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8-K - 8-K - CRYOLIFE INCc199-20180503x8k.htm

Exhibit 99.1





FOR IMMEDIATE RELEASE



Contacts:



CryoLife                                                                             

The Ruth Group

D. Ashley Lee

Tram Bui / Emma Poalillo

Executive Vice President, Chief Financial Officer and Chief Operating Officer

646-536-7035 / 7024

tbui@theruthgroup.com

Phone: 770-419-3355

epoalillo@theruthgroup.com



CryoLife Reports First Quarter 2018 Results



First Quarter and Recent Business Highlights:

·

Total revenues increased 37 percent to $61.9 million in the first quarter of 2018 compared to the first quarter of 2017

·

Non-GAAP revenues increased 9 percent in the first quarter of 2018 compared to the first quarter of 2017; Non-GAAP revenues increased 5 percent on a constant currency basis

·

On-X® revenues increased 16 percent in the first quarter of 2018 compared to the first quarter of 2017

·

JOTEC® revenues were $14.5 million in the first quarter of 2018

·

Non-GAAP JOTEC revenues increased 20 percent in the first quarter of 2018 compared to first quarter of 2017 

·

GAAP net loss of ($3.9) million, or ($0.11) per fully diluted common share;  Non-GAAP net income of $793,000, or $0.02 per fully diluted common share 



ATLANTA, GA – (May 2,  2018) – CryoLife, Inc. (NYSE: CRY),  a leading cardiac and vascular surgery company focused on aortic disease, announced today its financial results for the first quarter ended March 31, 2018



Pat Mackin, Chairman, President, and Chief Executive Officer, said, “Our solid first quarter results established a strong start to the year with revenue growth across all four of our major product lines, and strong revenue growth in our On-X and JOTEC product lines.  In the first quarter, On-X posted revenue growth of 16 percent and JOTEC posted non-GAAP revenue growth of 20 percent.    We believe that this growth confirms that our strategy of focusing on highly differentiated products in aortic repair, through a highly trained direct sales force, is working.  Importantly, the JOTEC integration remains on track and we expect incremental margin benefit from our direct sales strategy.  



Mr. Mackin added,  We remain excited about the R&D pipeline from JOTEC, as we continue advancing  the clinical development of BioGlue® China and PerClot®When we combine these initiatives, we have the potential to increase our current addressable market by approximately $1 billion above and beyond the $2 billion market opportunity we have following the JOTEC acquisitionGiven our strong momentum, we are optimistic that 2018 will prove to be another successful year as we believe we will be able to accomplish our key operational goals and achieve our full year guidance.”


 



Revenues for the first quarter of 2018 increased 37 percent to $61.9 million, compared to $45.1 million for the first quarter of 2017.  The increase was primarily driven by $14.5 million in revenues from JOTEC and revenue growth in On-X,  and to a lesser extent, tissue processing and BioGlue.  Non-GAAP revenues for the first quarter of 2018 increased 9 percent compared to the first quarter of 2017, and increased 5 percent on a constant currency basis.    A reconciliation of GAAP to non-GAAP financial metrics is included as part of this press release.



Net loss for the first quarter of 2018 was ($3.9)  million, or ($0.11) per fully diluted common share, compared to net income of $2.2 million, or $0.06 per fully diluted common share for the first quarter of 2017.  Non-GAAP net income for the first quarter of 2018 was $793,000, or $0.02 per fully diluted common share, compared to non-GAAP net income of $3.9 million, or $0.11 per fully diluted common share for the first quarter of 2017. 



The Company is reiterating its full year 2018 financial guidance, as summarized below, and expects revenues in the second quarter of 2018 to be between $63.0 million and $65 million.



Total Revenues

$250.0 million - $256.0 million

Gross Margins

65.5% - 66.5%

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

R&D Expenses

$23.0 million - $25.0 million

Non-GAAP Tax Rate

Mid 20%

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

Non-GAAP EPS

$0.29 - $0.32

(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 period in 2017 prior to the closing of the acquisition of JOTEC on December 1, 2017.  The Company’s other non-GAAP results exclude (as applicable) business development and integration expenses; gain on sale of business components; amortization expenses; and inventory basis step-up expense.  The Company believes that these non-GAAP

 

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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,  May 3, 2018 at 8:00 a.m. ET 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. ET.  A replay of the teleconference will be available through May 10, and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13678913.



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 90 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 our forecasted revenues, gross margins, R&D expenses, income tax rate and non-GAAP earnings per share; our forecasted integration and related expenses, depreciation expense, amortization expense and interest expense for 2018; our belief that our revenue growth confirms that our strategy of focusing on highly differentiated products in aortic repair, through a highly trained direct sales force, is working; our belief that the JOTEC integration remains on track; our expectation that we will have incremental margin benefit from our direct sales strategy; our belief that we have the potential to increase our current addressable market by approximately $1 billion above and beyond the $2 billion market opportunity we have following the JOTEC acquisition; and our beliefs that 2018 will prove to be another successful year and that we will be able to accomplish our key operational goals and achieve our full year guidance for 2018; our belief that our BioGlue China clinical trial is on track for potential regulatory approval in the second half of

 

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2019 and our PerClot FDA clinical trial is on track for potential regulatory approval between the second half of 2019 and first half of 2020; 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 the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for year ended December 31, 2017. These risks and uncertainties also include that our beliefs regarding the benefits of the On-X and JOTEC acquisitions, including that these acquisitions provide us with product portfolios that are technologically and clinically differentiated and offer strong competitive advantages, substantially enhance our growth potential and ability to drive profitable growth, strengthen our direct sales force, significantly accelerate our going direct strategy, increase our cross-selling opportunities, and significantly enhance our R&D capabilities and pipeline may be incorrect; our projections of markets sizes and revenue growth rates for our four product lines, clinical trial timelines and clearance or approval times for new products or new indications may be incorrect or may change over time. As with most acquisitions, the successful integration of JOTEC’s business with ours may take longer and prove more costly than expected, and we may experience currently unforeseen difficulties related to the JOTEC products and our combined sales forces’ ability to successfully market them.  If we experience problems that slow the integration of JOTEC's business with CryoLife’s business, we may not be able to secure the anticipated financial and operational benefits of the acquisition as soon as anticipated, or at all.  We may also inherit unforeseen risks and uncertainties related to JOTEC's business, particularly if the information received by CryoLife during the due diligence phase of this transaction was incomplete or inaccurate. Our plans with respect to the transaction’s financing could change based on currently unforeseen circumstances. CryoLife does not undertake to update its forward-looking statements, whether as a result of new information, future events, or otherwise.  



 

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CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)







 

 

 

 

 

 



 

(Unaudited)



 

Three Months Ended



 

March 31,



 

2018

 

2017

Revenues:

 

 

 

 

 

 

Products

 

$

43,598 

 

$

27,396 

Preservation services

 

 

18,350 

 

 

17,663 

Total revenues

 

 

61,948 

 

 

45,059 



 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

Products

 

 

14,157 

 

 

8,017 

Preservation services

 

 

8,563 

 

 

7,530 

Total cost of products and preservation services

 

 

22,720 

 

 

15,547 



 

 

 

 

 

 

Gross margin

 

 

39,228 

 

 

29,512 



 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

General, administrative, and marketing

 

 

37,348 

 

 

22,871 

Research and development

 

 

5,370 

 

 

4,093 

Total operating expenses

 

 

42,718 

 

 

26,964 



Operating (loss) income

 

 

(3,490)

 

 

2,548 



 

 

 

 

 

 

Interest expense

 

 

3,656 

 

 

801 

Interest income

 

 

(59)

 

 

(40)

Other (income) expense, net

 

 

(181)

 

 

43 



 

 

 

 

 

 



(Loss) income before income taxes

 

 

(6,906)

 

 

1,744 

Income tax benefit

 

 

(3,051)

 

 

(479)



 

 

 

 

 

 

Net (loss) income

 

$

(3,855)

 

$

2,223 



 

 

 

 

 

 

(Loss) income per common share:

 

 

 

 

 

 

Basic

 

$

(0.11)

 

$

0.07 

Diluted

 

$

(0.11)

 

$

0.06 



 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

Basic

 

 

36,146 

 

 

32,439 

Diluted

 

 

36,146 

 

 

33,604 



 

 

 

 

 

 



 

 

 

 

 

 



 

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CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)





 

 

 

 

 

 



 

(Unaudited)



 

Three Months Ended



 

March 31,



 

2018

 

2017

Products:

 

 

 

 

 

 

BioGlue and BioFoam

 

$

15,970 

 

$

15,681 

JOTEC

 

 

14,460 

 

 

-

On-X

 

 

10,309 

 

 

8,860 

CardioGenesis cardiac laser therapy

 

 

1,346 

 

 

1,585 

PerClot

 

 

972 

 

 

819 

PhotoFix

 

 

541 

 

 

451 

Total Products

 

 

43,598  27,396 



 

 

Preservation services:

 

 

 

 

 

 

Cardiac tissue

 

 

8,103 

 

 

7,502 

Vascular tissue

 

 

10,247 

 

 

10,161 

Total preservation services

 

 

18,350 

 

 

17,663 



 

 

 

 

 

 

Total revenues

 

$

61,948 

 

$

45,059 



 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

U.S.

 

$

34,888 

 

$

33,534 

International

 

 

27,060 

 

 

11,525 

Total revenues

 

$

61,948 

 

$

45,059 



 

 

 

 

 

 



 

 

 

 

 

 











(Unaudited)

 

 



March 31,

 

December 31,



2018

 

2017



 

 

 

 

 

Cash, cash equivalents, and restricted securities

$

27,392 

 

$

40,753 

Total current assets

 

165,093 

 

 

179,280 

Total assets

 

583,175 

 

 

589,693 

Total current liabilities

 

32,888 

 

 

42,940 

Total liabilities

 

302,187 

 

 

312,635 

Shareholders’ equity

 

280,988 

 

 

277,058 



 

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CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Net (Loss) Income and Diluted (Loss) Income Per Common Share

(In thousands, except per share data)





 

 

 

 

 

 



 

(Unaudited)



 

Three Months Ended



 

March 31,



 

2018

 

2017



 

 

 

 

 

 

GAAP:

 

 

 

 

 

 

(Loss) income before income taxes

 

$

(6,906)

 

$

1,744

Income tax benefit

 

 

(3,051)

 

 

(479)

Net (loss) income

 

$

(3,855)

 

$

2,223



 

 

 

 

 

 

Diluted (loss) income per common share:

 

$

(0.11)

 

$

0.06



 

 

 

 

 

 

Reconciliation of income before income taxes,

 

 

 

 

 

 

GAAP to adjusted net income, non-GAAP:

 

 

 

 

 

 



 

 

 

 

 

 

(Loss) income before income taxes, GAAP

 

$

(6,906)

 

$

1,744 

Adjustments:

 

 

 

 

 

 

Business development and integration expenses

 

 

3,722 

 

 

288 

Amortization expense

 

 

2,735

 

 

1,142 

  Inventory basis step-up expense

 

 

1,506 

 

 

2,049 

Adjusted income before income taxes,

 

 

 

 

 

 

non-GAAP

 

 

1,057 

 

 

5,223 



 

 

 

 

 

 

Income tax expense calculated at a

 

 

 

 

 

 

    pro forma tax rate of 25%

 

 

264 

 

 

1,306 

Adjusted net income, non-GAAP

 

$

793 

 

$

3,917 



 

 

 

 

 

 

Reconciliation of diluted (loss) income per common

 

 

 

 

 

 

      share, GAAP to adjusted diluted (loss) income per

 

 

 

 

 

 

common share, non-GAAP:

 

 

 

 

 

 



 

 

 

 

 

 

Diluted (loss) income per common share – GAAP

 

$

(0.11)

 

$

0.06 

Adjustments:

 

 

 

 

 

 

  Business development and integration expenses

 

 

0.10 

 

 

0.01 

Amortization expense

 

 

0.07 

 

 

0.03 

Inventory basis step-up expense

 

 

0.04 

 

 

0.06 

Tax effect of non-GAAP adjustments

 

 

(0.05)

 

 

(0.02)

Effect of 25% pro forma tax rate

 

 

(0.03)

 

 

(0.03)

Adjusted diluted income per common share,

 

 

 

 

 

 

   non-GAAP:

 

$

0.02

 

$

0.11



 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

      shares outstanding:

 

 

36,985

 

 

33,604



 

 

 

 

 

 



 

 

 

 

 

 



 

 

 

 

 

 



 

 

 

 

 

 







 

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CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Revenues; Gross Margin; General, Administrative, and Marketing

Adjusted EBITDA

(In thousands, except per share data)





 

 

 

 

 

 

 

 



 

(Unaudited)



 

Three Months Ended



 

March 31,



 

2018

 

2017

 

Growth Rate



 

 

 

 

 

 

 

 

Reconciliation of total revenues, GAAP to

 

 

 

 

 

 

 

 

total revenues, non-GAAP:

 

 

 

 

 

 

 

 

Total revenues, GAAP

 

$

61,948

 

$

45,059

 

37%

Plus: JOTEC pre-acquisition revenues

 

 

--

 

 

12,006

 

 

Total revenues, non-GAAP

 

 

61,948

 

 

57,065

 

9%

Impact of changes in currency exchange

 

 

--

 

 

2,193

 

 

Total constant currency revenues, non-GAAP

 

$

61,948

 

$

59,258

 

5%



 

 

 

 

 

 

 

 



 

(Unaudited)

 

 



 

Three Months Ended

 

 



 

March 31,

 

 



 

 

2018

 

 

2017

 

 

Reconciliation of gross margin %, GAAP to

 

 

 

 

 

 

 

 

gross margin %, non-GAAP:

 

 

 

 

 

 

 

 

Total revenues, GAAP

 

$

61,948

 

$

45,059

 

 

Gross margin, GAAP

 

$

39,228

 

$

29,512

 

 

Gross margin %, GAAP

 

 

63% 

 

 

65% 

 

 



 

 

 

 

 

 

 

 

Gross margin, GAAP

 

$

39,228

 

$

29,512

 

 

Plus: Inventory basis step-up expense

 

 

1,506

 

 

2,049

 

 

Gross margin, non-GAAP

 

$

40,734

 

$

31,561

 

 

Gross margin %, non-GAAP

 

 

66% 

 

 

70% 

 

 



 

 

 

 

 

 

 

 



 

(Unaudited)

 

 



 

Three Months Ended

 

 



 

March 31,

 

 



 

 

2018

 

 

2017

 

 

Reconciliation of general, administrative, and marketing, GAAP

 

 

 

 

 

 

 

 

to general, administrative, and marketing, non-GAAP:

 

 

 

 

 

 

 

 

General, administrative, and marketing, GAAP

 

$

37,348

 

$

22,871

 

 

Less: Business development and integration expenses

 

 

(3,722)

 

 

(288)

 

 

General, administrative, and marketing, non-GAAP

 

$

33,626

 

$

22,583

 

 



 

 

 

 

 

 

 

 



 

(Unaudited)

 

 



 

Three Months Ended

 

 



 

March 31,

 

 



 

 

2018

 

 

2017

 

 

Reconciliation of net (loss) income, GAAP

 

 

 

 

 

 

 

 

to adjusted EBITDA, non-GAAP:

 

 

 

 

 

 

 

 

Net (loss) income, GAAP

 

$

(3,855)

 

$

2,223

 

 

Adjustments:

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

 

4,376

 

 

2,168

 

 

Income tax benefit

 

 

(3,051)

 

 

(479)

 

 

Interest income

 

 

(59)

 

 

(40)

 

 

Interest expense

 

 

3,656

 

 

801

 

 

Inventory basis step-up expense

 

 

1,506

 

 

2,049

 

 

Business development and integration expenses

 

 

3,722

 

 

288

 

 

Stock-based compensation expense

 

 

1,248

 

 

1,796

 

 

Adjusted EBITDA, non-GAAP

 

$

7,543

 

$

8,806

 

 



 

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