UNITED STATES

SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

 

 

CURRENT  REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):  February 15, 2016

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CRYOLIFE, INC.

(Exact name of registrant as specified in its charter)
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1655 Roberts Boulevard, N.W.,  Kennesaw,  Georgia  30144
(Address of principal executive office) (zip code)

Registrant's telephone number, including area code: (770) 419-3355

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(Former name or former address, if changed since last report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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Section 2 Financial Information

 

Item 2.02 Results of Operations and Financial Condition.

 

On February 15, 2016, CryoLife, Inc. (“CryoLife” or the “Company”) issued a press release announcing its financial results for the year and quarter ended December 31, 2015.   CryoLife hereby incorporates by reference herein the information set forth in its press release dated February 15, 2016, a copy of which is attached hereto as Exhibit 99.1. Except as otherwise provided in the press release, the press release speaks only as of the date of such press release and it shall not create any implication that the affairs of CryoLife have continued unchanged since such date. 

 

The information provided pursuant to this Item 2.02 is to be considered “furnished” pursuant to Item 2.02 of Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, nor shall it be deemed incorporated by reference into any of CryoLife’s reports or filings with the Securities and Exchange Commission, whether made before or after the date hereof, except as expressly set forth by specific reference in such report or filing.

 

Except for the historical information contained in this report, the statements made by CryoLife are forward-looking statements that involve risks and uncertainties. All such statements are subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. CryoLife’s future financial performance could differ significantly from the expectations of management and from results expressed or implied in the press release.  Please refer to the last paragraph of the text portion of the press release for further discussion about forward-looking statements. For further information on risk factors, please refer to “Risk Factors” contained in CryoLife’s Form 10-K filed for the year ended December 31, 2014 and its subsequent filings with the Securities and Exchange Commission,  as well as in the press release attached as Exhibit 99.1 hereto. CryoLife disclaims any obligation or duty to update or modify these forward-looking statements.

 

Section 9Financial Statements and Exhibits.

Item 9.01(d)   Exhibits.

 

(a) Financial Statements.

Not applicable.

 

(b) Pro Forma Financial Information.

Not applicable.

 

(c) Shell Company Transactions.

Not applicable.

 

(d) Exhibits.

 

 

 

 

*  This exhibit is furnished, not filed.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, CryoLife, Inc. has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

CRYOLIFE, INC.

 

 

 

Date:  February 16, 2016

 

 

 

 

 

 

 

 

 

 

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FOR IMMEDIATE RELEASE

 

Contacts:

 

 

CryoLife Reports Fourth Quarter and Full Year 2015 Financial Results

 

Recent Highlights:

 

 

ATLANTA, GA – (February 15,  2016) – 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 2015. 

 

J. Patrick Mackin, Chairman, President, and Chief Executive Officer, said, “2015 was a year of significant progress for CryoLife, with positive momentum on key strategic initiatives throughout the year.  As a result, we achieved record quarterly revenues of $39.8 million in the fourth quarter, with gross margin of 67 percent, a significant year-over-year and sequential improvement.  As we look to 2016, we added to our growth and margin expansion potential with the recent acquisition of On-X, which expands our market opportunity with a differentiated mechanical heart valve technology and more than doubles our U.S. cardiac surgery sales force.  We also strengthened our focus on cardiac surgery through the sale of the HeRO product line.   Overall, we are optimistic that our internal and business development initiatives have positioned the Company to deliver an enhanced growth trajectory and profitability.”  

 

Revenues for the fourth quarter of 2015 increased 7 percent to $39.8 million, compared to $37.2 million for the fourth quarter of 2014.  Foreign currency exchange adversely affected revenues for the fourth quarter of 2015 by $379,000, or  1 percent.  Product revenues were $23.9 million for the fourth quarter of 2015, up 10 percent from $21.7 million in the fourth quarter of 2014.  This primarily reflects increases in revenues in CardioGenesis cardiac laser therapy, PhotoFix™,  and ProCol®.    Tissue processing revenues were $15.9 million for the fourth quarter of 2015, up 3 percent compared to $15.5 million for the fourth quarter of 2014, driven primarily by an increase in average service fees.    

 

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Revenues for the full year of 2015 increased 1 percent to $145.9 million, compared to $144.6 million for the full year of 2014.  Foreign currency exchange adversely affected revenues for the full year of 2015 by $1.5 million, or 1 percent.  Product revenues were $83.1 million for the full year of 2015, up 1 percent from $81.9 million in the full year of 2014.  Product revenues reflect increased revenues from CardioGenesis cardiac laser therapy and from the recent launches of ProCol and PhotoFix, partially offset by a decrease in BioGlue® revenues primarily due to the transition to a direct sales model in France on October 1st and the strengthening U.S. dollar.  Tissue processing revenues were $62.8 million for the full year of 2015,  flat compared to the full year of 2014. 

 

Net income for the fourth quarter of 2015 was $2.6 million, or $0.09 per basic and fully diluted common share, compared to net income of $1.8 million, or $0.06 per basic and fully diluted common share, for the fourth quarter of 2014.  Excluding certain items as shown in the schedules below, adjusted non-GAAP fully diluted earnings per share was $0.13 in the fourth quarter of 2015, compared to $0.06 in the fourth quarter of 2014. 

 

Net income for the full year of 2015 was $4.0 million, or $0.14 per basic and fully diluted common share, compared to net income of $7.3 million, or $0.26 per basic and $0.25 per fully diluted common share, for the full year of 2014.  Excluding certain items as shown in the schedules below, adjusted non-GAAP fully diluted earnings per share was $0.30 in the full year of 2015, compared to $0.26 in the full year of 2014. 

 

The Company’s 2016 financial guidance is summarized below. 

 

 

The Company’s financial guidance for the full year of 2016 is subject to the risks described below in the last paragraph of this press release, prior to the financial tables.    The guidance does not include any effect related to future business development activities,  transaction and integration costs, acquisition related amortization, and other unusual charges.

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.  Non-GAAP adjusted net income and adjusted income per common share excludes business development expenses; severance expenses associated with certain

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employee departures, including the retirement of the Company’s former President, CEO, and Executive Chairman; amortization expenses; the write-off of PerClot Topical inventory related to the injunction from the Medafor Litigation; intangible impairment; the allowance for uncollectable notes receivable; the gain on contingent consideration; and the gain on sale of Medafor investment.  The non-GAAP disclosures have been calculated using a proforma tax rate of 38% for all periods.  The non-GAAP disclosures presented below differ from the non-GAAP disclosures previously presented in 2015 due to the addition of amortization expenses as an adjustment item.  The Company expects amortization expenses to increase significantly in 2016 due to the acquisition of On-X and believes adjusting amortization expenses will provide better comparative information to investors regarding the Company’s on-going operating performance.  The Company intends to present this non-GAAP format in future reports.  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 to its on-going efforts to acquire additional complementary products and businesses and the transaction expenses incurred in connection with recently acquired 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 our business operations and can vary significantly between periods as a result of factors such as, new acquisitions, 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 promise 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 23 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13629845.

 

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 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 CryoLife’s expected increased growth and margin expansion potential and expanded market opportunity resulting from the recent acquisition of On-X our ability to focus more on cardiac surgery as a result of the divestiture of our HeRO product line, and CryoLife being positioned for enhanced growth trajectory and profitability as a result of internal and business

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development initiatives.  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 market opportunities for mechanical heart valves may be incorrect and/or may shrink due to factors beyond our control; and the expected benefits of focusing market opportunities may be incorrect.  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.

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CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)

 

 

 

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CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)

 

 

 

 

 

 

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CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP Disclosures

(In thousands, except per share data)

 

 

 

 

 

 

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