Attached files

file filename
8-K - 8-K - CRYOLIFE INCcry-20210211x8k.htm

Exhibit 99.1

 

CRY-Tag-Logo-Black-Transparent

Picture 2



FOR IMMEDIATE RELEASE



Contacts:





 

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 Fourth Quarter and Full Year 2020 Financial Results



Fourth Quarter and Recent Business Highlights:

·

Achieved total revenues of $67.9 million in the fourth quarter 2020 versus $69.7 million in the fourth quarter of 2019

o

Total revenues decreased 3% on a GAAP basis and 5%  on a non-GAAP proforma constant currency basis versus fourth quarter 2019

o

Excluding TMR, fourth quarter revenues decreased 2% on a non-GAAP proforma basis and 3% on a non-GAAP proforma constant currency basis versus fourth quarter 2019

·

Achieved net loss of ($3.5) million, or ($0.09) per share

·

Achieved non-GAAP net income of $7.9 million, or $0.20 per share 



ATLANTA, GA – (February 11, 2021) – CryoLife, Inc. (NYSE: CRY),  a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the fourth quarter and full year ended December 31, 2020. 



“Despite the ongoing impact of COVID-19 on our business, we were able to generate solid quarterly results and advance our key operational goals.  We completed the integration of Ascyrus, launched our newest JOTEC products, and made good progress on enrollment in our PROACT Xa clinical trial,” commented Pat Mackin, Chairman, President, and Chief Executive Officer.  Additionally, our manufacturing facilities continued to run at near capacity and our supply chain remains largely intact.    We  also continued to invest in our commercial channels and R&D programs related to products that we believe will deliver revenue in 2021 and 2022, including our regulatory approvals for U.S. PerClot, BioGlue China and PROACT Mitral.  We also progressed in our efforts to obtain regulatory approval for Ascyrus in the US and other countries.  These fundamental drivers, combined with declining COVID-19 infection rates and accelerating vaccination programs in various regions around the world, make us optimistic that the second half of 2021 should be the start of a  prolonged period of growth for CryoLife.”



Page 1 of 8

 


 

Fourth Quarter 2020 Financial Results

Total revenues for the fourth quarter of 2020 were $67.9 million, reflecting a decrease of 3% on a GAAP basis and a decrease of 5% on a non-GAAP proforma constant currency basis, both compared to the fourth quarter of 2019.  Revenue performance across all product lines reflected the impact of the COVID-19 pandemic on the number of procedures using our products.



Net loss for the fourth quarter of 2020 was $(3.5) million, or $(0.09) per fully diluted common share, compared to net loss of ($0.7) million, or ($0.02) per fully diluted common share for the fourth quarter of 2019.  Non-GAAP net income for the fourth quarter of 2020 was $7.9 million, or $0.20 per fully diluted common share, compared to non-GAAP net income of $4.2 million, or $0.11 per fully diluted common share for the fourth quarter of 2019.  Loss for the fourth quarter of 2020 includes pretax expense of $4.8 million of business development costs primarily related to the Ascyrus acquisition, partially offset by pretax benefit of  $1.2 million resulting from a change in the Company’s paid time off policy and a non-cash pretax benefit of $3.0 million related to the reversal of performance-based stock compensation because financial targets were not met due to the impact of COVID-19.



Full Year 2020 Financial Results

Total revenues for 2020 were $253.2 million, reflecting a decrease of 8% on both a GAAP and non-GAAP proforma constant currency basis, both compared to the full year of 2019.  Revenue performance across all product lines reflected the impact of the COVID-19 pandemic on the number of procedures using our products.



Net loss for 2020 was ($16.7) million, or ($0.44) per fully diluted common share, compared to net income of $1.7 million, or $0.05 per fully diluted common share for the full year of 2019.  Non-GAAP net income for the full year of 2020 was $9.7 million, or $0.25 per fully diluted common share, compared to non-GAAP net income of $12.9 million, or $0.34 per fully diluted common share for the full year of 2019.  Loss for the full year of 2020 includes pretax expense of $12.3 million of business development costs primarily related to the Ascyrus and Endospan transactions, partially offset by pretax benefit of $1.2 million resulting from a change in the Company’s paid time off policy and a non-cash pretax benefit of $3.0 million related to the reversal of performance-based stock compensation because financial targets were not met due to the impact of COVID-19.



The independent registered public accounting firm's audit report with respect to the Company's fiscal year-end financial statements will not be issued until the Company completes its annual report on Form 10-K.  Accordingly, the financial results reported in this earnings release are preliminary pending completion of the audit.



2021 Financial Outlook 

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



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



Page 2 of 8

 


 

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, February 11, 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 February 18, 2021 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13715710.



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



Page 3 of 8

 


 

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 foreword-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, despite the ongoing impact of COVID-19 on our business, we were able to generate solid quarterly results, advance on our key operational goals, and make good progress on enrollment in our PROACT Xa clinical trial; our R&D programs in which we continued to invest in 2020, such as U.S. PerClot, BioGlue China and PROACT Mitral, will deliver revenue in 2021 and 2022, and our fundamental drivers, combined with declining COVID-19 infection rates and accelerating vaccination programs in various regions around the world, starting in the second half of 2021, should lead to 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 may not be achieved and the continued effects of COVID-19 and government mandates implemented to address 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.

Page 4 of 8

 


 





CryoLife, Inc. and Subsidiaries

Financial Highlights

(In thousands, except per share data)









 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

 



Three Months Ended

 

Twelve Months Ended



December 31,

 

December 31,



 

2020

 

 

2019

 

 

2020

 

 

2019

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

50,502 

 

$

50,193 

 

$

179,299 

 

$

197,246 

Preservation services

 

17,394 

 

 

19,504 

 

 

73,928 

 

 

78,976 

Total revenues

 

67,896 

 

 

69,697 

 

 

253,227 

 

 

276,222 



 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

14,050 

 

 

14,001 

 

 

50,128 

 

 

55,022 

Preservation services

 

9,255 

 

 

9,144 

 

 

35,315 

 

 

38,187 

Total cost of products and preservation services

 

23,305 

 

 

23,145 

 

 

85,443 

 

 

93,209 



 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

44,591 

 

 

46,552 

 

 

167,784 

 

 

183,013 



 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

36,103 

 

 

37,609 

 

 

141,136 

 

 

143,011 

Research and development

 

6,574 

 

 

5,312 

 

 

24,207 

 

 

22,960 

Total operating expenses

 

42,677 

 

 

42,921 

 

 

165,343 

 

 

165,971 



 

 

 

 

 

 

 

 

 

 

 

Operating income

 

1,914 

 

 

3,631 

 

 

2,441 

 

 

17,042 



 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

4,718 

 

 

3,626 

 

 

16,698 

 

 

14,886 

Interest income

 

(36)

 

 

(130)

 

 

(217)

 

 

(738)

Other (income) expense, net

 

(2,676)

 

 

(1,412)

 

 

3,134 

 

 

1,250 



 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes

 

(92)

 

 

1,547 

 

 

(17,174)

 

 

1,644 

Income tax expense (benefit)

 

3,366 

 

 

2,228 

 

 

(492)

 

 

(76)



 

 

 

 

 

 

 

 

 

 

 

Net (loss) income

$

(3,458)

 

$

(681)

 

$

(16,682)

 

$

1,720 



 

 

 

 

 

 

 

 

 

 

 

(Loss) income per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.09)

 

 

(0.02)

 

$

(0.44)

 

$

0.05 

Diluted

$

(0.09)

 

 

(0.02)

 

$

(0.44)

 

$

0.05 



 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

38,613 

 

 

37,274 

 

 

37,861 

 

 

37,118 

Diluted

 

38,613 

 

 

37,274 

 

 

37,861 

 

 

37,860 



Page 5 of 8

 


 









CryoLife, Inc. and Subsidiaries

Financial Highlights

(In thousands)









 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Twelve Months Ended



December 31,

 

December 31,



2020

 

2019

 

2020

 

2019

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue

$

17,083 

 

$

17,777 

 

$

62,068 

 

$

68,611 

Aortic stents and stent grafts

 

17,731 

 

 

16,038 

 

 

61,663 

 

 

64,974 

On-X

 

13,668 

 

 

13,345 

 

 

48,053 

 

 

50,096 

PhotoFix

 

1,113 

 

 

1,002 

 

 

4,169 

 

 

3,754 

PerClot

 

801 

 

 

981 

 

 

2,882 

 

 

3,795 

CardioGenesis cardiac laser therapy

 

106 

 

 

1,050 

 

 

464 

 

 

6,016 

         Total products

 

50,502 

 

 

50,193 

 

 

179,299 

 

 

197,246 



 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

9,135 

 

 

10,145 

 

$

37,893 

 

$

40,879 

Vascular tissue

 

8,195 

 

 

9,359 

 

 

35,852 

 

 

38,097 

NeoPatch

 

64 

 

 

--

 

 

183 

 

 

--

Total preservation services

 

17,394 

 

 

19,504 

 

 

73,928 

 

 

78,976 



 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

67,896 

 

$

69,697 

 

$

253,227 

 

$

276,222 



 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

U.S.

$

35,103 

 

$

37,005 

 

$

138,274 

 

$

150,553 

International

 

32,793 

 

 

32,692 

 

 

114,953 

 

 

125,669 

Total revenues

$

67,896 

 

$

69,697 

 

$

253,227 

 

$

276,222 







 

 

 

 

 



 

 

 

 



December 31,

 

December 31,



2020

 

2019

Cash, cash equivalents, and restricted securities

$

61,958 

 

$

34,294 

Total current assets

 

234,589 

 

 

187,390 

Total assets

 

789,404 

 

 

605,654 

Total current liabilities

 

60,468 

 

 

45,195 

Total liabilities

 

460,691 

 

 

319,958 

Shareholders’ equity

 

328,713 

 

 

285,696 



Page 6 of 8

 


 









CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

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

(In thousands, except per share data)







 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Twelve Months Ended



December 31,

 

December 31,



 

2020

 

 

2019

 

 

2020

 

 

2019

GAAP:

 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes

$

(92)

 

$

1,547 

 

$

(17,174)

 

$

1,644 

Income tax expense (benefit)

 

3,366 

 

 

2,228 

 

 

(492)

 

 

(76)

Net (loss) income

$

(3,458)

 

$

(681)

 

$

(16,682)

 

$

1,720 



 

 

 

 

 

 

 

 

 

 

 

Diluted (loss) income per common share:

$

(0.09)

 

$

(0.02)

 

$

(0.44)

 

$

0.05 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

38,613 

 

 

37,274 

 

 

37,861 

 

 

37,860 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of (loss) income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

GAAP to adjusted net income, non-GAAP

 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes, GAAP

$

(92)

 

$

1,547 

 

$

(17,174)

 

$

1,644 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development, integration, and severance expense

 

4,839 

 

 

526 

 

 

12,320 

 

 

3,088 

Amortization expense

 

4,334 

 

 

3,054 

 

 

13,764 

 

 

10,850 

Non-cash interest expense

 

1,395 

 

 

406 

 

 

3,656 

 

 

1,631 

Corporate rebranding expense

 

15 

 

 

--

 

 

336 

 

 

--

Adjusted income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

 

10,491 

 

 

5,533 

 

 

12,902 

 

 

17,213 



 

 

 

 

 

 

 

 

 

 

 

Income tax expense calculated at a

 

 

 

 

 

 

 

 

 

 

 

pro forma tax rate of 25%

 

2,623 

 

 

1,383 

 

 

3,226 

 

 

4,303 

Adjusted net income, non-GAAP

$

7,868 

 

$

4,150 

 

$

9,676 

 

$

12,910 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of diluted (loss) income per common share, GAAP

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

Diluted (loss) income per common share, GAAP:

$

(0.09)

 

$

(0.02)

 

$

(0.44)

 

$

0.05 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development, integration, and severance expense

 

0.12 

 

 

0.02 

 

 

0.32 

 

 

0.08 

Amortization expense

 

0.11 

 

 

0.08 

 

 

0.36 

 

 

0.28 

Non-cash interest expense

 

0.04 

 

 

0.01 

 

 

0.09 

 

 

0.04 

Effect of 25% pro forma tax rate

 

0.09 

 

 

0.05 

 

 

0.10 

 

 

(0.01)

Corporate rebranding expense

 

--

 

 

--

 

 

0.01 

 

 

--

Tax effect of non-GAAP adjustments

 

(0.07)

 

 

(0.03)

 

 

(0.19)

 

 

(0.10)

Adjusted diluted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

0.20 

 

$

0.11 

 

$

0.25 

 

$

0.34 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

39,100 

 

 

37,914 

 

 

38,369 

 

 

37,860 

Page 7 of 8

 


 



CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Revenues and Adjusted EBITDA

(In thousands, except per share data)







 

 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Twelve Months Ended



December 31,

 

December 31,



2020

 

2019

Growth Rate

 

2020

 

2019

Growth Rate

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

67,896 

 

$

69,697 

-3%

 

$

253,227 

 

$

276,222 

-8%

Including AMDS prior to acquisition  

 

--

 

 

547 

 

 

 

2,088 

 

 

2,339 

 

Total GAAP revenues including
AMDS

 

67,896 

 

 

70,244 

-3%

 

 

255,315 

 

 

278,561 

-8%

Impact of changes in currency exchange

 

--

 

 

1,024 

 

 

 

--

 

 

(708)

 

Total constant currency revenues including
AMDS, non-GAAP

$

67,896 

 

$

71,268 

-5%

 

$

255,315 

 

$

277,853 

-8%



 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

67,896 

 

$

69,697 

-3%

 

$

253,227 

 

$

276,222 

-8%

Including AMDS prior to acquisition  

 

--

 

 

547 

 

 

 

2,088 

 

 

2,339 

 

Excluding CardioGenesis cardiac laser therapy

 

(106)

 

 

(1,050)

 

 

 

(464)

 

 

(6,016)

 

Total GAAP revenues including
AMDS and excluding CardioGenesis

 

67,790 

 

 

69,194 

-2%

 

 

254,851 

 

 

272,545 

-6%

Impact of changes in currency exchange

 

--

 

 

1,024 

 

 

 

--

 

 

(708)

 

Total constant currency revenues including
AMDS and excluding CardioGenesis, non-GAAP

$

67,790 

 

$

70,218 

-3%

 

$

254,851 

 

$

271,837 

-6%







 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

 

(Unaudited)



Three Months Ended

 

 

Twelve Months Ended



December 31,

 

 

December 31,



2020

 

2019

 

 

2020

 

2019

Reconciliation of net (loss) income, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

adjusted EBITDA, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income, GAAP

$

(3,458)

 

$

(681)

 

 

$

(16,682)

 

$

1,720 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

5,894 

 

 

5,060 

 

 

 

20,712 

 

 

18,317 

Interest expense

 

4,718 

 

 

3,626 

 

 

 

16,698 

 

 

14,886 

Business development, integration, and severance expense

 

4,839 

 

 

526 

 

 

 

12,320 

 

 

3,088 

Stock-based compensation expense

 

(520)

 

 

2,218 

 

 

 

6,912 

 

 

8,799 

Corporate rebranding expense

 

15 

 

 

--

 

 

 

336 

 

 

--

Interest income

 

(36)

 

 

(130)

 

 

 

(217)

 

 

(738)

Income tax expense (benefit)

 

3,366 

 

 

2,228 

 

 

 

(492)

 

 

(76)

(Income) loss on foreign currency revaluation

 

(2,688)

 

 

(1,437)

 

 

 

(1,829)

 

 

1,232 

Adjusted EBITDA, non-GAAP

$

12,130 

 

$

11,410 

 

 

$

37,758 

 

$

47,228 







Page 8 of 8