CryoLife Provides Initial 2010 Financial Guidance
December 01 2009 - 7:34AM
PR Newswire (US)
Company expects record revenues and operating profits in 2010
ATLANTA, Dec. 1 /PRNewswire-FirstCall/ -- CryoLife, Inc.
(NYSE:CRY), an implantable biological medical device and
cardiovascular tissue processing company, announced its initial
financial guidance for 2010. The Company expects total revenues for
the full year of 2010 to be between $118.0 million and $123.0
million, which includes between $1.5 million and $2.5 million
related to funding received from the Department of Defense in
connection with the development of BioFoam. The Company expects
tissue processing and BioGlue revenues to increase between
mid-single and low-double digits on a percentage basis in 2010
compared to 2009, with HemoStase revenues increasing significantly
more than that on a percentage basis. The Company expects earnings
per share of between $0.36 and $0.40 for 2010, which reflects
several process improvements, expense control and cost cutting
initiatives that the Company implemented during the fourth quarter
of 2009, including a reduction in workforce that is expected to
reduce costs and expenses in excess of $2 million in 2010. The
reduction in workforce and attrition results in an approximate 10%
decrease in number of employees since the beginning of 2009. The
Company expects to record a charge of approximately $400,000 in the
fourth quarter of 2009 in connection with these actions. Webcast of
Presentation at Piper Jaffray Annual Health Care Conference The
Company's presentation today at the Piper Jaffray 21st Annual
Health Care Conference at The New York Palace Hotel on December 1,
2009 at 4:30 pm ET will be webcast. Steven G. Anderson, president
and chief executive officer of CryoLife, Inc., is scheduled to
present. CryoLife's live presentation may be accessed through its
Web site, http://www.cryolife.com/, on the Investor Relations page.
An archived copy of the presentation will be available for 30 days
on the same Web site. About CryoLife, Inc. Founded in 1984,
CryoLife, Inc. is a leader in the processing and distribution of
implantable living human tissues for use in cardiac and vascular
surgeries throughout the U.S. and Canada. The Company's CryoValve®
SG pulmonary heart valve, processed using CryoLife's proprietary
SynerGraft® technology, has FDA 510(k) clearance for the
replacement of diseased, damaged, malformed, or malfunctioning
native or prosthetic pulmonary valves. The Company's CryoPatch® SG
pulmonary cardiac patch has FDA 510(k) clearance for the repair or
reconstruction of the right ventricular outflow tract (RVOT), which
is a surgery commonly performed in children with congenital heart
defects, such as Tetralogy of Fallot, Truncus Arteriosus, and
Pulmonary Atresia. CryoPatch SG is distributed in three anatomic
configurations: pulmonary hemi-artery, pulmonary trunk, and
pulmonary branch. The Company's BioGlue® Surgical Adhesive is FDA
approved as an adjunct to sutures and staples for use in adult
patients in open surgical repair of large vessels. BioGlue is also
CE marked in the European Community and approved in Canada and
Australia for use in soft tissue repair. The Company's BioFoam®
Surgical Matrix is CE marked in the European Community for use as
an adjunct in the sealing of abdominal parenchymal tissues (liver
and spleen) when cessation of bleeding by ligature or other
conventional methods is ineffective or impractical. BIOGLUE
Aesthetic(TM) Medical Adhesive is CE marked in the European
Community for periosteal fixation following endoscopic browplasty
(brow lift) in reconstructive plastic surgery and is distributed by
a third party for this indication. CryoLife distributes
HemoStase(TM), a hemostatic agent, in much of the U.S. for use in
cardiac and vascular surgery and in the European Community and
Canada for cardiac, vascular, and general surgery, subject to
certain exclusions. Statements made in this press release that look
forward in time or that express management's beliefs, expectations
or hopes are forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These statements
include those regarding anticipated 2010 performance and the impact
of process improvements, expense control and cost cutting
initiatives. These future events may not occur as and when
expected, if at all, and, together with our business, are subject
to various risks and uncertainties. These risks and uncertainties
include that we are significantly dependent on revenues from
BioGlue and there are a variety of risks affecting BioGlue,
CryoValve SG pulmonary heart valves and other SynerGraft processed
tissues and products may not be accepted by the marketplace, the
CryoValve SG pulmonary heart valve has a one year shelf life, we
are dependent on the availability of sufficient quantities of
tissue from human donors, the CryoValve SG pulmonary heart valve
post-clearance study requested by the FDA may not provide the
expected positive results, our products and tissues we process and
preserve have allegedly caused and may in the future cause injury
to patients, and we have been and may be exposed to tissue
processing and product liability claims and additional regulatory
scrutiny as a result, the possibility that the FDA could impose
additional restrictions on the Company's operations, issue a 483,
or warning letter, or require a recall, or prevent the Company from
processing and distributing tissues or manufacturing and
distributing other products, our failure to adequately comply with
government regulations could result in loss of revenues and
customers as well as additional compliance expense, our ability to
borrow under our credit facility may be limited, the credit
facility limits our ability to pursue significant acquisitions, the
financial and credit liquidity crisis may adversely affect our
ability to borrow money or raise capital, the current and future
economic crisis may adversely affect our business and financial
condition, there are limitations on our use of net operating loss
carry-forwards that could result in our inability to use them fully
or at all, adverse regulatory action outside of the U.S. could
affect our business, physicians have been and may be reluctant to
implant or use our preserved tissues or products, our existing
insurance policies may not be sufficient to cover our actual claims
liability, current economic conditions may impact demand for our
tissues and products, intense competition may affect our ability to
operate profitably, we may be unable to obtain adequate insurance
at a reasonable cost or at all, uncertainties related to patents
and protection of proprietary technology may adversely affect the
value of our intellectual property, uncertainties related to
patents and protection of proprietary technology for products
distributed by us may adversely affect our ability to distribute
those products, we are dependent on key personnel, we may not be
successful in obtaining necessary clinical results and regulatory
approvals for products and services in development, and our new
products and services may not achieve market acceptance, we may be
unable to effectively leverage our existing sales force to sell
HemoStase, the lawsuit we filed against Medafor regarding our
distribution agreement with Medafor may adversely impact our
relationship with Medafor and could hamper or prevent us from
distributing HemoStase, Medafor has attempted to terminate our
distribution agreement with it and may attempt to do so again in
the future, rapid technological change could cause our services and
products to become obsolete, extensive government regulation may
adversely affect our ability to develop and sell products and
services, we have experienced operating losses and negative cash
flows in the past, and we must continue to address the underlying
causes in order to continue to operate profitably and generate
positive cash flows, investments in new technologies and
acquisitions of products or distribution rights may not be
successful, if we are not successful in expanding our business
activities in international markets, we will be unable to pursue
one of our strategies for increasing our revenues, continued
deflation of foreign currencies relative to the U.S. dollar could
materially and adversely impact our business, and future healthcare
policies, healthcare reimbursement methods, and healthcare
reimbursement policies may affect the availability, amount, and
timing of our revenues, financial condition and profitability. The
impact of process improvements, expense control and cost cutting
initiatives is subject to a number of risks and uncertainties
including the risk that unforeseen eventualities could cause
expenses to rise or make it desirable for us to refill previously
eliminated positions and that process improvements will not achieve
the desired results or the acceptance of regulators. These risks
and uncertainties include the risk factors detailed in our
Securities and Exchange Commission filings, including our Form 10-K
filing for the year ended December 31, 2008, our Form 10Q filing
for the quarter ended March 31, 2009, our Form 10-Q filing for the
quarter ended June 30, 2009, our Form 10-Q filing for the quarter
ended September 30, 2009, and the Company's other SEC filings. The
Company does not undertake to update its forward-looking
statements. For additional information about the company, visit
CryoLife's Web site: http://www.cryolife.com/. Media Contacts: D.
Ashley Lee Executive Vice President, Chief Financial Officer and
Chief Operating Officer Phone: 770-419-3355 DATASOURCE: CryoLife,
Inc. CONTACT: D. Ashley Lee, Executive Vice President, Chief
Financial Officer and Chief Operating Officer, +1-770-419-3355 Web
Site: http://www.cryolife.com/
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