EX-99.1 2 cry-20200731xex99_1.htm EX-99.1 202051 8K EXH 991 - Q2 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

Brian Johnston / Lynn Lewis

Phone:  631-807-1986

investors@cryolife.com



CryoLife Reports Second Quarter 2020 Financial Results



Second Quarter and Recent Business Highlights:

·

Achieved total revenues of $53.8 million in the second quarter 2020 versus $71.1 million in the second quarter of 2019

o

Total revenues decreased 24% and decreased 23% on a non-GAAP constant currency basis versus second quarter 2019

·

Completed $100.0 million convertible debt financing for general corporate purposes, including the repayment of approximately $30.0 million outstanding under the revolving credit facility

·

Initiated enrollment in PROACT Xa clinical trial

·

Initiated limited market release of E-vita Open NEO and E-nside and limited relaunch of NEXUS™



ATLANTA, GA – (July 30, 2020) – CryoLife, Inc. (NYSE: CRY),  a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the second quarter ended June 30, 2020. 



“Despite the disruptions to our business from COVID-19, we posted a solid second quarter and advanced on several of our key initiatives.  We believe our business is weathering the pandemic well, as we believe the majority of products in our portfolio are used in procedures that cannot be postponed or delayed for long,” commented Pat Mackin, Chairman, President, and Chief Executive Officer.  "We saw an improvement in procedure volumes sequentially month to month from April to June with a corresponding increase in revenue growth over those months.  Our manufacturing facilities continue to run at near capacity and our supply chain remains largely intact.  We have continued to fund R&D programs related to products that we believe will deliver revenue in 2021 and 2022, including our regulatory approvals for U.S. PerClot PMA, BioGlue China and PROACT Mitral.  We initiated limited market releases for Evita Open NEO and E-nside, with E-nya anticipated to follow by October, and a limited relaunch of NEXUS.  We also initiated enrollment in our PROACT Xa clinical trial.  Lastly, we completed a $100.0 million convertible debt financing to use for general corporate purposes, including the repayment of our $30.0 million revolver draw down.  We have the financial strength to be opportunistic on the business development front.  Given these achievements in the second quarter, we anticipate continued momentum in the second half of 2020 and are optimistic that we will have a  strong 2021.”



Page 1 of 7

 


 

 

 

 

Second Quarter Financial Results

Total revenues for the second quarter of 2020 were $53.8 million, reflecting a decrease of (24%), and (23%) on a non-GAAP constant currency basis, both compared to the second quarter of 2019.  Decreases in all product lines reflect the impact of the COVID-19 pandemic on the number of procedures using our products.



Net loss for the second quarter of 2020 was ($3.7) million, or ($0.10) per fully diluted common share, compared to net income of $2.8 million, or $0.07 per fully diluted common share for the second quarter of 2019.  Non-GAAP net loss for the second quarter of 2020 was ($835,000), or ($0.02) per fully diluted common share, compared to non-GAAP net income of $4.1 million, or $0.11 per fully diluted common share for the second quarter of 2019. 



2020 Financial Outlook 

Due to uncertainties resulting from the COVID-19 pandemic, the Company is not issuing 2020 financial guidance at this time.



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 expense, severance expense, amortization expense, inventory basis step-up expense, loss on foreign currency revaluation, stock-based compensation expense, and corporate rebranding expense.  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.

Page 2 of 7

 


 

 

 

 

Webcast and Conference Call Information

The Company will hold a teleconference call and live webcast later today, July 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 August 6, 2020 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13706961.



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 us weathering the pandemic well; our belief that the majority of products in our portfolio are used in procedures that cannot be postponed or delayed for long; that we are continuing to fund R&D programs for products that will deliver revenue in 2021 and 2022, including our regulatory approvals for U.S. PerClot PMA, BioGlue China and PROACT Mitral; we will relaunch E-nya on a limited basis by October, 2020; we have the financial strength to be opportunistic on the business development front; and we will have continued momentum in the second half of 2020 and a strong 2021.  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 the continued effects of COVID-19 and government mandates implemented to address the pandemic.  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.

Page 3 of 7

 


 

 

 

 





CryoLife, Inc. and Subsidiaries

Financial Highlights

(In thousands, except per share data)









 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



 

2020

 

 

2019

 

 

2020

 

 

2019

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

37,268 

 

$

51,168 

 

$

83,688 

 

$

99,569 

Preservation services

 

16,503 

 

 

19,971 

 

 

36,512 

 

 

39,075 

Total revenues

 

53,771 

 

 

71,139 

 

 

120,200 

 

 

138,644 



 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

10,040 

 

 

14,489 

 

 

23,080 

 

 

28,315 

Preservation services

 

7,841 

 

 

9,684 

 

 

17,059 

 

 

19,090 

Total cost of products and preservation services

 

17,881 

 

 

24,173 

 

 

40,139 

 

 

47,405 



 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

35,890 

 

 

46,966 

 

 

80,061 

 

 

91,239 



 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

32,288 

 

 

34,623 

 

 

71,290 

 

 

71,143 

Research and development

 

5,522 

 

 

5,841 

 

 

11,878 

 

 

11,389 

Total operating expenses

 

37,810 

 

 

40,464 

 

 

83,168 

 

 

82,532 



 

 

 

 

 

 

 

 

 

 

 

Operating (loss) income

 

(1,920)

 

 

6,502 

 

 

(3,107)

 

 

8,707 



 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

3,652 

 

 

3,811 

 

 

7,040 

 

 

7,705 

Interest income

 

(66)

 

 

(233)

 

 

(168)

 

 

(349)

Other (income) expense, net

 

(740)

 

 

185 

 

 

2,922 

 

 

262 



 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes

 

(4,766)

 

 

2,739 

 

 

(12,901)

 

 

1,089 

Income tax benefit

 

(1,077)

 

 

(93)

 

 

(2,547)

 

 

(1,446)



 

 

 

 

 

 

 

 

 

 

 

Net (loss) income

$

(3,689)

 

$

2,832 

 

$

(10,354)

 

$

2,535 



 

 

 

 

 

 

 

 

 

 

 

(Loss) income per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.10)

 

$

0.08 

 

$

(0.27)

 

$

0.07 

Diluted

$

(0.10)

 

$

0.07 

 

$

(0.27)

 

$

0.07 



 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

37,520 

 

 

37,156 

 

 

37,455 

 

 

36,968 

Diluted

 

37,520 

 

 

37,838 

 

 

37,455 

 

 

37,789 



 

 

 

 

 

 

 

 

 

 

 

Net (loss) income

$

(3,689)

 

$

2,832 

 

$

(10,354)

 

$

2,535 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

4,434 

 

 

2,995 

 

 

(29)

 

 

(786)

Comprehensive income (loss)

$

745 

 

$

5,827 

 

$

(10,383)

 

$

1,749 







Page 4 of 7

 


 

 

 

 

CryoLife, Inc. and Subsidiaries

Financial Highlights

 (In thousands)









 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



2020

 

2019

 

2020

 

2019

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue

$

12,437 

 

$

17,933 

 

$

29,174 

 

$

35,155 

JOTEC

 

13,174 

 

 

17,208 

 

 

28,642 

 

 

33,162 

On-X

 

10,116 

 

 

12,410 

 

 

22,318 

 

 

24,141 

PhotoFix

 

880 

 

 

935 

 

 

1,922 

 

 

1,665 

PerClot

 

497 

 

 

784 

 

 

1,357 

 

 

1,834 

CardioGenesis cardiac laser therapy

 

164 

 

 

1,898 

 

 

275 

 

 

3,612 

         Total products

 

37,268 

 

 

51,168 

 

 

83,688 

 

 

99,569 



 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

$

8,061 

 

$

10,500 

 

 

18,079 

 

 

19,430 

Vascular tissue

 

8,396 

 

 

9,471 

 

 

18,372 

 

 

19,645 

NeoPatch

 

46 

 

 

--

 

 

61 

 

 

--

Total preservation services

 

16,503 

 

 

19,971 

 

 

36,512 

 

 

39,075 



 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

53,771 

 

$

71,139 

 

$

120,200 

 

$

138,644 



 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

U.S.

$

30,392 

 

$

38,239 

 

$

66,839 

 

$

75,563 

International

 

23,379 

 

 

32,900 

 

 

53,361 

 

 

63,081 

Total revenues

$

53,771 

 

$

71,139 

 

$

120,200 

 

$

138,644 







 

 

 

 

 



(Unaudited)

 

 

 



June 30,

 

December 31,



2020

 

2019

Cash, cash equivalents, and restricted securities

$

126,118 

 

$

34,294 

Total current assets

 

287,121 

 

 

187,390 

Total assets

 

693,254 

 

 

605,654 

Total current liabilities

 

48,933 

 

 

45,195 

Total liabilities

 

396,698 

 

 

319,958 

Shareholders’ equity

 

296,556 

 

 

285,696 



Page 5 of 7

 


 

 

 

 









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

 

Six Months Ended



June 30,

 

June 30,



 

2020

 

 

2019

 

 

2020

 

 

2019

GAAP:

 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes

$

(4,766)

 

$

2,739 

 

$

(12,901)

 

$

1,089 

Income tax benefit

 

(1,077)

 

 

(93)

 

 

(2,547)

 

 

(1,446)

Net (loss) income

$

(3,689)

 

$

2,832 

 

$

(10,354)

 

$

2,535 



 

 

 

 

 

 

 

 

 

 

 

Diluted (loss) income per common share

$

(0.10)

 

$

0.07 

 

$

(0.27)

 

$

0.07 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of (loss) income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes, GAAP:

$

(4,766)

 

$

2,739 

 

$

(12,901)

 

$

1,089 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Amortization expense

 

3,000 

 

 

2,557 

 

 

6,033 

 

 

5,136 

Business development, integration, and severance expense

 

653 

 

 

203 

 

 

1,476 

 

 

1,312 

Corporate rebranding expense

 

--

 

 

--

 

 

321 

 

 

--

Adjusted (loss) income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

 

(1,113)

 

 

5,499 

 

 

(5,071)

 

 

7,537 

Income tax (benefit) expense calculated at a

 

 

 

 

 

 

 

 

 

 

 

pro forma tax rate of 25%

 

(278)

 

 

1,375 

 

 

(1,268)

 

 

1,884 

Adjusted net (loss) income, non-GAAP

$

(835)

 

$

4,124 

 

$

(3,803)

 

$

5,653 



 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

Diluted (loss) income per common share, GAAP:

$

(0.10)

 

$

0.07 

 

$

(0.27)

 

$

0.07 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Amortization expense

 

0.08 

 

 

0.06 

 

 

0.16 

 

 

0.13 

Business development, integration, and severance expense

 

0.02 

 

 

--

 

 

0.04 

 

 

0.03 

Corporate rebranding expense

 

--

 

 

--

 

 

0.01 

 

 

--

Tax effect of non-GAAP adjustments

 

(0.02)

 

 

--

 

 

(0.05)

 

 

(0.03)

Effect of 25% pro forma tax rate

 

--

 

 

(0.02)

 

 

0.01 

 

 

(0.05)

Adjusted diluted (loss) income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

$

(0.02)

 

$

0.11 

 

$

(0.10)

 

$

0.15 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

37,520 

 

 

37,838 

 

 

37,455 

 

 

37,789 

 



Page 6 of 7

 


 

 

 

 

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

 

Six Months Ended



June 30,

 

June 30,



2020

 

2019

Growth Rate

 

2020

 

2019

Growth Rate

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

53,771 

 

$

71,139 

-24%

 

$

120,200 

 

$

138,644 

-13%

Impact of changes in currency exchange

 

--

 

 

(1,095)

 

 

 

--

 

 

(1,723)

 

Total constant currency revenues, non-GAAP

$

53,771 

 

$

70,044 

-23%

 

$

120,200 

 

$

136,921 

-12%



 

 

 

 

 

 

 

 

 

 

 

 

 













 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

 

(Unaudited)



Three Months Ended

 

 

Six Months Ended



June 30,

 

 

June 30,



2020

 

2019

 

 

2020

 

2019

Reconciliation of net (loss) income, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

adjusted EBITDA, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income, GAAP

$

(3,689)

 

$

2,832 

 

 

$

(10,354)

 

$

2,535 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

4,743 

 

 

4,381 

 

 

 

9,642 

 

 

8,731 

Interest expense

 

3,652 

 

 

3,811 

 

 

 

7,040 

 

 

7,705 

Stock-based compensation expense

 

2,510 

 

 

2,266 

 

 

 

5,074 

 

 

4,119 

Business development, integration, and severance expense

 

653 

 

 

203 

 

 

 

1,476 

 

 

1,312 

Corporate rebranding expense

 

--

 

 

--

 

 

 

321 

 

 

--

Interest income

 

(66)

 

 

(233)

 

 

 

(168)

 

 

(349)

(Income) loss on foreign currency revaluation

 

(744)

 

 

176 

 

 

 

2,919 

 

 

250 

Income tax benefit

 

(1,077)

 

 

(93)

 

 

 

(2,547)

 

 

(1,446)

Adjusted EBITDA, non-GAAP

$

5,982 

 

$

13,343 

 

 

$

13,403 

 

$

22,857 







Page 7 of 7