EX-99.1 2 cry-20190430xex99_1.htm EX-99.1 20190430 8K EXH 991 - Q1 2019 PR

Exhibit 99.1

 



FOR IMMEDIATE RELEASE



Contacts:





 

CryoLife

Gilmartin Group LLC

D. Ashley Lee

Greg Chodaczek / Lynn Lewis

Executive Vice President, Chief Financial Officer and Chief Operating Officer

Phone:  646-924-1769

investors@cryolife.com

Phone: 770-419-3355

 



CryoLife Reports First Quarter 2019 Financial Results



First Quarter and Recent Business Highlights:

·

Total revenues were $67.5 million in the first quarter of 2019, reflecting year over year growth of 9%  and an 11%  increase on a non-GAAP constant currency basis, both compared to the first quarter of 2018

o

On-X® revenues increased 14%, and 15% on a non-GAAP constant currency basis, both compared to the first quarter of 2018

o

JOTEC® revenues increased 10%, and 18% on a non-GAAP constant currency basis, both compared to the first quarter of 2018

·

Net loss was ($297,000), or  ($0.01) per fully diluted common share;  non-GAAP net income was $1.5 million, or $0.04 per fully diluted common share



ATLANTA, GA – (April 30,  2019) – 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, 2019



We had a successful start to the year posting solid financial results and advancing our clinical and R&D programs.  Our strategy of differentiated products focused on select markets, supported by a well-trained direct sales force, is allowing us to continue to take market share,” said Pat Mackin, Chairman, President, and Chief Executive Officer.  “Given our strong performance in the first quarter and the expected launch of the initial phase of our next generation products, we remain on track to deliver high single-digit top line growth in 2019.  Our pipeline programs have increased our addressable market opportunity to $3.5 billion, positioning the Company for substantial growth in the coming years.”



First Quarter 2019 Financial Results

Total revenues for the first quarter of 2019 were $67.5 million, reflecting growth of 9%, and 11% on a non-GAAP constant currency basis, both compared to the first quarter of 2018.  The increase was driven by strong revenue growth from JOTEC, On-X, and BioGlue.    



Net loss for the first quarter of 2019 was ($297,000), or ($0.01) per fully diluted common share, compared to a  net loss of ($3.9) million, or ($0.11) per fully diluted common share for the first quarter of 2018.  Non-GAAP net income for the first quarter of 2019 was $1.5 million, or $0.04 per fully diluted common share, compared to non-GAAP net income of $793,000, or $0.02 per fully diluted common share for the first 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 results exclude (as applicable) business development and integration expenses, amortization expense, and inventory basis step-up expense.  The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions, and 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.  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 does, however, expect to incur similar types of expenses 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,  April 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 May 7, 2019 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13690095.



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

 

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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 our strategy of differentiated products focused on select markets, supported by a well-trained direct sales force, is allowing us to  continue to take market share; the timing of our expected launch of the initial phase of our next generation products; our belief that we remain on track to deliver high single-digit top line growth in 2019; our belief that our addressable market opportunity is $3.5 billion; and our belief that we are positioned for substantial growth in the coming years.  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.



 

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CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)







 

 

 

 

 

 



 

(Unaudited)



 

Three Months Ended



 

March 31,



 

2019

 

2018

Revenues:

 

 

 

 

 

 

Products

 

$

48,401 

 

$

43,598 

Preservation services

 

 

19,104 

 

 

18,350 

Total revenues

 

 

67,505 

 

 

61,948 



 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

Products

 

 

13,826 

 

 

14,157 

Preservation services

 

 

9,406 

 

 

8,563 

Total cost of products and preservation services

 

 

23,232 

 

 

22,720 



 

 

 

 

 

 

Gross margin

 

 

44,273 

 

 

39,228 



 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

General, administrative, and marketing

 

 

36,520 

 

 

37,348 

Research and development

 

 

5,548 

 

 

5,370 

Total operating expenses

 

 

42,068 

 

 

42,718 

Operating income (loss)

 

 

2,205 

 

 

(3,490)



 

 

 

 

 

 

Interest expense

 

 

3,894 

 

 

3,656 

Interest income

 

 

(116)

 

 

(59)

Other expense (income), net

 

 

77 

 

 

(181)



 

 

 

 

 

 

Loss before income taxes

 

 

(1,650)

 

 

(6,906)

Income tax benefit

 

 

(1,353)

 

 

(3,051)



 

 

 

 

 

 

Net loss

 

$

(297)

 

$

(3,855)



 

 

 

 

 

 

Loss per common share:

 

 

 

 

 

 

Basic

 

$

(0.01)

 

$

(0.11)

Diluted

 

$

(0.01)

 

$

(0.11)



 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

Basic

 

 

36,778 

 

 

36,146 

Diluted

 

 

36,778 

 

 

36,146 



 

 

 

 

 

 



 

 

 

 

 

 





 

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CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)





 

 

 

 

 

 



 

(Unaudited)



 

Three Months Ended



 

March 31,



 

2019

 

2018

Products:

 

 

 

 

 

 

BioGlue

 

$

17,222 

 

$

15,970 

JOTEC

 

 

15,954 

 

 

14,460 

On-X

 

 

11,731 

 

 

10,309 

CardioGenesis cardiac laser therapy

 

 

1,714 

 

 

1,346 

PerClot

 

 

1,050 

 

 

972 

PhotoFix

 

 

730 

 

 

541 

Total Products

 

 

48,401  43,598 

   

 

 

Preservation services:

 

 

 

 

 

 

Cardiac tissue

 

 

8,930 

 

 

8,103 

Vascular tissue

 

 

10,174 

 

 

10,247 

Total preservation services

 

 

19,104 

 

 

18,350 



 

 

 

 

 

 

Total revenues

 

$

67,505 

 

$

61,948 



 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

U.S.

 

$

37,325 

 

$

34,888 

International

 

 

30,180 

 

 

27,060 

Total revenues

 

$

67,505 

 

$

61,948 



 

 

 

 

 

 



 

 

 

 

 

 











 

 

 

 

 



(Unaudited)

 

 



March 31,

 

December 31,



2019

 

2018



 

 

 

 

 

Cash, cash equivalents, and restricted securities

$

41,075 

 

$

42,236 

Total current assets

 

178,652 

 

 

179,168 

Total assets

 

586,928 

 

 

571,091 

Total current liabilities

 

36,423 

 

 

34,523 

Total liabilities

 

314,306 

 

 

296,024 

Shareholders’ equity

 

272,622 

 

 

275,067 



 

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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)



 

Three Months Ended



 

March 31,



 

2019

 

2018



 

 

 

 

 

 

GAAP:

 

 

 

 

 

 

Loss before income taxes

 

$

(1,650)

 

$

(6,906)

Income tax benefit

 

 

(1,353)

 

 

(3,051)

Net loss

 

$

(297)

 

$

(3,855)



 

 

 

 

 

 

Diluted loss per common share:

 

$

(0.01)

 

$

(0.11)



 

 

 

 

 

 

Reconciliation of income before income taxes,

 

 

 

 

 

 

GAAP to adjusted net income, non-GAAP:

 

 

 

 

 

 



 

 

 

 

 

 

Loss before income taxes, GAAP

 

$

(1,650)

 

$

(6,906)

Adjustments:

 

 

 

 

 

 

Business development and integration expenses

 

 

1,109 

 

 

3,722 

Amortization expense

 

 

2,579 

 

 

2,735 

  Inventory basis step-up expense

 

 

--

 

 

1,506 

Adjusted income before income taxes,

 

 

 

 

 

 

non-GAAP

 

 

2,038 

 

 

1,057 



 

 

 

 

 

 

Income tax expense calculated at a

 

 

 

 

 

 

    pro forma tax rate of 25%

 

 

510 

 

 

264 

Adjusted net income, non-GAAP

 

$

1,528 

 

$

793 



 

 

 

 

 

 

Reconciliation of diluted (loss) income per common

 

 

 

 

 

 

      share, GAAP to adjusted diluted (loss) income per

 

 

 

 

 

 

common share, non-GAAP:

 

 

 

 

 

 



 

 

 

 

 

 

Diluted loss per common share – GAAP

 

$

(0.01)

 

$

(0.11)

Adjustments:

 

 

 

 

 

 

  Business development and integration expenses

 

 

0.03 

 

 

0.10 

Amortization expense

 

 

0.07 

 

 

0.07 

Inventory basis step-up expense

 

 

--

 

 

0.04 

Tax effect of non-GAAP adjustments

 

 

(0.03)

 

 

(0.05)

Effect of 25% pro forma tax rate

 

 

(0.02)

 

 

(0.03)

Adjusted diluted income per common share,

 

 

 

 

 

 

   non-GAAP:

 

$

0.04 

 

$

0.02 



 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

      shares outstanding:

 

 

37,711 

 

 

36,985 



 

 

 

 

 

 



 

 

 

 

 

 



 

 

 

 

 

 



 

 

 

 

 

 





















 

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CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Revenues; Gross Margin; General, Administrative, and Marketing

Adjusted EBITDA

(In thousands, except per share data)





 

 

 

 

 

 

 

 



 

(Unaudited)



 

Three Months Ended



 

March 31,



 

2019

 

2018

 

Growth Rate



 

 

 

 

 

 

 

 

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

 

 

Total revenues, GAAP

 

$

67,505 

 

$

61,948 

 

9% 

Impact of changes in currency exchange

 

 

--

 

 

(1,337)

 

 

Total constant currency revenues, non-GAAP

 

$

67,505 

 

$

60,611 

 

11% 



 

 

 

 

 

 

 

 



 

 

 

 

Reconciliation of total JOTEC revenues, GAAP to

 

 

 

 

 

 

 

 

total JOTEC revenues, non-GAAP:

 

 

 

 

 

 

 

 

Total JOTEC revenues, GAAP

 

$

15,954 

 

$

14,460 

 

10% 

Impact of changes in currency exchange

 

 

--

 

 

(986)

 

 

Total constant currency JOTEC revenues, non-GAAP

 

$

15,954 

 

$

13,474 

 

18% 



 

 

 

 



 

 

 

 

Reconciliation of total On-X revenues, GAAP to

 

 

 

 

 

 

 

 

total On-X revenues, non-GAAP:

 

 

 

 

 

 

 

 

Total On-X revenues, GAAP

 

$

11,731 

 

$

10,309 

 

14% 

Impact of changes in currency exchange

 

 

--

 

 

(77)

 

 

Total constant currency On-X revenues, non-GAAP

 

$

11,731 

 

$

10,232 

 

15% 



 

 

 

 

 

 

 

 





 

(Unaudited)



 

Three Months Ended



 

March 31,



 

 

2019

 

 

2018

Reconciliation of net (loss) income, GAAP

 

 

 

 

 

 

to adjusted EBITDA, non-GAAP:

 

 

 

 

 

 

Net (loss) income, GAAP

 

$

(297)

 

$

(3,855)

Adjustments:

 

 

 

 

 

 

Depreciation and amortization expense

 

 

4,350 

 

 

4,376 

Income tax benefit

 

 

(1,353)

 

 

(3,051)

Interest income

 

 

(116)

 

 

(59)

Interest expense

 

 

3,894 

 

 

3,656 

Inventory basis step-up expense

 

 

-

 

 

1,506 

Business development and integration expenses

 

 

1,109 

 

 

3,722 

Loss (gain) on foreign currency revaluation

 

 

74 

 

 

(32)

Stock-based compensation expense

 

 

1,853 

 

 

1,248 

Adjusted EBITDA, non-GAAP

 

$

9,514 

 

$

7,511 



 

 

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