EX-99.1 2 cry-20200430xex99_1.htm EX-99.1 2020.5.1 8K EXH 99.1 - Q1 2020 PR

Exhibit 99.1

 

CRY-Tag-Logo-Black-Transparent

Picture 2



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

Greg Chodaczek / Lynn Lewis

Phone:  347-620-7010

investors@cryolife.com



CryoLife Reports First Quarter 2020 Financial Results



First Quarter and Recent Business Highlights:

·

Achieved total revenues of $66.4 million in the first quarter 2020 versus preliminary first quarter 2020 revenues of $65.5 million

o

Total revenues decreased 2% and decreased 1% on a constant currency basis versus first quarter 2019

o

Excluding TMR, total revenues increased 1% and increased 2% on a constant currency basis versus first quarter of 2019

·

Received CE Mark for our Frozen Elephant Trunk E-vita OPEN NEO

·

Received renewed CE Mark status for our AAP Ascending Aortic Prosthesis

·

Secured Credit Facility Covenant Modification to Enhance Liquidity



ATLANTA, GA – (April 30, 2020) – 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, 2020. 



"During these challenging times, we are focused on protecting our employees’ health and safety while continuing to supply our customers and patients who depend on our life saving and life sustaining products," commented Pat Mackin, Chairman, President, and Chief Executive Officer.  "Our business is well suited to weather the impact of this global pandemic given the nature of the procedures in which our products are used.  Our manufacturing facilities have been running at near capacity and our supply chain remained largely intact.  We have continued to fund R&D programs related to products that could deliver revenue in 2021 and 2022, including our U.S. PerClot PMA, BioGlue China and PROACT Mitral.  Further, we renegotiated our Credit Facility covenant to have greater financial flexibility, if necessary.  Given our recent device approvals, and the ongoing progress made on our key growth initiatives, we expect 2021 to be a strong year for CryoLife.”



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First Quarter 2020 Financial Results

Total revenues for the first quarter of 2020 were $66.4 million, reflecting a decrease of  (2%), and (1%) on a non-GAAP constant currency basis, both compared to the first quarter of 2019.  Growth in tissue processing and On-X revenues was offset by decreases in BioGlue and JOTEC revenues. 



Net loss for the first quarter of 2020 was ($6.7) million, or ($0.18) per fully diluted common share, compared to a net loss of ($297,000), or ($0.01) per fully diluted common share for the first quarter of 2019.  Non-GAAP net loss for the first quarter of 2020 was ($3.0) million, or ($0.08) per fully diluted common share, compared to non-GAAP net income of $1.5 million, or $0.04 per fully diluted common share for the first quarter of 2019.  Net loss on both a GAAP and non-GAAP basis reflects a $3.7 million pretax loss primarily related to non-cash unrealized foreign currency losses on intercompany payable balances.



2020 Financial Outlook 

As previously reported on April 1, 2020, the Company has withdrawn its 2020 financial guidance due to uncertainties resulting from the COVID-19 pandemic.



All numbers are presented on a GAAP basis except where expressly referenced as non-GAAP.  The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort.  These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP.



The Company's financial performance for 2020 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 and integration expenses, amortization expense, inventory basis step-up expense, loss on foreign currency revaluation, stock-based compensation expense, and corporate rebranding expenses.  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

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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 30, 2020 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 7, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13702193.



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.  Such forward-looking statements reflect the views of management at the time such statements are made.  These statements include our beliefs that our business is well suited to weather the impact of  the COVID-19 pandemic given the nature of the procedures in which our products are used; that we are funding R&D programs for products that could deliver revenue in 2021 and 2022, including our U.S. PerClot PMA, BioGlue China, and PROACT Mitral; that the renegotiation of our Credit Facility covenant will give us greater financial flexibility, if necessary; and that we expect 2021 to be a strong year 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.  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, 2019.  CryoLife does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

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CryoLife, Inc. and Subsidiaries

Financial Highlights

(In thousands, except per share data)









 

 

 

 

 



Three Months Ended



March 31,



 

2020

 

 

2019

Revenues:

 

 

 

 

 

Products

$

46,420 

 

$

48,401 

Preservation services

 

20,009 

 

 

19,104 

Total revenues

 

66,429 

 

 

67,505 



 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

Products

 

13,040 

 

 

13,826 

Preservation services

 

9,218 

 

 

9,406 

Total cost of products and preservation services

 

22,258 

 

 

23,232 



 

 

 

 

 

Gross margin

 

44,171 

 

 

44,273 



 

 

 

 

 

Operating expenses:

 

 

 

 

 

General, administrative, and marketing

 

39,002 

 

 

36,520 

Research and development

 

6,356 

 

 

5,548 

Total operating expenses

 

45,358 

 

 

42,068 



 

 

 

 

 

Operating (loss) income

 

(1,187)

 

 

2,205 



 

 

 

 

 

Interest expense

 

3,388 

 

 

3,894 

Interest income

 

(102)

 

 

(116)

Other expense, net

 

3,662 

 

 

77 



 

 

 

 

 

Loss before income taxes

 

(8,135)

 

 

(1,650)

Income tax benefit

 

(1,470)

 

 

(1,353)



 

 

 

 

 

Net loss

$

(6,665)

 

$

(297)



 

 

 

 

 

Loss per common share:

 

 

 

 

 

Basic

$

(0.18)

 

$

(0.01)

Diluted

$

(0.18)

 

$

(0.01)



 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

Basic

 

37,390 

 

 

36,778 

Diluted

 

37,390 

 

 

36,778 



 

 

 

 

 

Net loss

$

(6,665)

 

$

(297)

Other comprehensive loss:

 

 

 

 

 

Foreign currency translation adjustments

 

(4,463)

 

 

(3,781)

Comprehensive loss

$

(11,128)

 

$

(4,078)



 

 

 

 

 



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CryoLife, Inc. and Subsidiaries

Financial Highlights

 (In thousands)









 

 

 

 

 



(Unaudited)



Three Months Ended



March 31,



2020

 

2019

Products:

 

 

 

 

 

BioGlue

$

16,737 

 

$

17,222 

JOTEC

 

15,268 

 

 

15,954 

On-X

 

12,202 

 

 

11,731 

PhotoFix

 

1,042 

 

 

730 

PerClot

 

860 

 

 

1,050 

NEXUS

 

200 

 

 

--

CardioGenesis cardiac laser therapy

 

111 

 

 

1,714 

         Total products

 

46,420 

 

 

48,401 



 

 

 

 

 

Preservation services:

 

 

 

 

 

Cardiac tissue

$

10,033 

 

$

8,930 

Vascular tissue

 

9,976 

 

 

10,174 

Total preservation services

 

20,009 

 

 

19,104 



 

 

 

 

 

Total revenues

$

66,429 

 

$

67,505 



 

 

 

 

 

Revenues:

 

 

 

 

 

U.S.

$

36,447 

 

$

37,325 

International

 

29,982 

 

 

30,180 

Total revenues

$

66,429 

 

$

67,505 







 

 

 

 

 



(Unaudited)

 

 

 



March 31,

 

December 31,



2020

 

2019

Cash, cash equivalents, and restricted securities

$

63,877 

 

$

34,294 

Total current assets

 

214,082 

 

 

187,390 

Total assets

 

621,033 

 

 

605,654 

Total current liabilities

 

43,685 

 

 

45,195 

Total liabilities

 

344,424 

 

 

319,958 

Shareholders’ equity

 

276,609 

 

 

285,696 



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CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Net Loss and Diluted (Loss) Income Per Common Share

(In thousands, except per share data)









 

 

 

 

 



(Unaudited)



Three Months Ended



March 31,



 

2020

 

 

2019

GAAP:

 

 

 

 

 

Loss before income taxes

$

(8,135)

 

$

(1,650)

Income tax benefit

 

(1,470)

 

 

(1,353)

Net loss

$

(6,665)

 

$

(297)



 

 

 

 

 

Diluted loss per common share:

$

(0.18)

 

$

(0.01)



 

 

 

 

 

Reconciliation of loss before income taxes,

 

 

 

 

 

GAAP to adjusted net (loss) income, non-GAAP

 

 

 

 

 

Loss before income taxes, GAAP

$

(8,135)

 

$

(1,650)

Adjustments:

 

 

 

 

 

Amortization expense

 

3,033 

 

 

2,579 

Business development and integration expenses

 

823 

 

 

1,109 

Corporate rebranding

 

321 

 

 

--

Adjusted (loss) income before income taxes,

 

 

 

 

 

non-GAAP

 

(3,958)

 

 

2,038 

Income tax expense calculated at a

 

 

 

 

 

pro forma tax rate of 25%

 

(989)

 

 

510 

Adjusted net (loss) income, non-GAAP

$

(2,969)

 

$

1,528 



 

 

 

 

 

Reconciliation of diluted loss per common share, GAAP

 

 

 

 

 

to adjusted diluted (loss) income per common share, non-GAAP:

 

 

 

 

 

Diluted loss per common share, GAAP:

$

(0.18)

 

$

(0.01)

Adjustments:

 

 

 

 

 

Amortization expense

 

0.08 

 

 

0.07 

Business development and integration expenses

 

0.02 

 

 

0.03 

Corporate rebranding

 

0.01 

 

 

--

Tax effect of non-GAAP adjustments

 

(0.03)

 

 

(0.03)

Effect of 25% pro forma tax rate

 

0.02 

 

 

(0.02)

Adjusted diluted (loss) income per common share,

 

 

 

 

 

non-GAAP:

$

(0.08)

 

$

0.04 



 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

shares outstanding

 

37,390 

 

 

37,711 

 











 







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CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Revenues

(In thousands, except per share data)







 

 

 

 

 

 



(Unaudited)



Three Months Ended



March 31,



2020

 

2019

Growth Rate

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

Total revenues, GAAP

$

66,429 

 

$

67,505 

-2%

Impact of changes in currency exchange

 

--

 

 

(629)

 

Total constant currency revenues, non-GAAP

$

66,429 

 

$

66,876 

-1%



 

 

 

 

 

 

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

Total revenues, GAAP

$

66,429 

 

$

67,505 

-2%

Less CardioGenesis cardiac laser therapy

 

(111)

 

 

(1,714)

 

Total GAAP revenues excluding
CardioGenesis

 

66,318 

 

 

65,791 

1%

Impact of changes in currency exchange

 

--

 

 

(629)

 

Total constant currency revenues excluding
CardioGenesis, non-GAAP

$

66,318 

 

$

65,162 

2%



 

 

 

 

 

 

Reconciliation of total BioGlue revenues, GAAP to

 

 

 

 

 

 

total BioGlue revenues, non-GAAP:

 

 

 

 

 

 

Total BioGlue revenues, GAAP

$

16,737 

 

$

17,222 

-3%

Impact of changes in currency exchange

 

--

 

 

(76)

 

Total constant currency BioGlue revenues, non-GAAP

$

16,737 

 

$

17,146 

-2%



 

 

 

 

 

 

Reconciliation of total On-X revenues, GAAP to

 

 

 

 

 

 

total On-X revenues, non-GAAP:

 

 

 

 

 

 

Total On-X revenues, GAAP

$

12,202 

 

$

11,731 

4%

Impact of changes in currency exchange

 

--

 

 

(17)

 

Total constant currency On-X revenues, non-GAAP

$

12,202 

 

$

11,714 

4%



 

 

 

 

 

 

Reconciliation of total JOTEC revenues, GAAP, to

 

 

 

 

 

 

total JOTEC revenues, non-GAAP:

 

 

 

 

 

 

Total JOTEC revenues, GAAP

$

15,268 

 

$

15,954 

-4%

Impact of changes in currency exchange

 

--

 

 

(534)

 

Total constant currency JOTEC revenues, non-GAAP

$

15,268 

 

$

15,420 

-1%



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CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Adjusted EBITDA

(In thousands, except per share data)











 

 

 

 

 



(Unaudited)



Three Months Ended



March 31,



2020

 

2019

Reconciliation of net loss, GAAP to

 

 

 

 

 

adjusted EBITDA, non-GAAP:

 

 

 

 

 

Net loss, GAAP

$

(6,665)

 

$

(297)

Adjustments:

 

 

 

 

 

Depreciation and amortization expense

 

4,898 

 

 

4,350 

Loss on foreign currency revaluation

 

3,663 

 

 

74 

Interest expense

 

3,388 

 

 

3,894 

Stock-based compensation expense

 

2,564 

 

 

1,853 

Business development and integration expenses

 

823 

 

 

1,109 

Corporate rebranding

 

321 

 

 

--

Interest income

 

(102)

 

 

(116)

Income tax benefit

 

(1,470)

 

 

(1,353)

Adjusted EBITDA, non-GAAP

$

7,420 

 

$

9,514 









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