Company posts fully diluted earnings per share of $0.09 for second
quarter of 2009; Revenues increased 6 percent sequentially for
second quarter of 2009 compared to first quarter of 2009 ATLANTA,
July 30 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE:CRY), an
implantable biological medical device and cardiovascular tissue
processing company, announced today that revenues for the second
quarter of 2009 increased 4 percent to a quarterly record of $28.2
million compared to $27.2 million for the second quarter of 2008.
Excluding orthopaedic tissue processing revenues of $44,000 and
$297,000 for the second quarters of 2009 and 2008, respectively,
revenues increased 5 percent for the second quarter of 2009.
Operating income for each of the second quarters of 2009 and 2008
was $4.2 million. Operating margin was 15 percent for each of the
second quarters of 2009 and 2008. Net income for the second quarter
of 2009 was $2.5 million, or $0.09 per basic and fully diluted
common share, compared to $3.9 million, or $0.14 per basic and
fully diluted common share for the second quarter of 2008. The
Company's effective income tax rate was 41 percent for the second
quarter of 2009, compared to 6 percent for the second quarter of
2008. The Company's effective income tax rate was lower in 2008 due
to the valuation allowance on the Company's deferred tax assets
during 2008. If the Company had recorded 2008 income taxes at a
normalized 41 percent effective tax rate, net income for the second
quarter of 2008 would have been $2.4 million and fully diluted
earnings per share would have been $0.09. Revenues for the first
six months of 2009 increased 4 percent to $54.9 million compared to
$52.7 million for the first six months of 2008. Excluding
orthopaedic tissue processing revenues of $129,000 and $624,000 for
the first six months of 2009 and 2008, respectively, revenues
increased 5 percent for the first six months of 2009. Operating
income increased 11 percent for the first six months of 2009 to
$7.7 million compared to $6.9 million for the first six months of
2008. Operating margin increased to 14 percent for the first six
months of 2009 compared to 13 percent for 2008. Net income for the
first six months of 2009 was $4.5 million, or $0.16 per basic and
fully diluted common share, compared to $6.7 million, or $0.24 per
basic and fully diluted common share for the first six months of
2008. If the Company had recorded 2008 income taxes at a normalized
41 percent effective tax rate, net income for the first six months
of 2008 would have been $4.1 million and fully diluted earnings per
share would have been $0.15. The Company has net operating loss
carryforwards that will largely reduce required cash payments for
federal and state income taxes for the 2009 tax year. Tissue
processing revenues for the second quarter of 2009 increased 3
percent to $14.1 million compared to $13.7 million for the second
quarter of 2008. Excluding orthopaedic tissue processing revenues
of $44,000 and $297,000 for the second quarter of 2009 and 2008,
respectively, tissue processing revenues increased 5 percent to
$14.0 million for the second quarter of 2009 compared to $13.4
million for the second quarter of 2008. The increase in tissue
processing revenues was primarily due to increased revenues from
vascular tissue for the second quarter of 2009 of $7.6 million as
compared to $7.1 million for the second quarter of 2008. Tissue
processing revenues for the first six months of 2009 increased 2
percent to $27.6 million compared to $27.1 million for the first
six months of 2008. Excluding orthopaedic tissue processing
revenues of $129,000 and $624,000 for the first six months of 2009
and 2008, respectively, tissue processing revenues increased 4
percent to $27.5 million for the first six months of 2009 compared
to $26.5 million for the first six months of 2008. The increase in
tissue processing revenues was primarily due to increased revenues
from vascular tissue for the first six months of 2009 of $15.4
million as compared to $13.9 million for the first six months of
2008. Revenues from the distribution of CryoValve SG pulmonary
heart valves increased to $1.5 million for the second quarter of
2009 from $1.4 million for the second quarter of 2008, representing
24 percent of the Company's cardiac tissue processing revenues for
the second quarter of 2009. Revenues from the distribution of
CryoValve SG pulmonary heart valves increased to $2.7 million for
the first six months 2009 from $1.6 million for the first six
months of 2008, representing 22 percent of the Company's cardiac
tissue processing revenues for the first six months of 2009.
BioGlue Surgical Adhesive revenues were $12.4 million for the
second quarter of 2009 compared to $13.0 million for the second
quarter of 2008, a decrease of 5 percent. Excluding the effects of
changes in foreign currency exchange rates for the second quarter
of 2009 compared to those in effect during the second quarter of
2008, which reduced BioGlue revenues by $331,000 for the second
quarter of 2009, BioGlue revenues would have been $12.7 million.
BioGlue revenues were $24.1 million for the first six months of
2009 compared to $24.9 million for the first six months of 2008, a
decrease of 3 percent. Excluding the effects of changes in foreign
currency exchange rates for the first six months of 2009 compared
to those in effect during the first six months of 2008, which
reduced BioGlue revenues by $639,000 for the first six months of
2009, BioGlue revenues would have been $24.8 million. U.S. BioGlue
revenues were $8.5 million and $9.1 million for the second quarters
of 2009 and 2008, respectively. U.S. BioGlue revenues were $16.9
million and $17.7 million for the first six months of 2009 and
2008, respectively. International BioGlue revenues were $3.9
million for each of the second quarters of 2009 and 2008.
International BioGlue revenues were $7.3 million and $7.2 million
for the first six months of 2009 and 2008, respectively. Other
medical device revenues for the second quarter of 2009 were $1.5
million compared to $308,000 for the second quarter of 2008. Other
medical device revenues for the first six months of 2009 were $2.7
million compared to $401,000 for the first six months of 2008.
Included in this revenue category for the second quarter and the
first six months of 2009 were $1.5 million and $2.6 million,
respectively, in sales of HemoStase(TM). Total tissue processing
and product gross margins were 63 percent and 66 percent for the
second quarters of 2009 and 2008, respectively. Total tissue
processing and product gross margins were 64 percent and 65 percent
for the first six months of 2009 and 2008, respectively. Tissue
processing gross margins were 43 percent and 46 percent for the
second quarters of 2009 and 2008, respectively. Tissue processing
gross margins were 44 percent and 46 percent for the first six
months of 2009 and 2008, respectively. General, administrative, and
marketing expenses for the second quarter of 2009 were $12.3
million compared to $12.4 million for the second quarter of 2008.
General, administrative, and marketing expenses for the first six
months of 2009 were $25.1 million compared to $24.4 million for the
first six months of 2008. These expenses included personnel costs,
advertising, physician education and training, and promotional
materials to support the Company's efforts to increase its tissue
processing service and product offerings, and current revenue
growth. General, administrative, and marketing expenses for the
second quarters of 2009 and 2008 included benefits of $495,000 and
$610,000, respectively, related to the adjustment of reserves for
product liability losses. General, administrative, and marketing
expenses for the first six months of 2009 and 2008 included
benefits of $460,000 and $530,000, respectively, related to the
adjustment of reserves for product liability losses. Research and
development expenses were $1.4 million and $1.3 million for the
second quarters of 2009 and 2008, respectively. Research and
development expenses were $2.4 million and $2.8 million for the
first six months of 2009 and 2008, respectively. Research and
development spending in 2009 is primarily focused on the Company's
protein hydrogel technologies and SynerGraft tissues and products.
As of June 30, 2009, the Company had $26.7 million in cash, cash
equivalents, and marketable securities, compared to $22.8 million
at December 31, 2008. Of this $26.7 million, $2.5 million was
received from the U.S. Department of Defense as advance funding for
the development of BioFoam protein hydrogel technology, and $5.0
million was designated as long-term restricted money market funds
due to a financial covenant requirement under the Company's credit
agreement. "CryoLife continues to thrive and expand as witnessed by
the record revenues in the second quarter of 2009, even in a very
adverse world economy," stated Steven G. Anderson, president and
chief executive officer. "We are very encouraged by our continued
growth and the trend we are establishing for 2009, and we will
continue to look for opportunities to expand our cardiac and
vascular surgery portfolios." 2009 Financial Guidance The Company
is updating its guidance for the full year of 2009. The Company
expects total revenues for the full year of 2009 to be between
$112.0 million and $116.0 million. The Company expects tissue
processing revenues to be between $57.0 million and $59.0 million.
The Company expects product revenues to be between $54.0 million
and $56.0 million, with BioGlue revenues to be between $49.0
million and $50.0 million for the full year of 2009 and other
medical device revenues, which consist primarily of sales of
HemoStase, to be between $5.0 million and $6.0 million in 2009.
Tissue processing and product revenues could be affected by several
factors, including but not limited to, the general economic
environment and its effect on demand for the Company's tissues and
products, and changes in foreign currency exchange rates and their
effects on revenues generated in international markets. Other
revenues for 2009 are expected to be approximately $1.0 million,
related to funding received from the Department of Defense in
connection with the development of BioFoam. The amount of other
revenues is largely dependent upon actual expenses incurred related
to the development of BioFoam. The Company expects general,
administrative, and marketing expenses of between $50.0 million and
$52.0 million, and research and development expenses of between
$5.0 million and $6.0 million for the full year of 2009. The
research and development expectations include approximately $1.0
million to be funded by the Department of Defense in connection
with the development of BioFoam. The Company expects operating
income to increase for the full year of 2009 compared to 2008.
However, the Company expects its effective income tax rate to be
approximately 41 percent in 2009 compared to a tax benefit in 2008.
As a result, earnings per share in 2009 will be lower than in 2008,
when the Company reversed a significant portion of the valuation
allowance on its deferred tax assets, which resulted in the
recognition of significant income tax benefits. 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 from July 30 through August 7 and
can be accessed by calling 877-660-6853 (toll free) or
201-612-7415. The account number for the replay is 244 and the
conference number is 327576. The live webcast and replay can be
accessed by going to the Investor Relations section of the CryoLife
Web site at http://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 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 pulmonary
valves. 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. 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 2009
performance and our growth prospects and statements regarding the
expected impact of our net operating loss carryforwards on our cash
outlays for tax obligations. 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, 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.
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 to be
filed for the quarter ended June 30, 2009, and the Company's other
SEC filings. The Company does not undertake to update its
forward-looking statements. CRYOLIFE, INC. AND SUBSIDIARIES
Financial Highlights (In thousands, except per share data) Three
Months Ended Six Months Ended June 30, June 30, ------------------
---------------- 2009 2008 2009 2008 ------------------
---------------- (Unaudited) (Unaudited) Revenues: Preservation
services $14,091 $13,725 $27,639 $27,149 Products 13,918 13,280
26,863 25,260 Other 154 150 349 314 ------------------
---------------- Total revenues 28,163 27,155 54,851 52,723
------------------ ---------------- Cost of preservation services
and products: Preservation services 8,027 7,449 15,518 14,767
Products 2,241 1,840 4,203 3,832 ------------------
---------------- Total cost of preservation services and products
10,268 9,289 19,721 18,599 ------------------ ----------------
Gross margin 17,895 17,866 35,130 34,124 ------------------
---------------- Operating expenses: General, administrative, and
marketing 12,306 12,358 25,054 24,425 Research and development
1,367 1,307 2,393 2,752 ------------------ ---------------- Total
operating expenses 13,673 13,665 27,447 27,177 ------------------
---------------- Operating income 4,222 4,201 7,683 6,947
------------------ ---------------- Interest expense 61 69 110 139
Interest income (20) (71) (63) (193) Other (income) expense, net
(60) 55 92 (27) ------------------ ---------------- Income before
income taxes 4,241 4,148 7,544 7,028 Income tax expense 1,739 260
3,093 375 ------------------ ---------------- Net income $ 2,502 $
3,888 $ 4,451 $ 6,653 ================== ================ Income
per common share: Basic $ 0.09 $ 0.14 $ 0.16 $ 0.24
================== ================ Diluted $ 0.09 $ 0.14 $ 0.16 $
0.24 ================== ================ Weighted average common
shares outstanding: Basic 28,067 27,756 28,038 27,661 Diluted
28,174 28,381 28,204 28,211 CRYOLIFE, INC. AND SUBSIDIARIES
Financial Highlights (In thousands) Three Months Ended Six Months
Ended June 30, June 30, ------------------ ---------------- 2009
2008 2009 2008 ------------------ ---------------- (Unaudited)
(Unaudited) Preservation Services: Cardiac tissue $ 6,470 $ 6,348
$12,062 $12,586 Vascular tissue 7,577 7,080 15,448 13,939
Orthopaedic tissue 44 297 129 624 ------------------
---------------- Total preservation services 14,091 13,725 27,639
27,149 ------------------ ---------------- Products: BioGlue 12,379
12,972 24,143 24,859 HemoStase 1,467 177 2,577 177 Other medical
devices 72 131 143 224 ------------------ ---------------- Total
products 13,918 13,280 26,863 25,260 ------------------
---------------- Other 154 150 349 314 ------------------
---------------- Total revenues $28,163 $27,155 $54,851 $52,723
================== ================ Revenues: U.S. $23,579 $22,834
$46,323 $44,834 International 4,584 4,321 8,528 7,889
------------------ ---------------- Total revenues $28,163 $27,155
$54,851 $52,723 ================== ================ June 30,
December 31, 2009 2008 ----------- ------------ (Unaudited) Cash
and cash equivalents and restricted securities $ 21,700 $ 17,763
Receivables, net 15,548 13,999 Deferred preservation costs 37,029
34,913 Inventories 6,621 7,077 Restricted money market funds,
long-term 5,000 5,000 Total assets 130,849 125,995 Shareholders'
equity 105,663 99,326 CRYOLIFE, INC. Unaudited Reconciliation of
Non-GAAP Net Income and Income per Common Share (In thousands,
except per share data) Three Months Ended Six Months Ended June 30,
June 30, ------------------ ---------------- 2009 2008 2009 2008
------------------ ---------------- Income before income taxes $
4,241 $ 4,148 $ 7,544 $ 7,028 Income tax expense 1,739 260 3,093
375 ------------------ ---------------- Net income $ 2,502 $ 3,888
$ 4,451 $ 6,653 ================== ================ Income per
common share: Basic $ 0.09 $ 0.14 $ 0.16 $ 0.24 ==================
================ Diluted $ 0.09 $ 0.14 $ 0.16 $ 0.24
================== ================ Weighted average common shares
outstanding: Basic 28,067 27,756 28,038 27,661 Diluted 28,174
28,381 28,204 28,211 Net income $ 3,888 $ 6,653 Non-GAAP
adjustments to net income: Tax calculated at 41% of income before
income taxes $ 1,701 $2,881 Less income tax expense, as reported
(260) (375) ---------- ---------- Additional income tax expense,
non-GAAP 1,441 2,506 ---------- ---------- Net income, non-GAAP $
2,447 $ 4,147 ========== ========== Income per common share,
non-GAAP: Basic $ 0.09 $ 0.15 ========== ========== Diluted $ 0.09
$ 0.15 ========== ========== Weighted average common shares
outstanding: Basic 27,756 27,661 Diluted 28,381 28,211 For
additional information about the company, visit CryoLife's Web
site: http://www.cryolife.com/. Media Contacts: D. Ashley Lee Katie
Brazel Executive Vice President, Fleishman Hillard Chief Financial
Officer and Phone: 404-739-0150 Chief Operating Officer Phone:
770-419-3355 DATASOURCE: CryoLife, Inc. CONTACT: D. Ashley Lee,
Executive Vice President, Chief Financial Officer and Chief
Operating Officer of CryoLife, +1-770-419-3355, or Katie Brazel, of
Fleishman Hillard, +1-404-739-0150 Web Site:
http://www.cryolife.com/
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