The Company's net loss from continuing operations for the second quarter
of 2010 was $4.2 million or $0.25 per ordinary share, compared with a
net loss from continuing operations of $3.8 million or $0.28 per
ordinary share, in the same period of 2009.
On a non-GAAP basis, excluding stock-compensation expense, the net loss
from continuing operations for the 2010 second quarter was $3.3 million
or $0.20 per ordinary share. This compares with a non-GAAP net loss from
continuing operations for the 2009 second quarter of $3.5 million or
$0.26 per ordinary share.
For the six months ended June 30, 2010 the Company reported revenues
from continuing operations of $97,000, compared with revenues from
continuing operations of $31,000 in the comparable prior year period.
The Company's net loss from continuing operations in the first half of
2010 was $7.8 million or $0.48 per ordinary share, compared with a net
loss from continuing operations of $7.2 million or $0.56 per ordinary
share in the same period of 2009.
On a non-GAAP basis, excluding stock-compensation expense, the net loss
from continuing operations for the first half of 2010 was $6.7 million
or $0.40 per ordinary share. This compares with a non-GAAP net loss from
continuing operations for the first half of 2009 of $6.7 million or
$0.52 per ordinary share.
Details reconciling non-GAAP amounts with GAAP amounts are provided in
the table below.
Rosetta Genomics ended the second quarter of 2010 with $7.7 million in
cash and cash equivalents, short-term bank deposit and marketable
securities, compared with $10.3 million as of December 31, 2009.
Conference Call
Rosetta Genomics management will host a conference call on Wednesday,
September 8, 2010 beginning at 10:00 a.m. Eastern time to discuss second
quarter 2010 financial results and recent corporate developments, and
answer questions. To access the live conference call, U.S. and Canadian
participants may dial (866) 239-5859; international participants may
dial (702) 495-1913. The access code for the call is 89504316.
To access the audio replay, beginning two hours after the event U.S. and
Canadian participants may dial (800) 642-1687; international
participants may dial (706) 645-9291. The access code for the replay is
89504316. The replay will be available through 12 midnight Eastern time
on September 10, 2010.
A live audio webcast of the call will also be available in the
"Investors" section of the Company's website at www.rosettagenomics.com.
An archived webcast will be available on the Company's website for 30
days beginning approximately two hours after the event.
About microRNAs
MicroRNAs (miRNAs) are recently discovered, small RNAs that act as
master regulators of protein synthesis, and have been shown to be highly
effective biomarkers. The unique advantage of microRNAs as biomarkers
lies in their high tissue specificity, and their exceptional stability
in the most routine preservation methods for biopsies, including
Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle
aspirate (FNA) cell blocks. It has been suggested that their small size
(19 to 21 nucleotides) enables them to remain intact in FFPE blocks, as
opposed to messenger RNA (mRNA), which tends to degrade rapidly. In
addition, early preclinical data has shown that by controlling the
levels of specific microRNAs, cancer cell growth may be reduced. To
learn more about microRNAs, please visit www.rosettagenomics.com.
About Rosetta Genomics
Rosetta Genomics is a leading developer of microRNA-based molecular
diagnostics. Founded in 2000, the company's integrative research
platform combining bioinformatics and state-of-the-art laboratory
processes has led to the discovery of hundreds of biologically validated
novel human microRNAs. Building on its strong patent position and
proprietary platform technologies, Rosetta Genomics is working on the
application of these technologies in the development of a full range of
microRNA-based diagnostic tools. The company's first three
microRNA-based tests, miRview™ squamous, miRview™ mets and miRview™
meso, are commercially available through its Philadelphia-based
CAP-accredited, CLIA-certified lab. To learn more, please visit www.rosettagenomics.com.
Forward-Looking Statements
Various statements in this news release concerning Rosetta's future
expectations, plans and prospects, including statements relating to the
timing of the launch of our diagnostic tests under development,
constitute forward-looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by these
forward-looking statements as a result of various important factors,
including the potential for increased FDA regulation of tests such as
the ones we are developing, and those risks more fully discussed under
"Key Information - Risk Factors" in Rosetta's Annual Report on Form 20-F
for the year ended December 31, 2009 on file with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent Rosetta's views only as of today and should not be relied upon
as representing its views as of any subsequent date. Rosetta does not
assume any obligation to update any forward-looking statements unless
required by law.
Use of Non-GAAP Financial Measures
This press release contains certain non-GAAP financial measures. A
"non-GAAP financial measure" refers to a numerical measure of historical
or future financial performance, financial position, or cash flows that
excludes (or includes) amounts that are included in (or excluded from)
the most directly comparable measure calculated and presented in
accordance with GAAP in the financial statements. In this release,
Rosetta provides non-GAAP net loss and non-GAAP net loss per share data
as additional information relating to its operating results. The
presentation of this additional information is not meant to be
considered in isolation or as a substitute for net loss or net loss per
share prepared in accordance with GAAP.
Pursuant to the requirements of Regulation G promulgated by the SEC, the
Company has provided a reconciliation of each non-GAAP financial measure
used in this earnings release and related conference call or webcast to
the most directly comparable financial measure prepared in accordance
with GAAP. This reconciliation is presented in a table below under the
heading "Reconciliation of GAAP to Non-GAAP Consolidated Statement of
Operation." Investors are encouraged to review these reconciliations to
ensure they have a thorough understanding of the reported non-GAAP
financial measures and their most directly comparable GAAP financial
measures.
Management uses these non-GAAP measures for internal reporting and
forecasting purposes. The Company has provided these non-GAAP financial
measures in addition to GAAP financial results because it believes that
these non-GAAP financial measures provide useful information to certain
investors and financial analysts for comparison across accounting
periods not influenced by certain non-cash items that are not used by
management when evaluating the Company's historical and prospective
financial performance.
[Tables to follow]
|
|
|
|
|
|
|
|
|
CONSOLIDATED BALANCE SHEETS
|
|
U.S. dollars in thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
|
|
2010
|
|
|
|
|
2009
|
|
|
|
|
2009
|
|
|
|
|
|
Unaudited
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
2,903
|
|
|
|
$
|
5,984
|
|
|
|
$
|
3,329
|
|
|
Restricted cash
|
|
|
|
993
|
|
|
|
|
1,178
|
|
|
|
|
1,076
|
|
|
Short-term bank deposits
|
|
|
|
1,144
|
|
|
|
|
8,326
|
|
|
|
|
3,143
|
|
|
Marketable securities
|
|
|
|
2,649
|
|
|
|
|
1,194
|
|
|
|
|
2,756
|
|
|
Trade receivables, net
|
|
|
|
131
|
|
|
|
|
31
|
|
|
|
|
72
|
|
|
Other accounts receivable and prepaid expenses
|
|
|
|
551
|
|
|
|
|
736
|
|
|
|
|
557
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
|
8,371
|
|
|
|
|
17,449
|
|
|
|
|
10,933
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SEVERANCE PAY FUND
|
|
|
|
103
|
|
|
|
|
75
|
|
|
|
|
92
|
|
|
PROPERTY AND EQUIPMENT, NET
|
|
|
|
1,376
|
|
|
|
|
1,275
|
|
|
|
|
1,216
|
|
|
LONG-TERM ACCOUNTS RECEIVABLES
|
|
|
|
260
|
|
|
|
|
606
|
|
|
|
|
502
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long term assets
|
|
|
|
1,739
|
|
|
|
|
1,956
|
|
|
|
|
1,810
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
$
|
10,110
|
|
|
|
$
|
19,405
|
|
|
|
$
|
12,743
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
Short-term bank loan, current maturities of capital lease and of
long-term bank loan
|
|
|
|
108
|
|
|
|
|
94
|
|
|
|
|
125
|
|
|
Trade payables
|
|
|
|
849
|
|
|
|
|
983
|
|
|
|
|
654
|
|
|
Other accounts payable and accruals
|
|
|
|
1,495
|
|
|
|
|
1,390
|
|
|
|
|
1,526
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
|
2,452
|
|
|
|
|
2,467
|
|
|
|
|
2,305
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
Long-term bank loan and capital lease
|
|
|
|
2
|
|
|
|
|
70
|
|
|
|
|
46
|
|
|
Convertible loan
|
|
|
|
-
|
|
|
|
|
1,500
|
|
|
|
|
1,500
|
|
|
Deferred revenue
|
|
|
|
1,928
|
|
|
|
|
1,928
|
|
|
|
|
1,928
|
|
|
Accrued severance pay
|
|
|
|
135
|
|
|
|
|
107
|
|
|
|
|
122
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Long-term Liabilities
|
|
|
|
2,065
|
|
|
|
|
3,605
|
|
|
|
|
3,596
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY:
|
|
|
|
|
|
|
|
|
|
|
Rosetta Genomics Shareholders equity:
|
|
|
|
|
|
|
|
|
|
|
Share capital:
|
|
|
|
39
|
|
|
|
|
32
|
|
|
|
|
32
|
|
|
Additional paid-in capital
|
|
|
|
74,485
|
|
|
|
|
67,295
|
|
|
|
|
68,174
|
|
|
Other comprehensive income
|
|
|
|
2
|
|
|
|
|
-
|
|
|
|
|
96
|
|
|
Deficit accumulated during the development stage
|
|
|
|
(69,662
|
)
|
|
|
|
(53,994
|
)
|
|
|
|
(61,460
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Rosetta
Genomics shareholders' equity
|
|
|
|
4,864
|
|
|
|
|
13,333
|
|
|
|
|
6,842
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-controlling interest
|
|
|
|
729
|
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Equity
|
|
|
$
|
5,593
|
|
|
|
$
|
13,333
|
|
|
|
$
|
6,842
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
shareholders' equity
|
|
|
$
|
10,110
|
|
|
|
$
|
19,405
|
|
|
|
$
|
12,743
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
U.S. dollars in thousands (except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
|
|
|
Six months ended
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
2010
|
|
|
|
|
2009
|
|
|
|
2010
|
|
|
|
|
2009
|
|
|
|
|
Unaudited
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
$
|
70
|
|
|
|
$
|
14
|
|
|
$
|
97
|
|
|
|
$
|
31
|
|
Cost of revenues:
|
|
|
|
140
|
|
|
|
|
167
|
|
|
|
298
|
|
|
|
|
305
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross loss
|
|
|
|
70
|
|
|
|
|
153
|
|
|
|
201
|
|
|
|
|
274
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net
|
|
|
|
1,941
|
|
|
|
|
1,432
|
|
|
|
3,561
|
|
|
|
|
3,117
|
|
Marketing and business development
|
|
|
|
1,569
|
|
|
|
|
1,435
|
|
|
|
2,745
|
|
|
|
|
2,299
|
|
General and administrative
|
|
|
|
854
|
|
|
|
|
749
|
|
|
|
1,583
|
|
|
|
|
1,499
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
4,364
|
|
|
|
|
3,616
|
|
|
|
7,889
|
|
|
|
|
6,915
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
|
4,434
|
|
|
|
|
3,769
|
|
|
|
8,090
|
|
|
|
|
7,189
|
|
Financial expenses(income) net
|
|
|
|
(9
|
)
|
|
|
|
30
|
|
|
|
(50
|
)
|
|
|
|
18
|
|
Net loss
|
|
|
|
4,425
|
|
|
|
|
3,799
|
|
|
|
8,040
|
|
|
|
|
7,207
|
|
Attributable to non controlling interest
|
|
|
|
(198
|
)
|
|
|
|
-
|
|
|
|
(219
|
)
|
|
|
|
-
|
|
Net loss attributable to Rosetta Genomics before discontinued
operation
|
|
|
|
4,227
|
|
|
|
|
3,799
|
|
|
|
7,821
|
|
|
|
|
7,207
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Rosetta Genomics from discontinued operation
|
|
|
|
381
|
|
|
|
|
1,621
|
|
|
|
381
|
|
|
|
|
1,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to Rosetta Genomics after discontinued
operation
|
|
|
$
|
4,608
|
|
|
|
$
|
5,420
|
|
|
$
|
8,202
|
|
|
|
$
|
9,039
|
|
Basic and diluted net loss per Ordinary share of continuing
operation attributable to Rosetta Genomics' shareholders
|
|
|
$
|
0.25
|
|
|
|
$
|
0.28
|
|
|
$
|
0.48
|
|
|
|
$
|
0.56
|
|
Basic and diluted net loss per Ordinary share of discontinuing
operation attributable to Rosetta Genomics' shareholders
|
|
|
$
|
0.02
|
|
|
|
$
|
0.12
|
|
|
$
|
0.02
|
|
|
|
$
|
0.14
|
|
Basic and diluted net loss per Ordinary share attributable to
Rosetta Genomics' shareholders
|
|
|
$
|
0.27
|
|
|
|
$
|
0.40
|
|
|
$
|
0.50
|
|
|
|
$
|
0.70
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of Ordinary shares used to computed basic
and diluted net loss per Ordinary share
|
|
|
|
16,778,127
|
|
|
|
|
13,581,036
|
|
|
|
16,508,281
|
|
|
|
|
12,880,557
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF GAAP TO NON-GAAP CONSOLIDATED STATEMENT OF
OPERATION:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months ended
|
|
|
Three Months ended
|
|
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
|
|
|
2010
|
|
|
|
|
2009
|
|
|
|
|
2010
|
|
|
|
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss as reported
|
|
|
|
$
|
7,821
|
|
|
|
$
|
7,207
|
|
|
|
$
|
4,227
|
|
|
|
|
$
|
3,799
|
|
|
NON-GAAP Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses reported for stock-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
|
|
(3
|
)
|
|
|
|
-
|
|
|
|
|
(3
|
)
|
|
|
|
|
-
|
|
|
Research and development, net
|
|
|
|
|
(302
|
)
|
|
|
|
(164
|
)
|
|
|
|
(234
|
)
|
|
|
|
|
(88
|
)
|
|
Marketing and business development
|
|
|
|
|
(524
|
)
|
|
|
|
(162
|
)
|
|
|
|
(446
|
)
|
|
|
|
|
(60
|
)
|
|
General and administrative
|
|
|
|
|
(288
|
)
|
|
|
|
(219
|
)
|
|
|
|
(215
|
)
|
|
|
|
|
(120
|
)
|
|
Total Adjustment
|
|
|
|
|
(1,117
|
)
|
|
|
|
(545
|
)
|
|
|
|
(898
|
)
|
|
|
|
|
(268
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-GAAP net loss
|
|
|
|
|
6,704
|
|
|
|
|
6,662
|
|
|
|
|
3,329
|
|
|
|
|
|
3,531
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NON-GAAP Basic net loss (income) per Ordinary share
|
|
|
|
$
|
0.41
|
|
|
|
$
|
0.52
|
|
|
|
$
|
0.20
|
|
|
|
|
$
|
0.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|

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