First Quarter and Recent Business Highlights:
- Achieved revenue of $83.2 million
in the first quarter of 2023 versus $77.2
million in the first quarter of 2022, an increase of 8% on a
GAAP basis and an increase of 10% on a non-GAAP constant currency
basis
- On-X revenues increased 23% on a GAAP basis and 24% on a
non-GAAP constant currency basis in the first quarter of 2023
compared to the first quarter of 2022
- Aortic stent graft revenues increased 3% on a GAAP basis and 8%
on a non-GAAP constant currency basis in the first quarter of 2023
compared to the first quarter of 2022
- Received notice from the FDA that the PerClot PMA is approvable
subject to finalization of the Establishment Inspection Report
(EIR) for our recent pre-approval inspection
ATLANTA, May 4, 2023
/PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading
cardiac and vascular surgery company focused on aortic disease,
today announced its financial results for the first quarter ended
March 31, 2023.
"I am pleased with our first quarter results, as we delivered
constant currency revenue growth of 10% year-over-year and remain
on track to achieve or exceed the revenue and EBITDA growth targets
for 2023 and beyond that we outlined last year. Our strong
performance was driven by year-over-year On-X revenue growth of 24%
and aortic stent graft revenue growth of 8%, with BioGlue also
growing 8%, and tissue processing revenue growing 7%, all on a
constant currency basis. We also saw Asia
Pacific and Latin American revenue grow 18% and 34%,
respectively, on a constant currency basis compared to last year,"
said Pat Mackin, Chairman,
President, and Chief Executive Officer.
Mr. Mackin added, "In addition to our strong financial
performance, we recently received an Approvable Letter from the FDA
for the PerClot PMA and expect approval after the report for our
recent pre-approval inspection is finalized. Following this
approval, we will receive a $14.3 million
dollar milestone payment, net of amounts owed to our former
partner, and begin shipping revenue generating PerClot product to
Baxter. Meanwhile, our recent hires at our German manufacturing
facility continue to ramp up their productivity, better positioning
the Company to meet the robust demand for our stent grafts. We are
also pleased to report that patient enrollment for the PERSEVERE
trial evaluating AMDS, a simple, elegant stent graft solution to
treat aortic arch disease, remains on track. Finally, we remain
confident in our ability to grow our total addressable market by
developing our pipeline and expanding our presence into new markets
and within our existing markets."
Mr. Mackin concluded, "We believe we remain well on track to
meet our 2024 year-end commitments to deliver double-digit
compounded annual constant currency revenue growth and achieve
adjusted EBITDA in excess of $75.0
million."
First Quarter 2023 Financial Results
Total revenues
for the first quarter of 2023 were $83.2
million, an increase of 8% on a GAAP basis and an increase
of 10% on a non-GAAP constant currency basis, both compared to the
first quarter of 2022.
Net loss for the first quarter of 2023 was ($13.5) million, or ($0.33) per fully diluted common share, compared
to net loss of ($3.4) million, or
($0.08) per fully diluted common
share for the first quarter of 2022. Net loss for the first quarter
of 2023 includes a pretax charge of $4.8
million related to contingent consideration for the
acquisition of AMDS. Non-GAAP net income for the first quarter of
2023 was $769,000, or $0.02 per fully diluted common share, compared to
non-GAAP net income of $1.1 million,
or $0.03 per fully diluted common
share for the first quarter of 2022.
2023 Financial Outlook
Artivion is raising its revenue
guidance range and now expects constant currency revenue growth of
between 9% and 12%, compared to the previous range of between 8%
and 12%, for the full year 2023 compared to 2022. The Company
expects revenues to be in a range of between $337.0 million and $348.0
million, compared to the previous range of between
$331.0 million and $343.0 million.
Additionally, Artivion expects adjusted EBITDA, as reported, to
increase greater than 25% in 2023 compared to 2022, resulting in
adjusted EBITDA in excess of $52.0
million in 2023, compared to its previous guidance of
adjusted EBITDA in excess of $50.0
million.
The Company's financial performance for 2023 and future periods
is subject to the risks identified below.
Non-GAAP Financial Measures
This press release
contains non-GAAP financial measures, including non-GAAP revenue,
non-GAAP net income, non-GAAP EBITDA, and non-GAAP general,
administrative, and marketing expenses. Investors should consider
this non-GAAP information in addition to, and not as a substitute
for, financial measures prepared in accordance with US GAAP. In
addition, this non-GAAP financial information may not be the same
as similar measures presented by other companies. The Company's
non-GAAP revenues are adjusted for the impact of changes in
currency exchange. The Company's non-GAAP net income; non-GAAP
EBITDA; and non-GAAP general, administrative, and marketing results
exclude (as applicable) depreciation and amortization expense;
interest income and expense; stock-based compensation expense; loss
or gain on foreign currency revaluation; clinical trial termination
expense; income tax expense or benefit; corporate rebranding
expense; business development, integration, and severance income or
expense; non-cash interest expense; and gain from sale of
non-financial assets. The Company generally uses non-GAAP financial
measures to facilitate management's review of the operational
performance of the company and as a basis for strategic planning.
Company management believes that these non-GAAP presentations
provide useful information to investors regarding unusual
non-operating transactions; the operating expense structure of the
Company's existing and recently acquired operations, without regard
to its on-going efforts to acquire additional complementary
products and businesses, and the transaction and integration
expenses incurred in connection with recently acquired and divested
product lines; and the operating expense structure excluding
fluctuations resulting from foreign currency revaluation and
stock-based compensation expense. The Company believes it is useful
to exclude certain expenses because such amounts in any specific
period may not directly correlate to the underlying performance of
its business operations or can vary significantly between periods
as a result of factors such as impact of recent acquisitions,
non-cash expense related to amortization of previously acquired
tangible and intangible assets, and any related adjustments to
their carrying values. The Company has adjusted for the impact of
changes in currency exchange from certain revenues to evaluate
comparable product growth rates on a constant currency basis. The
Company does, however, expect to incur similar types of expenses
and currency exchange impacts in the future, and this non-GAAP
financial information should not be viewed as a statement or
indication that these types of expenses will not recur. Company
management encourages investors to review the Company's
consolidated financial statements and publicly filed reports in
their entirety, including the reconciliation of GAAP to non-GAAP
financial measures."
Webcast and Conference Call Information
The Company
will hold a teleconference call and live webcast later today,
May 4, 2023, at 4:30 p.m. ET to discuss the results, followed by
a question and answer session. To participate in the conference
call dial 862-298-0702 a few minutes prior to 4:30 p.m. ET. The teleconference replay will be
available approximately one hour following the completion of the
event and can be accessed by calling (toll free) 877-660-6853 or
201-612-7415. The conference number for the replay is 13737780.
The live webcast and replay can be accessed by going to the
Investors section of the Artivion website at www.Artivion.com and
selecting the heading Webcasts & Presentations.
About Artivion, Inc.
Headquartered in suburban
Atlanta, Georgia, Artivion, Inc.
is a medical device company focused on developing simple, elegant
solutions that address cardiac and vascular surgeons' most
difficult challenges in treating patients with aortic diseases.
Artivion's four major groups of products include: aortic stent
grafts, surgical sealants, On-X mechanical heart valves, and
implantable cardiac and vascular human tissues. Artivion markets
and sells products in more than 100 countries worldwide. For
additional information about Artivion, visit our website,
www.artivion.com.
Forward Looking Statements
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. Such forward-looking statements reflect the
views of management at the time such statements are made. These
statements include our beliefs that we will be better positioned to
meet the robust demand for our stent grafts by the enhanced
productivity of our larger German production staff; we remain
confident in our ability to grow our total addressable market by
developing our pipeline and expanding our presence into new markets
and within our existing markets; and we remain well on track to
meet our 2024 year-end commitments to deliver double-digit
compounded annual constant currency revenue growth and achieve
adjusted EBITDA in excess of $75.0
million." These forward-looking statements are subject to a
number of risks, uncertainties, estimates, and assumptions that may
cause actual results to differ materially from current
expectations, including that the benefits anticipated from the
Ascyrus Medical LLC transaction and Endospan agreements may not be
achieved at all or at the levels we had originally anticipated; the
benefits anticipated from our clinical trials may not be achieved
or achieved on our anticipated timeline; our products may not be
able to consistently retain their existing regulatory approvals or
special regulatory approvals in order to be commercialized;
products in our pipeline may not receive regulatory approval at all
or receive regulatory approval on our anticipated timelines; our
products that obtain regulatory approval may not be adopted by the
market as much as we anticipate or at all; and the continued
effects of pandemics, including COVID-19 and new COVID-19 variants,
and continued hospital staffing shortages could adversely impact
our results. These risks and uncertainties include the risk factors
detailed in our Securities and Exchange Commission filings,
including our Form 10-K for the year ended December 31, 2022 and our Form 10-Q for the
quarter ended March 31, 2023.
Artivion does not undertake to update its forward-looking
statements, whether as a result of new information, future events,
or otherwise.
Artivion, Inc. and
Subsidiaries Condensed Consolidated Statements of
Operations and Comprehensive Loss In Thousands, Except
Per Share Data (Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2023
|
|
2022
|
Revenues:
|
|
|
|
Products
|
$
62,291
|
|
$
57,542
|
Preservation
services
|
20,938
|
|
19,671
|
Total
revenues
|
83,229
|
|
77,213
|
|
|
|
|
Cost of products and
preservation services:
|
|
|
|
Products
|
19,533
|
|
17,408
|
Preservation
services
|
9,969
|
|
9,086
|
Total cost of
products and preservation services
|
29,502
|
|
26,494
|
|
|
|
|
Gross
margin
|
53,727
|
|
50,719
|
|
|
|
|
Operating
expenses:
|
|
|
|
General,
administrative, and marketing
|
50,365
|
|
38,955
|
Research and
development
|
7,223
|
|
10,128
|
Total operating
expenses
|
57,588
|
|
49,083
|
|
|
|
|
Operating (loss)
income
|
(3,861)
|
|
1,636
|
|
|
|
|
Interest
expense
|
6,096
|
|
3,948
|
Interest
income
|
(75)
|
|
(16)
|
Other (income) expense,
net
|
(963)
|
|
133
|
|
|
|
|
Loss before income
taxes
|
(8,919)
|
|
(2,429)
|
Income tax
expense
|
4,613
|
|
960
|
|
|
|
|
Net
loss
|
$
(13,532)
|
|
$
(3,389)
|
|
|
|
|
Loss per
share:
|
|
|
|
Basic
|
$
(0.33)
|
|
$
(0.08)
|
Diluted
|
$
(0.33)
|
|
$
(0.08)
|
|
|
|
|
Weighted-average
common shares outstanding:
|
|
|
|
Basic
|
40,432
|
|
39,850
|
Diluted
|
40,432
|
|
39,850
|
|
|
|
|
Net
loss
|
$
(13,532)
|
|
$
(3,389)
|
Other comprehensive
loss:
|
|
|
|
Foreign currency
translation adjustments
|
3,616
|
|
(3,775)
|
Comprehensive
loss
|
$
(9,916)
|
|
$
(7,164)
|
Artivion, Inc. and
Subsidiaries Condensed Consolidated Balance
Sheets In Thousands
|
|
|
|
|
|
|
March 31,
2023
|
|
December 31,
2022
|
|
(Unaudited)
|
|
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
30,773
|
|
$
39,351
|
Trade receivables,
net
|
62,760
|
|
61,820
|
Other
receivables
|
3,952
|
|
7,764
|
Inventories,
net
|
76,273
|
|
74,478
|
Deferred preservation
costs, net
|
47,415
|
|
46,371
|
Prepaid expenses and
other
|
19,508
|
|
17,550
|
Total current
assets
|
240,681
|
|
247,334
|
|
|
|
|
Goodwill
|
245,648
|
|
243,631
|
Acquired technology,
net
|
149,833
|
|
151,263
|
Operating lease
right-of-use assets, net
|
41,473
|
|
41,859
|
Property and equipment,
net
|
38,716
|
|
38,674
|
Other intangibles,
net
|
30,807
|
|
31,384
|
Deferred income
taxes
|
2,373
|
|
1,314
|
Other assets
|
7,542
|
|
7,339
|
Total
assets
|
$
757,073
|
|
$
762,798
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
9,473
|
|
$
12,004
|
Accrued
expenses
|
9,678
|
|
12,374
|
Accrued
compensation
|
9,028
|
|
13,810
|
Taxes
payable
|
6,911
|
|
2,635
|
Current maturities of
operating leases
|
3,398
|
|
3,308
|
Accrued procurement
fees
|
2,155
|
|
2,111
|
Current portion of
long-term debt
|
1,620
|
|
1,608
|
Other
liabilities
|
1,698
|
|
1,825
|
Total current
liabilities
|
43,961
|
|
49,675
|
|
|
|
|
Long-term
debt
|
306,279
|
|
306,499
|
Contingent
consideration
|
45,200
|
|
40,400
|
Non-current maturities
of operating leases
|
40,774
|
|
41,257
|
Deferred income
taxes
|
23,826
|
|
24,499
|
Deferred compensation
liability
|
6,127
|
|
5,468
|
Non-current finance
lease obligation
|
3,582
|
|
3,644
|
Other
liabilities
|
7,407
|
|
7,027
|
Total
liabilities
|
$
477,156
|
|
$
478,469
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Shareholders'
equity:
|
|
|
|
Preferred
stock
|
—
|
|
—
|
Common stock (75,000
shares authorized, 42,366 and 41,830 shares issued and outstanding
in
2023 and 2022, respectively)
|
424
|
|
418
|
Additional paid-in
capital
|
342,883
|
|
337,385
|
Retained
deficit
|
(30,749)
|
|
(17,217)
|
Accumulated other
comprehensive loss
|
(17,993)
|
|
(21,609)
|
Treasury stock, at
cost, 1,487 shares as of March 31, 2023 and December 31,
2022
|
(14,648)
|
|
(14,648)
|
Total shareholders'
equity
|
279,917
|
|
284,329
|
|
|
|
|
Total liabilities
and shareholders' equity
|
$
757,073
|
|
$
762,798
|
Artivion, Inc. and
Subsidiaries Condensed Consolidated Statement of Cash
Flows In Thousands (Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2023
|
|
2022
|
Net cash flows from
operating activities:
|
|
|
|
Net loss
|
$
(13,532)
|
|
$
(3,389)
|
|
|
|
|
Adjustments to
reconcile net loss to net cash from operating
activities:
|
|
|
|
Depreciation and
amortization
|
5,734
|
|
5,881
|
Change in fair value
of contingent consideration
|
4,800
|
|
(1,800)
|
Non-cash
compensation
|
3,341
|
|
3,166
|
Non-cash lease
expense
|
1,802
|
|
1,920
|
Write-down of
inventories and deferred preservation costs
|
1,123
|
|
989
|
Deferred income
taxes
|
(2,167)
|
|
(2,966)
|
Other
|
754
|
|
496
|
Changes in operating
assets and liabilities:
|
|
|
|
Receivables
|
3,540
|
|
(1,710)
|
Prepaid expenses and
other assets
|
(2,014)
|
|
1,494
|
Inventories and
deferred preservation costs
|
(3,222)
|
|
(1,359)
|
Accounts payable,
accrued expenses, and other liabilities
|
(6,313)
|
|
(3,320)
|
Net cash flows used
in operating activities
|
(6,154)
|
|
(598)
|
|
|
|
|
Net cash flows from
investing activities:
|
|
|
|
Capital
expenditures
|
(2,238)
|
|
(2,239)
|
Acquisition of
intangible assets
|
(605)
|
|
(469)
|
Net cash flows used
in investing activities
|
(2,843)
|
|
(2,708)
|
|
|
|
|
Net cash flows from
financing activities:
|
|
|
|
Proceeds from exercise
of stock options and issuance of common stock
|
2,581
|
|
2,318
|
Redemption and
repurchase of stock to cover tax withholdings
|
(590)
|
|
(1,730)
|
Repayment of term
loan
|
(690)
|
|
(694)
|
Other
|
(130)
|
|
(129)
|
Net cash flows
provided by (used in) financing activities
|
1,171
|
|
(235)
|
|
|
|
|
Effect of exchange rate
changes on cash and cash equivalents
|
(752)
|
|
(61)
|
Decrease in cash and
cash equivalents
|
(8,578)
|
|
(3,602)
|
|
|
|
|
Cash and cash
equivalents beginning of period
|
39,351
|
|
55,010
|
Cash and cash
equivalents end of period
|
$
30,773
|
|
$
51,408
|
Artivion, Inc. and
Subsidiaries Financial
Highlights In Thousands (Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2023
|
|
2022
|
Products:
|
|
|
|
Aortic stent
grafts
|
$
26,150
|
|
$
25,506
|
On-X
|
17,656
|
|
14,371
|
Surgical
sealants
|
16,703
|
|
15,681
|
Other
|
1,782
|
|
1,984
|
Total
products
|
62,291
|
|
57,542
|
|
|
|
|
Preservation
services
|
20,938
|
|
19,671
|
Total
revenues
|
$
83,229
|
|
$
77,213
|
|
|
|
|
Revenues:
|
|
|
|
US
|
$
41,333
|
|
$
37,735
|
International
|
41,896
|
|
39,478
|
Total
revenues
|
$
83,229
|
|
$
77,213
|
Artivion, Inc. and
Subsidiaries Reconciliation of GAAP to
Non-GAAP Revenues and General, Administrative, and
Marketing Expense In Thousands
(Unaudited)
|
|
|
Revenues for
the
Three Months Ended
March 31,
|
|
Percent
Change
From Prior
Year
|
|
2023
|
|
2022
|
|
|
US
GAAP
|
|
US
GAAP
|
|
Exchange
rate effect
|
|
Constant
Currency
|
|
Constant
Currency
|
Products:
|
|
|
|
|
|
|
|
|
|
Aortic stent
grafts
|
$
26,150
|
|
$
25,506
|
|
$
(1,238)
|
|
$
24,268
|
|
8 %
|
On-X
|
17,656
|
|
14,371
|
|
(146)
|
|
14,225
|
|
24 %
|
Surgical
sealants
|
16,703
|
|
15,681
|
|
(286)
|
|
15,395
|
|
8 %
|
Other
|
1,782
|
|
1,984
|
|
(15)
|
|
1,969
|
|
-9 %
|
Total
products
|
62,291
|
|
57,542
|
|
(1,685)
|
|
55,857
|
|
12 %
|
|
|
|
|
|
|
|
|
|
|
Preservation
services
|
20,938
|
|
19,671
|
|
(35)
|
|
19,636
|
|
7 %
|
Total
|
$
83,229
|
|
$
77,213
|
|
$
(1,720)
|
|
$
75,493
|
|
10 %
|
|
Three Months
Ended
March 31,
|
|
2023
|
|
2022
|
Reconciliation of
G&A expense, GAAP to adjusted G&A,
non-GAAP:
|
|
|
|
General,
administrative, and marketing expense, GAAP
|
$
50,365
|
|
$
38,955
|
Business
development, integration, and severance expense (income)
|
4,997
|
|
(1,579)
|
Corporate
rebranding expense
|
149
|
|
883
|
Adjusted G&A,
non-GAAP
|
$
45,219
|
|
$
39,651
|
Artivion, Inc. and
Subsidiaries Reconciliation of GAAP to
Non-GAAP Adjusted
EBITDA In Thousands (Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2023
|
|
2022
|
Reconciliation of
net loss, GAAP to adjusted EBITDA, non-GAAP:
|
|
|
|
Net loss,
GAAP
|
$
(13,532)
|
|
$
(3,389)
|
Adjustments:
|
|
|
|
Interest
expense
|
6,096
|
|
3,948
|
Depreciation and
amortization expense
|
5,734
|
|
5,881
|
Business
development, integration, and severance expense (income)
|
5,452
|
|
(1,579)
|
Income tax
expense
|
4,613
|
|
960
|
Stock-based
compensation expense
|
3,341
|
|
3,166
|
Corporate rebranding
expense
|
149
|
|
883
|
Interest
income
|
(75)
|
|
(16)
|
(Gain) loss on foreign
currency revaluation
|
(973)
|
|
133
|
Adjusted EBITDA,
non-GAAP
|
$
10,805
|
|
$
9,987
|
Artivion Inc.
and Subsidiaries Reconciliation of GAAP to
Non-GAAP Net Income and Diluted Income Per Common
Share In Thousands, Except Per Share
Data (Unaudited)
|
|
|
Three Months
Ended
March 31,
|
|
2023
|
|
2022
|
GAAP:
|
|
|
|
Loss before income
taxes
|
$
(8,919)
|
|
$
(2,429)
|
Income tax
expense
|
4,613
|
|
960
|
Net
loss
|
$
(13,532)
|
|
$
(3,389)
|
|
|
|
|
Diluted loss per
common share
|
$
(0.33)
|
|
$
(0.08)
|
|
|
|
|
Diluted
weighted-average common shares outstanding
|
40,432
|
|
39,850
|
|
|
|
|
Reconciliation of
loss before income taxes, GAAP to adjusted income,
non-GAAP:
|
|
|
|
Loss before income
taxes, GAAP:
|
$
(8,919)
|
|
$
(2,429)
|
Adjustments:
|
|
|
|
Business development,
integration, and severance expense (income)
|
5,452
|
|
(1,579)
|
Amortization
expense
|
3,881
|
|
4,084
|
Non-cash interest
expense
|
462
|
|
456
|
Corporate rebranding
expense
|
149
|
|
883
|
Adjusted income
before income taxes, non-GAAP
|
1,025
|
|
1,415
|
|
|
|
|
Income tax expense
calculated at a tax rate of 25%
|
256
|
|
354
|
Adjusted net
income, non-GAAP
|
$
769
|
|
$
1,061
|
|
|
|
|
Reconciliation of
diluted loss per common share, GAAP to adjusted diluted income
per
common share, non-GAAP:
|
|
|
|
Diluted loss per
common share, GAAP:
|
$
(0.33)
|
|
$
(0.08)
|
Adjustments:
|
|
|
|
Effect of 25% tax
rate
|
0.17
|
|
0.04
|
Business development,
integration, and severance expense (income)
|
0.13
|
|
(0.04)
|
Amortization
expense
|
0.10
|
|
0.10
|
Non-cash interest
expense
|
0.01
|
|
0.01
|
Corporate rebranding
expense
|
—
|
|
0.02
|
Tax effect of non-GAAP
adjustments
|
(0.06)
|
|
(0.02)
|
Adjusted diluted
income per common share, non-GAAP
|
$
0.02
|
|
$
0.03
|
|
|
|
|
Reconciliation of
diluted weighted-average common shares outstanding GAAP to
diluted
weighted-average common shares outstanding,
non-GAAP:
|
|
|
|
Diluted
weighted-average common shares outstanding, GAAP:
|
40,432
|
|
39,850
|
Adjustments:
|
|
|
|
Effect of dilutive
stock options and awards
|
418
|
|
441
|
Diluted
weighted-average common shares outstanding, non-GAAP
|
40,850
|
|
40,291
|
Contacts:
Artivion
|
Gilmartin Group
LLC
|
D. Ashley
Lee
|
Brian Johnston / Lynn
Lewis
|
Executive Vice
President &
|
Phone:
332-895-3222
|
Chief Financial
Officer
|
investors@artivion.com
|
Phone:
770-419-3355
|
|
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SOURCE Artivion, Inc.