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8-K - 8-K - CRYOLIFE INCc199-20170216x8k.htm

Exhibit 99.1







FOR IMMEDIATE RELEASE



Contacts:





 

CryoLife

The Ruth Group

D. Ashley Lee

Nick Laudico / Zack Kubow

Executive Vice President, Chief Financial Officer

and Chief Operating Officer

646-536-7030 / 7020

nlaudico@theruthgroup.com

Phone: 770-419-3355

zkubow@theruthgroup.com





CryoLife Reports Fourth Quarter and Full Year 2016 Financial Results



Provides 2017 Financial Guidance



Fourth Quarter Highlights:

·

Revenues Increased 13 Percent Year-over-Year to $45.0 Million; Non-GAAP Revenues Decreased Two Percent Year-over-Year

·

Gross Margins Increased to 69 Percent; Non-GAAP Gross Margins Increased to 71 Percent

·

GAAP Net Income was $2.9 Million, or $0.09 Per Fully Diluted Common Share;  Non-GAAP Net Income was $4.1 Million, or $0.12 Per Fully Diluted Common Share



ATLANTA, GA – (February 15,  2017) – CryoLife, Inc. (NYSE: CRY),  a leading medical device and tissue processing company focused on cardiac surgery, announced today its results for the fourth quarter and full year of 2016. 



Pat Mackin, Chairman, President, and Chief Executive Officer, said, “We continued to make meaningful progress on all of our key strategic initiatives in the fourth quarterAlthough our top line was slightly below our upwardly revised guidance, we are confident it was not due to competitive pressures or a  decline in demand for our products as our business momentum remains strongFurthermore, we exceeded our net income guidance and posted a  69 percent gross margin in the quarter.      



Mr. Mackin added, 2016 was a transformational and highly successful year for CryoLifeWe effectively repositioned our product portfolio through the acquisition of On-X and divestiture of non-core technologies, which allowed us to combine three sales forces into a single U.S. cardiac surgery team and expand our direct presence in international markets.    We were able to expand our margins substantially over the course of the year and added to a highly experienced management team.  We expect our focused portfolio of industry leading technologies, combined with our active business development efforts, to positively impact our results in the future.”           



Revenues for the fourth quarter of 2016 increased 13 percent to $45.0 million, compared to $39.8 million for the fourth quarter of 2015.  The increase was primarily driven by the acquisition of On-X Life Technologies (On-X) in January 2016, partially offset by a decrease in HeRO Graft


 

 

and TMR revenues.  Non-GAAP revenues for the fourth quarter of 2016 decreased two percent compared to the fourth quarter of 2015.  A reconciliation of GAAP financial metrics to non-GAAP financial metrics is included as part of this press release.



Revenues for the full year of 2016 increased 24 percent to $180.4 million, compared to $145.9 million for the full year of 2015.  The increase was primarily driven by the acquisition of On-X, along with revenue increases in BioGlue, and cardiac and vascular tissues, partially offset by decreases in HeRO Graft and TMR revenues.  Non-GAAP revenues for the full year of 2016 increased five percent compared to the full year of 2015. 



GAAP net income for the fourth quarter of 2016 was $2.9 million, or $0.09 per basic and fully diluted common share, compared to net income of $2.6 million, or $0.09 per basic and fully diluted common share, for the fourth quarter of 2015.  Non-GAAP net income for the fourth quarter of 2016 was $4.1 million, or $0.12 per fully diluted common share, compared to non-GAAP net income of $3.9 million, or $0.13 per fully diluted common share for the fourth quarter of 2015. 



GAAP net income for the full year of 2016 was $10.8 million, or $0.33 per basic and $0.32 per fully diluted common share, compared to net income of $4.0 million, or $0.14 per basic and fully diluted common share, for the full year of 2015.  Non-GAAP net income for the full year of 2016 was $16.0 million, or $0.48 per fully diluted common share, compared to non-GAAP net income of $8.7 million, or $0.30 per fully diluted common share for the full year of 2015.  



The Company’s 2017 financial guidance is summarized below. 



2017 Financial Guidance Summary

Total revenues

$188 million - $192 million

Product revenues

Year-over-year mid-single digits % non-GAAP revenue increase

Tissue processing revenues

Year-over-year mid-single digits % revenue increase

Gross margins

Between 68% - 69%

R&D expenses

$17.0 million - $19.0 million

Income tax rate

Low to Mid 30%

Non-GAAP income per common share

$0.40 - $0.43



All numbers in the table above are GAAP 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 the full year of 2017 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 (as applicable) On-X revenues for the period in 2016 prior to the closing of the acquisition and On-X revenues for the comparable periods of 2015 and excludes revenues for the HeRO Graft and ProCol product lines for 2016 and 2015.  The Company’s other non-GAAP results exclude (as applicable) business development expenses; gain on sale of business components; amortization expenses; acquisition inventory basis step-up expense; severance expenses associated with certain employee departures; the gain on sale of Medafor investment; the write-off of PerClot Topical inventory; and intangible impairment.  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 and can vary significantly between periods as a result of factors such as new acquisitions, non-cash expense related to amortization of previously acquired tangible and intangible assets, or unusual compensation expenses.  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 at 8:00 a.m. Eastern Time to discuss the results followed by a question and answer session hosted by Mr. Mackin.



To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 8:00 a.m.  A replay of the teleconference will be available February 16 through February  22 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13655099.



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 surgical procedures.  CryoLife markets and sells products in more than 80 countries worldwide.  For additional information about CryoLife, visit our website, www.cryolife.com



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 those regarding our financial guidance for 2017, and the impact of our focused portfolio of industry leading technologies and business development efforts on our 2017 results 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 that the expected benefits of a larger sales force or our market opportunities due to our focus on the cardiac surgery market may be incorrect or may not be achieved; and our business development efforts may not be successful.  These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2015, and our subsequent filings with the SEC. CryoLife does not undertake to update its forward-looking statements.



 

 


 

 

CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)







 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

Twelve Months Ended



December 31,

 

December 31,



2016

 

2015

 

2016

 

2015

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

28,925 

 

$

23,913 

 

$

113,992 

 

$

83,081 

Preservation services

 

16,104 

 

 

15,925 

 

 

66,388 

 

 

 62,817

Total revenues

 

45,029 

 

 

39,838 

 

 

180,380 

 

 

145,898 



 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

6,734 

 

 

5,108 

 

 

28,033 

 

 

18,663 

Preservation services

 

7,100 

 

 

8,214 

 

 

33,448 

 

 

36,516 

Total cost of products and

 

 

 

 

 

 

 

 

 

 

 

preservation services

 

13,834 

 

 

13,322 

 

 

61,481 

 

 

55,179 



 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

31,195 

 

 

26,516 

 

 

118,899 

 

 

90,719 



 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

22,246 

 

 

19,139 

 

 

91,548 

 

 

74,929 

Research and development

 

3,844 

 

 

2,540 

 

 

13,446 

 

 

10,436 

Total operating expenses

 

26,090 

 

 

21,679 

 

 

104,994 

 

 

85,365 

 

  Gain from sale of business components

 

 

 

 

 

 

 

 

 

 

 

 

 

 

--

 

 

 

 

--

 

 

(7,915)

 

 

--



Operating income

 

   5,105

 

 

4,837 

 

 

    21,820

 

 

5,354 



 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

      787

 

 

    (44)

 

 

3,043 

 

 

     (62)

Interest income

 

     (24)

 

 

    (16)

 

 

      (72)

 

 

    (45)

Gain on sale of Medafor investment

 

        --

 

 

        --

 

 

         --

 

 

(891)

Other expense, net

 

583 

 

 

     280

 

 

437 

 

 

   484



 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

3,759 

 

 

4,617 

 

 

18,412 

 

 

5,868 

Income tax expense

 

862 

 

 

1,981 

 

 

7,634 

 

 

   1,863



 

 

 

 

 

 

 

 

 

 

 

Net income

$

2,897 

 

$

2,636 

 

$

10,778 

 

$

4,005 



 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

0.09 

 

$

0.09 

 

$

0.33 

 

$

0.14 

Diluted

$

0.09 

 

$

0.09 

 

$

0.32 

 

$

0.14 



 

 

 

 

 

 

 

 

 

 

 

Dividends declared per common share

$

--

 

$

0.0300 

 

$

--

 

$

0.1200 



 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

32,223 

 

 

27,914 

 

 

31,855 

 

 

27,744 

Diluted

 

33,443 

 

 

28,687 

 

 

32,822 

 

 

28,542 



 

 


 

 



CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)





 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

Twelve Months Ended



December 31,

 

           December 31,



2016

 

2015

 

2016

 

2015

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue and BioFoam

On-X

$

15,9829,073 

 

$

16,488

--

 

$

63,46134,232 

 

$

59,332

--

CardioGenesis cardiac laser therapy

 

2,367 

 

 

3,487 

 

 

7,864 

 

 

9,419 

PerClot

 

1,038 

 

 

1,096 

 

 

4,021 

 

 

4,083 

PhotoFix

 

465 

 

 

437 

 

 

1,871 

 

 

1,396 

HeRO Graft

 

--

 

 

2,008 

 

 

2,325 

 

 

7,546 

ProCol

 

--

 

 

397 

 

 

218 

 

 

1,305 

         Total products

 

28,925 

 

 

23,913 

 

 

113,992 

 

 

83,081 



 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

7,442 

 

 

  6.970

 

 

29,697 

 

 

28,059 

Vascular tissue

 

  8,662

 

 

  8,955

 

 

36,691 

 

 

34,758 

Total preservation services

 

16,104 

 

 

15,925 

 

 

66,388 

 

 

62,817 



 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

45,029 

 

$

39,838 

 

$

180,380 

 

$

145,898 



 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

  U.S.

$

32,885 

 

$

30,797 

 

$

131,727

 

$

114,978 

International

 

12,144 

 

 

9,041 

 

 

  48,653

 

 

30,920 

Total revenues

$

45,029 

 

$

39,838 

 

$

180,380 

 

$

145,898 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 











December 31,

 

December 31,



2016

 

2015



 

 

 

 

 

Cash, cash equivalents, and restricted cash and securities

$

57,341 

 

$

43,418 

Total current assets

 

147,233 

 

 

109,663 

Total assets

 

316,140 

 

 

181,179 

Total current liabilities

 

30,102 

 

 

19,605 

Total liabilities

 

107,157 

 

 

25,928 

Shareholders’ equity

 

208,983 

 

 

155,251 

 

 


 

 

CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Net Income and Diluted Income per Common Share

(In thousands, except per share data)





 

 

 

 

 

 

 

 

 

 

 



   Three Months Ended

 

     Twelve Months Ended



December 31,

 

December 31,



 2016

 

   2015

 

    2016

 

    2015

GAAP:

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

$

3,759 

 

$

4,617 

 

$

18,412 

 

$

5,868 

Income tax expense

 

862 

 

 

1,981 

 

 

7,634 

 

 

1,863 

Net income

$

  2,897

 

$

2,636 

 

$

10,778 

 

$

4,005 



 

 

 

 

 

 

 

 

 

 

 

Diluted income per common share:

$

    0.09

 

$

0.09 

 

$

0.32 

 

$

0.14 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding:

 

33,443 

 

 

28,687 

 

 

32,822 

 

 

28,542 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of income before income

 

 

 

 

 

 

 

 

 

 

 

taxes, GAAP to net income, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Income before income taxes, GAAP

$

3,759 

 

$

4,617 

 

$

18,412 

 

$

5,868 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development expenses

 

832 

 

 

1,126 

 

 

7,880 

 

 

3,006 

Gain on sale of business components

 

--

 

 

--

 

 

(7,915)

 

 

--    

Amortization expense

 

1,153 

 

 

615 

 

 

4,426 

 

 

2,135 

Acquisition inventory basis step-up expense

 

822 

 

 

--

 

 

3,039 

 

 

--

Severance expenses

 

--

 

 

--

 

 

--

 

 

2,965 

Gain on sale of Medafor investment

 

--

 

 

--

 

 

--

 

 

(891)

Write-off of PerClot Topical inventory

 

--

 

 

--

 

 

--

 

 

498 

Intangible impairment

 

--

 

 

--

 

 

--

 

 

457 

Income before income taxes, non-GAAP

 

6,566 

 

 

6,358 

 

 

25,842 

 

 

14,038 



 

 

 

 

 

 

 

 

 

 

 

Income tax expense calculated at 38% normalized

 

 

 

 

 

 

 

 

 

 

 

tax rate

 

2,495 

 

 

2,416 

 

 

9,820 

 

 

5,334 

Net income, non-GAAP

$

4,071 

 

$

3,942 

 

$

16,022 

 

$

8,704 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of diluted income per

 

 

 

 

 

 

 

 

 

 

 

common share, GAAP to diluted income per

 

 

 

 

 

 

 

 

 

 

 

common share, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Diluted income per common share, GAAP:

$

0.09 

 

$

0.09 

 

$

0.32 

 

$

0.14 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development expenses

 

0.02 

 

 

0.04 

 

 

0.24 

 

 

0.10 

Gain on sale of business components

 

--

 

 

--

 

 

(0.24)

 

 

--

Amortization expense

 

0.03 

 

 

0.02 

 

 

0.13 

 

 

0.07 

Acquisition inventory basis step-up expense

 

0.02 

 

 

--

 

 

0.09 

 

 

--

Severance expenses

 

--

 

 

--

 

 

--

 

 

0.10 

Gain on sale of Medafor investment

 

--

 

 

--

 

 

--

 

 

(0.03)

Write-off of PerClot Topical inventory

 

--

 

 

--

 

 

--

 

 

0.02 

Intangible impairment

 

--

 

 

--

 

 

--

 

 

0.02 

Tax effect of non-GAAP adjustments

 

(0.02)

 

 

(0.02)

 

 

(0.08)

 

 

(0.11)

Effect of 38% normalized tax rate

 

(0.02)

 

 

--

 

 

0.02 

 

 

(0.01)

Diluted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

0.12 

 

$

0.13 

 

$

0.48 

 

$

0.30 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding:

 

33,443 

 

 

28,687 

 

 

32,822 

 

 

28,542 



 

 

 

 

 

 

 

 

 

 

 











 

 


 

 

CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Revenues; Gross Margin; General, Administrative, and Marketing

(In thousands, except per share data)





 

 

 

 

 

 

 

 

 

 

 

 

 



           Three Months Ended

 

             Twelve Months Ended



December 31,

 

December 31,



  2016

 

2015

Growth Rate

 

2016

 

 2015

Growth Rate

Reconciliation of total revenues, GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

to total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

45,029 

 

$

39,838 

13%

 

$

180,380 

 

$

145,898 

24%

Plus: On-X pre acquisition revenues

 

--

 

 

8,285 

 

 

 

1,627 

 

 

33,368 

 

Less: HeRO revenues

 

--

 

 

(2,008)

 

 

 

(2,325)

 

 

(7,546)

 

Less: ProCol revenues

 

--

 

 

(397)

 

 

 

(218)

 

 

(1,305)

 

Total revenues, non-GAAP

$

45,029 

 

$

45,718 

(2%)

 

$

179,464 

 

$

170,415 

5%



 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

 

     Twelve Months Ended

 



December 31,

 

 

December 31,

 



2016

 

2015

 

 

2016

 

2015

 

Reconciliation of gross margin %,

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP to gross margin %,

 

 

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

45,029 

 

$

39,838 

 

 

$

180,380 

 

$

145,898 

 

Gross margin, GAAP

$

31,195 

 

$

26,516 

 

 

$

118,899 

 

$

90,719 

 

Gross margin %, GAAP

 

69% 

 

 

67% 

 

 

 

66% 

 

 

62% 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

Gross margin, GAAP

$

31,195 

 

$

26,516 

 

 

$

118,899 

 

$

90,719 

 

Plus: Acquisition inventory basis step-

 

 

 

 

 

 

 

 

 

 

 

 

 

up expense

 

822 

 

 

--

 

 

 

3,039 

 

 

--

 

Gross margin, non-GAAP

$

32,017 

 

$

26,516 

 

 

$

121,938 

 

$

90,719 

 

Gross margin %, non-GAAP

 

71% 

 

 

67% 

 

 

 

68% 

 

 

62% 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 



Three Months Ended

 

 

Twelve Months Ended

 



December 31,

 

 

December 31,

 



2016

 

2015

 

 

2016

 

2015

 

Reconciliation of general,

 

 

 

 

 

 

 

 

 

 

 

 

 

administrative, and marketing,

 

 

 

 

 

 

 

 

 

 

 

 

 

expense, GAAP to general,

 

 

 

 

 

 

 

 

 

 

 

 

 

administrative, and marketing,

 

 

 

 

 

 

 

 

 

 

 

 

 

expense, non-GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

 

 

 

 

 

 

 

 

 

 

 

 

expense, GAAP

$

22,246 

 

$

19,139 

 

 

$

91,548 

 

$

74,929 

 

Less: Business development

 

 

 

 

 

 

 

 

 

 

 

 

 

expenses

 

(832)

 

 

(1,126)

 

 

 

(7,880)

 

 

(3,006)

 

General, administrative, and

 

 

 

 

 

 

 

 

 

 

 

 

 

marketing expense,

 

 

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

$

21,414 

 

$

18,013 

 

 

$

83,668 

 

$

71,923