CRYOLIFE INC - FORM 8-K - EX-99.1

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8-K - 8-K - CRYOLIFE INC	cry-20210429x8k.htm

Exhibit 99.1

CRY-Tag-Logo-Black-Transparent

FOR IMMEDIATE RELEASE

Contacts:

Phone: 770-419-3355

/ Lynn Lewis

CryoLife

D. Ashley Lee

Executive Vice President, Chief Financial Officer and

Chief Operating Officer

Phone: 770-419-3355

Gilmartin Group LLC

Brian Johnston / Lynn Lewis

Phone: 631-807-1986

investors@cryolife.com

CryoLife Reports First Quarter 2021 Financial Results

First Quarter and Recent Business Highlights:

Achieved total revenues of $71.1 million in the first quarter 2021 versus $66.4 million in the first quarter of 2020, an increase of 7% on a GAAP basis and 3% on a non-GAAP proforma constant currency basis

Net loss was ($3.1) million, or ($0.08) per share, in the first quarter of 2021

Non-GAAP net income was $1.4 million, or $0.03 per share, in the first quarter of 2021

ATLANTA, GA – (April 29, 2021) – CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the first quarter ended March 31, 2021.

“Despite the ongoing impact of COVID-19 on our business, we saw our business return to growth on both a GAAP and proforma constant currency basis in the first quarter. Growth was driven by our new product launches outside of the U.S., a recovery in procedure volume in the U.S., an improved JOTEC inventory position, and our international expansion efforts, evidenced by double digit revenue growth in both Asia and Europe,” commented Pat Mackin, Chairman, President, and Chief Executive Officer.

“Additionally, we made progress on our regulatory strategy and are on-track to file PMAs for PerClot and PROACT Mitral later in 2021, which should help drive growth in 2022 and 2023. We also made solid progress on enrollment in our PROACT Xa clinical trial and advanced R&D programs that should deliver additional growth opportunities beginning in 2024. We are optimistic that the second half of 2021 will be the start of a prolonged period of growth for CryoLife.”

First Quarter 2021 Financial Results

Total revenues for the first quarter of 2021 were $71.1 million, reflecting an increase of 7% on a GAAP basis and 3% on a non-GAAP proforma constant currency basis, both compared to the first quarter of 2020.

Net loss for the first quarter of 2021 was $(3.1) million, or $(0.08) per fully diluted common share, compared to net loss of ($6.7) million, or ($0.18) per fully diluted common share for the first quarter of 2020. Non-GAAP net income for the first quarter of 2021 was $1.4 million, or $0.03 per fully diluted common share, compared to non-GAAP net loss of ($2.7) million, or ($0.07) per fully diluted common share for the first quarter of 2020.

The financial results reported in this earnings release are preliminary pending the Company’s filing of its quarterly report on Form 10-Q, which it expects to file on April 30, 2021.

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2021 Financial Outlook

Due to continued uncertainties resulting from the COVID-19 global pandemic, particularly in Europe, the Company is not issuing full year 2021 financial guidance at this time.

The Company's financial performance for 2021 is subject to the risks identified below.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures. Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. 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 net income and non-GAAP EBITDA results exclude (as applicable) business development, integration, and severance expense; depreciation and amortization expense; interest income and expense; non-cash interest expense; loss on foreign currency revaluation; stock-based compensation expense; corporate rebranding expense; and income tax expense (benefit). The Company 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 acquisitions, or non-cash expense related to amortization of previously acquired tangible and intangible assets. The Company has excluded the impact of changes in currency exchange from certain revenues to evaluate 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.

Webcast and Conference Call Information

The Company will hold a teleconference call and live webcast later today, April 29, 2021 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To listen to the live teleconference, please dial 201-689-8261. A replay of the teleconference will be available through May 6, 2021 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13718912.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.

About CryoLife, Inc.

Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. CryoLife markets and sells products in more than 100 countries worldwide. For additional information about CryoLife, visit our website, www.cryolife.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. Readers are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date of this press release and reflect the view of management as of the date of this press release. Such forward-looking statements reflect the views of management at the time such statements are made. These statements include our beliefs that our PMAs for PerClot and PROACT Mitral, if approved, should help drive our growth in 2022 and 2023; our PROACT Xa clinical trial and advanced R&D programs, if

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successful, should deliver additional growth opportunities for us beginning in 2024; and the second half of 2021 will be the start of a prolonged period of growth for CryoLife. 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 distribution agreement may not be achieved and the continued effects of COVID-19, including decelerating vaccination or vaccine adoption rates, or government mandates implemented to address the effects of the pandemic 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 year ended December 31, 2020. CryoLife does not assume any obligation, and expressly disclaims any duty to update any of its forward-looking statements, whether as a result of new information, future events, or otherwise.

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CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

(Unaudited)



	Three Months Ended
	March 31,
		2021		2020
Revenues:
Products	$	53,345	$	46,420
Preservation services		17,742		20,009
Total revenues		71,087		66,429

Cost of products and preservation services:
Products		14,911		13,040
Preservation services		8,338		9,218
Total cost of products and preservation services		23,249		22,258

Gross margin		47,838		44,171

Operating expenses:
General, administrative, and marketing		38,638		39,002
Research and development		7,754		6,356
Total operating expenses		46,392		45,358

Operating income (loss)		1,446		(1,187)

Interest expense		4,040		3,388
Interest income		(24)		(102)
Other expense, net		1,931		3,662

Loss before income taxes		(4,501)		(8,135)
Income tax benefit		(1,363)		(1,470)

Net loss	$	(3,138)	$	(6,665)

Loss per common share:
Basic	$	(0.08)	$	(0.18)
Diluted	$	(0.08)	$	(0.18)

Weighted-average common shares outstanding:
Basic		38,738		37,390
Diluted		38,738		37,390

Net loss	$	(3,138)	$	(6,665)
Other comprehensive loss:
Foreign currency translation adjustments		(10,290)		(4,463)
Comprehensive loss	$	(13,428)	$	(11,128)

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CryoLife, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands)


	March 31,		December 31,
	2021		2020
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	56,552	$	61,412
Restricted securities		550		546
Trade receivables, net		48,320		45,964
Other receivables		2,416		2,788
Inventories		73,375		73,038
Deferred preservation costs		39,250		36,546
Prepaid expenses and other		15,220		14,295
Total current assets		235,683		234,589

Goodwill		253,950		260,061
Acquired technology, net		178,964		186,091
Other intangibles, net		39,274		40,966
Operating lease right-of-use assets, net		39,073		18,571
Property and equipment, net		31,497		33,077
Deferred income taxes		1,657		1,446
Other assets		14,734		14,603
Total assets	$	794,832	$	789,404

LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Current portion of contingent consideration	$	16,800	$	16,430
Accrued compensation		10,644		10,192
Accounts payable		8,952		9,623
Accrued expenses		8,564		7,472
Accrued procurement fees		3,402		3,619
Current maturities of operating leases		1,548		5,763
Current portion of long-term debt		1,174		1,195
Taxes payable		3,229		2,808
Other liabilities		3,705		3,366
Total current liabilities		58,018		60,468

Long-term debt		310,058		290,468
Contingent consideration		44,100		43,500
Non-current maturities of operating leases		38,441		14,034
Deferred income taxes		29,272		34,713
Deferred compensation liability		5,436		5,518
Other liabilities		12,176		11,990
Total liabilities	$	497,501	$	460,691

Commitments and contingencies

Shareholders' equity:
Preferred stock		--		--
Common stock (issued shares of 40,585 in 2021 and 40,394 in 2020)		406		404
Additional paid-in capital		301,449		316,192
Retained earnings		13,671		20,022
Accumulated other comprehensive (loss) income		(3,547)		6,743
Treasury stock, at cost, 1,487 shares as of March 31, 2021 and December 31, 2020, respectively		(14,648)		(14,648)
Total shareholders' equity		297,331		328,713

Total liabilities and shareholders' equity	$	794,832	$	789,404

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CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statement of Cash Flows

(In thousands)

(Unaudited)


	Three Months Ended
	March 31,
		2021		2020
Net cash flows from operating activities:
Net loss	$	(3,138)	$	(6,665)

Adjustments to reconcile net loss to net cash from operating activities:
Depreciation and amortization		6,006		4,898
Non-cash compensation		2,480		2,564
Non-cash lease expense		1,758		1,746
Write-down of inventories and deferred preservation costs		1,274		720
Change in fair value of contingent consideration		970		--
Deferred income taxes		(4,241)		(265)
Other		787		461
Changes in operating assets and liabilities:
Accounts payable, accrued expenses, and other liabilities		1,590		(2,489)
Prepaid expenses and other assets		(1,291)		982
Receivables		(3,301)		3,557
Inventories and deferred preservation costs		(5,933)		(2,874)
Net cash flows (used in) provided by operating activities		(3,039)		2,635

Net cash flows from investing activities:
Capital expenditures		(1,502)		(2,539)
Other		692		(364)
Net cash flows used in investing activities		(810)		(2,903)

Net cash flows from financing activities:
Proceeds from revolving line of credit		--		30,000
Proceeds from exercise of stock options and issuance of common stock		861		1,064
Redemption and repurchase of stock to cover tax withholdings		(1,813)		(1,712)
Repayment of debt		(701)		(691)
Other		(442)		(146)
Net cash flows (used in) provided by financing activities		(2,095)		28,515

Effect of exchange rate changes on cash, cash equivalents, and restricted securities		1,088		1,336
(Decrease) increase in cash, cash equivalents, and restricted securities		(4,856)		29,583

Cash, cash equivalents, and restricted securities beginning of period		61,958		34,294
Cash, cash equivalents, and restricted securities end of period	$	57,102	$	63,877

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CryoLife, Inc. and Subsidiaries

Financial Highlights

(In thousands)


	(Unaudited)
	Three Months Ended
	March 31,
	2021		2020
Products:
Aortic stents and stent grafts	$	20,205	$	15,468
Surgical sealants		17,828		16,737
On-X		13,095		12,202
Other		2,217		2,013
Total products		53,345		46,420

Preservation services		17,742		20,009
Total revenues	$	71,087	$	66,429

Revenues:
U.S.	$	36,318	$	36,447
International		34,769		29,982
Total revenues	$	71,087	$	66,429

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CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Revenues and Adjusted EBITDA

(In thousands, except per share data)


	(Unaudited)
	Three Months Ended
	March 31,
	2021		2020		Growth Rate
Reconciliation of total revenues, GAAP to
total revenues, non-GAAP:
Total revenues, GAAP	$	71,087	$	66,429	7%
Including AMDS prior to acquisition		--		698
Total GAAP revenues including AMDS		71,087		67,127	6%
Impact of changes in currency exchange		--		1,725
Total constant currency revenues including AMDS, non-GAAP	$	71,087	$	68,852	3%


	(Unaudited)
	Three Months Ended
	$
	2021		2020
Reconciliation of operating income (loss), GAAP to
adjusted operating income, non-GAAP:
Operating income (loss)	$	1,446	$	(1,187)
Amortization expense		4,260		3,033
Business development, integration, and severance expense		1,470		823
Adjusted operating income, non-GAAP	$	7,176	$	2,669


	(Unaudited)
	Three Months Ended
	March 31,
	2021		2020
Reconciliation of net loss, GAAP to
adjusted EBITDA, non-GAAP:
Net loss, GAAP	$	(3,138)	$	(6,665)
Adjustments:
Depreciation and amortization expense		6,006		4,898
Interest expense		4,040		3,388
Stock-based compensation expense		2,480		2,564
Loss on foreign currency revaluation		1,886		3,663
Business development, integration, and severance expense		1,470		823
Corporate rebranding expense		15		321
Interest income		(24)		(102)
Income tax benefit		(1,363)		(1,470)
Adjusted EBITDA, non-GAAP	$	11,372	$	7,420

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CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Net Income (Loss) and Diluted Income (Loss) Per Common Share

(In thousands, except per share data)


	(Unaudited)
	Three Months Ended
	March 31,
		2021		2020
GAAP:
Loss before income taxes	$	(4,501)	$	(8,135)
Income tax benefit		(1,363)		(1,470)
Net loss	$	(3,138)	$	(6,665)

Diluted loss per common share:	$	(0.08)	$	(0.18)

Diluted weighted-average common
shares outstanding		38,738		37,390

Reconciliation of loss before income taxes,
GAAP to adjusted income (loss), non-GAAP
Loss before income taxes, GAAP:	$	(4,501)	$	(8,135)
Adjustments:
Amortization expense		4,260		3,033
Business development, integration, and severance expense		1,470		823
Non-cash interest expense		568		405
Corporate rebranding expense		15		321
Adjusted income (loss) before income taxes,
non-GAAP		1,812		(3,553)

Income tax expense (benefit) calculated at a
pro forma tax rate of 25%		453		(888)
Adjusted net income (loss), non-GAAP	$	1,359	$	(2,665)

Reconciliation of diluted loss per common share, GAAP
to adjusted diluted income (loss) per common share, non-GAAP:
Diluted loss per common share, GAAP:	$	(0.08)	$	(0.18)
Adjustments:
Amortization expense		0.11		0.08
Business development, integration, and severance expense		0.04		0.02
Non-cash interest expense		0.01		0.01
Corporate rebranding expense		--		0.01
Tax effect of non-GAAP adjustments		(0.04)		(0.03)
Effect of 25% pro forma tax rate		(0.01)		0.02
Adjusted diluted income (loss) per common share,
non-GAAP	$	0.03	$	(0.07)

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:		38,738		37,390
Adjustments:
Stock options		326		--
Contingently returnable shares		289		--
Diluted weighted-average common shares outstanding, non-GAAP1		39,353		37,390
1- Diluted weighted-average common shares outstanding, non-GAAP does not include the dilutive impact of the Senior Convertible Notes

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