EX-99.1 2 c199-20150728ex99109e8ab.htm EX-99.1 8K 2Q Financials 2015 Exhibit 991 07-28-15

EXHIBIT 99.1

 

 

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 Second Quarter Financial Results

 

Recent Highlights:

·

Received Expanded Indication for BioGlue® in Japan

·

Announced Plans to Transition to Direct Sales Model in France

 

 

ATLANTA, GA – (July 28, 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 second quarter and first six months of 2015

 

Pat Mackin, Chairman, President and Chief Executive Officer, said, “During the quarter we continued to execute on our growth strategy with solid progress on several of our top organizational objectives.  In June, we announced plans to transition to a direct sales model in France, advancing our strategic presence in international markets.  Earlier this month, we received an expanded indication for BioGlue in Japan, which doubled our market opportunity and is consistent with our strategy to gain new indications for our product portfolio.”  

 

Revenues for the second quarter of 2015 increased 2 percent to $35.5 million, compared to $34.7 million for the second quarter of 2014.  Product revenues were $19.9 million for the second quarter of 2015, down slightly from $20.4 million in the second quarter of 2014.  This reflects a  year-over-year increase in HeRO® Graft revenues and the recent launches of ProCol® and PhotoFix, offset by decreases in CardioGenesis® cardiac laser therapy, BioGlue, and PerClot® revenues.  The change in product revenues was primarily due to changes in distribution models and the strengthening U.S. dollar.    Tissue processing revenues were $15.6 million for the second quarter of 2015, up 9 percent compared to $14.3 million for the second quarter of 2014, driven primarily by an increase in average service fees.    

 

Revenues for the first six months of 2015 decreased 2 percent to $69.4 million, compared to $70.4 million for the first six months of 2014.  Product revenues were $39.3 million for the first six months of 2015, down slightly from $39.8 million in the first six months of 2014.  Product revenues reflect recent launches of ProCol and PhotoFix, and the year-over-year increases in CardioGenesis cardiac laser therapy and HeRO Graft revenues, offset by decreases in BioGlue and PerClot revenues due to changes in distribution models and the strengthening U.S. dollar.  Tissue processing revenues were $30.0 million for the first six months of 2015, down slightly compared to $30.6 million for the first six months of 2014. 

 


 

 

Net loss for the second quarter of 2015 was ($502,000), or ($0.02) per basic and fully diluted common share, compared to net income of $2.2 million, or $0.08 per basic and  fully diluted common share, for the second quarter of 2014.  Excluding certain items as shown in the schedules below, proforma non-GAAP fully diluted earnings per share was $0.03 in the second quarter of 2015, compared to $0.05 in the second quarter of 2014. 

 

Net loss for the first six months of 2015 was ($776,000), or ($0.03) per basic and fully diluted common share, compared to net income of $3.2 million, or $0.12 per basic and $0.11 per fully diluted common share, for the first six months of 2014.  Excluding certain items as shown in the schedules below, proforma non-GAAP fully diluted earnings per share was $0.03 in the first half of 2015, as compared to $0.09 in the first half 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

$148.5 million – $150.5 million

3% – 4% increase

Product revenues

Mid-single digits % increase

Low-single digits % increase

Tissue processing revenues

Low-single digits % increase

Low-single digits % increase

Gross margins

Approximately 60%

Approximately 60%

R&D expenses

$13.0 million - $14.0 million

$13.0 million - $14.0 million

Earnings per share

Breakeven

Breakeven

 

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 July 28 through August 4 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13614274.

 

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.

 

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 statements include those regarding: the timing of patient enrollment in our PerClot IDE clinical trial and FDA approval of various indications for PerClot; the timing and effect on our financial performance of implementing improvements in our tissue processing business; our plans, expectations, and the market opportunities for ProCol and PhotoFix; our plans to transition to a direct sales organization in France and our expectations regarding the benefits of that transition; the market opportunity related to the expansion of the indication for BioGlue in Japan; our 2015 effective tax rate; our expectations regarding foreign exchange rates; and our anticipated performance for the remainder of fiscal 2015. The risks and uncertainties affecting these statements include that: our anticipated performance for fiscal 2015 is subject to the general risks associated with our business; there is no guarantee that the FDA will approve the surgical version of PerClot for distribution in the U.S. in accordance with our expected timeframe, or at all; our PerClot clinical trial is subject to a number of execution risks,  and it may ultimately be unsuccessful; there is no guarantee that we will be able to attain the levels of revenue and profitability that we anticipate for PerClot; as part of our patent litigation against Medafor, Inc. regarding PerClot (the “Medafor Litigation”), we have been enjoined from selling, marketing, and distributing PerClot in the U.S.; there is no guarantee that we will ultimately prevail in the Medafor Litigation, and if we do not prevail, we will continue to be prohibited from selling PerClot in the U.S., or we may have to pay substantial royalties to sell PerClot in the U.S., until Medafor’s patent expires;  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 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 complete the transition to a direct sales organization in France, or recognize the anticipated benefits of such transition, within our anticipated timeframe, or at all; the market opportunity for the expanded BioGlue indication 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

 

Six Months Ended

 

June 30,

 

June 30,

 

2015

 

2014

 

2015

 

2014

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

19,918 

 

$

20,350 

 

$

39,309 

 

$

39,805 

Preservation services

 

15,608 

 

 

14,340 

 

 

30,048 

 

 

30,616 

Total revenues

 

35,526 

 

 

34,690 

 

 

69,357 

 

 

70,421 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

4,244 

 

 

4,131 

 

 

9,277 

 

 

7,932 

Preservation services

 

9,728 

 

 

8,175 

 

 

18,859 

 

 

17,632 

Total cost of products and

 

 

 

 

 

 

 

 

 

 

 

preservation services

 

13,972 

 

 

12,306 

 

 

28,136 

 

 

25,564 

 

 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

21,554 

 

 

22,384 

 

 

41,221 

 

 

44,857 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

19,327 

 

 

17,959 

 

 

38,296 

 

 

36,234 

Research and development

 

2,684 

 

 

2,203 

 

 

4,936 

 

 

4,705 

Total operating expenses

 

22,011 

 

 

20,162 

 

 

43,232 

 

 

40,939 

 

 

 

 

 

 

 

 

 

 

 

 

Operating (loss) income

 

(457)

 

 

2,222 

 

 

(2,011)

 

 

3,918 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

30 

 

 

(16)

 

 

60 

 

 

45 

Interest income

 

(12)

 

 

(45)

 

 

(15)

 

 

(48)

Gain on sale of Medafor investment

 

(891)

 

 

--

 

 

(891)

 

 

--

Other expense (income), net

 

250 

 

 

(111)

 

 

442 

 

 

(210)

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

166 

 

 

2,394 

 

 

(1,607)

 

 

4,131 

Income tax expense (benefit)

 

668 

 

 

233 

 

 

(831)

 

 

911 

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income

$

(502)

 

$

2,161 

 

$

(776)

 

$

3,220 

 

 

 

 

 

 

 

 

 

 

 

 

(Loss) Income per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.02)

 

$

0.08 

 

$

(0.03)

 

$

0.12 

Diluted

$

(0.02)

 

$

0.08 

 

$

(0.03)

 

$

0.11 

 

 

 

 

 

 

 

 

 

 

 

 

Dividends declared per common share

$

0.0300 

 

$

0.0300 

 

$

0.0600 

 

$

0.0575 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

27,713 

 

 

27,502 

 

 

27,619 

 

 

27,439 

Diluted

 

27,713 

 

 

28,317 

 

 

27,619 

 

 

28,382 

 


 

 

CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

June 30,

 

June 30,

 

2015

 

2014

 

2015

 

2014

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue and BioFoam

$

14,519 

 

$

15,389 

 

$

28,561 

 

$

30,629 

PerClot

 

1,036 

 

 

1,143 

 

 

2,012 

 

 

2,059 

CardioGenesis cardiac laser therapy

 

1,943 

 

 

2,084 

 

 

4,080 

 

 

3,768 

HeRO Graft

 

1,744 

 

 

1,705 

 

 

3,604 

 

 

3,320 

ProCol

 

333 

 

 

29 

 

 

537 

 

 

29 

PhotoFix

 

343 

 

 

--

 

 

515 

 

 

--

         Total products

 

19,918 

 

 

20,350 

 

 

39,309 

 

 

39,805 

 

 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

6,889 

 

 

6,454 

 

 

13,552 

 

 

13,644 

Vascular tissue

 

8,719 

 

 

7,886 

 

 

16,496 

 

 

16,972 

Total preservation services

 

15,608 

 

 

14,340 

 

 

30,048 

 

 

30,616 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

35,526 

 

$

34,690 

 

$

69,357 

 

$

70,421 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

  U.S.

$

27,777 

 

$

26,351 

 

$

54,811 

 

$

53,783 

International

 

7,749 

 

 

8,339 

 

 

14,546 

 

 

16,638 

Total revenues

$

35,526 

 

$

34,690 

 

$

69,357 

 

$

70,421 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

December 31,

 

2015

 

2014

 

 

 

 

 

 

Cash, cash equivalents, and restricted cash and securities

$

40,944 

 

$

39,259 

Total current assets

 

108,632 

 

 

106,028 

Total assets

 

176,068 

 

 

176,157 

Total current liabilities

 

19,187 

 

 

20,627 

Total liabilities

 

26,526 

 

 

27,472 

Shareholders’ equity

 

149,542 

 

 

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

 

Six Months Ended

 

June 30,

 

June 30,

 

       2015

 

      2014

 

       2015

 

      2014

GAAP:

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

$

166 

 

$

2,394 

 

$

(1,607)

 

$

4,131 

Income tax expense (benefit)

 

668 

 

 

233 

 

 

(831)

 

 

911 

Net (loss) income

$

(502)

 

$

2,161 

 

$

(776)

 

$

3,220 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted (loss) income per common share:

$

(0.02)

 

$

0.08 

 

$

(0.03)

 

$

0.11 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding:

 

27,713 

 

 

28,317 

 

 

27,619 

 

 

28,382 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation excluding items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes, GAAP

$

166 

 

$

2,394 

 

$

(1,607)

 

$

4,131 

Excluding:

 

 

 

 

 

 

 

 

 

 

 

Severance expenses

 

1,389 

 

 

--

 

 

1,857 

 

 

--

Business development expenses

 

857 

 

 

 

 

1,063 

 

 

17 

Intangible impairment

 

--

 

 

--

 

 

457 

 

 

--

Gain on sale of Medafor investment

 

(891)

 

 

--

 

 

(891)

 

 

--

Write-off of PerClot Topical inventory

 

--

 

 

--

 

 

498 

 

 

--

Adjusted income before income taxes,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

 

1,521 

 

 

2,399 

 

 

1,377 

 

 

4,148 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense calculated at a

 

 

 

 

 

 

 

 

 

 

 

    proforma tax rate of 38%

 

578 

 

 

912 

 

 

523 

 

 

1,576 

Adjusted net income, non-GAAP

$

943 

 

$

1,487 

 

$

854 

 

$

2,572 

 

 

 

 

 

 

 

 

 

 

 

 

Adjusted net income, non-GAAP allocated to

 

 

 

 

 

 

 

 

 

 

 

   participating securities – diluted

 

21 

 

 

25 

 

 

50 

 

 

47 

Adjusted net income, non-GAAP

 

 

 

 

 

 

 

 

 

 

 

applicable to common shareholders

 

 

 

 

 

 

 

 

 

 

 

– diluted

$

922 

 

$

1,462 

 

$

804 

 

$

2,525 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted adjusted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

0.03 

 

$

0.05 

 

$

0.03 

 

$

0.09 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted-weighted average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding, non-GAAP:

 

28,393 

 

 

28,317 

 

 

28,335 

 

 

28,382 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 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 stating that the Company cannot sell PerClot Topical in the U.S. The above non-GAAP items have been calculated using a proforma tax rate of 38% for all periods. The 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 its ongoing efforts to acquire additional complementary products and businesses and the transaction expenses incurred in connection with recently acquired businesses. 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 promise or indication that these types of expenses will not recur.