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8-K - 8-K - CRYOLIFE INCc199-20181101x8k.htm

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 Third Quarter 2018 Results





Third Quarter and Recent Business Highlights:

·

Total revenues increased 47 percent to $64.6 million in the third quarter of 2018 compared to the third quarter of 2017

·

Non-GAAP total revenues increased 17 percent in the third quarter of 2018 compared to the third quarter of 2017; Non-GAAP total revenues increased 17 percent on a constant currency basis

·

On-X® revenues increased 36 percent in the third quarter of 2018 compared to the third quarter of 2017

·

JOTEC® revenues were $15.0 million in the third quarter of 2018, a 32 percent increase on a Non-GAAP basis compared to the third quarter of 2017 

·

Net income was  $1.6 million or $0.04 per fully diluted common share; Non-GAAP net income was $3.1 million, or $0.08 per fully diluted common share 





ATLANTA, GA – (October 31,  2018) – 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, 2018



“We had a very successful third quarter which included strong revenue growth, market share gains, new account growth and progress on our clinical and R&D programs,” said Pat Mackin, Chairman, President, and Chief Executive Officer.  “Our On-X and JOTEC products continue to gain momentum as our direct salesforce is effectively conveying the differentiating attributes of these products.  We expect our business momentum to continue and we are therefore updating our full year guidance.  Looking ahead, we have many internal initiatives that we believe can drive substantial future growth.  Given our highly experienced leadership team, we are confident we can deliver on our goals and objectives for 2018.” 



Third Quarter 2018 Financial Results

Total revenues for the third quarter of 2018 increased 47 percent to $64.6 million, compared to $44.0 million for the third quarter of 2017.  The increase was primarily driven by $15.0 million in revenues from JOTEC and strong revenue growth from On-X and tissue processing.  Non-


 

GAAP total revenues for the third quarter of 2018 increased 17 percent, compared to the third quarter of 2017,  a 17 percent increase on a constant currency basis.    



Net income for the third quarter of 2018 was $1.6 million, or $0.04 per fully diluted common share, compared to net income of $1.3 million, or $0.04 per fully diluted common share for the third quarter of 2017.  Non-GAAP net income for the third quarter of 2018 was $3.1 million, or $0.08 per fully diluted common share, compared to non-GAAP net income of $3.1 million, or $0.09 per fully diluted common share for the third quarter of 2017. 



2018 Financial Outlook 

The Company is updating its full-year 2018 financial guidance, as summarized below, and expects total revenues in the fourth  quarter of 2018 to be between $66.5 million and $67.5 million.    





Previous

Revised

Total Revenues

$256.0 million - $260.0 million

$261.5 million - $262.5 million

Gross Margins

65.5% - 66.5%

(includes $3.5 million non-cash charges related to acquired JOTEC inventory and distributor inventory buy backs)

65.5% - 66.5%

(includes $2.8 million non-cash charges related to acquired JOTEC inventory and distributor inventory buy backs)

R&D Expenses

$23.0 million - $25.0 million

$22.0 million - $23.0 million

Non-GAAP Tax Rate

Mid 20%

(excludes effect of nondeductible transaction costs and the tax effect of stock compensation expenses)

same

Non-GAAP EPS

$0.29 - $0.32

(assumes approximately 37.5 million fully diluted shares outstanding and 25% effective tax rate)

 

$0.30 - $0.33

(assumes approximately 37.5 million fully diluted shares outstanding and 25% effective tax rate)





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 2018 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 revenues include JOTEC revenues for the same nine-month period in 2017 prior to the closing of the acquisition of JOTEC on December 1, 2017The Company did not own JOTEC during the nine-month period ended September 30, 2017, so the Company is unable to report its GAAP revenue

 

Page 2 of 9

 


 

growth for the nine-month period ended September 30, 2018 compared to the same period in 2017.    The Company’s other 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 tomorrow,  November  1,  2018 at 8:30 a.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 8, 2018 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13684106.



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 forecasted revenues, gross margins, R&D expenses, non-GAAP income tax rate and non-GAAP earnings per share; and our beliefs that our On-X and JOTEC products continue to gain momentum as our direct salesforce is effectively conveying the differentiating attributes of these products, that we expect our business momentum to continue, that we have many internal initiatives that we believe can drive substantial future growth and that we are confident we can deliver on our goals and objectives for 2018.  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 expectationsThese risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for year ended December

 

Page 3 of 9

 


 

31, 2017.   CryoLife does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.

 

Page 4 of 9

 


 

CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)







 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

(Unaudited)



Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



2018

 

2017

 

2018

 

2017

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

45,152 

 

$

27,029 

 

$

138,063 

 

$

84,519 

Preservation services

 

19,446 

 

 

16,970 

 

 

56,979 

 

 

52,357 

Total revenues

 

64,598 

 

 

43,999 

 

 

195,042 

 

 

136,876 



 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

12,459 

 

 

6,220 

 

 

40,166 

 

 

21,196 

Preservation services

 

9,425 

 

 

7,917 

 

 

27,083 

 

 

23,401 

Total cost of products and

 

 

 

 

 

 

 

 

 

 

 

preservation services

 

21,884 

 

 

14,137 

 

 

67,249 

 

 

44,597 



 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

42,714 

 

 

29,862 

 

 

127,793 

 

 

92,279 



 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

32,871 

 

 

24,756 

 

 

104,946 

 

 

71,016 

Research and development

 

5,225 

 

 

4,277 

 

 

16,314 

 

 

13,098 

Total operating expenses

 

38,096 

 

 

29,033 

 

 

121,260 

 

 

84,114 

Operating income

 

  4,618

 

 

829 

 

 

  6,533

 

 

8,165 



 

 

 

 

 

 

 

 

 

 

 



Interest expense

 

4,104 

 

 

      851

 

 

  11,863

 

 

2,486 

Interest income

 

     (52)

 

 

(64)

 

 

 (141)

 

 

(159)

Other (income) expense, net

 

(1,542)

 

 

        21

 

 

     (257)

 

 

(70)



 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 2,108

 

 

21 

 

 

(4,932)

 

 

 5,908

Income tax expense (benefit)

 

    543

 

 

  (1,304)

 

 

(2,868)

 

 

    (803)



 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

$

  1,565

 

$

1,325 

 

$

(2,064)

 

$

6,711 



 

 

 

 

 

 

 

 

 

 

 

Income (loss) per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

    0.04

 

$

0.04 

 

$

(0.06)

 

$

0.20 

Diluted

$

    0.04

 

$

0.04 

 

$

(0.06)

 

$

0.19 



 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

36,526 

 

 

32,887 

 

 

36,331 

 

 

32,665 

Diluted

 

37,610 

 

 

34,057 

 

 

36,331 

 

 

33,851 



 

Page 5 of 9

 


 



CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)





(Unaudited)

 

(Unaudited)



Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



2018

 

2017

 

2018

 

2017

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue and BioFoam

$

15,646 

 

$

15,730 

 

$

48,685 

 

$

48,094 

JOTEC

 

15,004 

 

 

--

 

 

46,669 

 

 

--

On-X

 

11,298 

 

 

8,326 

 

 

33,495 

 

 

27,048 

CardioGenesis cardiac laser therapy

 

1,590 

 

 

1,489 

 

 

4,514 

 

 

5,130 

PerClot

 

882 

 

 

886 

 

 

2,822 

 

 

2,641 

PhotoFix

 

732 

 

 

598 

 

 

1,878 

 

 

1,606 

         Total products

 

45,152 

 

 

27,029 

 

 

138,063 

 

 

84,519 



 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

9,502 

 

 

7,932 

 

 

26,660 

 

 

23,911 

Vascular tissue

 

9,944 

 

 

9,038 

 

 

30,319 

 

 

28,446 

Total preservation services

 

19,446 

 

 

16,970 

 

 

56,979 

 

 

52,357 



 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

64,598 

 

$

43,999 

 

$

195,042 

 

$

136,876 



 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

  U.S.

$

36,516 

 

$

32,208 

 

$

108,123 

 

$

100,454 

International

 

28,082 

 

 

11,791 

 

 

86,919 

 

 

36,422 

Total revenues

$

64,598 

 

$

43,999 

 

$

195,042 

 

$

136,876 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

(Unaudited)

September 30,

 

December 31,



2018

 

2017



 

 

 

 

 

Cash, cash equivalents, and restricted securities

$

35,311 

 

$

40,753 

Total current assets

 

173,952 

 

 

179,280 

Total assets

 

569,695 

 

 

589,693 

Total current liabilities

 

30,749 

 

 

42,940 

Total liabilities

 

292,888 

 

 

312,635 

Shareholders’ equity

 

276,807 

 

 

277,058 



 

Page 6 of 9

 


 

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

 

Nine Months Ended



September 30,

 

September 30,



2018

 

2017

 

2018

 

2017

GAAP:

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

$

 2,108

 

$

      21

 

$

(4,932)

 

$

 5,908

Income tax expense (benefit)

 

    543

 

 

 (1,304)

 

 

(2,868)

 

 

    (803)

Net income (loss)

$

1,565

 

$

 1,325

 

$

(2,064)

 

$

 6,711



 

 

 

 

 

 

 

 

 

 

 

Diluted income (loss) per common share:

$

  0.04

 

$

   0.04

 

$

  (0.06)

 

$

   0.19



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

37,610

 

 

34,057

 

 

36,331

 

 

33,851



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of income (loss) before income

 

 

 

 

 

 

 

 

 

 

 

taxes, GAAP to adjusted net income,

     non-GAAP:

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes, GAAP

$

 2,108

 

$

      21

 

$

(4,932)

 

$

 5,908

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development and integration expenses

 

 1,917

 

 

 2,998

 

 

 6,933

 

 

 4,380

Amortization expense

 

 2,707

 

 

 1,140

 

 

 8,195

 

 

 3,423

Gain on On-X escrow settlement

 

 (2,675)

 

 

       --

 

 

 (2,675)

 

 

       --

Inventory basis step-up expense

 

      62

 

 

      32

 

 

 2,805

 

 

 2,144

Adjusted income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

 

 4,119

 

 

 4,191

 

 

 10,326

 

 

15,855



 

 

 

 

 

 

 

 

 

 

 

Income tax expense calculated at 25% pro forma

 

 

 

 

 

 

 

 

 

 

 

tax rate

 

 1,030

 

 

 1,048

 

 

 2,582

 

 

 3,964

Adjusted net income, non-GAAP

$

 3,089

 

$

 3,143

 

$

 7,744

 

$

11,891



 

 

 

 

 

 

 

 

 

 

 

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:

$

   0.04

 

$

  0.04

 

$

   (0.06)

 

$

   0.19

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Amortization expense

 

   0.08

 

 

   0.04

 

 

   0.22

 

 

   0.10

Business development and integration expenses

 

   0.05

 

 

   0.09

 

 

   0.19

 

 

   0.13

Gain on On-X escrow settlement

 

(0.07)

 

 

        --

 

 

   (0.07)

 

 

        --

Inventory basis step-up expense

 

       --

 

 

        --

 

 

   0.07

 

 

   0.06

Tax effect of non-GAAP adjustments

 

(0.02)

 

 

(0.04)

 

 

   (0.10)

 

 

(0.07)

Effect of 25% pro forma tax rate

 

       --

 

 

   (0.04)      

 

 

   (0.04)

 

 

(0.07)

Adjusted diluted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

   0.08

 

$

   0.09

 

$

  0.21

 

$

   0.34



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

37,610

 

 

34,057

 

 

37,351

 

 

33,851



 

 

 

 

 

 

 

 

 

 

 









 

Page 7 of 9

 


 

CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Revenues; Gross Margin; General, Administrative, and Marketing

(In thousands, except per share data)





(Unaudited)

 

(Unaudited)



Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



2018

 

2017

Growth Rate

 

2018

 

2017

Growth Rate

Reconciliation of total revenues, GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

to total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

64,598 

 

$

43,999 

47%

 

$

195,042 

 

$

136,876 

42%

Plus: JOTEC pre-acquisition

revenues

 

--

 

 

11,339 

 

 

 

          --

 

 

36,439 

 

Total revenues, non-GAAP

$

64,598 

 

$

55,338 

17%

 

$

195,042 

 

$

173,315 

13%

Impact of changes in currency exchange

 

      --

 

 

  (203)

 

 

 

          --

 

 

3,625 

 

Total constant currency revenues, non-GAAP

$

64,598

 

$

55,135 

17%

 

$

 195,042

 

$

176,940 

10%



 

 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

 

(Unaudited)

 



Three Months Ended

 

 

Nine Months Ended

 



September 30,

 

 

September 30,

 



2018

 

2017

 

 

2018

 

2017

 

Reconciliation of gross margin %,

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP to gross margin %,

 

 

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

64,598 

 

$

43,999 

 

 

$

195,042 

 

$

136,876 

 

Gross margin, GAAP

$

42,714 

 

$

29,862 

 

 

$

127,793 

 

$

92,279 

 

Gross margin %, GAAP

 

66% 

 

 

68% 

 

 

 

66% 

 

 

67% 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

Gross margin, GAAP

$

42,714 

 

$

29,862 

 

 

$

127,793 

 

$

92,279 

 

Plus: Inventory basis step- up

 

 

 

 

 

 

 

 

 

 

 

 

 

expense

 

62 

 

 

32 

 

 

 

2,805 

 

 

2,144 

 

Gross margin, non-GAAP

$

42,776 

 

$

29,894 

 

 

$

130,598 

 

$

94,423 

 

Gross margin %, non-GAAP

 

66% 

 

 

68% 

 

 

 

67% 

 

 

69% 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

 

(Unaudited)

 



Three Months Ended

 

 

Nine Months Ended

 



September 30,

 

 

September 30,

 



2018

 

2017

 

 

2018

 

2017

 

Reconciliation of general,

 

 

 

 

 

 

 

 

 

 

 

 

 

administrative, and marketing,

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP to general, administrative, 

 

 

 

 

 

 

 

 

 

 

 

 

 

and marketing, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing,

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP

$

32,871

 

$

24,756

 

 

$

104,946

 

$

71,016

 

Less: Business development and

 

 

 

 

 

 

 

 

 

 

 

 

 

integration expenses

 

(1,917)

 

 

(2,998)

 

 

 

(6,933)

 

 

(4,380)

 

General, administrative, and

 

 

 

 

 

 

 

 

 

 

 

 

 

marketing, non-GAAP

$

30,954

 

$

21,758

 

 

$

 98,013

 

$

66,636

 























 

Page 8 of 9

 


 

CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Net Income (Loss) to Adjusted EBITDA

(In thousands)





 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



(Unaudited)

 

 

(Unaudited)

 



Three Months Ended

 

 

Nine Months Ended

 



September 30,

 

 

September 30,

 



2018

 

2017

 

 

2018

 

2017

 

Reconciliation of net income (loss),

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP to adjusted EBITDA,          non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss), GAAP

$

 1,565

 

$

1,325

 

 

$

(2,064)

 

$

6,711

 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

     (52)

 

 

(64)

 

 

 

(141)

 

 

(159)

 

Interest expense

 

4,104

 

 

   851

 

 

 

11,863

 

 

2,486

 

Income tax expense (benefit)

 

   543

 

 

(1,304)

 

 

 

(2,868)

 

 

  (803)

 

Depreciation and amortization expense

 

4,530

 

 

 2,331

 

 

 

13,636

 

 

6,683

 

Loss (gain) on foreign currency

revaluation

 

   683

 

 

     21

 

 

 

 2,141

 

 

(78)

 

Business development and integration     expenses

 

 1,917

 

 

2,998

 

 

 

 6,933

 

 

4,380

 

Gain on On-X escrow settlement

 

(2,675)

 

 

      --

 

 

 

 (2,675)

 

 

      --

 

Inventory basis step-up expense

 

     62

 

 

     32

 

 

 

 2,805

 

 

2,144

 

Stock-based compensation expense

 

1,565

 

 

1,856

 

 

 

 4,685

 

 

5,652

 

Adjusted EBITDA, non-GAAP

$

12,242

 

$

8,046

 

 

$

34,315

 

$

27,016

 



 

Page 9 of 9