Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery
company, today reported its financial results for the quarter ended
September 30, 2009. Product sales for the third quarter of 2009 were
$22.3 million, an 8% increase over product sales of $20.6 million in the
third quarter of 2008. The 2009 third quarter results included $400,000
in U.S. sales of Cortoss™, the Company’s new and innovative synthetic
biomaterial that was cleared by the FDA in June 2009 for the treatment
of vertebral compression fractures. In July 2009, Orthovita initiated a
limited, controlled launch of Cortoss in the U.S. using a small group of
its highly trained direct sales representatives, and expanded the launch
to its entire sales force for the fourth quarter of 2009.
Gross profit during the third quarter of 2009 was $15.1 million, or 68%
of sales, compared to $13.9 million, or 68% of sales, in the third
quarter of 2008. Operating expenses in the third quarter of 2009 were
$16.1 million, a 7% increase over operating expenses of $15.1 million in
the third quarter of 2008.
The operating loss for the third quarter of 2009 decreased to $1.0
million compared to an operating loss of $1.2 million in the third
quarter of 2008. The net loss for the quarter ended September 30, 2009
was $1.7 million, or $0.02 per common share, which was unchanged from
the third quarter of 2008.
"The most significant news of the third quarter was our controlled
launch of Cortoss in the United States,” said Antony Koblish, President
and Chief Executive Officer of Orthovita. "There are subtle but
important differences in the application of the Cortoss technology
compared to standard polymethylmethacrylate (PMMA) bone cement, and we
wanted to ensure the best possible clinical outcomes as we introduced
this innovative new technology to surgeons and patients. I am very
pleased to report that surgeons adapted readily to the use of Cortoss,
and many were impressed with the product’s ease of use, therapeutic fill
and flow characteristics and strong clinical benefit. Several surgeons
have commented that these features allow them to complete cases in less
time than previously required. A number of surgeons are also using
Cortoss in their more difficult cases and achieving favorable outcomes
for their patients.”
"In September, following additional clinical training, all of our direct
sales representatives began targeting surgeons for potential Cortoss
use. Cortoss is a new technology, so our representatives need to spend
quite a bit of time addressing new technology committees in hospitals
before the product is approved and ordered. We are gratified to see that
nearly two-thirds of the hospitals that have ordered Cortoss have
already placed reorders for the product.”
"Total sales in the third quarter of 2009 increased over the
corresponding 2008 quarter at a slower rate than in previous quarters,”
commented Nancy Broadbent, Senior Vice President and Chief Financial
Officer of Orthovita. "The third quarter is typically affected by summer
seasonality, but we believe this had less of an impact in 2008 because
of the rapid uptake of Vitoss Bioactive Foam launched earlier in 2008.
We believe that sales force productivity in the 2009 quarter was also
adversely affected by the launch of Cortoss in the U.S. and the time
required educating physicians and hospital new technology committees
about Cortoss.”
For the first nine months of 2009, product sales increased 22% to $68.5
million, compared to $56.1 million for the first nine months of 2008.
This increase was due primarily to higher sales of Vitoss Bioactive
Foam. Gross profit for the nine months ended September 30, 2009 was $
46.7 million, or 68% of product sales, compared to $37.2 million, or 66%
of product sales, in the nine months ended September 30, 2008. This
improvement in gross margin was largely due to a more favorable product
mix.
The operating loss in the first nine months of 2009 was $1.5 million
compared to an operating loss of $8.5 million in the first nine months
of 2008. This improvement resulted from higher sales and gross margins,
which were partially offset by higher (5.0%) operating expenses in the
first nine months of 2009 compared to the first nine months of 2008. The
net loss for the first nine months of 2009 was $3.6 million, or $0.05
per common share, compared to a net loss of $9.5 million, or $0.13 per
common share, in the first nine months of 2008.
Cash, cash equivalents and short-term investments were $22.5 million at
September 30, 2009, compared to $32.3 million at December 31, 2008. For
the nine months ended September 30, 2009, the net cash and cash
equivalents used in operating activities was $5.9 million, compared to
$11.7 million for the nine months ended September 30, 2008. Net cash and
cash equivalents used in operating activities for the nine months ended
September 30, 2009 decreased as compared with the nine months ended
September 30, 2008, primarily due to a decrease in the operating loss.
Conference Call
Antony Koblish, President and Chief Executive Officer, and Nancy C.
Broadbent, Senior Vice President and Chief Financial Officer of
Orthovita, will host a conference call at 8:30 a.m. Eastern Time on
Thursday, November 5, 2009 to review and discuss the third quarter 2009
financial results. The phone number to join the conference call from
within the U.S. is (888) 815-2919, and from outside the U.S. is (706)
643-3675; the conference identification number is 35689143. Listeners
are advised to dial in ten minutes prior to the scheduled start time for
the conference call. A replay of the conference call will be available
for two weeks beginning November 5, 2009 at 11:30 a.m. Eastern Time, and
ending November 19, 2009, at 11:59 p.m. Eastern Time. You may listen to
the replay by dialing within the U.S. (800) 642-1687 or by dialing from
outside the U.S. (706) 645-9291. The replay identification number is
35689143.
About the Company
Orthovita is an orthobiologics and biosurgery company that develops and
markets novel medical devices. Our orthobiologics platform offers
products for the fusion, regeneration, and fixation of human bone. Our
biosurgery platform offers products for controlling intra-operative
bleeding, also known as hemostasis. Our current fusion and regeneration
products are based on our proprietary VITOSSTM Bone Graft
Substitute technology and address the non-structural bone graft market
with synthetic, bioactive alternatives to patient- and cadaver-derived
bone tissue. CORTOSSTM Bone Augmentation Material, an
injectable, polymer composite that mimics the structural characteristics
of human bone, provides the basis for our fixation portfolio. CORTOSS
received clearance in June 2009 for vertebral augmentation. Our
hemostasis portfolio includes VITAGELTM Surgical Hemostat, a
unique, collagen-based matrix that controls bleeding and facilitates
healing, and VITASURE™ Absorbable Hemostat, a plant-based product that
can be deployed quickly throughout surgery.
Disclosure Notice
This press release may contain forward-looking statements regarding
Orthovita’s current expectations of future events that involve risks and
uncertainties, including, without limitation, the demand and market
acceptance of our products, including CORTOSS, our ability to
successfully launch Cortoss, our ability to achieve our sales and net
loss forecast for 2009, and other aspects of our business. Such
statements are based on management’s current expectations and are
subject to a number of substantial risks and uncertainties that could
cause actual results or timeliness to differ materially from those
addressed in the forward-looking statements.
Factors that may
cause such a difference are listed from time to time in reports filed by
the Company with the U.S. Securities and Exchange Commission (SEC),
including but not limited to risks described in our most recently filed
Form 10-K under the caption "Risk Factors.”
Further
information about these and other relevant risks and uncertainties may
be found in Orthovita’s filings with the SEC, all of which are available
from the SEC as well as other sources. Orthovita undertakes no
obligation to publicly update any forward-looking statements.
|
|
|
ORTHOVITA, INC. AND SUBSIDIARIES
|
|
Summary Financial Information (Unaudited)
|
|
|
|
Statements of Operations Data:
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
|
2009
|
|
|
|
2008
|
|
|
|
PRODUCT SALES
|
|
$
|
22,295,070
|
|
|
100
|
%
|
|
$
|
20,563,081
|
|
|
100
|
%
|
|
|
$
|
68,476,675
|
|
|
100
|
%
|
|
$
|
56,068,078
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COST OF SALES
|
|
|
7,149,818
|
|
|
32
|
%
|
|
|
6,682,197
|
|
|
32
|
%
|
|
|
|
21,826,529
|
|
|
32
|
%
|
|
|
18,850,313
|
|
|
34
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT
|
|
|
15,145,252
|
|
|
68
|
%
|
|
|
13,880,884
|
|
|
68
|
%
|
|
|
|
46,650,146
|
|
|
68
|
%
|
|
|
37,217,765
|
|
|
66
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General & administrative expenses
|
|
|
3,443,940
|
|
|
15
|
%
|
|
|
2,671,559
|
|
|
13
|
%
|
|
|
|
9,148,039
|
|
|
13
|
%
|
|
|
8,202,293
|
|
|
15
|
%
|
|
Selling & marketing expenses
|
|
|
10,819,777
|
|
|
49
|
%
|
|
|
10,957,284
|
|
|
53
|
%
|
|
|
|
33,433,176
|
|
|
49
|
%
|
|
|
32,236,273
|
|
|
57
|
%
|
|
Research & development expenses
|
|
|
1,885,648
|
|
|
8
|
%
|
|
|
1,456,380
|
|
|
7
|
%
|
|
|
|
5,542,759
|
|
|
8
|
%
|
|
|
5,292,670
|
|
|
9
|
%
|
|
Total operating expenses
|
|
|
16,149,365
|
|
|
72
|
%
|
|
|
15,085,223
|
|
|
73
|
%
|
|
|
|
48,123,974
|
|
|
70
|
%
|
|
|
45,731,236
|
|
|
81
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING LOSS
|
|
|
(1,004,113
|
)
|
|
(4
|
%)
|
|
|
(1,204,339
|
)
|
|
(6
|
%)
|
|
|
|
(1,473,828
|
)
|
|
(2
|
%)
|
|
|
(8,513,471
|
)
|
|
(15
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTEREST EXPENSE
|
|
|
(756,081
|
)
|
|
(3
|
%)
|
|
|
(814,013
|
)
|
|
(4
|
%)
|
|
|
|
(2,342,272
|
)
|
|
(3
|
%)
|
|
|
(1,976,195
|
)
|
|
(4
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTEREST INCOME
|
|
|
28,572
|
|
|
<1%
|
|
|
264,517
|
|
|
1
|
%
|
|
|
|
238,569
|
|
|
<1%
|
|
|
1,075,520
|
|
|
2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAIN/(LOSS) ON SALE OR DISPOSAL OF ASSETS
|
|
|
4,995
|
|
|
<1%
|
|
|
74,074
|
|
|
(<1%)
|
|
|
|
4,995
|
|
|
<1%
|
|
|
(71,909
|
)
|
|
(<1%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME TAXES
|
|
|
(1,726,627
|
)
|
|
(8
|
%)
|
|
|
(1,679,761
|
)
|
|
(8
|
%)
|
|
|
|
(3,572,536
|
)
|
|
(5
|
%)
|
|
|
(9,486,055
|
)
|
|
(17
|
%)
|
|
INCOME TAXES
|
|
|
(14,350
|
)
|
|
(<1%)
|
|
|
(14,350
|
)
|
|
(<1%)
|
|
|
|
(43,050
|
)
|
|
(<1%)
|
|
|
(43,050
|
)
|
|
(<1%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$
|
(1,740,977
|
)
|
|
(8
|
%)
|
|
$
|
(1,694,111
|
)
|
|
(8
|
%)
|
|
|
$
|
(3,615,586
|
)
|
|
(5
|
%)
|
|
$
|
(9,529,105
|
)
|
|
(17
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS PER SHARE, BASIC AND DILUTED
|
|
$
|
(0.02
|
)
|
|
|
|
$
|
(0.02
|
)
|
|
|
|
|
$
|
(0.05
|
)
|
|
|
|
$
|
(0.13
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS PER COMMON
SHARE
|
|
|
76,279,297
|
|
|
|
|
|
75,820,540
|
|
|
|
|
|
|
76,088,467
|
|
|
|
|
|
75,790,134
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ORTHOVITA, INC. AND SUBSIDIARIES
|
|
Summary Financial Information (Unaudited)
|
|
|
|
|
|
|
|
|
Balance Sheet Data:
|
|
|
September 30, 2009
|
|
December 31, 2008
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
|
$
|
8,195,622
|
|
$
|
8,518,118
|
|
Short-term investments
|
|
|
|
14,326,372
|
|
|
23,772,385
|
|
Accounts receivable, net
|
|
|
|
10,695,012
|
|
|
10,880,623
|
|
Inventories
|
|
|
|
25,269,431
|
|
|
19,757,268
|
|
Other current assets
|
|
|
|
674,199
|
|
|
693,889
|
|
Total current assets
|
|
|
|
59,160,636
|
|
|
63,622,283
|
|
Property and equipment, net
|
|
|
|
17,834,820
|
|
|
14,437,926
|
|
License and technology intangibles, net
|
|
|
|
11,749,438
|
|
|
12,353,783
|
|
Other assets
|
|
|
|
1,120,720
|
|
|
756,533
|
|
Total assets
|
|
|
$
|
89,865,614
|
|
$
|
91,170,525
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
$
|
10,795,160
|
|
$
|
11,410,382
|
|
Notes payable, net of debt discount
|
|
|
|
34,020,245
|
|
|
33,808,606
|
|
Other long-term liabilities
|
|
|
|
423,984
|
|
|
309,852
|
|
Total liabilities
|
|
|
|
45,239,389
|
|
|
45,528,840
|
|
Total shareholders’ equity
|
|
|
|
44,626,225
|
|
|
45,641,685
|
|
Total liabilities and shareholders’ equity
|
|
|
$
|
89,865,614
|
|
$
|
91,170,525
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flow Data:
|
|
|
Nine Months Ended September 30,
|
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
$
|
(5,968,863
|
)
|
|
$
|
(11,737,273
|
)
|
|
|
|
|
|
|
|
|
Net cash provided by investing activities
|
|
|
$
|
4,303,772
|
|
|
$
|
2,980,710
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
$
|
1,238,475
|
|
|
$
|
10,146,948
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
$
|
104,120
|
|
|
$
|
(395,617
|
)
|
|
|
|
|
|
|
|
|
|
|
|