CryoLife Reports First Quarter 2021 Financial Results

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ATLANTAApril 29, 2021 /PRNewswire/ —

First Quarter and Recent Business Highlights:

  • Achieved total revenues of $71.1 million in the first quarter 2021 versus $66.4 million in the first quarter of 2020, an increase of 7% on a GAAP basis and 3% on a non-GAAP proforma constant currency basis
  • Net loss was ($3.1) million, or ($0.08) per share, in the first quarter of 2021
  • Non-GAAP net income was $1.4 million, or $0.03 per share, in the first quarter of 2021

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, 2021.

“Despite the ongoing impact of COVID-19 on our business, we saw our business return to growth on both a GAAP and proforma constant currency basis in the first quarter.  Growth was driven by our new product launches outside of the U.S., a recovery in procedure volume in the U.S., an improved JOTEC inventory position, and our international expansion efforts, evidenced by double digit revenue growth in both Asia and Europe,” commented Pat Mackin, Chairman, President, and Chief Executive Officer.

“Additionally, we made progress on our regulatory strategy and are on-track to file PMAs for PerClot and PROACT Mitral later in 2021, which should help drive growth in 2022 and 2023.  We also made solid progress on enrollment in our PROACT Xa clinical trial and advanced R&D programs that should deliver additional growth opportunities beginning in 2024.  We are optimistic that the second half of 2021 will be the start of a prolonged period of growth for CryoLife.”

First Quarter 2021 Financial Results
Total revenues for the first quarter of 2021 were $71.1 million, reflecting an increase of 7% on a GAAP basis and 3% on a non-GAAP proforma constant currency basis, both compared to the first quarter of 2020.

Net loss for the first quarter of 2021 was $(3.1) million, or $(0.08) per fully diluted common share, compared to net loss of ($6.7) million, or ($0.18) per fully diluted common share for the first quarter of 2020.  Non-GAAP net income for the first quarter of 2021 was $1.4 million, or $0.03 per fully diluted common share, compared to non-GAAP net loss of ($2.7) million, or ($0.07) per fully diluted common share for the first quarter of 2020.

The financial results reported in this earnings release are preliminary pending the Company’s filing of its quarterly report on Form 10-Q, which it expects to file on April 30, 2021.

2021 Financial Outlook
Due to continued uncertainties resulting from the COVID-19 global pandemic, particularly in Europe, the Company is not issuing full year 2021 financial guidance at this time.

The Company’s financial performance for 2021 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 net income and non-GAAP EBITDA results exclude (as applicable) business development, integration, and severance expense; depreciation and amortization expense; interest income and expense; non-cash interest expense; loss on foreign currency revaluation; stock-based compensation expense; corporate rebranding expense; and income tax expense (benefit).  The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions; 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; and the operating expense structure excluding fluctuations resulting from foreign currency revaluation and stock-based compensation expense.  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 has excluded the impact of changes in currency exchange from certain revenues to evaluate growth rates on a constant currency basis.  The Company does, however, expect to incur similar types of expenses and currency exchange impacts 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 later today, April 29, 2021 at 4:30 p.m. ET to discuss the results followed by a question and answer session.  To listen to the live teleconference, please dial 201-689-8261.  A replay of the teleconference will be available through May 6, 2021 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The Conference ID for the replay is 13718912.

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 100 countries worldwide.  For additional information about CryoLife, visit our website, www.cryolife.com.

Forward Looking Statements
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.  Readers are cautioned not to place undue reliance on these forward-looking statements, which are made as of the date of this press release and reflect the view of management as of the date of this press release.  Such forward-looking statements reflect the views of management at the time such statements are made.  These statements include our beliefs that our PMAs for PerClot and PROACT Mitral, if approved, should help drive our growth in 2022 and 2023; our PROACT Xa clinical trial and advanced R&D programs, if successful, should deliver additional growth opportunities for us beginning in 2024; and the second half of 2021 will be the start of a prolonged period of growth for CryoLife. 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, including that the benefits anticipated from the Ascyrus Medical LLC transaction and Endospan distribution agreement may not be achieved and the continued effects of COVID-19, including decelerating vaccination or vaccine adoption rates, or government mandates implemented to address the effects of the pandemic could adversely impact our results.  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, 2020.  CryoLife does not assume any obligation, and expressly disclaims any duty to update any of its forward-looking statements, whether as a result of new information, future events, or otherwise.

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except per share data)

(Unaudited)

Three Months Ended

March 31,

2021

2020

Revenues:

Products

$

53,345

$

46,420

Preservation services

17,742

20,009

Total revenues

71,087

66,429

Cost of products and preservation services:

Products

14,911

13,040

Preservation services

8,338

9,218

Total cost of products and preservation services

23,249

22,258

Gross margin

47,838

44,171

Operating expenses:

General, administrative, and marketing

38,638

39,002

Research and development

7,754

6,356

Total operating expenses

46,392

45,358

Operating income (loss)

1,446

(1,187)

Interest expense

4,040

3,388

Interest income

(24)

(102)

Other expense, net

1,931

3,662

Loss before income taxes

(4,501)

(8,135)

Income tax benefit

(1,363)

(1,470)

Net loss

$

(3,138)

$

(6,665)

Loss per common share:

Basic

$

(0.08)

$

(0.18)

Diluted

$

(0.08)

$

(0.18)

Weighted-average common shares outstanding:

Basic

38,738

37,390

Diluted

38,738

37,390

Net loss

$

(3,138)

$

(6,665)

Other comprehensive loss:

Foreign currency translation adjustments

(10,290)

(4,463)

Comprehensive loss

$

(13,428)

$

(11,128)

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands)

March 31,

December 31,

2021

2020

(Unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$

56,552

$

61,412

Restricted securities

550

546

Trade receivables, net

48,320

45,964

Other receivables

2,416

2,788

Inventories

73,375

73,038

Deferred preservation costs

39,250

36,546

Prepaid expenses and other

15,220

14,295

Total current assets

235,683

234,589

Goodwill

253,950

260,061

Acquired technology, net

178,964

186,091

Other intangibles, net

39,274

40,966

Operating lease right-of-use assets, net

39,073

18,571

Property and equipment, net

31,497

33,077

Deferred income taxes

1,657

1,446

Other assets

14,734

14,603

Total assets

$

794,832

$

789,404

LIABILITIES AND SHAREHOLDERS’ EQUITY

Current liabilities:

Current portion of contingent consideration

$

16,800

$

16,430

Accrued compensation

10,644

10,192

Accounts payable

8,952

9,623

Accrued expenses

8,564

7,472

Accrued procurement fees

3,402

3,619

Current maturities of operating leases

1,548

5,763

Current portion of long-term debt

1,174

1,195

Taxes payable

3,229

2,808

Other liabilities

3,705

3,366

Total current liabilities

58,018

60,468

Long-term debt

310,058

290,468

Contingent consideration

44,100

43,500

Non-current maturities of operating leases

38,441

14,034

Deferred income taxes

29,272

34,713

Deferred compensation liability

5,436

5,518

Other liabilities

12,176

11,990

Total liabilities

$

497,501

$

460,691

Commitments and contingencies

Shareholders’ equity:

Preferred stock

Common stock (issued shares of 40,585 in 2021 and 40,394 in 2020)

406

404

Additional paid-in capital

301,449

316,192

Retained earnings

13,671

20,022

Accumulated other comprehensive (loss) income

(3,547)

6,743

Treasury stock, at cost, 1,487 shares as of March 31, 2021
 and December 31, 2020, respectively

(14,648)

(14,648)

Total shareholders’ equity

297,331

328,713

Total liabilities and shareholders’ equity

$

794,832

$

789,404

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statement of Cash Flows

(In thousands)

(Unaudited)

Three Months Ended

March 31,

2021

2020

Net cash flows from operating activities:

Net loss

$

(3,138)

$

(6,665)

Adjustments to reconcile net loss to net cash from operating activities:

Depreciation and amortization

6,006

4,898

Non-cash compensation

2,480

2,564

Non-cash lease expense

1,758

1,746

Write-down of inventories and deferred preservation costs

1,274

720

Change in fair value of contingent consideration

970

Deferred income taxes

(4,241)

(265)

Other

787

461

Changes in operating assets and liabilities:

Accounts payable, accrued expenses, and other liabilities

1,590

(2,489)

Prepaid expenses and other assets

(1,291)

982

Receivables

(3,301)

3,557

Inventories and deferred preservation costs

(5,933)

(2,874)

Net cash flows (used in) provided by operating activities

(3,039)

2,635

Net cash flows from investing activities:

Capital expenditures

(1,502)

(2,539)

Other

692

(364)

Net cash flows used in investing activities

(810)

(2,903)

Net cash flows from financing activities:

Proceeds from revolving line of credit

30,000

Proceeds from exercise of stock options and issuance of common stock

861

1,064

Redemption and repurchase of stock to cover tax withholdings

(1,813)

(1,712)

Repayment of debt

(701)

(691)

Other

(442)

(146)

Net cash flows (used in) provided by financing activities

(2,095)

28,515

Effect of exchange rate changes on cash, cash equivalents, and restricted securities

1,088

1,336

(Decrease) increase in cash, cash equivalents, and restricted securities

(4,856)

29,583

Cash, cash equivalents, and restricted securities beginning of period

61,958

34,294

Cash, cash equivalents, and restricted securities end of period

$

57,102

$

63,877

CryoLife, Inc. and Subsidiaries

Financial Highlights

(In thousands)

(Unaudited)

Three Months Ended

March 31,

2021

2020

Products:

Aortic stents and stent grafts

$

20,205

$

15,468

Surgical sealants

17,828

16,737

On-X

13,095

12,202

Other

2,217

2,013

Total products

53,345

46,420

Preservation services

17,742

20,009

Total revenues

$

71,087

$

66,429

Revenues:

U.S.

$

36,318

$

36,447

International

34,769

29,982

Total revenues

$

71,087

$

66,429

CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Revenues and Adjusted EBITDA

(In thousands, except per share data)

(Unaudited)

Three Months Ended

March 31,

2021

2020

Growth
Rate

Reconciliation of total revenues, GAAP to

total revenues, non-GAAP:

Total revenues, GAAP

$

71,087

$

66,429

7%

Including AMDS prior to acquisition  

698

Total GAAP revenues including
AMDS

71,087

67,127

6%

Impact of changes in currency exchange

1,725

Total constant currency revenues including
AMDS, non-GAAP

$

71,087

$

68,852

3%

(Unaudited)

Three Months Ended

$

2021

2020

Reconciliation of operating income (loss), GAAP to

adjusted operating income, non-GAAP:

Operating income (loss)

$

1,446

$

(1,187)

Amortization expense

4,260

3,033

Business development, integration, and severance expense

1,470

823

Adjusted operating income, non-GAAP

$

7,176

$

2,669

(Unaudited)

Three Months Ended

March 31,

2021

2020

Reconciliation of net loss, GAAP to

adjusted EBITDA, non-GAAP:

Net loss, GAAP

$

(3,138)

$

(6,665)

Adjustments:

Depreciation and amortization expense

6,006

4,898

Interest expense

4,040

3,388

Stock-based compensation expense

2,480

2,564

Loss on foreign currency revaluation

1,886

3,663

Business development, integration, and severance expense

1,470

823

Corporate rebranding expense

15

321

Interest income

(24)

(102)

Income tax benefit

(1,363)

(1,470)

Adjusted EBITDA, non-GAAP

$

11,372

$

7,420

CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

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

(In thousands, except per share data)

(Unaudited)

Three Months Ended

March 31,

2021

2020

GAAP:

Loss before income taxes

$

(4,501)

$

(8,135)

Income tax benefit

(1,363)

(1,470)

Net loss

$

(3,138)

$

(6,665)

Diluted loss per common share:

$

(0.08)

$

(0.18)

Diluted weighted-average common

shares outstanding

38,738

37,390

Reconciliation of loss before income taxes,

GAAP to adjusted income (loss), non-GAAP

Loss before income taxes, GAAP:

$

(4,501)

$

(8,135)

Adjustments:

Amortization expense

4,260

3,033

Business development, integration, and severance expense

1,470

823

Non-cash interest expense

568

405

Corporate rebranding expense

15

321

Adjusted income (loss) before income taxes,

non-GAAP

1,812

(3,553)

Income tax expense (benefit) calculated at a

pro forma tax rate of 25%

453

(888)

Adjusted net income (loss), non-GAAP

$

1,359

$

(2,665)

Reconciliation of diluted loss per common share, GAAP

to adjusted diluted income (loss) per common share, non-GAAP:

Diluted loss per common share, GAAP:

$

(0.08)

$

(0.18)

Adjustments:

Amortization expense

0.11

0.08

Business development, integration, and severance expense

0.04

0.02

Non-cash interest expense

0.01

0.01

Corporate rebranding expense

0.01

Tax effect of non-GAAP adjustments

(0.04)

(0.03)

Effect of 25% pro forma tax rate

(0.01)

0.02

Adjusted diluted income (loss) per common share,

non-GAAP

$

0.03

$

(0.07)

Reconciliation of diluted weighted-average common shares outstanding GAAP

to diluted weighted-average common shares outstanding, non-GAAP:

Diluted weighted-average common shares outstanding, GAAP:

38,738

37,390

Adjustments:

Stock options

326

Contingently returnable shares

289

Diluted weighted-average common shares outstanding, non-GAAP1

39,353

37,390

1- Diluted weighted-average common shares outstanding, non-GAAP does not include the dilutive impact of the Senior Convertible Notes

Contacts:

CryoLife

D. Ashley Lee

Executive Vice President, Chief Financial Officer and

Chief Operating Officer

Phone: 770-419-3355

Gilmartin Group LLC

Brian Johnston / Lynn Lewis

Phone: 631-807-1986

investors@cryolife.com 

SOURCE CryoLife, Inc.

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