EX-99.1 2 cry-20190730xex99_1.htm EX-99.1 2019.07.31 8K EXH 99.1 - Q2 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 Second Quarter 2019 Financial Results





Second Quarter and Recent Business Highlights:

·

Total revenues were $71.1 million in the second quarter of 2019, reflecting year over year growth of 4% and a 7% increase on a non-GAAP constant currency basis, both compared to the second quarter of 2018

o

BioGlue® revenues increased 5%, and 7% on a non-GAAP constant currency basis, both compared to the second quarter of 2018

o

On-X® revenues increased 4%, and 5% on a non-GAAP constant currency basis, both compared to the second quarter of 2018

o

JOTEC® revenues were flat, and increased 8% on a non-GAAP constant currency basis,

both compared to the second quarter of 2018

·

Net income was $2.8 million, or $0.07 per fully diluted common share; non-GAAP net income was $4.1 million, or $0.11 per fully diluted common share



ATLANTA, GA – (July 30, 2019) – 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, 2019. 



Our second quarter performance marked another period of consistent growth despite headwinds.  We also continued to make important progress advancing our clinical pipeline and R&D programs” said Pat Mackin, Chairman, President, and Chief Executive Officer.  “We expect the second half of 2019 to commence the start of a multi-year launch of next generation products into existing and new geographies.  This is an exciting time in our history and we are confident we have the right mix of differentiated products supported by our experienced sales organization to take the Company to higher levels of revenue performance.”



Page 1 of 8

 


 

 

Second Quarter 2019 Financial Results

Total revenues for the second quarter of 2019 were $71.1 million, reflecting growth of 4%, and 7% on a non-GAAP constant currency basis, both compared to the second quarter of 2018.  The non-GAAP increase was driven by revenue growth from BioGlue, On-X, JOTEC, and tissue processing. 



Net income for the second quarter of 2019 was $2.8 million, or $0.07 per fully diluted common share, compared to a net income of $226,000, or $0.01 per fully diluted common share for the second quarter of 2018.  Non-GAAP net income for the second quarter of 2019 was $4.1 million, or $0.11 per fully diluted common share, compared to non-GAAP net income of $3.9 million, or $0.10 per fully diluted common share for the second quarter of 2018. 



2019 Financial Outlook 

CryoLife is reiterating its full-year financial guidance, with total revenues for 2019 expected to be in the range of $280 million to $284 million and non-GAAP earnings per share expected to be between $0.28 and $0.32. 



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, July 30, 2019 at 4:30 p.m. EDT 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 7, 2019 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13692463.



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 belief that we expect the second half of 2019 to commence the start of a multi-year launch of next generation products into existing and new geographies and we have the right mix of differentiated products supported by our experienced sales organization to take the Company to higher levels of revenue performance.  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

 


 

 

CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)











 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



2019

 

2018

 

 

2019

 

 

2018

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

51,168 

 

$

49,313 

 

$

99,569 

 

$

92,911 

Preservation services

 

19,971 

 

 

19,183 

 

 

39,075 

 

 

37,533 

Total revenues

 

71,139 

 

 

68,496 

 

 

138,644 

 

 

130,444 



 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

14,489 

 

 

13,550 

 

 

28,315 

 

 

27,707 

Preservation services

 

9,684 

 

 

9,095 

 

 

19,090 

 

 

17,658 

Total cost of products and preservation services

 

24,173 

 

 

22,645 

 

 

47,405 

 

 

45,365 



 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

46,966 

 

 

45,851 

 

 

91,239 

 

 

85,079 



 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

34,623 

 

 

34,727 

 

 

71,143 

 

 

72,075 

Research and development

 

5,841 

 

 

5,719 

 

 

11,389 

 

 

11,089 

Total operating expenses

 

40,464 

 

 

40,446 

 

 

82,532 

 

 

83,164 

Operating income

 

6,502 

 

 

5,405 

 

 

8,707 

 

 

1,915 



 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

3,811 

 

 

4,103 

 

 

7,705 

 

 

7,759 

Interest income

 

(233)

 

 

(30)

 

 

(349)

 

 

(89)

Other expense, net

 

185 

 

 

1,466 

 

 

262 

 

 

1,285 



 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

2,739 

 

 

(134)

 

 

1,089 

 

 

(7,040)

Income tax benefit

 

(93)

 

 

(360)

 

 

(1,446)

 

 

(3,411)



 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

$

2,832 

 

$

226 

 

$

2,535 

 

$

(3,629)



 

 

 

 

 

 

 

 

 

 

 

Income (loss) per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

0.08 

 

$

0.01 

 

$

0.07 

 

$

(0.10)

Diluted

$

0.07 

 

$

0.01 

 

$

0.07 

 

$

(0.10)



 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

37,156 

 

 

36,318 

 

 

36,968 

 

 

36,233 

Diluted

 

37,838 

 

 

37,249 

 

 

37,789 

 

 

36,233 



 

Page 4 of 8

 


 

 





CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)











 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



2019

 

2018

 

 

2019

 

 

2018

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue

$

17,933 

 

$

17,069 

 

$

35,155 

 

$

33,039 

JOTEC

 

17,208 

 

 

17,205 

 

 

33,162 

 

 

31,665 

On-X

 

12,410 

 

 

11,888 

 

 

24,141 

 

 

22,197 

CardioGenesis cardiac laser therapy

 

1,898 

 

 

1,578 

 

 

3,612 

 

 

2,924 

PerClot

 

784 

 

 

968 

 

 

1,834 

 

 

1,940 

PhotoFix

 

935 

 

 

605 

 

 

1,665 

 

 

1,146 

         Total products

 

51,168 

 

 

49,313 

 

 

99,569 

 

 

92,911 



 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

10,500 

 

 

9,055 

 

 

19,430 

 

 

17,158 

Vascular tissue

 

9,471 

 

 

10,128 

 

 

19,645 

 

 

20,375 

Total preservation services

 

19,971 

 

 

19,183 

 

 

39,075 

 

 

37,533 



 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

71,139 

 

$

68,496 

 

$

138,644 

 

$

130,444 



 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

  U.S.

$

38,239 

 

$

36,719 

 

$

75,563 

 

$

71,607 

International

 

32,900 

 

 

31,777 

 

 

63,081 

 

 

58,837 

Total revenues

$

71,139 

 

$

68,496 

 

$

138,644 

 

$

130,444 







 

 

 

 

 



(Unaudited)

 

 



June 30,

 

December 31,



2019

 

2018



 

 

 

 

 

Cash, cash equivalents, and restricted securities

$

40,255 

 

$

42,236 

Total current assets

 

188,557 

 

 

179,168 

Total assets

 

597,123 

 

 

571,091 

Total current liabilities

 

37,468 

 

 

34,523 

Total liabilities

 

314,970 

 

 

296,024 

Shareholders’ equity

 

282,153 

 

 

275,067 







 

Page 5 of 8

 


 

 

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)

 

(Unaudited)



Three Months Ended

 

Six Months Ended



June 30,

 

June 30,



2019

 

2018

 

2019

 

2018

GAAP:

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

$

2,739 

 

$

(134)

 

$

1,089 

 

$

(7,040)

Income tax benefit

 

(93)

 

 

(360)

 

 

(1,446)

 

 

(3,411)

Net income (loss)

$

2,832 

 

$

226 

 

$

2,535 

 

$

(3,629)



 

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share:

$

0.07 

 

$

0.01 

 

$

0.07 

 

$

(0.10)



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of income (loss) before income

 

 

 

 

 

 

 

 

 

 

 

taxes, GAAP to adjusted net income,

 

 

 

 

 

 

 

 

 

 

 

     non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes, GAAP

$

2,739 

 

$

(134)

 

$

1,089 

 

$

(7,040)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development and integration expenses

 

203 

 

 

1,294 

 

 

1,312 

 

 

5,016 

Amortization expense

 

2,557 

 

 

2,753 

 

 

5,136 

 

 

5,488 

Inventory basis step-up expense

 

--

 

 

1,237 

 

 

--

 

 

2,743 

Adjusted income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

 

5,499 

 

 

5,150 

 

 

7,537 

 

 

6,207 

Income tax expense calculated at a

 

 

 

 

 

 

 

 

 

 

 

pro forma tax rate of 25%

 

1,375 

 

 

1,288 

 

 

1,884 

 

 

1,552 

Adjusted net income, non-GAAP

$

4,124 

 

$

3,862 

 

$

5,653 

 

$

4,655 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of diluted income (loss) per

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share, GAAP:

$

0.07 

 

$

0.01 

 

$

0.07 

 

$

(0.10)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development and integration expenses

 

--

 

 

0.03 

 

 

0.03 

 

 

0.13 

Amortization expense

 

0.06 

 

 

0.07 

 

 

0.13 

 

 

0.14 

Inventory basis step-up expense

 

--

 

 

0.03 

 

 

--

 

 

0.07 

Tax effect of non-GAAP adjustments

 

--

 

 

(0.03)

 

 

(0.03)

 

 

(0.08)

Effect of 25% pro forma tax rate

 

(0.02)

 

 

(0.01)

 

 

(0.05)

 

 

(0.04)

Adjusted diluted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

0.11 

 

$

0.10 

 

$

0.15 

 

$

0.12 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

37,838 

 

 

37,249 

 

 

37,789 

 

 

37,152 





 

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

 

Six Months Ended



June 30,

 

June 30,



2019

 

2018

Growth Rate

 

2019

 

2018

Growth Rate

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

71,139 

 

$

68,496 

4%

 

$

138,644 

 

$

130,444 

6%

Impact of changes in currency exchange

 

--

 

 

(1,738)

 

 

 

--

 

 

(3,074)

 

Total constant currency revenues, non-GAAP

$

71,139 

 

$

66,758 

7%

 

$

138,644 

 

$

127,370 

9%



 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of total BioGlue revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total BioGlue revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total BioGlue revenues, GAAP

$

17,933 

 

$

17,069 

5%

 

$

35,155 

 

$

33,039 

6%

Impact of changes in currency exchange

 

--

 

 

(295)

 

 

 

--

 

 

(517)

 

Total constant currency BioGlue revenues, non-GAAP

$

17,933 

 

$

16,774 

7%

 

$

35,155 

 

$

32,522 

8%



 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of total On-X revenues, GAAP to

 

 

 

 

 

 

 

 

 

 

 

 

 

total On-X revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total On-X revenues, GAAP

$

12,410 

 

$

11,888 

4%

 

$

24,141 

 

$

22,197 

9%

Impact of changes in currency exchange

 

--

 

 

(91)

 

 

 

--

 

 

(168)

 

Total constant currency On-X revenues, non-GAAP

$

12,410 

 

$

11,797 

5%

 

$

24,141 

 

$

22,029 

10%



 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of total JOTEC revenues, GAAP, to

 

 

 

 

 

 

 

 

 

 

 

 

 

total JOTEC revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total JOTEC revenues, GAAP

$

17,208 

 

$

17,205 

0%

 

$

33,162 

 

$

31,665 

5%

Impact of changes in currency exchange

 

--

 

 

(1,299)

 

 

 

--

 

 

(2,284)

 

Total constant currency JOTEC revenues, non-GAAP

$

17,208 

 

$

15,906 

8%

 

$

33,162 

 

$

29,381 

13%



 

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

 

 

Six Months Ended



June 30,

 

 

June 30,



2019

 

2018

 

 

2019

 

2018

Reconciliation of net income (loss), GAAP

 

 

 

 

 

 

 

 

 

 

 

 

to adjusted EBITDA, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss), GAAP

$

2,832 

 

$

226 

 

 

$

2,535 

 

$

(3,629)

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

4,381 

 

 

4,730 

 

 

 

8,731 

 

 

9,106 

Income tax benefit

 

(93)

 

 

(360)

 

 

 

(1,446)

 

 

(3,411)

Interest income

 

(233)

 

 

(30)

 

 

 

(349)

 

 

(89)

Interest expense

 

3,811 

 

 

4,103 

 

 

 

7,705 

 

 

7,759 

Inventory basis step-up expense

 

--

 

 

1,237 

 

 

 

--

 

 

2,743 

Business development and integration expenses

 

203 

 

 

1,294 

 

 

 

1,312 

 

 

5,016 

Loss on foreign currency revaluation

 

176 

 

 

1,477 

 

 

 

250 

 

 

1,458 

Stock-based compensation expense

 

2,266 

 

 

1,872 

 

 

 

4,119 

 

 

3,120 

Adjusted EBITDA, non-GAAP

$

13,343 

 

$

14,549 

 

 

$

22,857 

 

$

22,073 



 

 

 

 

 

 

 

 

 

 

 

 











 

Page 8 of 8