CryoLife Reports Record Quarterly Revenues of $28.2 Million
Company posts fully diluted earnings per share of $0.07 for third quarter of
2009; Revenues increased 5 percent for third quarter of 2009 compared to third
quarter of 2008
ATLANTA, Oct. 29 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), an
implantable biological medical device and cardiovascular tissue processing
company, announced today that revenues for the third quarter of 2009 increased
5 percent to a quarterly record of $28.2 million compared to $26.8 million for
the third quarter of 2008.
Net income for the third quarter of 2009 was $1.9 million, or $0.07 per basic
and fully diluted common share, compared to $3.6 million, or $0.13 per basic
and $0.12 per fully diluted common share for the third quarter of 2008. The
Company's effective income tax rate was 41 percent for the third quarter of
2009, compared to 6 percent for the third 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 third quarter of 2008 would have been $2.2 million and fully diluted
earnings per share would have been $0.08.
Revenues for the first nine months of 2009 increased 4 percent to a record
$83.1 million compared to $79.5 million for the first nine months of 2008.
Net income for the first nine months of 2009 was $6.3 million, or $0.22 per
basic and fully diluted common share, compared to $10.2 million, or $0.37 per
basic and $0.36 per fully diluted common share for the first nine months of
2008. If the Company had recorded 2008 income taxes at a normalized 41
percent effective tax rate, net income for the first nine months of 2008 would
have been $6.4 million and fully diluted earnings per share would have been
$0.22. 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.
Preservation service revenues for the third quarter of 2009 increased 6
percent to $15.0 million compared to $14.2 million for the third quarter of
2008. The increase in preservation service revenues was primarily due to
increased shipments of cardiac and vascular tissues for the third quarter of
2009 compared to the third quarter of 2008.
Preservation service revenues for the first nine months of 2009 increased 3
percent to $42.7 million compared to $41.3 million for the first nine months
of 2008. Excluding orthopaedic tissue processing revenues of $148,000 and
$662,000 for the first nine months of 2009 and 2008, respectively,
preservation service revenues increased 5 percent to $42.5 million for the
first nine months of 2009 compared to $40.7 million for the first nine months
of 2008. The increase in preservation service revenues was primarily due to
increased revenues from vascular tissue for the first nine months of 2009
compared to the first nine months of 2008.
Revenues from the distribution of CryoValve® SG pulmonary heart valves and
CryoPatch® SG pulmonary cardiac patches increased to $1.9 million for the
third quarter of 2009 from $1.7 million for the third quarter of 2008,
representing 26 percent of the Company's cardiac tissue processing revenues
for the third quarter of 2009. Revenues from the distribution of CryoValve SG
and CryoPatch SG increased to $4.6 million for the first nine months of 2009
from $3.4 million for the first nine months of 2008, representing 24 percent
of the Company's cardiac tissue processing revenues for the first nine months
of 2009.
Product revenues, which consists primarily of sales of BioGlue® Surgical
Adhesive and HemoStase(TM), were $12.8 million for the third quarter of 2009
compared to $12.2 million for the third quarter of 2008, an increase of 5
percent. Excluding the effects of changes in foreign currency exchange rates
for the third quarter of 2009 compared to those in effect during the third
quarter of 2008, which reduced revenues by $132,000 for the third quarter of
2009, product revenues would have been $12.9 million.
Product revenues were $39.7 million for the first nine months of 2009 compared
to $37.5 million for the first nine months of 2008, an increase of 6 percent.
Excluding the effects of changes in foreign currency exchange rates for the
first nine months of 2009 compared to those in effect during the third quarter
of 2008, which reduced revenues by $804,000 for the first nine months of 2009,
product revenues would have been $40.5 million.
Total preservation services and product gross margins were 60 percent and 64
percent for the third quarters of 2009 and 2008, respectively. Total
preservation services and product gross margins were 62 percent and 64 percent
for the first nine months of 2009 and 2008, respectively.
Preservation services gross margins were 41 percent and 46 percent for the
third quarters of 2009 and 2008, respectively. Preservation services gross
margins were 43 percent and 46 percent for the first nine months of 2009 and
2008, respectively.
Product gross margins were 82 percent and 83 percent for the third quarters of
2009 and 2008, respectively. Product gross margins were 84 percent for each
of the first nine months of 2009 and 2008.
General, administrative, and marketing expenses for the third quarter of 2009
were $12.4 million compared to $12.1 million for the third quarter of 2008.
General, administrative, and marketing expenses for the first nine months of
2009 were $37.4 million compared to $36.5 million for the first nine months of
2008. These expenses included personnel costs, advertising, physician
education and training, and promotional materials to support current revenue
growth and the Company's efforts to increase its preservation service and
product offerings.
General, administrative, and marketing expenses for the first nine months of
2009 and 2008 included benefits of $405,000 and $449,000, respectively,
related to the adjustment of reserves for product liability losses.
Research and development expenses were $1.5 million and $1.2 million for the
third quarters of 2009 and 2008, respectively. Research and development
expenses were $3.9 million for each of the first nine months of 2009 and 2008.
Research and development spending in 2009 is primarily focused on the
Company's BioGlue and related products and SynerGraft® tissues and products.
As of September 30, 2009, the Company had $32.0 million in cash, cash
equivalents, and restricted securities, compared to $22.8 million at December
31, 2008. Of this $32.0 million, $2.6 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.
"We saw several key milestones during the third quarter of 2009, including the
510(k) clearance for CryoPatch SG, the Humanitarian Use Device designation for
CryoValve SG aortic heart valve, and the CE Mark and first human implants of
BioFoam," stated Steven G. Anderson, president and chief executive officer.
"We will continue to drive the development of our SynerGraft and BioGlue and
related product platforms forward to bring new innovative solutions to cardiac
and vascular surgeons, and the patients they serve."
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 near the lower end of
its range of guidance of between $112.0 million and $116.0 million. The
Company expects preservation services revenues to be near the lower end of its
previous range of guidance of between $57.0 million and $59.0 million. The
Company expects product revenues to be near the lower end of its previous
range of guidance of between $54.0 million and $56.0 million, with BioGlue
revenues to be slightly below its previous range of guidance of between $49.0
million and $50.0 million for the full year of 2009 and HemoStase revenues to
be near the higher end of its previous range of guidance of 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 to be near
the lower end of its previous range of guidance 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.
2010 Financial Guidance
The Company plans to issue its initial 2010 financial guidance on either
December 1 or 2, 2009 in connection with its presentation at the Piper Jaffray
Healthcare Conference in New York.
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
October 29 through November 5 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 333891.
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 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 or prosthetic pulmonary valves. The Company's
CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair
or reconstruction of the right ventricular outflow tract (RVOT), which is a
surgery commonly performed in children with congenital heart defects, such as
Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG
is distributed in three anatomic configurations: pulmonary hemi-artery,
pulmonary trunk, and pulmonary branch. 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's BioFoam® Surgical Matrix is CE marked in the
European Community for use as an adjunct in the sealing of abdominal
parenchymal tissues (liver and spleen) when cessation of bleeding by ligature
or other conventional methods is ineffective or impractical. 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 development of our SynerGraft and BioGlue and related
product platforms 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, the CryoPatch SG 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 economic crisis and future economic crises 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, Medafor may in the future attempt to terminate
our distribution agreement, 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 foreign revenues, 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
10Q filing for the quarter ended June 30, 2009, our Form 10-Q to be filed for
the quarter ended September 30, 2009, and the Company's other SEC filings.
The Company does not undertake to update its forward-looking statements.
Media Contact
D. Ashley Lee
Executive Vice President, Chief Financial Officer and
Chief Operating Officer
Phone: 770-419-3355
CRYOLIFE, INC. AND SUBSIDIARIES
Financial Highlights
(In thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2009 2008 2009 2008
---- ---- ---- ----
(Unaudited) (Unaudited)
Revenues:
Preservation services $15,033 $14,188 $42,672 $41,337
Products 12,806 12,239 39,669 37,499
Other 380 377 729 691
--- --- --- ---
Total revenues 28,219 26,804 83,070 79,527
------ ------ ------ ------
Cost of preservation services
and products:
Preservation services 8,903 7,615 24,421 22,382
Products 2,275 2,028 6,478 5,860
----- ----- ----- -----
Total cost of preservation
services and products 11,178 9,643 30,899 28,242
------ ----- ------ ------
Gross margin 17,041 17,161 52,171 51,285
------ ------ ------ ------
Operating expenses:
General, administrative, and
marketing 12,386 12,072 37,440 36,497
Research and development 1,461 1,186 3,854 3,938
----- ----- ----- -----
Total operating expenses 13,847 13,258 41,294 40,435
------ ------ ------ ------
Operating income 3,194 3,903 10,877 10,850
----- ----- ------ ------
Interest expense 58 62 168 201
Interest income (10) (92) (73) (285)
Other expense, net 8 142 100 115
- --- --- ---
Income before income taxes 3,138 3,791 10,682 10,819
Income tax expense 1,276 235 4,369 610
----- --- ----- ---
Net income $1,862 $3,556 $6,313 $10,209
====== ====== ====== =======
Income per common share:
Basic $0.07 $0.13 $0.22 $0.37
===== ===== ===== =====
Diluted $0.07 $0.12 $0.22 $0.36
===== ===== ===== =====
Weighted average common shares
outstanding:
Basic 28,145 27,899 28,074 27,741
Diluted 28,382 28,703 28,261 28,384
CRYOLIFE, INC. AND SUBSIDIARIES
Financial Highlights
(In thousands)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2009 2008 2009 2008
---- ---- ---- ----
(Unaudited) (Unaudited)
Preservation services:
Cardiac tissue $7,315 $7,034 $19,377 $19,620
Vascular tissue 7,699 7,116 23,147 21,055
Orthopaedic tissue 19 38 148 662
-- -- --- ---
Total preservation services 15,033 14,188 42,672 41,337
------ ------ ------ ------
Products:
BioGlue and related products 11,180 11,623 35,323 36,482
HemoStase 1,562 549 4,139 726
Other medical devices 64 67 207 291
-- -- --- ---
Total products 12,806 12,239 39,669 37,499
------ ------ ------ ------
Other 380 377 729 691
--- --- --- ---
Total revenues $28,219 $26,804 $83,070 $79,527
======= ======= ======= =======
Revenues:
U.S. $23,941 $22,916 $70,264 $67,750
International 4,278 3,888 12,806 11,777
----- ----- ------ ------
Total revenues $28,219 $26,804 $83,070 $79,527
======= ======= ======= =======
September 30, December 31,
2009 2008
---- ----
(Unaudited)
Cash and cash equivalents and restricted
securities $27,046 $17,763
Receivables, net 15,293 13,999
Deferred preservation costs 36,737 34,913
Inventories 6,462 7,077
Restricted money market funds, long-term 5,000 5,000
Total assets 133,299 125,995
Shareholders' equity 108,260 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 Nine Months Ended
September 30, September 30,
------------- -------------
2009 2008 2009 2008
---- ---- ---- ----
Income before income taxes $3,138 $3,791 $10,682 $10,819
Income tax expense 1,276 235 4,369 610
----- --- ----- ---
Net income $1,862 $3,556 $6,313 $10,209
====== ====== ====== =======
Income per common share:
Basic $0.07 $0.13 $0.22 $0.37
===== ===== ===== =====
Diluted $0.07 $0.12 $0.22 $0.36
===== ===== ===== =====
Weighted average common shares
outstanding:
Basic 28,145 27,899 28,074 27,741
Diluted 28,382 28,703 28,261 28,384
Net income $3,556 $10,209
Non-GAAP adjustments to net income:
Tax calculated at 41% of income
before income taxes 1,554 4,436
Less income tax expense, as reported (235) (610)
----- -----
Additional income tax expense, non-GAAP 1,319 3,826
----- -----
Net income, non-GAAP $2,237 $6,383
====== ======
Income per common share, non-GAAP:
Basic $0.08 $0.23
===== =====
Diluted $0.08 $0.22
===== =====
Weighted average common shares
outstanding:
Basic 27,899 27,741
Diluted 28,703 28,384
For additional information about the company, visit CryoLife's Web site:
www.cryolife.com.
SOURCE CryoLife, Inc.
D. Ashley Lee, Executive Vice President, Chief Financial Officer and Chief
Operating Officer, +1-770-419-3355
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