-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WDMuYiLPoN6K2J094TDayFlNvCbxhyCTMkdv4DcMFDR/VhSARpEmOGTTgik2MV/d NI/HD1tsNFaDyA8DGiSYHw== 0000914062-07-000336.txt : 20070731 0000914062-07-000336.hdr.sgml : 20070731 20070731083528 ACCESSION NUMBER: 0000914062-07-000336 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070731 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070731 DATE AS OF CHANGE: 20070731 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CRYOLIFE INC CENTRAL INDEX KEY: 0000784199 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 592417093 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-13165 FILM NUMBER: 071011198 BUSINESS ADDRESS: STREET 1: 1655 ROBERTS BOULEVARD N W STREET 2: STE 142 CITY: KENNESAW STATE: GA ZIP: 30144 BUSINESS PHONE: 7704193355 MAIL ADDRESS: STREET 1: 1655 ROBERTS BOULEVARD N W STREET 2: STE 142 CITY: KENNESAW STATE: GA ZIP: 30144 8-K 1 cryolife8k73107.htm FORM 8-K cryolife8k73107.htm
 

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):  July 31, 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.

On July 31, 2007, CryoLife, Inc. (“CryoLife” or the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2007 and the first half of 2007.  CryoLife hereby incorporates by reference herein the information set forth in its Press Release dated July 31, 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 the date of such press release and it shall not create any implication that the affairs of CryoLife have continued unchanged since such date.

The press release includes non-GAAP financial measures, including adjusted non-GAAP net income and earnings per share, and management believes that these non-GAAP financial measures provide a better period-to-period comparison of operational performance.
 
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 9Financial 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.

 
2

 
(d) Exhibits.

 
Exhibit Number
Description
     
 
99.1*
Press release dated July 31, 2007
 
*  This exhibit is furnished, not filed.
 
 
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:  July 31, 2007
By:       /s/ D. A. Lee
 
Name:  D. Ashley Lee
 
Title:    Executive Vice President, Chief  Operating Officer and Chief Financial Officer
   


3

EX-99.1 2 cryolife8k73107ex99.htm PRESS RELEASE cryolife8k73107ex99.htm
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 Reports Second Quarter and First Half 2007 Financial Results

Company posts second quarter net income of $1.3 million and $0.05 per share compared to $217,000 and $0.00 per share in 2006;
First half 2007 revenues increased 18 percent compared to 2006
 
ATLANTA, GA…(July 31, 2007)…CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced today that revenues for the second quarter of 2007 increased 11 percent to $23.0 million compared to $20.8 million in the second quarter of 2006.  Net income in the second quarter of 2007 was $1.3 million, and $0.05 per basic and fully diluted common share, compared to net income of $217,000, and $0.00 per basic and fully diluted common share in the second quarter of 2006.

Excluding an $866,000 charge for the change in the valuation of the derivative related to the Company’s preferred stock, a $548,000 charge related to stock-based compensation and a $490,000 gain related to the adjustment of reserves for product liability losses, adjusted net income for the second quarter of 2007 was $2.2 million, and $0.09 per basic and $0.08 per fully diluted common share.  Excluding a $403,000 charge related to stock-based compensation and an $800,000 benefit related to the adjustment of reserves for product liability losses, adjusted net loss in the second quarter of 2006 was ($180,000), and ($0.02) per basic and fully diluted common share.

Revenues for the first half of 2007 increased 18 percent to $47.5 million compared to $40.2 million in the first half of 2006.  Net income in the first half of 2007 was $2.6 million, or $0.10 per basic and $0.09 per fully diluted common share, compared to a net loss of ($1.6 million), or ($0.08) per basic and fully diluted common share in the first half of 2006.

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Excluding a $923,000 charge related to stock-based compensation, an $821,000 charge for the change in the valuation of the derivative related to the Company’s preferred stock, a $686,000 charge related to executive retirement benefits, and a $505,000 gain related to the adjustment of reserves for product liability losses, adjusted net income in the first half of 2007 was $4.6 million, and $0.17 per basic and fully diluted common share.  Excluding a $647,000 charge related to stock-based compensation and a $670,000 gain related to the adjustment of reserves for product liability losses, adjusted net loss in the first half of 2006 was ($1.6 million), and ($0.08) per basic and fully diluted common share.

Steven G. Anderson, president and CEO of CryoLife, Inc., stated, “The improvement in the Company’s operating results enables us to continue the execution of the strategy that we approved in 2006.  We continue to focus on our core business and to explore opportunities that will position the Company for future growth and value creation.”

Tissue processing revenues in the second quarter of 2007 increased 15 percent to $11.7 million compared to $10.2 million in the second quarter of 2006.  Tissue processing revenues in the first half of 2007 increased 26 percent to $24.7 million compared to $19.5 million in the first half of 2006.  Tissue processing revenues increased primarily due to an increase in demand for the Company’s processed tissues.

BioGlue® revenues were $10.9 million for the second quarter of 2007 compared to $10.3 million in the second quarter of 2006, an increase of 6 percent.  U.S. BioGlue revenues were $7.7 million and $7.5 million in the second quarter of 2007 and 2006, respectively.  International BioGlue revenues were $3.2 million and $2.8 million in the second quarter of 2007 and 2006, respectively.

BioGlue revenues were $22.1 million for the first half of 2007 compared to $20.1 million in the first half of 2006, an increase of 10 percent.  U.S. BioGlue revenues were $16.0 million and $14.9 million in the first half of 2007 and 2006, respectively.  International BioGlue revenues were $6.1 million and $5.2 million in the first half of 2007 and 2006, respectively.

Total product and tissue processing gross margins were 61 percent in the second quarter and first half of 2007 compared to 56 percent in the second quarter and first half of 2006.  Tissue processing gross margins in the second quarter of 2007 were 40 percent compared to 31 percent in the second quarter of 2006.  Tissue processing gross margins in the first half of 2007 were 41 percent compared to 29 percent in the first half of 2006.  The increase in total product and tissue processing gross margins was primarily the result of price increases.

General, administrative, and marketing expenses in the second quarter of 2007 were $10.8 million compared to $10.2 million in the second quarter of 2006.  General, administrative, and marketing expenses in the second quarter of 2007 included a $548,000 charge related to stock-based compensation and a $490,000 gain related to the adjustment of reserves for product liability losses.  General, administrative, and marketing expenses in the second quarter of 2006 included a $403,000 charge related to stock-based compensation and an $800,000 benefit related to the adjustment of reserves for product liability losses.

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5


General, administrative, and marketing expenses in the first half of 2007 were $23.2 million compared to $21.6 million in the first half of 2006.  General, administrative, and marketing expenses for the first half of 2007 included a $923,000 charge related to stock-based compensation, a $686,000 charge related to executive retirement benefits, and a $505,000 gain related to the adjustment of reserves for product liability losses.  General, administrative, and marketing expenses for the first half of 2006 included a $647,000 charge related to stock-based compensation and a $670,000 gain related to the adjustment of reserves for product liability losses.

Other income and expenses in the second quarter and first half of 2007 included an $866,000 and an $821,000 charge, respectively, for the change in the valuation of the derivative related to the Company’s preferred stock.  Other income and expenses in the second quarter and first half of 2006 include an $11,000 and a $67,000 charge, respectively, for the change in the value of the derivative related to the Company’s preferred stock.

Research and development expenses were $978,000 and $837,000 in the second quarters of 2007 and 2006, respectively.  Research and development expenses were $2.0 million and $1.7 million in the first half of 2007 and 2006, respectively.

As of June 30, 2007, the Company had  $11.4 million in cash, cash equivalents and marketable securities (at market), of which $1.7 million was received from the U.S. Department of Defense as advance funding for the development of protein hydrogel technology for use on the battlefield.


2007 Guidance

As announced on July 11, 2007 the Company now expects revenues for the full year of 2007 to be between $93.0 and $96.0 million.  The Company expects BioGlue revenues to be between $43.5 and $44.5 million, and tissue processing revenues to be between $48.5 and $50.5 million for the full year of 2007.  Other device revenues are expected to be approximately $1 million in 2007.

The Company expects general, administrative, and marketing expenses of between $46.0 million and $48.0 million, and research and development expenses of between $4.0 million and $5.0 million, for the full year of 2007.


Webcast and Conference Call Information

The Company will hold a teleconference call and live webcast today at 10:00 a.m. Eastern Time 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 July 31 – August 7, 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 248380.

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6


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.


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 2007 results.  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 the Company’s strategic directives may not generate anticipated revenue and earnings growth, the RTI exchange and service agreement may not result in some or all of the positive benefits anticipated, that sources of cardiovascular and vascular tissue procurement for RTI may choose not to make that tissue available to the Company or may not be able to meet the Company's tissue processing standards, or the Company may otherwise be unable to replace the orthopedic revenues that it expects to continue to decrease as a result of the RTI agreement with cardiovascular or vascular revenues, that expected cost savings and synergies from the RTI agreement may not occur when and as anticipated, the Company's efforts to continue to increase revenue may not be effective, since their effectiveness is subject to such factors as competitive pressures and tissue availability, that the Company's efforts to develop and introduce new products outside the U.S. may be unsuccessful, that the Company's efforts to improve procurement and tissue processing yields may not continue to prove effective, the possibility that the FDA could impose additional restrictions on the Company's operations, require a recall, or prevent the Company from processing and distributing tissues or manufacturing and distributing other products, that products and services under development, including BioDisc, may not be commercially feasible, the Company’s SynerGraft products may not receive FDA approval when anticipated or at all, that the Company may not have sufficient borrowing or other capital availability to fund its business, that pending litigation cannot be settled on terms acceptable to the Company, that the Company may not have sufficient resources to pay punitive damages (which are not covered by insurance) or other liabilities in excess of available insurance, the possibility of decreases in the Company's working capital if cash flow does not continue at its current improved levels, that to the extent the Company does not have sufficient resources to pay the claims against it, it may be forced to cease operations or seek protection under applicable bankruptcy laws, changes in laws and regulations applicable to CryoLife, that the Company may be unable to obtain sufficient financing to fully pursue its strategic plan, 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. AND SUBSIDIARIES
Financial Highlights
(In thousands, except per share data)

   
Three Months Ended
   
Six Months Ended
 
   
June 30,
   
June 30,
 
   
2007
   
2006
   
2007
   
2006
 
   
(Unaudited)
   
(Unaudited)
 
Revenues:
                       
Human tissue preservation services
  $
11,711
    $
10,181
    $
24,672
    $
19,520
 
Products
   
11,156
     
10,569
     
22,551
     
20,621
 
Other
   
144
     
4
     
312
     
62
 
Total revenues
   
23,011
     
20,754
     
47,535
     
40,203
 
                                 
Costs and expenses:
                               
Human tissue preservation services
   
6,976
     
7,034
     
14,608
     
13,797
 
Products
   
1,881
     
2,082
     
3,829
     
4,005
 
General, administrative, and marketing
   
10,842
     
10,245
     
23,177
     
21,557
 
Research and development
   
978
     
837
     
2,036
     
1,746
 
Interest expense
   
187
     
188
     
340
     
335
 
Interest income
    (105 )     (103 )     (202 )     (210 )
Change in valuation of derivative
   
866
     
11
     
821
     
67
 
Other expense, net
   
13
     
357
     
102
     
344
 
Total costs and expenses
   
21,638
     
20,651
     
44,711
     
41,641
 
Earnings (loss) before income taxes
   
1,373
     
103
     
2,824
      (1,438 )
Income tax expense (benefit)
   
82
      (114 )    
179
     
125
 
Net income (loss)
  $
1,291
    $
217
    $
2,645
    $ (1,563 )
                                 
Effect of preferred stock dividends
   
--
      (244 )     (243 )     (487 )
Net income (loss) applicable to common shares
  $
1,291
    $ (27 )   $
2,402
    $ (2,050 )
                                 
Income (loss) per common share:
                               
Basic
  $
0.05
    $ (0.00 )   $
0.10
    $ (0.08 )
Diluted
  $
0.05
    $ (0.00 )   $
0.09
    $ (0.08 )
                                 
Weighted average common shares outstanding:
                               
Basic
   
25,480
     
24,807
     
25,234
     
24,783
 
Diluted
   
26,333
     
24,807
     
25,969
     
24,783
 
                                 
Revenues from:
                               
Cardiovascular
  $
5,048
    $
3,788
    $
10,021
    $
7,361
 
Vascular
   
5,428
     
4,554
     
11,567
     
8,598
 
Orthopaedic
   
1,235
     
1,839
     
3,084
     
3,561
 
Total preservation services
   
11,711
     
10,181
     
24,672
     
19,520
 
                                 
BioGlue
   
10,930
     
10,333
     
22,093
     
20,090
 
Other implantable medical devices
   
226
     
236
     
458
     
531
 
 Total products
   
11,156
     
10,569
     
22,551
     
20,621
 
                                 
Other
   
144
     
4
     
312
     
62
 
         Total revenues
  $
23,011
    $
20,754
    $
47,535
    $
40,203
 
                                 
Domestic revenues
  $
19,410
    $
17,558
    $
40,812
    $
34,200
 
International revenues
   
3,601
     
3,196
     
6,723
     
6,003
 
         Total revenues
  $
23,011
    $
20,754
    $
47,535
    $
40,203
 
 
 
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8


CRYOLIFE, INC. AND SUBSIDIARIES
Financial Highlights
(In thousands)


   
June 30,
   
December 31,
 
   
2007
   
2006
 
   
(Unaudited)
       
             
Cash and cash equivalents, marketable securities,
  $
11,445
    $
8,669
 
 at market, and restricted securities
               
Trade receivables, net
   
13,295
     
12,553
 
Other receivables
   
1,390
     
1,403
 
Deferred preservation costs, net
   
22,705
     
19,278
 
Inventories
   
5,834
     
5,153
 
Total assets
   
87,677
     
79,865
 
Shareholders’ equity
   
56,609
     
52,088
 


 
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CRYOLIFE, INC. AND SUBSIDIARIES
Unaudited Reconciliation of Adjusted Net Income (Loss)
(In thousands, except per share data)

   
Three Months Ended
   
Six Months Ended
 
   
June 30,
   
June 30,
 
   
2007
   
2006
   
2007
   
2006
 
                                 
Net income (loss) – as reported
  $
1,291
    $
217
    $
2,645
    $ (1,563 )
                                 
Adjustments to net income (loss):
                               
Stock-based compensation
   
548
     
403
     
923
     
647
 
Adjustment of reserves for product liability losses
    (490 )     (800 )     (505 )     (670 )
Executive retirement benefits
   
--
     
--
     
686
     
--
 
Change in valuation of derivative
   
866
     
--
     
821
     
--
 
                                 
Adjusted net income (loss)
  $
2,215
    $ (180 )   $
4,570
    $ (1,586 )
                                 
Effect of preferred stock dividends
   
--
      (244 )     (243 )     (487 )
Adjusted net income (loss) applicable to
                               
common shares
  $
2,215
    $ (424 )   $
4,327
    $ (2,073 )
                                 
Weighted average common shares
                               
outstanding – Basic
   
25,480
     
24,807
     
25,234
     
24,783
 
                                 
Adjusted income (loss) per common share – Basic
  $
0.09
    $ (0.02 )   $
0.17
    $ (0.08 )



Numerator for adjusted diluted income (loss) per
                       
common share:
                       
Adjusted net income (loss)
  $
2,215
      (180 )   $
4,570
      (1,586 )
Less effect of preferred stock dividends
   
--
      (244 )     (243 )     (487 )
Adjusted net income (loss) applicable to common
                               
stock
  $
2,215
      (424 )   $
4,327
      (2,073 )
                                 
Denominator for adjusted diluted income (loss) per
                               
common share:
                               
Basic weighted-average common shares
   
25,480
     
24,807
     
25,234
     
24,783
 
Effect of dilutive stock options
   
853
     
--
     
735
     
--
 
                                 
Weighted average common shares
                               
outstanding - Diluted
   
26,333
     
24,807
     
25,969
     
24,783
 
                                 
Adjusted income (loss) per common share – Diluted
  $
0.08
    $ (0.02 )   $
0.17
    $ (0.08 )





For additional information about the company, visit CryoLife’s Web site:
http://www.cryolife.com
END


10


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-----END PRIVACY-ENHANCED MESSAGE-----