UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
|
FORM
8-K
|
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): October 11,
2007
_______________________
CRYOLIFE,
INC.
(Exact
name of registrant as specified in its charter)
_________________________
|
Florida
|
1-13165
|
59-2417093
|
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
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):
|
o
|
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
|
o
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
o
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
|
o
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
Section
2 Financial
Information
Item
2.02 Results of Operations and Financial
Condition.
The
information provided pursuant to
this Item 2.02 is to be considered “filed” under the Securities Exchange Act of
1934 (“Exchange Act”) and incorporated by reference into those filings of
CryoLife, Inc. (“CryoLife” or the “Company”) that provide for the incorporation
of all reports and documents filed by CryoLife under the Exchange
Act.
On
October 11, 2007, CryoLife issued a
press release announcing its preliminary revenue results for the third quarter
and first nine months of 2007 and projected revenues for 2007. CryoLife hereby
incorporates by reference herein the information set forth in its Press Release
dated October 11, 2007, 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 its date and does not create any implication that the affairs of CryoLife
have continued unchanged since such date.
The
press release may be deemed to
include non-GAAP financial measures, including combined cardiac and vascular
tissue preservation revenues. Management believes this measure is an
appropriate and useful means of presenting financial information to investors
because the Company recently discontinued procuring and cryopreserving
orthopedic tissue, and the performance of the Company’s remaining cryopreserved
tissues is particularly relevant to the Company’s potential future
performance.
All
statements relating to the
Company's anticipated revenues for the third quarter and first nine months
of
2007 and the Company’s projected revenues for 2007 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
quarter-end closing procedures.
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.
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
release dated October 11, 2007
|
2
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.
|
CRYOLIFE,
INC.
|
|
|
Date: October
12, 2007
|
By: /s/
D. A. Lee
|
|
Name: D.
Ashley Lee
|
|
|
Title:
Executive Vice President, Chief
|
|
|
Operating Officer and
Chief
|
|
|
Financial Officer
|
3
Exhibit
99.1
FOR
IMMEDIATE RELEASE
Media
Contacts:
|
D.
Ashley Lee
|
Katie
Brazel
|
|
Executive
Vice President, Chief Operating Officer and
|
Fleishman
Hillard
|
|
Chief
Financial Officer
|
Phone:
404-739-0150
|
|
Phone:
770-419-3355
|
CryoLife
Announces Preliminary Third Quarter 2007 Revenues of
Approximately
$21.9 Million
Combined
cardiac and vascular tissue processing revenues in the third quarter of 2007
increased 25 percent compared to the third quarter of 2006
FDA
completes re-inspection
ATLANTA…(October
11, 2007)…CryoLife, Inc. (NYSE: CRY), a biomaterials,
medical device and tissue processing company, announced today that product
and
preservation services revenues for the third quarter of 2007 were approximately
$21.9 million compared to $20.0 million in the third quarter of 2006, an
increase of 9 percent. Product and preservation services revenues for
the first nine months of 2007 were approximately $69.1 million compared to
$60.1
million in the first nine months of 2006, an increase of 15
percent.
BioGlue®
revenues were
approximately $10.3 million for the third quarter of 2007 compared to $9.4
million in the third quarter of 2006, an increase of 9
percent. BioGlue revenues were approximately $32.4 million for the
first nine months of 2007 compared to $29.5 million in the first nine months
of
2006, an increase of 10 percent.
Combined
cardiac and vascular tissue preservation revenues increased 25 percent in the
third quarter of 2007 to $10.8 million, compared to $8.7 million in the third
quarter of 2006, on a 17 percent increase in unit shipments. Combined
cardiac and vascular tissue preservation revenues increased 31 percent in the
first nine months of 2007 to $32.4 million compared to $24.6 million in the
first nine months of 2006, on a 20 percent increase in unit
shipments. Orthopaedic tissue preservation revenues declined during
the periods presented because the Company has stopped procuring and processing
such tissue pursuant to its Exchange and Service Agreement with Regeneration
Technologies, Inc.
-
more
-
4
Total
tissue preservation services revenues were approximately $11.3 million in the
third quarter of 2007, compared to $10.3 million in the third quarter of 2006,
an increase of 10 percent. Total tissue preservation services
revenues were approximately $36.0 million in the first nine months of 2007
compared to $29.8 million in the first nine months of 2006, an increase of
21
percent.
“We
expect to post another profitable quarter for the third quarter of
2007. However, based on the results of the first nine months of 2007,
we believe that we will be slightly below the lower end of our previous range
of
revenue guidance, which was $93 million,” noted Steven G. Anderson, CryoLife
president and chief executive officer.
"In
addition, I’m pleased to announce that the FDA has completed a re-inspection of
our facilities and no 483 Notice of Observations was issued. The
re-inspection was related to our 510(k) submission for our CryoValve SG heart
valve,” Mr. Anderson added. “The re-inspection, coupled with our
recent response to the FDA, completes the actions required of us at this point
in connection with the FDA’s review of our 510(k) application for CryoValve SG
heart valves. We remain optimistic that we will receive clearance for
our CryoValve SG heart valve 510(k) application,” Mr. Anderson
concluded.
All
statements relating to the Company's 2007 third quarter and first nine months
revenues contained in this release are preliminary and unaudited, and may change
based on the completion of customary quarter-end closing and review
procedures.
Webcast
and Conference Call Information
CryoLife's
third quarter 2007 financial results will be released on Thursday, November
1,
2007. The Company will hold a teleconference call and live webcast at
10:00 a.m. Eastern Time, November 1, 2007, to discuss the results followed
by a
question and answer session hosted by Mr. Anderson.
To
listen
to the live teleconference please dial 201-689-8261 a few minutes prior to
10:00
a.m. A replay of the teleconference will be available November 1
through November 8, 2007 and can be accessed by calling (toll free) 877-660-
6853 or 201-612-7415. The account number for the replay is 244 and the
conference number is 257727.
The
live
webcast and replay can be accessed by going to the Investor Relations section
of
the CryoLife Web site at www.cryolife.com and selecting the heading
Webcasts & Presentations.
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 States and 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 Canada and Australia for use in soft tissue
repair. The Company also distributes the CryoLife-O'Brien® stentless
porcine
heart valve and the SG Model 100 vascular graft, which are CE marked for
distribution within the European Community.
5
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 third quarter and full year of 2007 and management’s expectations
regarding FDA review of the 510(k) application for SynerGraft® heart
valves. 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 third quarter
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.
-
more
-
6
CRYOLIFE,
INC.
Financial
Highlights
(In
thousands)
|
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
|
September
30,
|
September
30,
|
|||||||||||||||
|
2007
|
2006
|
2007
|
2006
|
|||||||||||||
|
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
|
Revenues
from:
|
||||||||||||||||
|
Cardiovascular
|
$ |
5,566
|
$ |
4,189
|
$ |
15,587
|
$ |
11,550
|
||||||||
|
Vascular
|
5,215
|
4,468
|
16,782
|
13,066
|
||||||||||||
|
Orthopaedic
|
566
|
1,662
|
3,650
|
5,223
|
||||||||||||
|
Total
preservation services
|
11,347
|
10,319
|
36,019
|
29,839
|
||||||||||||
|
BioGlue
|
10,280
|
9,444
|
32,373
|
29,534
|
||||||||||||
|
Bioprosthetic
devices
|
157
|
243
|
480
|
774
|
||||||||||||
|
CardioWrap
|
108
|
--
|
243
|
--
|
||||||||||||
|
Total
products
|
10,545
|
9,687
|
33,096
|
30,308
|
||||||||||||
|
Total
product and preservation services
|
||||||||||||||||
|
revenues
|
$ |
21,892
|
$ |
20,006
|
$ |
69,115
|
$ |
60,147
|
||||||||
For
additional information about the company, visit CryoLife’s Web
site:
http://www.cryolife.com
END
7