UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
washington,
d.c. 20549
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FORM
8-K
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CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): January 10,
2008
_______________________
CRYOLIFE,
INC.
(Exact
name of registrant as specified in its charter)
_________________________
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Florida
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1-13165
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59-2417093
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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1655
Roberts Boulevard, N.W., Kennesaw, Georgia 30144
(Address
of principal executive office) (zip code)
Registrant's
telephone number, including area code: (770) 419-3355
_____________________________________________________________
(Former
name or former address, if changed since last report)
_________________________
Check
the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation
of
the registrant under any of the following provisions (see General Instruction
A.2. below):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
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Section
2 Financial
Information
Item
2.02 Results of Operations and
Financial Condition.
On
January 10, 2008, CryoLife, Inc.
(“CryoLife” or the “Company”) issued a press release announcing its preliminary
revenue results for fiscal 2007 and the fourth quarter thereof. CryoLife hereby
incorporates by reference herein the information set forth in its Press Release
dated January 10, 2008, a copy of which is attached hereto as Exhibit 99.1.
Except as otherwise provided in the press release, the press release speaks
only
as of the date of such press release, and it shall not create any implication
that the affairs of CryoLife have continued unchanged since such
date.
All
statements relating to the Company's
fourth quarter and full year 2007 revenues contained in the attached press
release are preliminary and unaudited and may change based on the completion
by
the Company's management and independent auditors of customary year-end closing
procedures.
The
press release includes tissue
preservation and product revenues and combined cardiac and vascular tissue
preservation services revenues. The Company’s GAAP revenues are composed of tissue preservation
services and product revenues plus other revenues, which include grant and
license revenues. Total other revenues for 2007 are not finalized, but are
not
expected to exceed one percent of total revenues. Combined cardiac
and vascular preservation services revenues have been adjusted from the
comparable segment revenue numbers to exclude revenues related to orthopedic
tissue preservation services. Tissue processing
segment
revenues have been adjusted to exclude revenues from orthopedic tissue
processing because the Company discontinued procuring and processing such tissue
as of January 1, 2007 and is currently only distributing those tissues that
were
processed prior to that time. Because the Company’s revenues from
these tissues will be reduced to zero in the near future, the Company believes
that the non-GAAP revenue numbers presented provide investors with a more
accurate measure of the relative revenue performance of the Company’s continuing
tissue preservation business.
CryoLife
believes that providing
adjusted non-GAAP revenues provides investors with greater transparency to
the
information used by CryoLife’s management in its financial and operational
decision-making and allows investors to see CryoLife’s results through the eyes
of management. CryoLife considers these non-GAAP financial measures to be useful
metrics for management and investors, allowing CryoLife’s management and
investors to compare CryoLife’s recurring core business operating results over
multiple periods.
Accordingly,
CryoLife believes that these
non-GAAP measures, when read in conjunction with the Company’s GAAP financials,
provide useful information to investors by offering:
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·
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the
ability to make more
meaningful period-to-period comparisons of the Company’s on-going
operating results;
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·
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the
ability to better identify
trends in the Company’s underlying business and perform related trend
analyses; and
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·
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a
better understanding of how
management plans and measures the Company’s underlying
business.
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2
The
information provided pursuant to
this Item 2.02 is to be considered “furnished” pursuant to Item 2.02 of Form 8-K
and shall not be deemed to be “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended, or otherwise subject to the
liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act
of
1933, as amended, nor shall it be deemed incorporated by reference into any
of
CryoLife’s reports or filings with the Securities and Exchange Commission
(“SEC”), whether made before or after the date hereof, except as expressly set
forth by specific reference in such report or filing.
Except
for the historical information
contained in this report, the statements made by CryoLife are forward-looking
statements that involve risks and uncertainties. All such statements are subject
to the safe harbor created by the Private Securities Litigation Reform Act
of
1995. CryoLife’s future financial performance could differ significantly from
the expectations of management and from results expressed or implied in the
press release. Please refer to the last paragraph of the press release for
further discussion about forward-looking statements. For further information
on
risk factors, please refer to “Risk Factors” contained in CryoLife’s Form 10-K
for the year ended December 31, 2006, as filed with the SEC, and any subsequent
SEC filings. CryoLife disclaims any obligation or duty to update or modify
these
forward-looking statements.
Section
9 Financial Statements
and
Exhibits
Item
9.01(c) Exhibits.
(a)
Financial
Statements.
Not
applicable.
(b)
Pro
Forma Financial
Information.
Not
applicable.
(c)
Shell
Company
Transactions.
Not
applicable.
(d)
Exhibits.
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Exhibit
Number
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Description
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99.1
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Press
release dated January 10, 2008
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3
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, CryoLife, Inc.
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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CRYOLIFE,
INC.
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Date: January
15, 2008
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By:
/s/ D. Ashley Lee
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Name:
D. Ashley Lee
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Title:
Executive Vice President, Chief Operating Officer and Chief Financial
Officer
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4
Exhibit
99.1
FOR
IMMEDIATE RELEASE
Media
Contacts:
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D.
Ashley Lee
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Mike
Greenwell
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Executive
Vice President, Chief Operating Officer and
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Fleishman
Hillard
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Chief
Financial Officer
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Phone:
404-739-0155
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Phone:
770-419-3355
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CryoLife
Announces Record Preservation Services
and
Product Revenues for 2007
Preliminary
full year and fourth quarter 2007 preservation services and product revenues
increased
16% and 17%, respectively, to approximately $93.7 million for the year and
$24.6
million
for the fourth quarter
ATLANTA…(January
10, 2008)…CryoLife,
Inc.
(NYSE: CRY), a
biomaterials, medical device and tissue processing company, announced
today that preservation services and product revenues for 2007 were
approximately $93.7 million compared to $81.1 million in 2006, an increase
of 16
percent. Preservation services and product revenues for the fourth
quarter of 2007 were approximately $24.6 million compared to $21.0 million
in
the fourth quarter of 2006, an increase of 17 percent. The Company’s
GAAP revenues are composed of preservation services and product revenues plus
other revenues, which include grant and license revenues. Total other
revenues for 2007 are not finalized, but are not expected to exceed one percent
of total revenues.
BioGlue®
revenues
were approximately $43.9 million for the full year of 2007 compared to $40.0
million in 2006, an increase of 10 percent. BioGlue revenues were
approximately $11.5 million in the fourth quarter of 2007, compared to $10.5
million in the fourth quarter of 2006, an increase of 10 percent.
Total
tissue preservation services
revenues were approximately $49.0 million for the full year of 2007 compared
to
$40.1 million in 2006, an increase of 22 percent. Tissue preservation
services revenues were approximately $13.0 million in the fourth quarter of
2007, compared to $10.2 million in the fourth quarter of 2006, an increase
of 27
percent.
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Combined
cardiac and vascular tissue
preservation revenues increased 36 percent for the full year of 2007 to $44.8
million compared to $32.9 million in 2006, on a 25 percent increase in unit
shipments. Combined cardiac and vascular tissue preservation revenues
increased 49 percent in the fourth quarter of 2007 to $12.4 million, compared
to
$8.3 million in the fourth quarter of 2006, on a 41 percent increase in unit
shipments.
Orthopaedic
tissue preservation
revenues decreased 41 percent for the full year of 2007 to $4.2 million,
compared to $7.1 million in 2006, and decreased 71 percent for the fourth
quarter of 2007 to $552,000, compared to $1.9 million in the fourth quarter
of
2006 because the Company stopped procuring and processing such tissue in January
2007 pursuant to its Exchange and Service Agreement with Regeneration
Technologies, Inc.
“The
strategic initiative that we
announced in late 2006 and implemented throughout 2007 has resulted in record
setting tissue preservation and product revenues for fiscal year 2007,” noted
Steven G. Anderson, CryoLife president and chief executive officer.
All
statements relating to the Company’s
fourth quarter and full year 2007 revenues contained in this release are
preliminary and unaudited and may change based on the completion by the
Company’s management and independent auditors of customary year-end closing
procedures.
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 United Statesand
Canada. 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 Canadaand
Australiafor
use in soft tissue
repair. The Company also distributes the CryoLife-O'Brien®stentless
porcine heart valve which is
CE marked for distribution within the European Community.
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 revenues for the fourth quarter and full year of
2007. These future events may not occur as and when expected, if at
all, and, together with the Company's business, are subject to various risks
and
uncertainties. These risks and uncertainties include that completion by the
Company's management and independent auditors of customary quarter-end closing
procedures could result in an adjustment to the Company's fourth quarter and
full year 2007 revenue numbers, and other risk factors detailed in CryoLife's
Securities and Exchange Commission filings, including CryoLife's Form 10-K
filing for the year ended December 31, 2006, its most recent Form 10-Q, and
the
Company's other SEC filings. The Company does not undertake to update its
forward- looking statements.
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CRYOLIFE,
INC.
Financial
Highlights
(In
thousands)
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Three
Months Ended
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Twelve
Months Ended
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|||||||||||||||
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December
31,
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December
31,
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|||||||||||||||
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2007
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2006
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2007
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2006
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(Unaudited)
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(Unaudited)
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Revenues
from:
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Cardiovascular
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$ | 6,511 | $ | 4,438 | $ | 22,098 | $ | 15,988 | ||||||||
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Vascular
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5,920 | 3,890 | 22,702 | 16,956 | ||||||||||||
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Orthopaedic
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552 | 1,911 | 4,202 | 7,134 | ||||||||||||
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Total
preservation services
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12,983 | 10,239 | 49,002 | 40,078 | ||||||||||||
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BioGlue
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11,511 | 10,491 | 43,884 | 40,025 | ||||||||||||
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Other
implantable medical devices
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105 | 238 | 828 | 1,012 | ||||||||||||
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Total
products
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11,616 | 10,729 | 44,712 | 41,037 | ||||||||||||
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Total
preservation services and product
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revenues
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$ | 24,599 | $ | 20,968 | $ | 93,714 | $ | 81,115 | ||||||||
Other
revenues for the full year and fourth quarter of 2006 were $196,000 and
$122,000, respectively. Total revenues for the full year and fourth
quarter of 2006 were $81.3 million and $21.1 million, respectively.
For
additional information about the company, visit CryoLife’s Web
site:
http://www.cryolife.com
END
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