25.02.2021 22:01:00

Lantheus Reports Fourth Quarter and Full Year 2020 Financial Results

Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today reported financial results for its fourth quarter and full year ended December 31, 2020.

The Company’s worldwide revenue for the fourth quarter of 2020 totaled $94.2 million, compared with $89.3 million for the fourth quarter of 2019, representing an increase of 5.4% over the prior year period. Full year 2020 worldwide revenues were $339.4 million, compared with $347.3 million for the full year 2019, representing a decrease of 2.3% over the prior year period.

The Company’s fourth quarter 2020 net loss was $3.4 million, or $0.05 per fully diluted share, as compared to net income of $10.5 million, or $0.26 per fully diluted share for the fourth quarter of 2019. Full year 2020 net loss was $13.5 million, or $0.25 per fully diluted share, as compared to net income of $31.7 million, or $0.79 per fully diluted share for the full year 2019.

The Company’s fourth quarter 2020 adjusted fully diluted earnings per share were $0.07, as compared to $0.34 for the fourth quarter of 2019, representing a decrease of 79.9% over the prior year period. The Company’s full year 2020 adjusted fully diluted earnings per share were $0.47, as compared to $1.17 for the full year 2019, representing a decrease of 59.5% over the prior year period.

Lastly, net cash provided by operating activities was $0.6 million and $16.4 million for the fourth quarter and full year 2020. Free Cash Flow was $(3.2) million for the fourth quarter of 2020, representing a decrease of approximately $20.9 million from the prior year period. Full year 2020 free cash flow was $3.9 million, as compared to $58.3 million for the full year 2019, representing a decrease of approximately $54.4 million from the prior year period.

"While 2020 presented extraordinary challenges, I thank our team for continuing to manufacture and deliver products to our customers throughout the year,” said Mary Anne Heino, President and CEO. "Our fourth quarter revenue growth was 5.4% over the prior year period and also represented steady improvement over the prior two quarters of 2020. During 2020, we advanced our strategic mandate by closing the Progenics acquisition in June and receiving FDA approval for DEFINITY RT in November as well as FDA acceptance and Priority Review designation for our PyL NDA in December. In 2021, we will continue to drive sustainable growth, expand product offerings to our customers, improve the lives of the patients we serve, and create value for our shareholders.”

Outlook

The Company guidance for the first quarter and full year 2021 is as follows:

 

 

Guidance Issued February 25, 2021

Q1 FY 2021 Revenue

 

$85 million - $89 million

Q1 FY 2021 Adjusted Fully Diluted EPS

 

$(0.03) - $0.00

 

 

Guidance Issued February 25, 2021

FY 2021 Revenue

 

$385 million - $400 million

FY 2021 Adjusted Fully Diluted EPS

 

$0.34 - $0.39

On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of adjusted fully diluted EPS to GAAP income per common share because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.

Internet Posting of Information

The Company routinely posts information that may be important to investors in the "Investors” section of its website at www.lantheus.com. The Company encourages investors and potential investors to consult its website regularly for important information about the Company.

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Thursday, February 25, 2021 at 4:30 p.m. ET. To access the live conference call via telephone, please dial 1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers) and provide passcode 5247866. A live webcast will be available in the Investors section of the Company’s website at www.lantheus.com.

A replay of the audio webcast will be available in the Investors section of our website at www.lantheus.com approximately two hours after completion of the call and will be archived for 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

About Lantheus Holdings, Inc.

Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow™ serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

Non-GAAP Financial Measures

The Company uses non-GAAP financial measures, such as adjusted net income and its line components; adjusted net income per share - fully diluted; and free cash flow. The Company’s management believes that the presentation of these measures provides useful information to investors. These measures may assist investors in evaluating the Company’s operations, period over period. However, these measures may exclude items that may be highly variable, difficult to predict and of a size that could have a substantial impact on the Company’s reported results of operations for a particular period. Management uses these and other non-GAAP measures internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

This press release includes forward-looking non-GAAP guidance for 2021 adjusted fully diluted EPS. No reconciliation of this forward-looking non-GAAP guidance is included in this press release because, due to the high variability and difficulty in making accurate forecasts and projections of some of the information that would be required to prepare such a reconciliation and the fact that some of the excluded information is not readily ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable GAAP financial measure without unreasonable efforts.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as "anticipate,” "believe,” "confident,” "could,” "estimate,” "expect,” "intend,” "may,” "plan,” "predict,” "project,” "target,” "will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include : (i) the impact of the global COVID-19 pandemic on our business, financial conditions or prospects, or on the timing and enrollment of our clinical trials; (ii) continued market expansion and penetration for our commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition as a result of patent and regulatory exclusivity expirations; (iii) our efforts in new product development, including for PyL, our prostate cancer diagnostic imaging agent, including our ability to obtain U.S. Food and Drug Administration approval of PyL in 2021, and new clinical applications for our products; (iv) our dependence upon third parties for the manufacture and supply of PyL and the timing of that manufacturing capacity becoming available; (v) the global Molybdenum-99 supply; (vi) our products manufactured at Jubilant HollisterStier and our recently-approved modified formulation of DEFINITY ("DEFINITY RT”) to be commercially manufactured at Samsung Biologics; (vii) the continued integration of the Progenics product and product candidate portfolio into our business following the June 2020 consummation of the Progenics acquisition; (viii) our ability to use in-house manufacturing capacity; (ix) the expected timing for commercialization of products we or our strategic partners may develop, including flurpiridaz F 18; (x) our ability to develop highly contextualized assessments of disease burden using artificial intelligence; and (xi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

- Tables Follow -

Lantheus Holdings, Inc.

Consolidated Statements of Operations

(in thousands, except per share data – unaudited)

 

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

 

2020

 

2019

 

2020

 

2019

Revenues

 

$

94,152

 

 

 

$

89,346

 

 

 

$

339,410

 

 

 

$

347,337

 

 

Cost of goods sold

 

55,501

 

 

 

44,781

 

 

 

200,649

 

 

 

172,526

 

 

Gross profit

 

38,651

 

 

 

44,565

 

 

 

138,761

 

 

 

174,811

 

 

Operating expenses

 

 

 

 

 

 

 

 

Sales and marketing

 

12,857

 

 

 

10,392

 

 

 

40,901

 

 

 

41,888

 

 

General and administrative

 

13,684

 

 

 

17,301

 

 

 

69,270

 

 

 

61,244

 

 

Research and development

 

12,638

 

 

 

4,434

 

 

 

32,788

 

 

 

20,018

 

 

Total operating expenses

 

39,179

 

 

 

32,127

 

 

 

142,959

 

 

 

123,150

 

 

Operating (loss) income

 

(528

)

 

 

12,438

 

 

 

(4,198

)

 

 

51,661

 

 

Interest expense

 

2,811

 

 

 

2,126

 

 

 

9,479

 

 

 

13,617

 

 

Loss on extinguishment of debt

 

 

 

 

 

 

 

 

 

 

3,196

 

 

Other (income) loss

 

(496

)

 

 

7,916

 

 

 

(2,198

)

 

 

6,221

 

 

(Loss) income before income taxes

 

$

(2,843

)

 

 

$

2,396

 

 

 

$

(11,479

)

 

 

$

28,627

 

 

Income tax expense (benefit)

 

569

 

 

 

(8,054

)

 

 

1,994

 

 

 

(3,040

)

 

Net (loss) income

 

$

(3,412

)

 

 

$

10,450

 

 

 

$

(13,473

)

 

 

$

31,667

 

 

Net (loss) income per common share:

 

 

 

 

 

 

 

 

Basic

 

$

(0.05

)

 

 

$

0.27

 

 

 

$

(0.25

)

 

 

$

0.81

 

 

Diluted

 

$

(0.05

)

 

 

$

0.26

 

 

 

$

(0.25

)

 

 

$

0.79

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

Basic

 

66,870

 

 

 

39,246

 

 

 

54,134

 

 

 

38,988

 

 

Diluted

 

66,870

 

 

 

40,133

 

 

 

54,134

 

 

 

40,113

 

 

Lantheus Holdings, Inc.

Consolidated Segment Revenues Analysis

(in thousands – unaudited)

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

2020

 

2019

 

% Change

 

2020

 

2019

 

% Change

U.S.

 

 

 

 

 

 

 

 

 

 

 

DEFINITY

58,924

 

 

 

57,678

 

 

 

2.2

 

%

 

207,270

 

 

 

211,777

 

 

 

(2.1

)

%

TechneLite

17,130

 

 

 

17,330

 

 

 

(1.2

)

%

 

69,729

 

 

 

72,534

 

 

 

(3.9

)

%

Other nuclear

10,427

 

 

 

8,225

 

 

 

26.8

 

%

 

36,864

 

 

 

36,231

 

 

 

1.7

 

%

Rebates and allowances

(5,304

)

 

 

(4,518

)

 

 

17.4

 

%

 

(19,067

)

 

 

(16,553

)

 

 

15.2

 

%

Total U.S. Revenues

81,177

 

 

 

78,715

 

 

 

3.1

 

%

 

294,796

 

 

 

303,989

 

 

 

(3.0

)

%

International

 

 

 

 

 

 

 

 

 

 

 

DEFINITY

1,807

 

 

 

1,695

 

 

 

6.6

 

%

 

6,046

 

 

 

5,731

 

 

 

5.5

 

%

TechneLite

5,615

 

 

 

3,264

 

 

 

72.0

 

%

 

16,512

 

 

 

14,058

 

 

 

17.5

 

%

Other nuclear

5,553

 

 

 

5,673

 

 

 

(2.1

)

%

 

22,060

 

 

 

23,574

 

 

 

(6.4

)

%

Rebates and allowances

 

 

 

(1

)

 

 

(100.0

)

%

 

(4

)

 

 

(15

)

 

 

(73.3

)

%

Total International Revenues

12,975

 

 

 

10,631

 

 

 

22.0

 

%

 

44,614

 

 

 

43,348

 

 

 

2.9

 

%

Worldwide

 

 

 

 

 

 

 

 

 

 

 

DEFINITY

60,731

 

 

 

59,373

 

 

 

2.3

 

%

 

213,316

 

 

 

217,508

 

 

 

(1.9

)

%

TechneLite

22,745

 

 

 

20,594

 

 

 

10.4

 

%

 

86,241

 

 

 

86,592

 

 

 

(0.4

)

%

Other nuclear

15,980

 

 

 

13,898

 

 

 

15.0

 

%

 

58,924

 

 

 

59,805

 

 

 

(1.5

)

%

Rebates and allowances

(5,304

)

 

 

(4,519

)

 

 

17.4

 

%

 

(19,071

)

 

 

(16,568

)

 

 

15.1

 

%

Total Revenues

$

94,152

 

 

 

$

89,346

 

 

 

5.4

 

%

 

$

339,410

 

 

 

$

347,337

 

 

 

(2.3

)

%

Lantheus Holdings, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(in thousands, except per share data – unaudited)

 

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

 

2020

 

2019

 

2020

 

2019

Net (loss) income

 

$

(3,412

)

 

 

$

10,450

 

 

 

$

(13,473

)

 

 

$

31,667

 

 

Stock and incentive plan compensation

 

3,623

 

 

 

2,991

 

 

 

14,075

 

 

 

12,571

 

 

Amortization of acquired intangible assets

 

4,683

 

 

 

451

 

 

 

10,770

 

 

 

1,804

 

 

Acquired debt fair value adjustment

 

(326

)

 

 

 

 

 

(711

)

 

 

 

 

Contingent consideration fair value adjustments

 

(2,800

)

 

 

 

 

 

(2,000

)

 

 

 

 

Non-recurring refinancing related fees

 

 

 

 

 

 

 

460

 

 

 

 

 

Non-recurring severance related fees

 

904

 

 

 

 

 

 

904

 

 

 

 

 

Extinguishment of debt

 

 

 

 

 

 

 

 

 

 

3,196

 

 

Arbitration award

 

 

 

 

(3,453

)

 

 

 

 

 

(3,453

)

 

Strategic collaboration and license costs

 

 

 

 

 

 

 

 

 

 

300

 

 

Integration costs

 

2,772

 

 

 

1,488

 

 

 

7,201

 

 

 

1,488

 

 

Acquisition-related costs

 

1,334

 

 

 

2,834

 

 

 

11,856

 

 

 

8,010

 

 

Impairment of long-lived assets

 

2,660

 

 

 

 

 

 

9,935

 

 

 

 

 

Other

 

35

 

 

 

 

 

 

(40

)

 

 

 

 

Income tax effect of non-GAAP adjustments(a)

 

(4,886

)

 

 

(1,134

)

 

 

(13,152

)

 

 

(8,583

)

 

Adjusted net income

 

$

4,587

 

 

 

$

13,627

 

 

 

$

25,825

 

 

 

$

47,000

 

 

Adjusted net income, as a percentage of revenues

 

4.9

 

%

 

15.3

 

%

 

7.6

 

%

 

13.5

 

%

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

 

2020

 

2019

 

2020

 

2019

Net (loss) income per share - diluted

 

$

(0.05

)

 

 

$

0.26

 

 

 

$

(0.25

)

 

 

$

0.79

 

 

Stock and incentive plan compensation

 

0.05

 

 

 

0.07

 

 

 

0.26

 

 

 

0.31

 

 

Amortization of acquired intangible assets

 

0.08

 

 

 

0.01

 

 

 

0.20

 

 

 

0.04

 

 

Acquired debt fair value adjustment

 

 

 

 

 

 

 

(0.01

)

 

 

 

 

Contingent consideration fair value adjustments

 

(0.04

)

 

 

 

 

 

(0.05

)

 

 

 

 

Non-recurring refinancing related fees

 

 

 

 

 

 

 

0.01

 

 

 

 

 

Non-recurring severance related fees

 

0.02

 

 

 

 

 

 

0.02

 

 

 

 

 

Extinguishment of debt

 

 

 

 

 

 

 

 

 

 

0.08

 

 

Arbitration award

 

 

 

 

(0.09

)

 

 

 

 

 

(0.09

)

 

Strategic collaboration and license costs

 

 

 

 

 

 

 

 

 

 

0.01

 

 

Integration costs

 

0.04

 

 

 

0.04

 

 

 

0.13

 

 

 

0.04

 

 

Acquisition-related costs

 

0.01

 

 

 

0.07

 

 

 

0.22

 

 

 

0.20

 

 

Impairment of long-lived assets

 

0.04

 

 

 

 

 

 

0.18

 

 

 

 

 

Income tax effect of non-GAAP adjustments(a)

 

(0.08

)

 

 

(0.02

)

 

 

(0.24

)

 

 

(0.21

)

 

Adjusted net income per share - diluted

 

$

0.07

 

 

 

$

0.34

 

 

 

$

0.47

 

 

 

$

1.17

 

 

Weighted-average common shares outstanding - diluted(b)

 

67,130

 

 

 

40,133

 

 

 

54,471

 

 

 

40,113

 

 

(a)

The income tax effect of the adjustments between GAAP net (loss) income and non-GAAP adjusted net income takes into account the tax treatment and related tax rate that apply to each adjustment in the applicable tax jurisdiction.

(b)

Diluted shares may differ for non-GAAP measures as compared to GAAP due to a GAAP net loss position.

Lantheus Holdings, Inc.

Reconciliation of Free Cash Flow

(in thousands – unaudited)

 

 

Three Months Ended
December 31,

 

Year Ended
December 31,

 

2020

 

2019

 

2020

 

2019

Net cash provided by operating activities

$

569

 

 

 

$

22,421

 

 

 

$

16,396

 

 

 

$

80,384

 

 

Capital expenditures

(3,785

)

 

 

(4,741

)

 

 

(12,474

)

 

 

(22,061

)

 

Free cash flow

$

(3,216

)

 

 

$

17,680

 

 

 

$

3,922

 

 

 

$

58,323

 

 

Lantheus Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands – unaudited)

 

 

December 31,
2020

 

December 31,
2019

Assets

 

 

 

Current assets

 

 

 

Cash and cash equivalents

$

79,612

 

 

$

92,919

 

Accounts receivable, net

54,002

 

 

43,529

 

Inventory

35,744

 

 

29,180

 

Other current assets

9,625

 

 

7,283

 

Assets held for sale

5,242

 

 

 

Total current assets

184,225

 

 

172,911

 

Property, plant and equipment, net

120,171

 

 

116,497

 

Intangibles, net

376,012

 

 

7,336

 

Goodwill

58,632

 

 

15,714

 

Deferred tax assets, net

70,147

 

 

71,834

 

Other long-term assets

60,634

 

 

21,627

 

Total assets

$

869,821

 

 

$

405,919

 

Liabilities and stockholders’ equity

 

 

 

Current liabilities

 

 

 

Current portion of long-term debt and other borrowings

$

20,701

 

 

$

10,143

 

Accounts payable

16,284

 

 

18,608

 

Accrued expenses and other liabilities

41,726

 

 

37,360

 

Liabilities held for sale

1,793

 

 

 

Total current liabilities

80,504

 

 

66,111

 

Asset retirement obligations

14,020

 

 

12,883

 

Long-term debt, net and other borrowings

197,699

 

 

183,927

 

Other long-term liabilities

63,393

 

 

28,397

 

Total liabilities

355,616

 

 

291,318

 

Total stockholders’ equity

514,205

 

 

114,601

 

Total liabilities and stockholders’ equity

$

869,821

 

 

$

405,919

 

 

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