Omrix Biopharmaceuticals, Inc. (“Omrix”
or the “Company”)
(NASDAQ: OMRI), a fully-integrated biopharmaceutical company that
develops and markets biosurgical and immunotherapy products, today
announced financial results for the third quarter ended September 30,
2008:
-
Third quarter 2008 total revenues were $21.3 million, a 34% increase,
from $15.8 million in the third quarter of 2007.
-
Third quarter 2008 product sales were $19.6 million, a 40% increase,
from $14.0 million in the third quarter of 2007.
-
Third quarter 2008 biosurgical product sales were $9.5 million, a 40%
increase, from $6.8 million in the third quarter of 2007.
-
Third quarter 2008 passive immunotherapy product and byproduct sales
were $10.1 million, a 40% increase, from $7.2 million in the third
quarter of 2007.
-
Third quarter operating income was $3.5 million, or 17% of total
revenues and a 52% increase, from $2.3 million, or 15% of total
revenues, in the third quarter of 2007.
-
Third quarter 2008 net income was $3.6 million, or $0.21 per share on
a diluted basis, from $3.7 million, or $0.21 per share on a diluted
basis, in the third quarter of 2007.
New Events:
-
Preliminary results from the Phase I/II study for Adhexil, the Company’s
anti-adhesion product candidate, demonstrate positive safety and
efficacy data. These results will be discussed in more detail during
the financial results conference call (please see “Conference
Call Information” below).
-
Approval of the Company’s clinical trial
application, or CTA, by the United Kingdom’s
MHRA (Medicines & Healthcare products Regulatory Agency) to conduct a
pivotal clinical study evaluating the safety and efficacy of the
Fibrin Pad in soft tissue severe bleeding.
Recent Events:
-
Announced interim results from its U.S. Phase II clinical trial
evaluating the safety and hemostatic effectiveness of the Company's
Fibrin Pad product candidate as an adjunct to control mild to moderate
soft tissue bleeding during abdominal, retroperitoneal, pelvic, and
thoracic surgery. Interim analysis at 90 patients, which were
randomized 2:1 Fibrin Pad to SURGICEL, indicated that the Fibrin Pad
was superior to SURGICEL in the primary efficacy endpoint, which
measured the proportion of subjects achieving hemostatic success at 4
minutes after randomization with no re-bleeding requiring treatment
during a subsequent 6-minute observation period.
-
Received approval for EVICEL™ Fibrin
Sealant (Human) from the European Medicines Agency (EMEA) as a
supportive treatment in surgery where standard surgical techniques are
insufficient and for the improvement of hemostasis and as suture
support for hemostasis in vascular surgery. With an EMEA approval,
EVICEL is licensed for marketing in the 27 countries of the European
Union, or EU. Per the terms of Omrix' and ETHICON's supply and
distribution agreement, ETHICON has the marketing rights for the EU.
“We are pleased to report solid financial
results, including record quarterly total revenues and product sales,”
stated Robert Taub, Chief Executive Officer. “In
particular, biosurgery recorded the best product sales quarter to date
as a result of volume increases. We remain committed to growing our
biosurgery franchise and are encouraged by the continued market
penetration of our commercialized products. In addition, our business is
beginning to show the benefits of economies of scale as evidenced by an
improvement in our operating margins in the third quarter. We have
reinvested the cash generated from our operations in capital
expenditures to support the future growth of our business.”
Third Quarter 2008 Financial Results
Total revenues for the third quarter of 2008 increased to $21.3 million,
a 35% increase, from $15.8 million in the third quarter of 2007.
Total product sales for the third quarter of 2008 increased to $19.6
million ($9.5 million from biosurgery products, $8.4 million from
immunotherapy products and $1.7 million from immunotherapy byproducts),
a 40% increase from $14.0 million ($6.8 million from biosurgery
products, $7.2 million from immunotherapy products and $0.0 from
immunotherapy byproducts) in the comparable quarter of 2007. Biosurgery
product sales increased 40% primarily due to increased unit sales of
Evicel and Evithrom. Passive immunotherapy product and byproduct sales
also increased by 40% primarily due to byproduct sales and an increase
in unit sales and unit price of Omrigam.
Gross profit for the third quarter of 2008 was $9.1 million, or 43% of
total revenues, compared to $6.3 million, or 40% of total revenues, in
the corresponding quarter of 2007. Gross profit was favorably impacted
by increased production and sales volumes and unfavorably impacted by
raw material price increases and the decline in value of the U.S. dollar
versus the New Israeli Shekel.
Research and development, including clinical and regulatory, expenses
increased to $1.6 million in the third quarter of 2008, a 73% increase,
from $0.9 million in the third quarter of 2007. This increase was driven
by an increase in personnel and in expenses mainly related to the
development of Adhexil, the Company’s
adhesion prevention product candidate, and other proprietary products,
for which Omrix currently retains full rights.
Selling, marketing, general and administrative expenses, or SG&A, in the
third quarter of 2008 increased to $4.0 million, a 31% increase,
compared to $3.0 million in the third quarter of 2007. Third quarter
2008 SG&A expenses include a $0.3 million reversal of a non-recurring
accrual resulting from the signing of a sub-lease agreement for the
German office. Excluding this non-recurring expense, SG&A in the third
quarter of 2008 would have been $4.3 million, a 40% increase, when
compared to $3.0 million in the third quarter of 2007. This increase was
mainly driven by a $0.6 million increase in salaries and related
expenses and costs for the Jerusalem plant of $0.4 million.
Operating income in the third quarter of 2008 increased to $3.5 million,
a 52% increase, compared to $2.3 million in the third quarter of 2007.
This increase was mainly driven by increased production volumes, total
revenues, and gross profit. This increase was partially offset by the
decline in value of the U.S. dollar versus the New Israeli Shekel and
higher operating expenses.
Financial income, net includes interest income, banking charges and
amounts generated by exchange rate fluctuations. In the third quarter of
2008, financial income, net amounted to $0.3 million, including interest
income of $0.5 million and foreign exchange losses of $0.2 million
compared to a total of $1.4 million, including interest income of $1.0
million and exchange gains of $0.4 million in the third quarter of 2007.
The lower interest income mainly reflects lower interest rates on our
cash and investments.
In 2008, Omrix’s Israeli subsidiary began to
accrue income taxes as it has fully utilized all of its tax-loss
carry-forwards. As it also receives tax benefits under the approved and
privileged enterprise status and as a “foreign
investors’ company”,
a significant portion of its taxable income enjoys a reduced tax rate in
2008. As a result, in 2008, the Company expects its effective income tax
rate to be approximately 10%.
Net income for the third quarter of 2008 was $3.6 million, or $0.21 per
share on a diluted basis, compared to $3.7 million, or $0.21 per share
on a diluted basis, in the third quarter of 2007.
Cash, cash equivalents and short-term investments totaled $80.6 million.
As of September 30, 2008, the Company had 17,121,398 shares of common
stock outstanding.
Full Year 2008 Guidance
The Company is reiterating its previously issued total product sales
guidance, which was increased on October 20, 2008 to between $70.0 and
$72.0 million from $68.0 million to $71.0 million, an expected
annualized growth of between approximately 35% and 39%, respectively,
when compared with 2007 product sales of $51.9 million. The Company is
also reiterating that in 2008 it expects an increase in biosurgery
product sales of approximately 75% when compared to 2007. Accordingly,
the Company expects biosurgery product sales in the fourth quarter of
2008 to be $9.9 million. In addition, the Company is raising its
previously issued guidance for immunotherapy product and byproduct sales
to approximately $36.0 to $38.0 million from $34.0 to $35.0 million for
the full year 2008.
Upcoming Milestones
The Company anticipates the following upcoming milestones:
-
Complete enrollment of 130 patients, of which 90 were enrolled as of
September 22, 2008, in the U.S. mild to moderate Phase II clinical
trial of the Fibrin Pad in late 2008/early 2009; and
-
Obtain approval of Hepatitis B Immunoglobulin (HBIG) in Sweden.
Conference Call Information
Omrix will host a conference call to discuss these financial results
today, Thursday, November 6, 2008, at 8:00 a.m. Eastern Time. To access
the live telephonic broadcast, U.S. callers should dial (866) 825-1709;
international callers may dial (617) 213-8060 and provide confirmation
code 60018854. A live audio webcast of the call will be available via
the Investor Relations' section of the Company's website at www.omrix.com.
Participants are urged to log on to the website 15 minutes prior to the
scheduled start time to download and install any necessary software.
An audio replay of the conference call will be available from 10:00 am
ET on Thursday, November 6, 2008 through Thursday, November 13, 2008 by
dialing (888) 286-8010 from the U.S. or (617) 801-6888 when calling
internationally, and entering confirmation code 83921144. The audio
webcast will be available on the company's website, www.omrix.com,
for 30 days.
About Omrix Biopharmaceuticals, Inc.
Omrix is a fully integrated biopharmaceutical company that develops,
manufactures and markets protein-based biosurgery and passive
immunotherapy products. Omrix' biosurgery product line includes products
and product candidates that are used for the control of bleeding, or
hemostasis, and other surgical applications. The Company's passive
immunotherapy product line includes antibody-rich products and product
candidates for the treatment of immune deficiencies, infectious diseases
and potential biodefense applications. For more information, please
visit www.omrix.com.
Safe Harbor Statement
This news release contains forward-looking statements. Forward-looking
statements provide the Company's current expectations or forecasts of
future events. Forward-looking statements include statements about the
Company's expectations, beliefs, plans, objectives, intentions,
assumptions and other statements that are not historical facts.
Forward-looking statements are subject to known and unknown risks and
uncertainties and are based on potentially inaccurate assumptions that
could cause actual results to differ materially from those expected or
implied by the forward-looking statements. The Company's actual results
could differ materially from those anticipated in forward-looking
statements for many reasons, including the factors described in the
Company's filings with the Securities and Exchange Commission (SEC),
including sections entitled "Risk Factors" and "Management's Discussion
and Analysis of Financial Condition and Results of Operations" in the
Company's Form 10-K as filed with the SEC on March 17, 2008, and the
Company's most recent quarterly reports on Form 10-Q and its current
reports on Form 8-K. Unless required by law, the Company undertakes no
obligation to publicly update or revise any forward-looking statement to
reflect circumstances or events after the date of this news release.
|
Consolidated Balance Sheets (Unaudited)
(USD$ in thousands, except share and per share data)
|
|
|
|
|
|
|
|
September 30, 2008
|
|
December 31, 2007
|
|
ASSETS
|
|
|
|
|
Cash and cash equivalents
|
$47,347
|
|
|
$25,885
|
|
|
Short-term investments
|
33,217
|
|
|
55,020
|
|
|
Trade receivables, net of allowance for doubtful accounts of $18 and
$38, respectively
|
26,517
|
|
|
23,052
|
|
|
Prepaid expenses and other current assets
|
1,138
|
|
|
1,624
|
|
|
Inventory
|
19,560
|
|
|
20,498
|
|
|
Current assets
|
127,779
|
|
|
126,079
|
|
|
Property, plant and equipment, net
|
24,806
|
|
|
14,905
|
|
|
Long-term investments
|
1,116
|
|
|
1,211
|
|
|
Long-term receivables
|
480
|
|
|
1,563
|
|
|
Other assets, net
|
1,157
|
|
|
1,526
|
|
|
Total assets
|
$155,338
|
|
|
$145,284
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
Accounts payable and accruals:
|
|
|
|
|
Trade
|
$8,214
|
|
|
$7,466
|
|
|
Other
|
8,501
|
|
|
8,229
|
|
|
Current liabilities
|
16,715
|
|
|
15,695
|
|
|
Deferred revenues
|
8,245
|
|
|
9,789
|
|
|
Other long-term liabilities
|
1,218
|
|
|
1,187
|
|
|
Long-term liabilities
|
9,463
|
|
|
10,976
|
|
|
Common stock of $0.01 par value -
|
|
|
|
|
Shares authorized: September 30, 2008 - 43,636,364; December 31,
2007 - 43,636,364
|
|
|
|
|
Shares issued: September 30, 2008 - 17,128,282; December 31, 2007 -
17,000,472
|
|
|
|
|
Shares outstanding: September 30, 2008 - 17,121,398; December 31,
2007 - 16,993,347
|
171
|
|
|
170
|
|
|
Preferred stock of $0.01 par value-
|
|
|
|
|
Shares authorized: September 30, 2008 - 7,272,727; December 31, 2007
- 7,272,727
|
|
|
|
|
Shares issued and outstanding: September 30, 2008 and December 31,
2007 -None
|
—
|
|
|
—
|
|
|
Additional paid-in capital
|
180,433
|
|
|
177,955
|
|
|
Treasury stock, at cost (September 30, 2008 - 7,125 ; December 31,
2007 - 7,125 shares)
|
(44
|
)
|
|
(44
|
)
|
|
Accumulated other comprehensive loss
|
(3,007
|
)
|
|
(2,394
|
)
|
|
Accumulated deficit
|
(48,393
|
)
|
|
(57,074
|
)
|
|
Stockholders ‘ equity
|
129,160
|
|
|
118,613
|
|
|
Total liabilities and stockholders’ equity
|
$155,338
|
|
|
$145,284
|
|
|
Consolidated Statements of Operations (Unaudited)
(USD$ in thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
|
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$19,564
|
|
$14,003
|
|
$52,862
|
|
$34,361
|
|
Development services and grants
|
|
1,687
|
|
1,824
|
|
5,293
|
|
6,793
|
|
Total revenues
|
|
21,251
|
|
15,827
|
|
58,155
|
|
41,154
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues:
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
11,027
|
|
8,221
|
|
29,957
|
|
20,982
|
|
Development services and grants
|
|
1,159
|
|
1,353
|
|
3,501
|
|
4,307
|
|
Total cost of revenues
|
|
12,186
|
|
9,574
|
|
33,458
|
|
25,289
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
9,065
|
|
6,253
|
|
24,697
|
|
15,865
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, clinical and regulatory expenses
|
|
1,582
|
|
916
|
|
5,128
|
|
3,098
|
|
Selling, marketing, general and administrative expenses
|
|
3,958
|
|
3,021
|
|
13,021
|
|
8,608
|
|
Operating income
|
|
3,525
|
|
2,316
|
|
6,548
|
|
4,159
|
|
|
|
|
|
|
|
|
|
|
|
Financial income, net
|
|
323
|
|
1,398
|
|
2,671
|
|
3,570
|
|
Other income
|
|
-
|
|
-
|
|
211
|
|
904
|
|
Income before income taxes
|
|
3,848
|
|
3,714
|
|
9,430
|
|
8,633
|
|
Provision for income taxes
|
|
250
|
|
0
|
|
750
|
|
0
|
|
Net income
|
|
$3,598
|
|
$3,714
|
|
$8,680
|
|
$8,633
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share –
Basic net income per share of common stock
|
|
$0.21
|
|
$0.22
|
|
$0.51
|
|
$0.51
|
|
Diluted net income per share of common stock
|
|
$0.21
|
|
$0.21
|
|
$0.50
|
|
$0.50
|
|
Weighted average number of shares of common stock outstanding
during the period used to compute basic net income per share
|
|
17,124,630
|
|
16,917,390
|
|
17,118,195
|
|
16,853,915
|
|
Weighted average number of shares of common stock outstanding
during the period used to compute diluted net income per share
|
|
17,321,273
|
|
17,301,538
|
|
17,303,262
|
|
17,307,443
|
Omrix Biopharmaceuticals, Inc.
Francesca M. DeMartino, 212-887-6510
Senior
Director, Investor Relations
francesca.demartino@omrix.com