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Exhibit 99.1

 

NEWS RELEASE

 

FOR IMMEDIATE RELEASE

 

Contacts:

 

CryoLife

D. Ashley Lee

Executive Vice President, Chief Financial Officer and Chief Operating Officer                                                                              Phone: 770-419-3355

The Ruth Group

Nick Laudico / Zack Kubow

646-536-7030 / 7020

nlaudico@theruthgroup.com

zkubow@theruthgroup.com

 

CryoLife Reports Third Quarter Financial Results

 

Recent Highlights:

·

Received Expanded Indication for BioGlue in Japan

·

Commenced Direct Sales in France

·

Strengthened Management Team

 

 

ATLANTA, GA – (October 27, 2015) – CryoLife, Inc. (NYSE: CRY),  a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today its results for the third quarter and first nine months of 2015

 

J. Patrick Mackin, Chairman, President, and Chief Executive Officer, said, “During the third quarter we made meaningful progress on many of our key strategic objectives which we expect to drive margin expansion and to enhance our growth profile beginning in 2016.    Our objectives include maximizing the opportunity for our recently launched products ProCol® and PhotoFix,  pursuing our indication expansion for BioGlue in Japan, and commencing direct sales in France effective October 1, 2015.   To oversee these efforts, we recently brought on a highly experienced leader to head our global sales and marketing function.   We also implemented new protocols in our tissue processing business that we expect to bring greater efficiency and to allow us to improve product availability and gross margins in the coming quarters.  Moreover, there were several large expenses in 2015, some of which will not likely recur in 2016.   Lastly, we are active in business development,  seeking to leverage our well-established relationships in cardiac and vascular surgery.  We are optimistic that, through business development, we can further enhance our growth trajectory.”  

 

Revenues for the third quarter of 2015 decreased 1 percent to $36.7 million, compared to $37.1 million for the third quarter of 2014.  Foreign currency exchange adversely affected revenues for the third quarter of 2015 by $336,000 or 1 percent.  Product revenues were $19.9 million for the third quarter of 2015, down 3 percent from $20.4 million in the third quarter of 2014.  This primarily reflects decreases in revenues in BioGlue and Cardiogenesis cardiac laser therapy, partially offset by increased revenues from the recent launches of ProCol and PhotoFix.    The decrease in product revenues was primarily due to the transition to a direct sales model in France and the strengthening U.S. dollar.    Tissue processing revenues were $16.8 million for the third quarter of 2015, up 1 percent compared to $16.7 million for the third quarter of 2014, driven primarily by an increase in average service fees.    

 


 

 

Revenues for the first nine months of 2015 decreased 1 percent to $106.1 million, compared to $107.5 million for the first nine months of 2014.  Foreign currency exchange adversely affected revenues for the first nine months of 2015 by $1.1 million, or 1 percent.  Product revenues were $59.2 million for the first nine months of 2015, down 2 percent from $60.2 million in the first nine months of 2014.  Product revenues reflect a decrease in BioGlue revenues primarily due to the transition to a direct sales model in France and the strengthening U.S. dollar, partially offset by increased revenues from the recent launches of ProCol and PhotoFix.  Tissue processing revenues were $46.9 million for the first nine months of 2015, down 1 percent compared to $47.3 million for the first nine months of 2014,  primarily due to a decrease in tissue shipments

 

Net income for the third quarter of 2015 was $2.1 million, or $0.08 per basic and $0.07 per fully diluted common share, compared to net income of $2.3 million, or $0.08 per basic and fully diluted common share, for the third quarter of 2014.  Excluding certain items as shown in the schedules below, proforma non-GAAP fully diluted earnings per share was $0.10 in the third quarter of 2015, compared to $0.09 in the third quarter of 2014. 

 

Net income for the first nine months of 2015 was $1.4 million, or $0.05 per basic and fully diluted common share, compared to net income of $5.5 million, or $0.20 per basic and $0.19 per fully diluted common share, for the first nine months of 2014.  Excluding certain items as shown in the schedules below, proforma non-GAAP fully diluted earnings per share was $0.13 in the first nine months of 2015, as compared to $0.18 in the first nine months of 2014. 

 

The Company’s updated 2015 financial guidance is summarized below.  The guidance does not include any effect related to future business development activities.

 

2015 Financial Guidance Summary

 

Previous

Current

Total revenues

$148.5 million – $150.5 million

3% – 4% increase over 2014

$146 million - $148 million

1% - 3% increase over 2014

Product revenues

Low-single digits % increase over 2014

Flat from 2014

Tissue processing revenues

Low-single digits % increase over 2014

Low-single digits % increase over 2014

Gross margins

Approximately 60%

Approximately 61%

R&D expenses

$13.0 million - $14.0 million

$11.0 million - $12.0 million

Earnings per share

Breakeven

$0.09 - $0.11

 

The Company’s financial guidance for the full year of fiscal 2015 is subject to the risks described below in the last paragraph of this press release, prior to the financial tables.

 

Webcast and Conference Call Information

 

The Company will hold a teleconference call and live webcast today at 10:00 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 10:00 a.m.  A replay of the teleconference will be available October 27 through November 2 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13622876.

 

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife Web site 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 implantable living tissues and medical devices used in cardiac and vascular surgical procedures.  CryoLife markets and sells products in more than 75 countries worldwide.  For additional information about CryoLife, visit our website, www.cryolife.com.

 

Cautionary Statement Regarding Forward-Looking Statements 

 

Statements made in this press release and during the accompanying earnings webcast 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 and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations.  These forward-looking statements include those regarding: our expected future results of operations, growth, and business outlook; progress with the ongoing launch of  ProCol and PhotoFix; our ability to execute on our direct sales model, the increased efficiency and improved product availability we expect from new protocols implemented in our tissue processing business; our ability to obtain changes to the protocol for the PerClot IDE, to enroll additional clinical sites as quickly as we expect, if at all, or to obtain FDA approval for PerClot by 2018; and the ability to enhance our growth trajectory through business development activities.  Forward-looking statements also include all statements that are not historical facts and may be identified by terms such as “continues,” “plans,” “believes,” “expects,” “anticipates,” “could,” “look forward to,” or similar expressions and the negatives of those terms.    The risks and uncertainties affecting these statements include that: the financial benefits expected from our tissue processing improvements could be less than anticipated and may not be realized within the timeframes anticipated; our beliefs regarding the market and growth opportunities for ProCol and PhotoFix may be incorrect, and even if correct, there is no guarantee that we will successfully grow ProCol and PhotoFix sales; we may not recognize the anticipated benefits from our transition to a direct sales organization in France when we expect, or at all; the market opportunity for the expanded indication for BioGlue in Japan and sales with respect to that indication may begin later, and/or be less than anticipated; continued fluctuation of foreign currencies relative to the U.S. dollar could materially, adversely affect our business; and although our guidance does not reflect activities related to ongoing or future business development activities, consummation of material business development transactions during fiscal 2015 could have a significant impact on our business and could cause our actual performance for 2015 to change materially from our current predictions. 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, 2014 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

 

Nine Months Ended

 

September 30,

 

September 30,

 

2015

 

2014

 

2015

 

2014

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

19,859 

 

$

20,405 

 

$

59,168 

 

$

60,210 

Preservation services

 

16,844 

 

 

16,664 

 

 

46,892 

 

 

47,280

Total revenues

 

36,703 

 

 

37,069 

 

 

106,060 

 

 

107,490 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

4,278 

 

 

4,167 

 

 

13,555 

 

 

12,099 

Preservation services

 

9,443 

 

 

9,103 

 

 

28,302 

 

 

26,735 

Total cost of products and

 

 

 

 

 

 

 

 

 

 

 

preservation services

 

13,721 

 

 

13,270 

 

 

41,857 

 

 

38,834 

 

 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

22,982 

 

 

23,799 

 

 

64,203 

 

 

68,656 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

17,494 

 

 

18,882 

 

 

55,790 

 

 

55,116 

Research and development

 

2,960 

 

 

1,902 

 

 

7,896 

 

 

6,607 

Total operating expenses

 

20,454 

 

 

20,784 

 

 

63,686 

 

 

61,723 

 

 

 

 

 

 

 

 

 

 

 

 

Operating income

 

   2,528

 

 

3,015 

 

 

     517

 

 

6,933 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

      (78)

 

 

       65

 

 

(18)

 

 

110 

Interest income

 

     (14)

 

 

       (1)

 

 

      (29)

 

 

(49)

Gain on sale of Medafor investment

 

        --

 

 

--

 

 

(891)

 

 

--

Other (income) expense, net

 

(238)

 

 

         4

 

 

204 

 

 

(206)

 

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

2,858 

 

 

2,947 

 

 

1,251 

 

 

7,078 

Income tax expense (benefit)

 

713 

 

 

621 

 

 

(118)

 

 

   1,532

 

 

 

 

 

 

 

 

 

 

 

 

Net income

$

2,145 

 

$

2,326 

 

$

1,369 

 

$

5,546 

 

 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

0.08 

 

$

0.08 

 

$

0.05 

 

$

0.20 

Diluted

$

0.07 

 

$

0.08 

 

$

0.05 

 

$

0.19 

 

 

 

 

 

 

 

 

 

 

 

 

Dividends declared per common share

$

0.0300 

 

$

0.0300 

 

$

0.0900 

 

$

0.0875 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

27,823 

 

 

27,367 

 

 

27,687 

 

 

27,414 

Diluted

 

28,596 

 

 

28,268 

 

 

28,487 

 

 

28,345 

 


 

 

CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

September 30,

 

September 30,

 

2015

 

2014

 

2015

 

2014

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue and BioFoam

$

14,283 

 

$

15,116 

 

$

42,844 

 

$

45,745 

PerClot

 

975 

 

 

998 

 

 

2,987 

 

 

3,057 

CardioGenesis cardiac laser therapy

 

1,852 

 

 

2,306 

 

 

5,932 

 

 

6,074 

HeRO Graft

 

1,934 

 

 

1,984 

 

 

5,538 

 

 

5,304 

ProCol

 

371 

 

 

 

 

908 

 

 

30 

PhotoFix

 

444 

 

 

--

 

 

959 

 

 

--

         Total products

 

19,859 

 

 

20,405 

 

 

59,168 

 

 

60,210 

 

 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

7,537 

 

 

  8,337

 

 

21,089 

 

 

21,981 

Vascular tissue

 

9,307 

 

 

  8,327

 

 

25,803 

 

 

25,299 

Total preservation services

 

16,844 

 

 

16,664 

 

 

46,892 

 

 

47,280 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

36,703 

 

$

37,069 

 

$

106,060 

 

$

107,490 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

  U.S.

$

29,370 

 

$

28,819 

 

$

  84,181

 

$

82,602 

International

 

7,333 

 

 

8,250 

 

 

  21,879

 

 

24,888 

Total revenues

$

36,703 

 

$

37,069 

 

$

106,060 

 

$

107,490 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

September 30,

 

December 31,

 

2015

 

2014

 

 

 

 

 

 

Cash, cash equivalents, and restricted cash and securities

$

44,345 

 

$

39,259 

Total current assets

 

112,828 

 

 

106,028 

Total assets

 

179,981 

 

 

176,157 

Total current liabilities

 

22,230 

 

 

20,627 

Total liabilities

 

28,088 

 

 

27,472 

Shareholders’ equity

 

151,893 

 

 

148,685 

 


 

CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of

Non-GAAP Adjusted Net Income and Adjusted Income per Common Share – Diluted

(In thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

September 30,

 

September 30,

 

       2015

 

      2014

 

       2015

 

      2014

GAAP:

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

$

2,858 

 

$

2,947 

 

$

1,251 

 

$

7,078 

Income tax expense (benefit)

 

713 

 

 

621 

 

 

(118)

 

 

1,532 

Net income

$

2,145 

 

$

2,326 

 

$

1,369 

 

$

5,546 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted income per common share:

$

    0.07

 

$

0.08 

 

$

0.05 

 

$

0.19 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding:

 

28,596 

 

 

28,268 

 

 

28,487 

 

 

28,345 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation excluding items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes, GAAP

$

2,858 

 

$

2,947 

 

$

1,251 

 

$

7,078 

Excluding:

 

 

 

 

 

 

 

 

 

 

 

Severance expenses

 

1,065 

 

 

1,026 

 

 

2,923 

 

 

1,438 

Business development expenses

 

817 

 

 

 

 

1,880 

 

 

18 

Intangible impairment

 

--

 

 

--

 

 

457 

 

 

--

Gain on sale of Medafor investment

 

--

 

 

--

 

 

(891)

 

 

--

Write-off of PerClot Topical inventory

 

--

 

 

--

 

 

498 

 

 

--

Adjusted income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

 

4,740 

 

 

3,974 

 

 

6,118 

 

 

8,534 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense calculated at a

 

 

 

 

 

 

 

 

 

 

 

    proforma tax rate of 38%

 

1,801 

 

 

1,510 

 

 

2,325 

 

 

3,243 

Adjusted net income, non-GAAP

$

2,939 

 

$

2,464 

 

$

3,793 

 

$

5,291 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted net income, non-GAAP allocated to

 

 

 

 

 

 

 

 

 

 

 

   participating securities – diluted

 

60 

 

 

54 

 

 

85 

 

 

105 

Adjusted net income, non-GAAP

 

 

 

 

 

 

 

 

 

 

 

applicable to common shareholders

 

 

 

 

 

 

 

 

 

 

 

– diluted

$

2,879 

 

$

2,410 

 

$

3,708 

 

$

5,186 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted adjusted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

0.10 

 

$

0.09 

 

$

0.13 

 

$

0.18 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted-weighted average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding, non-GAAP:

 

28,596 

 

 

28,268 

 

 

28,487 

 

 

28,345 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.  Non-GAAP adjusted net income and adjusted income per common share excludes expenses related to one-time expenses associated with certain employee departures, including the retirement of the Company’s former President, CEO, and Executive Chairman, expenses related to business development, expenses related to intangible impairment, the gain on sale of Medafor investment, and the write-off of PerClot inventory related to the injunction from the Medafor Litigation.    The above non-GAAP items have been calculated using a proforma tax rate of 38% for all periodsThe Company believes that this non-GAAP presentation provides 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 ongoing efforts to acquire additional complementary products and businesses and the transaction expenses incurred in connection with recently acquired product linesThe 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 promise or indication that these types of expenses will not recur.