EX-99.1 2 cry-20191030xex99_1.htm EX-99.1 20191031 8K EXH 991 - Q3 2019 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:  646-924-1769

investors@cryolife.com



CryoLife Reports Third Quarter 2019 Financial Results



Third Quarter and Recent Business Highlights:

·

Total revenues were $67.9 million in the third quarter of 2019, reflecting year over year growth of 5% and a 6% increase on a non-GAAP constant currency basis, both compared to the third quarter of 2018

o

On-X® revenues increased 12%, and 12% on a non-GAAP constant currency basis, both compared to the third quarter of 2018

o

JOTEC® revenues increased 5%, and 9% on a non-GAAP constant currency basis, both compared to the third quarter of 2018 

·

Net loss was ($134,000), or $0.00 per fully diluted common share; non-GAAP net income was $2.2 million, or $0.06 per fully diluted common share



ATLANTA, GA – (October 30, 2019) – CryoLife, Inc. (NYSE: CRY),  a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the third quarter ended September 30, 2019. 



Our third quarter results were in line with our expectations, and through the first three quarters of 2019 we have delivered constant currency growth of 8% relative to the same period last year,” said Pat Mackin, Chairman, President, and Chief Executive Officer.  “The anticipated effects from continued currency headwinds and temporary issues with TMR handpiece supply in the US are causing us to lower our full year top line guidance.  We believe the upcoming launch of three next-generation JOTEC products in the EU combined with the recent addition of NEXUS, manufacturing improvements at JOTEC, and the anticipated commencement of the PROACT Xa trial position us well for 2020 and beyond.”    



Third Quarter 2019 Financial Results

Total revenues for the third quarter of 2019 were $67.9 million, reflecting growth of 5%, and 6% on a non-GAAP constant currency basis, both compared to the third quarter of 2018.  The increase was driven by revenue growth from On-X, JOTEC, and tissue processing. 

Page 1 of 8

 


 

 

Net loss for the third quarter of 2019 was ($134,000), or $0.00 per fully diluted common share, compared to a net income of $1.6 million, or $0.04 per fully diluted common share for the third quarter of 2018.  Net loss for the third quarter of 2019 includes $1.2 million in business development expenses.  Non-GAAP net income for the third quarter of 2019 was $2.2 million, or $0.06 per fully diluted common share, compared to non-GAAP net income of $3.1 million, or $0.08 per fully diluted common share for the third quarter of 2018. 



2019 Financial Outlook 

CryoLife expects total revenues for 2019 to be in the range of $276.5 million to $278.5 million.  This compares to the previous expected range of $280.0 million to $284.0 million for the year, with the change due to the effects of foreign currency and a lack of availability of TMR handpieces in the fourth quarter of 2019.  Non-GAAP earnings per share are still expected to be between $0.28 and $0.32 for the full year. 



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 guidance for 2019 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, and stock-based compensation 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 8

 


 

 

Webcast and Conference Call Information

The Company will hold a teleconference call and live webcast later today, October 30, 2019 at 5:30 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 November 6, 2019 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13695440.



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 revenue and non-GAAP earnings per share guidance, and our beliefs that the effects of our TMR handpiece supply in the US are temporary and that the upcoming launch in the EU of three of our next-generation JOTEC products, combined with the recent addition in the EU of NEXUS, manufacturing improvements at JOTEC, and anticipated commencement of the PROACT Xa trial position us well for 2020 and beyond.”    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, 2018.  CryoLife does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

 

 

Page 3 of 8

 


 

Exhibit 99.1

 



CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)









 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



 

2019

 

 

2018

 

 

2019

 

 

2018

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

47,484 

 

$

45,152 

 

$

147,053 

 

$

138,063 

Preservation services

 

20,397 

 

 

19,446 

 

 

59,472 

 

 

56,979 

Total revenues

 

67,881 

 

 

64,598 

 

 

206,525 

 

 

195,042 



 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

12,706 

 

 

12,459 

 

 

41,021 

 

 

40,166 

Preservation services

 

9,953 

 

 

9,425 

 

 

29,043 

 

 

27,083 

Total cost of products and preservation services

 

22,659 

 

 

21,884 

 

 

70,064 

 

 

67,249 



 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

45,222 

 

 

42,714 

 

 

136,461 

 

 

127,793 



 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

34,259 

 

 

32,871 

 

 

105,402 

 

 

104,946 

Research and development

 

6,259 

 

 

5,225 

 

 

17,648 

 

 

16,314 

Total operating expenses

 

40,518 

 

 

38,096 

 

 

123,050 

 

 

121,260 



 

 

 

 

 

 

 

 

 

 

 

Operating income

 

4,704 

 

 

4,618 

 

 

13,411 

 

 

6,533 



 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

3,555 

 

 

4,104 

 

 

11,260 

 

 

11,863 

Interest income

 

(259)

 

 

(52)

 

 

(608)

 

 

(141)

Other expense, net

 

2,400 

 

 

(1,542)

 

 

2,662 

 

 

(257)



 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes

 

(992)

 

 

2,108 

 

 

97 

 

 

(4,932)

Income tax (benefit) expense

 

(858)

 

 

543 

 

 

(2,304)

 

 

(2,868)



 

 

 

 

 

 

 

 

 

 

 

Net (loss) income

$

(134)

 

$

1,565 

 

$

2,401 

 

$

(2,064)



 

 

 

 

 

 

 

 

 

 

 

(Loss) income per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

0.00 

 

$

0.04 

 

$

0.06 

 

$

(0.06)

Diluted

$

0.00 

 

$

0.04 

 

$

0.06 

 

$

(0.06)



 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

37,255 

 

 

36,526 

 

 

37,065 

 

 

36,331 

Diluted

 

37,255 

 

 

37,610 

 

 

37,850 

 

 

36,331 



Page 4 of 8

 


 

 

CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)







 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



2019

 

2018

 

2019

 

2018

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue

$

15,679 

 

$

15,646 

 

$

50,834 

 

$

48,685 

JOTEC

 

15,774 

 

 

15,004 

 

 

48,936 

 

 

46,669 

On-X

 

12,610 

 

 

11,298 

 

 

36,751 

 

 

33,495 

CardioGenesis cardiac laser therapy

 

1,354 

 

 

1,590 

 

 

4,966 

 

 

4,514 

PerClot

 

980 

 

 

882 

 

 

2,814 

 

 

2,822 

PhotoFix

 

1,087 

 

 

732 

 

 

2,752 

 

 

1,878 

         Total products

 

47,484 

 

 

45,152 

 

 

147,053 

 

 

138,063 



 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

11,304 

 

 

9,502 

 

 

30,734 

 

 

26,660 

Vascular tissue

 

9,093 

 

 

9,944 

 

 

28,738 

 

 

30,319 

Total preservation services

 

20,397 

 

 

19,446 

 

 

59,472 

 

 

56,979 



 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

67,881 

 

$

64,598 

 

$

206,525 

 

$

195,042 



 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

U.S.

$

37,981 

 

$

36,516 

 

$

113,548 

 

$

108,123 

International

 

29,900 

 

 

28,082 

 

 

92,977 

 

 

86,919 

Total revenues

$

67,881 

 

$

64,598 

 

$

206,525 

 

$

195,042 







 

 

 

 

 



 

 

 

 

 



(Unaudited)

 

 

 



September 30,

 

December 31,



2019

 

2018

Cash, cash equivalents, and restricted securities

$

37,177 

 

$

42,236 

Total current assets

 

181,354 

 

 

179,168 

Total assets

 

592,602 

 

 

571,091 

Total current liabilities

 

42,190 

 

 

34,523 

Total liabilities

 

315,101 

 

 

296,024 

Shareholders’ equity

 

277,501 

 

 

275,067 



















 

Page 5 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

 

Nine Months Ended



September 30,

 

September 30,



 

2019

 

 

2018

 

 

2019

 

 

2018

GAAP:

 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes

$

(992)

 

$

2,108 

 

$

97 

 

$

(4,932)

Income tax (benefit) expense

 

(858)

 

 

543 

 

 

(2,304)

 

 

(2,868)

Net (loss) income

$

(134)

 

$

1,565 

 

$

2,401 

 

$

(2,064)



 

 

 

 

 

 

 

 

 

 

 

Diluted (loss) income per common share:

$

0.00 

 

$

0.04 

 

$

0.06 

 

$

(0.06)



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of (loss) income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

GAAP to adjusted net income, non-GAAP

 

 

 

 

 

 

 

 

 

 

 

(Loss) income before income taxes, GAAP

$

(992)

 

$

2,108 

 

$

97 

 

$

(4,932)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development and integration expenses

 

1,250 

 

 

1,917 

 

 

2,562 

 

 

6,933 

Amortization expense

 

2,660 

 

 

2,707 

 

 

7,796 

 

 

8,195 

Gain on On-X escrow settlement

 

--

 

 

(2,675)

 

 

--

 

 

(2,675)

Inventory basis step-up expense

 

--

 

 

62 

 

 

--

 

 

2,805 

Adjusted income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

 

2,918 

 

 

4,119 

 

 

10,455 

 

 

10,326 

Income tax expense calculated at a

 

 

 

 

 

 

 

 

 

 

 

pro forma tax rate of 25%

 

730 

 

 

1,030 

 

 

2,614 

 

 

2,582 

Adjusted net income, non-GAAP

$

2,188 

 

$

3,089 

 

$

7,841 

 

$

7,744 



 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share, GAAP:

$

0.00 

 

$

0.04 

 

$

0.06 

 

$

(0.06)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development and integration expenses

 

0.03 

 

 

0.05 

 

 

0.06 

 

 

0.19 

Amortization expense

 

0.07 

 

 

0.08 

 

 

0.20 

 

 

0.22 

Gain on On-X escrow settlement

 

--

 

 

(0.07)

 

 

--

 

 

(0.07)

Inventory basis step-up expense

 

--

 

 

--

 

 

--

 

 

0.07 

Tax effect of non-GAAP adjustments

 

(0.02)

 

 

(0.02)

 

 

(0.05)

 

 

(0.10)

Effect of 25% pro forma tax rate

 

(0.02)

 

 

--

 

 

(0.06)

 

 

(0.04)

Adjusted diluted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

0.06 

 

$

0.08 

 

$

0.21 

 

$

0.21 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

37,940 

 

 

37,610 

 

 

37,850 

 

 

37,351 









 

Page 6 of 8

 


 

 



CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Revenues

(In thousands, except per share data)







 

 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



2019

 

2018

Growth Rate

 

2019

 

2018

Growth Rate

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

67,881 

 

$

64,598 

5%

 

$

206,525 

 

$

195,042 

6%

Impact of changes in currency exchange

 

--

 

 

(701)

 

 

 

--

 

 

(3,775)

 

Total constant currency revenues, non-GAAP

$

67,881 

 

$

63,897 

6%

 

$

206,525 

 

$

191,267 

8%



 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of total On-X revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total On-X revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total On-X revenues, GAAP

$

12,610 

 

$

11,298 

12%

 

$

36,751 

 

$

33,495 

10%

Impact of changes in currency exchange

 

--

 

 

(46)

 

 

 

--

 

 

(214)

 

Total constant currency On-X revenues, non-GAAP

$

12,610 

 

$

11,252 

12%

 

$

36,751 

 

$

33,281 

10%



 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of total JOTEC revenues, GAAP, to

 

 

 

 

 

 

 

 

 

 

 

 

 

total JOTEC revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total JOTEC revenues, GAAP

$

15,774 

 

$

15,004 

5%

 

$

48,936 

 

$

46,669 

5%

Impact of changes in currency exchange

 

--

 

 

(496)

 

 

 

--

 

 

(2,780)

 

Total constant currency JOTEC revenues, non-GAAP

$

15,774 

 

$

14,508 

9%

 

$

48,936 

 

$

43,889 

11%



 

Page 7 of 8

 


 

 



CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Adjusted EBITDA

(In thousands, except per share data)







 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

 

(Unaudited)



Three Months Ended

 

 

Nine Months Ended



September 30,

 

 

September 30,



2019

 

2018

 

 

2019

 

2018

Reconciliation of net (loss) income, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

adjusted EBITDA, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income, GAAP

$

(134)

 

$

1,565 

 

 

$

2,401 

 

$

(2,064)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

4,526 

 

 

4,530 

 

 

 

13,257 

 

 

13,636 

Income tax (benefit) expense

 

(858)

 

 

543 

 

 

 

(2,304)

 

 

(2,868)

Interest income

 

(259)

 

 

(52)

 

 

 

(608)

 

 

(141)

Interest expense

 

3,555 

 

 

4,104 

 

 

 

11,260 

 

 

11,863 

Gain on On-X escrow settlement

 

--

 

 

(2,675)

 

 

 

--

 

 

(2,675)

Inventory basis step-up expense

 

--

 

 

62 

 

 

 

--

 

 

2,805 

Business development and integration expenses

 

1,250 

 

 

1,917 

 

 

 

2,562 

 

 

6,933 

Loss on foreign currency revaluation

 

2,419 

 

 

683 

 

 

 

2,669 

 

 

2,141 

Stock-based compensation expense

 

2,462 

 

 

1,565 

 

 

 

6,581 

 

 

4,685 

Adjusted EBITDA, non-GAAP

$

12,961 

 

$

12,242 

 

 

$

35,818 

 

$

34,315 





 

Page 8 of 8