EATONTOWN, N.J., March 4 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: ), a leader in the emerging field of biologic products for
regenerative healing, today reported financial results for the fourth
quarter and full year ended December 31, 2009. Results were in-line with
the limited, preliminary financial results the Company released on January
14, 2010.
"2009 was a challenging year as we focused on launching several new,
proprietary biologic products, pursuing regulatory approval for our
Duratech(TM) BioRegeneration Matrix and making further enhancements to our
distribution and sales strategy," said Sam Owusu-Akyaw, President and Chief
Executive Officer of Osteotech. "We successfully initiated the
commercialization process for the MagniFuse(TM) Bone Graft and Plexur M®
Innovative Grafting product families, and we improved the instrumentation
of the FacetLinx(TM) Fusion Technology product. With these significant
steps forward, we continued the transformation of Osteotech to a business
that is leveraging its technology assets into a portfolio of innovative and
clinically efficacious procedure-specific products."
Recent and Upcoming Corporate Developments
-- Early in the fourth quarter, the Company announced the first U.S. spinal
surgery using MagniFuse PC (Posterior Cervical), which officially marked
the start of the controlled release for the family of products based
upon the MagniFuse technology platform. MagniFuse PC was used during a
posterior cervical fusion surgery and the surgeon cited the specialized
biologic as being easy-to-use and intuitive with a differentiated
self-contained delivery system.
-- In the fourth quarter, Osteotech signed a multi-year tissue supply
agreement with Community Tissue Services (CTS) with an initial term
spanning 10 years. The agreement replaced a previous contract between
the two companies that would have expired in 2011. Under the terms of
the agreement, CTS will supply Osteotech with whole donors and cortical
shafts based upon periodic forecast requirements and available tissue
supply.
-- Also during the fourth quarter, the Company announced Plexur M had been
utilized in a variety of surgeries focused on orthopedic trauma, joint
replacements and oncology-related procedures.
-- Late in the fourth quarter, Osteotech submitted a 510(k) application to
the U.S. Food and Drug Administration (FDA) to obtain marketing
clearance for the use of its Duratech BioRegeneration Matrix to repair
or replace the dura mater in various cranial surgical procedures. The
Company expects to receive preliminary feedback from the FDA regarding
the pending application late in the first quarter of 2010.
-- Early in the first quarter of 2010, the Company announced that it
expanded its financial flexibility with a new, unused $10 million line
of credit established in late December. This new line of credit,
coupled with the Company's cash position and the consideration it will
receive from a new licensing agreement, should provide the resources
necessary to allow Osteotech to continue to execute its growth strategy.
-- The Company is scheduled to make a corporate presentation to investors
at the Canaccord Adams Musculoskeletal Conference on March 9, 2010.
-- Osteotech intends to showcase its new proprietary biologic product
portfolio at its booth (Booth No. 1061) during the Annual Meeting of the
American Academy of Orthopaedic Surgeons (AAOS), in New Orleans,
Louisiana from March 10 to 12, 2010. A number of surgeons will present
the clinical results stemming from their use of MagniFuse and Plexur M
at the Osteotech booth during the meeting.
"We have worked diligently to engineer products that meet the
procedure-specific needs of the markets we serve, and based upon the
feedback and excitement among our surgeon customers, we believe we have
successfully achieved that goal," continued Mr. Owusu-Akyaw. "Throughout
2009, we made progress bolstering our go-to-market and distributor channel
strategy, and in 2010 our goal is to significantly strengthen the selling
process within the channel. We are working toward an important inflection
point where our superior products and technology and our sales strategy all
converge to support long-term revenue growth and profitability. We will
continue to invest prudently in enhancing all of these essential elements
of our growth strategy."
"The new products are the key to our revenue growth in 2010 and we
expect them to generate $10 million to $12 million in revenue during 2010,"
continued Mr. Owusu-Akyaw. "This assessment reflects the delays we
experienced in launching our new products, the timing of submissions to the
FDA for marketing clearance and the recognition that the hospital product
approval process will need to be managed differently than originally
anticipated."
Financial Results
Revenue for the three months ended December 31, 2009 was $26.3 million,
including $1.0 million from new products, compared with $24.6 million for
the three months ended December 31, 2008. The increase in revenue for the
fourth quarter of 2009 compared with the same period of 2008 was primarily
driven by the $3.3 million in revenue realized from an agreement to license
certain of the Company's tissue processing technology. This increase in
revenue was partially offset by the anticipated reduction in revenue from
the client services business and a decline in domestic unit sales volume.
Excluding client services, private label demineralized bone matrix and the
license agreement revenue, fourth quarter 2009 revenue declined 3% compared
with fourth quarter 2008 revenue.
Revenue for the full year ended December 31, 2009 was $96.7 million
compared with $103.8 million reported for 2008. New product revenue was
$1.3 million for 2009. The decline in revenue for the year was primarily
driven by: the anticipated reduction in revenue from the Company's services
businesses, which declined $6.4 million; a decline in international revenue
reflecting the challenging general economic conditions and the impact from
the temporary suspension of tissue products from the Company's Bulgarian
subsidiary instituted in December 2008 and removed in late July 2009; and
lower domestic unit sales volume. This decline was partially offset by the
revenue received in conjunction with the Company's aforementioned license
agreement.
Net income for the fourth quarter ended December 31, 2009 was $890,000,
or $0.05 per diluted share, compared with net loss of $409,000, or $0.02
per share, for the fourth quarter of 2008. Net loss for the full year ended
December 31, 2009 was $4.0 million, or $0.22 per share, compared with net
income of $2.2 million, or $0.12 per diluted share, for 2008. The net loss
in 2009 is primarily due to the Company's anticipated reductions in service
revenue and the resulting lower gross margins. Net loss for 2009 was
partially offset by the $2.3 million in profit that the Company's agreement
to license certain tissue processing technology contributed to net income.
Guidance
Based upon current market conditions, the exit of certain lines of
business in 2009, the realization of all of revenue under the licensing
arrangements in 2009, the regulatory environment and the Company's internal
expectations, Osteotech is providing the following financial guidance for
2010:
-- Total revenue is expected to range between $97 million and $101 million,
with between $10 million and $12 million in revenue stemming from new
products; and
-- Net income is expected to range between breakeven and a loss of $.05 per
share.
Conference Call Today, March 4, 2010
The Osteotech management team will host a conference call on March 4,
2010 at 9:00 a.m. (EST) to discuss fourth quarter and full year 2009
financial results, recent corporate developments and guidance for 2010. The
call can be accessed by dialing 1-866-202-4367 (domestic) or 1-617-213-8845
(international) and indicating access code 56692568. The conference call
will also be simultaneously webcast at . A replay of the
call will be available two hours after completion of the live call through
midnight, Thursday, March 18, 2010 by dialing 1-888-286-8010 and indicating
access code 47904889.
About Osteotech
Osteotech, Inc., headquartered in Eatontown, New Jersey, is a global
leader in providing biologic solutions for regenerative medicine to support
surgeons and their patients in the repair of the musculoskeletal system
through the development of innovative therapy-driven products that
alleviate pain, promote biologic healing and restore function. For further
information regarding Osteotech or the conference call, please go to
Osteotech's website at .
Certain statements made throughout this press release that are not
historical facts are forward-looking statements (as defined in the Private
Securities Litigation Reform Act of 1995) regarding the Company's future
plans, objectives and expected performance. Any such forward-looking
statements are based on assumptions that the Company believes are
reasonable, but are subject to a wide range of risks and uncertainties and,
therefore, there can be no assurance that actual results may not differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause actual results to differ materially
include, but are not limited to, the Company's ability to develop and
introduce new products, differences in anticipated and actual product and
service introduction dates, the ultimate success of those products in the
marketplace, the continued acceptance and growth of current products and
services, the impact of competitive products and services, the availability
of sufficient quantities of suitable donated tissue and the success of cost
control and margin improvement efforts. For a more detailed discussion of
certain of these factors, see the Company's periodic reports filed with the
Securities and Exchange Commission from time to time, including the latest
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. All
information in this press release is as of March 4, 2010 and the Company
does not intend to update this information.
OSTEOTECH, INC. and Subsidiaries
CONSOLIDATED STATEMENTS OF OPERATIONS
(dollars in thousands, except per share data)
(unaudited)
Three Months Ending Year Ending
December 31, December 31,
------------------- ----------------
2009 2008 2009 2008
---- ---- ---- ----
Revenue $26,315 $24,567 $96,678 $103,814
Cost of revenue 12,702 11,148 49,108 48,770
------ ------ ------ ------
Gross profit 13,613 13,419 47,570 55,044
Marketing, selling and
general and administrative
expenses 10,962 11,553 43,996 45,032
Research and development
expenses 1,291 2,162 6,486 7,435
----- ----- ----- -----
12,253 13,715 50,482 52,467
Operating income (loss) 1,360 (296) (2,912) 2,577
Interest expense, net (349) (310) (1,412) (1,072)
Other (64) 8 42 961
--- -- -- ---
Income (loss) before income
taxes 947 (598) (4,282) 2,466
Income tax expense (benefit) 57 (189) (265) 263
-- ---- ---- ---
Net income (loss) $890 $(409) $(4,017) $2,203
==== ===== ======= ======
Earnings (loss) per share:
Basic $0.05 $(0.02) $(0.22) $0.12
Diluted $0.05 $(0.02) $(0.22) $0.12
Shares used in computing
earnings (loss) per share:
Basic 18,028,682 17,918,606 17,968,971 17,833,902
Diluted 18,163,717 17,918,606 17,968,971 18,083,584
CONSOLIDATED SEGMENT REVENUE DETAIL
(dollars in thousands)
(unaudited)
Three Months Ended Year Ended
December 31, December 31,
------------ -------------
2009 2008 2009 2008
---- ---- ---- ----
DBM $13,337 $14,398 $56,782 $61,961
Hybrid/Synthetic 1,286 900 3,575 3,087
Traditional Tissue 5,713 4,651 21,534 20,258
Spinal Allografts 1,918 2,020 7,626 8,499
Client Services 130 1,674 2,143 8,201
Other Product Lines 3,931 924 5,018 1,808
----- --- ----- -----
Revenue $26,315 $24,567 $96,678 $103,814
======= ======= ======= ========
OSTEOTECH, INC. and Subsidiaries
CONDENSED CONSOLIDATED BALANCE SHEETS
(dollars in thousands)
(unaudited)
December 31, December 31,
2009 2008
---- ----
Assets
Cash and cash equivalents $10,708 $18,823
Accounts receivable, net 16,165 17,968
Deferred processing costs 38,562 38,715
Inventories 1,819 1,467
Prepaid expenses and other current assets 3,247 3,115
----- -----
Total current assets 70,501 80,088
Property, plant and equipment, net 29,575 34,005
Other assets 16,861 13,022
------ ------
$116,937 $127,115
======== ========
Liabilities and Stockholders' Equity
Accounts payable and accrued liabilities $16,206 $23,569
Current maturities of capital lease
obligation 994 895
--- ---
Total current liabilities 17,200 24,464
Capital lease obligation 12,181 13,175
Other liabilities 7,270 6,626
----- -----
Total liabilities 36,651 44,265
Stockholders' equity 80,286 82,850
------ ------
$116,937 $127,115
======== ========
SOURCE Osteotech, Inc.
Posted By
Josh Sandberg has been recruiting specifically in the musculoskeletal industry for over 8 years. Throughout this time, he has been able to have a positive impact on his client’s businesses. With an educational background in Business Management, Josh is adept to discern which people will be the best fit for the company he is searching for by understanding how candidates will incorporate with the company’s culture and operational nuances. His experience as an executive in a start-up business has granted him the ability to understand what is takes to thrive in a hands–on environment, where desire and dedication are paramount for success.
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