CryoLife Reports Third Quarter 2021 Financial Results

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ATLANTANov. 4, 2021 /PRNewswire/ —

Third Quarter and Recent Business Highlights:

  • Achieved total revenues of $72.2 million in the third quarter 2021 versus $65.1 million in the third quarter of 2020, an increase of 11% on a GAAP basis and 9% on a non-GAAP proforma constant currency basis
  • Net income was $10.6 million, or $0.26 per share, in the third quarter of 2021
  • Non-GAAP net loss was ($1.2) million, or ($0.03) per share, in the third 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 third quarter ended September 30, 2021.

“Despite meaningful headwinds from the Delta variant in the third quarter, we still generated revenue growth on both a GAAP and pro forma constant currency basis compared to the prior year and compared to 2019, driven by our recent product launches and strength in our U.S. On-X aortic valve business. We’ve also made progress in driving growth across APAC and LATAM as we continue to expand our commercial footprint and seek new regulatory approvals,” said Pat Mackin, Chairman, President, and Chief Executive Officer.

“Additionally, we have submitted PMAs to FDA for PerClot and PROACT Mitral and anticipate receiving approvals for both in 2022. We’ve also made significant progress with enrollment in our PROACT Xa clinical trial and continue to advance several other programs which are expected to deliver incremental growth beginning in 2024.”

“Given our solid financial foundation, performance of our new products, market expansion opportunities and a strong pipeline, CryoLife is very well positioned now and for the future.”

Third Quarter 2021 Financial Results
Total revenues for the third quarter of 2021 were $72.2 million, reflecting an increase of 11% on a GAAP basis and 9% on a non-GAAP proforma constant currency basis, both compared to the third quarter of 2020.

Net income for the third quarter of 2021 was $10.6 million, or $0.26 per fully diluted common share, compared to net loss of ($2.9) million, or ($0.08) per fully diluted common share for the third quarter of 2020. Non-GAAP net loss for the third quarter of 2021 was ($1.2) million, or ($0.03) per fully diluted common share, compared to non-GAAP net income of $4.9 million, or $0.13 per fully diluted common share for the third 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 November 5, 2021.

2021 Financial Outlook
The Company is maintaining its second half of 2021 proforma constant currency growth outlook of between 7 and 10% compared to the second half of 2019, but due to the strengthening dollar, revenues for the full year are expected to be between $296.0 and $299.0 million dollars and fourth quarter revenues are expected to be between $76.5 and $79.5 million dollars, reflecting pro forma constant currency growth of between 9.5% and 13.7% over the fourth quarter of 2019. This forecast is based on our estimates of the current and an anticipated diminishing impact of COVID-19 on our business.

The Company’s financial performance for the remainder of 2021 and future periods is subject to the risks identified below.

Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including non-GAAP revenue, non-GAAP net income, non-GAAP EBITDA, and non-GAAP adjusted operating income. 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 are adjusted for revenues of acquired and divested product lines and the impact of changes in currency exchange. The Company’s non-GAAP net income, non-GAAP EBITDA, and non-GAAP adjusted operating income results exclude (as applicable) business development, integration, and severance expense; gain from sale of non-financial assets; depreciation and amortization expense; interest income and expense; non-cash interest expense; loss (gain) on foreign currency revaluation; stock-based compensation expense; corporate rebranding expense; and income tax expense (benefit). The Company generally uses non-GAAP financial measures to facilitate management’s review of the operational performance of the company and as a basis for strategic planning. Company management 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 adjusted for the impact of acquired and divested product lines and changes in currency exchange from certain revenues to evaluate comparable product 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. Company management encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.

Webcast and Conference Call Information
The Company will hold a teleconference call and live webcast later today, November 4, 2021 at 4:30 p.m. ET to discuss the results followed by a question and answer session. To participate in the conference call dial 862-298-0702. An audio replay will be available through November 11, 2021 and can be accessed by dialing (toll free) 877-660-6853 or 201-612-7415. The Conference ID for the replay is 13724263.

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. Forward-looking statements include statements related to future regulatory approvals, the progress and future results of clinical trials, future product launches, commercial footprint expansion, market performance of our current and future products, revenue and earnings growth related to current and newly introduced products, our forecasted revenue and earnings, and the effects of the COVID-19 pandemic on our business. 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, that the benefits anticipated from our clinical trials may not be achieved or achieved on our anticipated timelines, that our product candidates may not receive regulatory approval or receive regulatory approval on our anticipated timelines, that our products that obtain regulatory approval may not be accepted by the market, 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.

Contacts:

CryoLife

Gilmartin Group LLC

D. Ashley Lee

Brian Johnston / Lynn Lewis

Executive Vice President, Chief Financial Officer and

Phone: 631-807-1986

Chief Operating Officer

investors@cryolife.com 

Phone: 770-419-3355

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations and Comprehensive Income/(Loss)

(In thousands, except per share data)

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2021

2020

2021

2020

Revenues:

Products

$

53,107

$

45,109

$

162,528

$

128,797

Preservation services

19,100

20,022

56,914

56,534

Total revenues

72,207

65,131

219,442

185,331

Cost of products and preservation services:

Products

15,503

12,998

46,592

36,078

Preservation services

8,915

9,001

26,710

26,060

Total cost of products and preservation services

24,418

21,999

73,302

62,138

Gross margin

47,789

43,132

146,140

123,193

Operating expenses:

General, administrative, and marketing

39,053

33,743

118,521

105,033

Research and development

9,972

5,755

26,086

17,633

Total operating expenses

49,025

39,498

144,607

122,666

Gain from sale of non-financial assets

(15,923)

(15,923)

Operating income

14,687

3,634

17,456

527

Interest expense

4,100

4,940

12,995

11,980

Interest income

(18)

(13)

(60)

(181)

Other expense, net

2,661

2,888

3,261

5,810

Income (loss) before income taxes

7,944

(4,181)

1,260

(17,082)

Income tax benefit

(2,638)

(1,311)

(4,006)

(3,858)

Net income (loss)

$

10,582

$

(2,870)

$

5,266

$

(13,224)

Income (loss) per share:

Basic

$

0.27

(0.08)

$

0.13

(0.35)

Diluted

$

0.26

$

(0.08)

$

0.13

$

(0.35)

Weighted-average common shares outstanding:

Basic

39,086

37,912

38,924

37,608

Diluted

44,453

37,912

39,496

37,608

Net income (loss)

$

10,582

$

(2,870)

$

5,266

$

(13,224)

Other comprehensive income (loss):

Foreign currency translation adjustments

(5,010)

8,698

(12,327)

8,669

Comprehensive income (loss)

$

5,572

$

5,828

$

(7,061)

$

(4,555)

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(In thousands)

September 30,

December 31,

2021

2020

(Unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$

64,587

$

61,412

Restricted securities

538

546

Trade receivables, net

49,682

45,964

Other receivables

5,494

2,788

Inventories, net

78,319

73,038

Deferred preservation costs

42,619

36,546

Prepaid expenses and other

16,104

14,295

Total current assets

257,343

234,589

Goodwill

252,441

260,061

Acquired technology, net

171,788

186,091

Operating lease right-of-use assets, net

46,913

18,571

Other intangibles, net

36,001

40,966

Property and equipment, net

36,973

33,077

Deferred income taxes

3,974

1,446

Other assets

13,221

14,603

Total assets

$

818,654

$

789,404

LIABILITIES AND SHAREHOLDERS’ EQUITY

Current liabilities:

Current portion of contingent consideration

$

17,600

$

16,430

Accounts payable

9,528

9,623

Accrued compensation

11,990

10,192

Accrued expenses

9,091

7,472

Accrued procurement fees

3,296

3,619

Taxes payable

3,129

2,808

Current maturities of operating leases

3,053

5,763

Current portion of long-term debt

1,640

1,195

Other liabilities

1,803

3,366

Total current liabilities

61,130

60,468

Long-term debt

307,765

290,468

Non-current maturities of operating leases

45,765

14,034

Contingent consideration

47,300

43,500

Deferred income taxes

27,339

34,713

Deferred compensation liability

5,571

5,518

Other liabilities

12,243

11,990

Total liabilities

$

507,113

$

460,691

Commitments and contingencies

Shareholders’ equity:

Preferred stock

Common stock (issued shares of 40,816 in 2021 and 40,394 in 2020)

408

404

Additional paid-in capital

309,290

316,192

Retained earnings

22,075

20,022

Accumulated other comprehensive (loss) income

(5,584)

6,743

Treasury stock, at cost, 1,487 shares as of September 30, 2021

 and December 31, 2020, respectively

(14,648)

(14,648)

Total shareholders’ equity

311,541

328,713

Total liabilities and shareholders’ equity

$

818,654

$

789,404

CryoLife, Inc. and Subsidiaries

Condensed Consolidated Statement of Cash Flows

(In thousands)

(Unaudited)

Nine Months Ended

September 30,

2021

2020

Net cash flows from operating activities:

Net income (loss)

$

5,266

$

(13,224)

Adjustments to reconcile net income (loss) to net cash from operating activities:

Depreciation and amortization

18,008

14,818

Non-cash compensation

7,471

7,432

Non-cash lease expense

5,566

5,324

Change in fair value of contingent consideration

4,970

Non-cash interest expense

2,025

2,261

Change in fair value of long-term loan

4,949

Deferred income taxes

(8,128)

(4,916)

Gain from sale of non-financial assets

(15,923)

Other

4,665

1,631

Changes in operating assets and liabilities:

Accounts payable, accrued expenses, and other liabilities

65

3,230

Prepaid expenses and other assets

(2,268)

(2,560)

Receivables

(8,032)

7,718

Inventories and deferred preservation costs

(16,986)

(19,744)

Net cash flows (used in) provided by operating activities

(3,301)

6,919

Net cash flows from investing activities:

Proceeds from sale of non-financial assets, net

19,000

Acquisition of Ascyrus, net of cash acquisition

(59,643)

Payments for Endospan agreements

(5,000)

Capital expenditures

(10,524)

(5,171)

Other

(4)

(968)

Net cash flows provided by (used in) investing activities

8,472

(70,782)

Net cash flows from financing activities:

Proceeds from exercise of stock options and issuance of common stock

3,531

2,079

Proceeds from issuance of convertible debt

100,000

Proceeds from revolving line of credit

30,000

Proceeds from financing insurance premiums

2,816

Repayment of revolving line of credit

(30,000)

Redemption and repurchase of stock to cover tax withholdings

(1,898)

(1,768)

Payment of debt issuance costs

(2,219)

(3,647)

Repayment of debt

(2,397)

(3,727)

Other

(439)

(463)

Net cash flows (used in) provided by financing activities

(3,422)

95,290

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

1,418

(1,086)

Increase in cash, cash equivalents, and restricted securities

3,167

30,341

Cash, cash equivalents, and restricted securities beginning of period

61,958

34,294

Cash, cash equivalents, and restricted securities end of period

$

65,125

$

64,635

CryoLife, Inc. and Subsidiaries

Financial Highlights

 (In thousands)

(Unaudited)

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2021

2020

2021

2020

Products:

Aortic stents and stent grafts

$

20,896

$

15,290

$

62,165

$

43,932

Surgical sealants

16,544

15,811

52,236

44,985

On-X

14,022

12,067

41,843

34,385

Other

1,645

1,941

6,284

5,495

Total products

53,107

45,109

162,528

128,797

Preservation services

19,100

20,022

56,914

56,534

Total revenues

$

72,207

$

65,131

$

219,442

$

185,331

Revenues:

U.S.

$

36,205

$

36,332

$

111,529

$

103,171

International

36,002

28,799

107,913

82,160

Total revenues

$

72,207

$

65,131

$

219,442

$

185,331

CryoLife, Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP

Revenues and Adjusted EBITDA

(In thousands, except per share data)

(Unaudited)

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2021

2020

Growth Rate

2021

2020

Growth Rate

Reconciliation of total revenues, GAAP to

total revenues, non-GAAP:

Total revenues, GAAP

$

72,207

$

65,131

11%

$

219,442

$

185,331

18%

Including AMDS prior to acquisition  

691

2,088

Excluding PerClot post sale

(498)

(498)

Impact of changes in currency exchange

824

4,358

Total proforma constant currency revenue, non-
GAAP

$

72,207

$

66,148

9%

$

219,442

$

191,279

15%

(Unaudited)

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2021

2020

2021

2020

Reconciliation of operating income, GAAP to

adjusted operating income, non-GAAP:

Operating income

$

14,687

$

3,634

$

17,456

$

527

Gain from sale of non-financial assets

(15,923)

(15,923)

Amortization expense

4,203

3,397

12,701

9,430

Operating business development, integration, and
severance expense

1,309

1,056

6,138

2,532

Corporate rebranding expense

461

523

321

Adjusted operating income, non-GAAP

$

4,737

$

8,087

$

20,895

$

12,810

(Unaudited)

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2021

2020

2021

2020

Reconciliation of net income (loss), GAAP to

adjusted EBITDA, non-GAAP:

Net income (loss), GAAP

$

10,582

$

(2,870)

$

5,266

$

(13,224)

Adjustments:

Depreciation and amortization expense

6,009

5,176

18,008

14,818

Interest expense

4,100

4,940

12,995

11,980

Stock-based compensation expense

2,876

2,358

7,471

7,432

Business development, integration, and severance
expense

1,309

6,005

6,138

7,481

Loss (gain) on foreign currency revaluation

2,576

(2,073)

3,097

846

Corporate rebranding expense

461

523

321

Interest income

(18)

(13)

(60)

(181)

Income tax benefit

(2,638)

(1,311)

(4,006)

(3,858)

Gain from sale of non-financial assets

(15,923)

(15,923)

Adjusted EBITDA, non-GAAP

$

9,334

$

12,212

$

33,509

$

25,615

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)

(Unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

2021

2020

2021

2020

GAAP:

Income (loss) before income taxes

$

7,944

$

(4,181)

$

1,260

$

(17,082)

Income tax benefit

(2,638)

(1,311)

(4,006)

(3,858)

Net income (loss)

$

10,582

$

(2,870)

$

5,266

$

(13,224)

Diluted income (loss) per common share:

$

0.26

$

(0.08)

$

0.13

$

(0.35)

Diluted weighted-average common shares outstanding

44,453

37,912

39,496

37,608

Reconciliation of income (loss) before income taxes,

GAAP to adjusted (loss) income, non-GAAP

Income (loss) before income taxes, GAAP:

$

7,944

$

(4,181)

$

1,260

$

(17,082)

Adjustments:

Amortization expense

4,203

3,397

12,701

9,430

Gain from sale of non-financial assets

(15,923)

(15,923)

Business development, integration, and severance expense

1,309

6,005

6,138

7,481

Non-cash interest expense

453

1,371

2,025

2,261

Corporate rebranding expense

461

523

321

Adjusted (loss) income before income taxes,

non-GAAP

(1,553)

6,592

6,724

2,411

Income tax (benefit) expense calculated at a

pro forma tax rate of 25%

(388)

1,648

1,681

603

Adjusted net (loss) income, non-GAAP

$

(1,165)

$

4,944

$

5,043

$

1,808

Reconciliation of diluted income (loss) per common share, GAAP

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

Diluted income (loss) per common share, GAAP:

$

0.26

$

(0.08)

$

0.13

$

(0.35)

Adjustments:

Amortization expense

0.11

0.09

0.33

0.25

Gain from sale of non-financial assets

(0.41)

(0.40)

Business development, integration, and severance expense

0.04

0.16

0.15

0.20

Non-cash interest expense

0.01

0.04

0.05

0.06

Corporate rebranding expense

0.01

0.01

0.01

Tax effect of non-GAAP adjustments

0.06

(0.07)

(0.03)

(0.13)

Effect of 25% pro forma tax rate

(0.11)

(0.01)

(0.11)

0.01

Adjusted diluted (loss) income per common share,

non-GAAP

$

(0.03)

$

0.13

$

0.13

$

0.05

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:

44,453

37,912

39,496

37,608

Adjustments:

Effect of dilutive stock options and awards

(505)

445

543

Effect of convertible senior notes

(4,862)

Diluted weighted-average common shares outstanding, non-GAAP

39,086

38,357

39,496

38,151

SOURCE CryoLife, Inc.

Related Links

http://www.cryolife.com

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