CryoLife Reports Second Quarter 2004 Financial Results

August 5, 2004 at 8:04 AM EDT
           BioGlue(R) Sales Increased 31% Over Second Quarter 2003

        BioGlue Syringe Delivery System Launched in the Second Quarter

                    Orthopaedic Tissue Revenues Increasing

ATLANTA, Aug. 5 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a biomaterials and biosurgical device company, today reported financial results for the second quarter and first six months of 2004.

Revenues for the second quarter 2004 were $15.3 million compared to $15.7 million in the second quarter of 2003. Revenues were $15.1 million in the first quarter of 2004. Net loss in the second quarter of 2004 was $3.4 million compared to $19.9 million in the second quarter of 2003. On a fully diluted basis, loss per common share for the second quarter 2004 was $.14 compared to a loss of $1.01 for the same period in 2003.

Revenues for the first half of 2004 were $30.4 million compared to $31.6 million in the first half of 2003. The net loss in the first six months of the year was $10.4 million compared to a net loss of $20.4 million in the same period last year. On a fully diluted basis, the loss per share was $.46 in the first half of 2004 compared to a $1.04 loss per share in the first half of 2003.

In the second quarter of 2004, BioGlue(R) sales increased 31% to $9.0 million compared to $6.8 million in the second quarter of 2003. BioGlue revenues were $8.6 million in the first quarter of 2004. U.S. BioGlue sales increased 32% to $7.0 million in the second quarter of 2004 compared to $5.3 million for the same period in 2003. International BioGlue sales increased 28% to $2.0 million in the second quarter of 2004 compared to $1.5 million for the same period in 2003. BioGlue revenues are expected to be between $8.6 million and $9.0 million in the third quarter of 2004.

"BioGlue is achieving strong growth because it has become an important product for surgeons in effectively controlling bleeding in certain surgical procedures. The BioGlue syringe delivery system was approved by the FDA and received CE mark approval for distribution in the EU in May 2004. This innovative, easy-to-use, disposable delivery device should encourage increased use of BioGlue and further its revenue growth," said Steven G. Anderson, CryoLife President and Chief Executive Officer. BioGlue revenues are expected to increase 22%-29% to $34-$36 million in 2004 from $27.8 million in 2003.

Tissue processing revenues, which include cardiac, vascular, and orthopaedic tissues, were $6.1 million in the second quarter of 2004 compared to $8.6 million in the second quarter of 2003. In the first quarter of 2004, tissue processing revenues were $6.2 million. Total tissue processing revenues are expected to be between $28 and $30 million in 2004 compared to $30.8 million in 2003. Projected tissue processing revenue for the third quarter is $7.0-$8.5 million.

Cardiac tissue processing revenues were $2.8 million in the second quarter of 2004 compared to $5.0 million in the second quarter of 2003 and $3.4 million in the first quarter of 2004. Vascular tissue processing revenues were $2.6 million in the second quarter of 2004 compared to $3.3 million in the second quarter of 2003 and $2.5 million in the first quarter of 2004. Orthopaedic revenues were $574,000 in the second quarter of 2004 compared to $280,000 in the second quarter of 2003 and $309,000 the first quarter of 2004. The Company initiated fee increases for processing its cardiac and vascular tissues in July 2004.

Steven Anderson stated, "The tissue processing gross margin improved to -25% in the second quarter of 2004 from -46% in the first quarter of 2004. This increase in the tissue processing gross margin was the result of recently implemented initiatives with tissue procurement organizations and several tissue processing improvements. The tissue processing gross margin is expected to continue to improve in the second half of the year and is expected to break even by the end of the fourth quarter 2004 and be positive in 2005."

Total tissue processing and product revenues are projected to be between $16 and $18 million in the third quarter of 2004, up from $15.3 million in the second quarter of 2004. Total tissue processing and product revenues are expected to increase 8%-13% to $64-$67 million for the full year 2004.

In the second quarter 2004, general, administrative, and marketing expenses were favorably affected by a reduction in product liability accruals of $800,000. The net loss in the second quarter of 2004 was favorably impacted by a $1.4 million tax refund. General, administrative, and marketing expenses are expected to be approximately $40-42 million in 2004, while research and development expenses are expected to be approximately $4 million in 2004. For the third quarter of 2004, the Company expects general, administrative, and marketing expenses of approximately $10-11 million and expects research and development expenses of approximately $1 million. As of June 30, 2004, the Company had approximately $23.7 million in aggregate cash, cash equivalents, and marketable securities.

The Company will hold a teleconference call and live web cast at 11:15 a.m. Eastern Daylight Time, August 5, 2004, to discuss second quarter 2004 results, followed by a question and answer session hosted by Steven G. Anderson, CryoLife President and Chief Executive Officer.

To listen to the live teleconference, please dial 973-582-2749 a few minutes prior to 11:15 a.m. No identification number is required. A replay of the teleconference will be available August 5 through August 10 and can be accessed by calling (toll free) 877-519-4471 or 973-341-3080. The identification number for the replay is 4973918. The live webcast can be accessed by going to the Investor Relations section of the CryoLife website at http://www.cryolife.com .

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 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 2004 revenues and expenses may not meet its expectations, that the Company's 2004 BioGlue revenues may not meet its expectations, that the demand for CryoLife preserved tissues may not return to prior levels, that the new BioGlue syringe delivery system may not encourage increased use of BioGlue, that the Company's general administrative and marketing expenses may not meet expectations due to higher than expected costs of resolving existing and future litigation, 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 FDA regulation of the Company's CryoValve SG and CryoVein SG may require significant time and expense, that the protein hydrogel products under development may not be commercially feasible, 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 severe decreases in the Company's revenues and working capital, 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 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, 2003, 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
                       website: http://www.cryolife.com


                                CRYOLIFE, INC.
                        Unaudited Financial Highlights
                      (In thousands, except share data)

                                      Three Months Ended    Six Months Ended
                                            June 30,             June 30,
                                        2004       2003      2004      2003

    Revenues:
      Products                         $9,203    $6,932   $18,062   $13,531
      Human tissue preservation
       services                         6,054     8,615    12,279    17,745
      Distribution and grant               57       166        59       357
        Total revenues                 15,314    15,713    30,400    31,633

    Costs and expenses:
      Products                          1,894     2,006     3,841     3,647
      Human tissue preservation
       services                         7,543     5,160    16,646     7,603
      General, administrative, and
       marketing                        9,693    23,539    19,841    35,131
      Research and development            891     1,088     1,812     2,005
      Interest expense                     59       147       102       279
      Interest income                     (64)     (116)     (130)     (247)
      Other expense, net                   21       166        37       140
        Total costs and expenses       20,037    31,990    42,149    48,558

    Loss before income taxes           (4,723)  (16,277)  (11,749)  (16,925)
      Income tax (benefit) expense     (1,371)    3,644    (1,371)    3,430
        Net loss                      $(3,352) $(19,921) $(10,378) $(20,355)

    Net loss per share:
      Basic                            $(0.14)   $(1.01)   $(0.46)   $(1.04)
      Diluted                          $(0.14)   $(1.01)   $(0.46)   $(1.04)

    Weighted average shares outstanding:
      Basic                            23,252    19,675    22,747    19,654
      Diluted                          23,252    19,675    22,747    19,654

    Revenues from:
      Cardiovascular                   $2,831    $5,036    $6,261    $9,761
      Vascular                          2,649     3,299     5,135     7,554
      Orthopaedic                         574       280       883       430
        Total cryopreservation          6,054     8,615    12,279    17,745

      BioGlue                           8,962     6,839    17,605    13,333
      Implantable medical devices         241        93       457       198
      Distribution and grant               57       166        59       357
        Total revenues                $15,314   $15,713   $30,400   $31,633

    International revenues             $2,327    $1,845    $4,419    $3,556
    Domestic revenues                  12,987    13,868    25,981    28,077
        Total revenues                $15,314   $15,713   $30,400   $31,633


                                CRYOLIFE, INC.
                             Financial Highlights
                                (In thousands)

                                                    Unaudited       Audited
                                                     June 30,       Dec. 31,
                                                       2004           2003

    Cash and cash equivalents                        $23,741        $11,916
     and marketable securities, at market
    Trade receivables, net                             7,625          6,377
    Other receivables, net                             2,231          1,865
    Deferred preservation costs, net                   7,382          8,811
    Inventories                                        4,572          4,450
    Total assets                                      87,751         75,027
    Shareholders' equity                              57,500         48,338


     Contact: Joseph T. Schepers
              Vice President, Corporate Communications
              (770) 419-3355
SOURCE  CryoLife, Inc.
CONTACT:  Joseph T. Schepers, Vice President, Corporate Communications of
CryoLife, Inc., +1-770-419-3355
Web site:  http://www.cryolife.com
(CRY)