Business Wire | Feb 25, 2021 04:02PM EST

Lantheus Reports Fourth Quarter and Full Year 2020 Financial Results

Feb. 25, 2021

NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Feb. 25, 2021--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(tm) serious medical conditions. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY(r) Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite(r) (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA(r) for the treatment of certain rare neuroendocrine tumors; and RELISTOR(r) 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 Year Ended December 31, December 31,

2020 2019 2020 2019

Revenues $ 94,152 $ 89,346 $ 339,410 $ 347,337

Cost of goods 55,501 44,781 200,649 172,526 sold

Gross profit 38,651 44,565 138,761 174,811

Operating expenses

Sales and 12,857 10,392 40,901 41,888 marketing

General and 13,684 17,301 69,270 61,244 administrative

Research and 12,638 4,434 32,788 20,018 development

Total operating 39,179 32,127 142,959 123,150 expenses

Operating (loss) (528 ) 12,438 (4,198 ) 51,661 income

Interest expense 2,811 2,126 9,479 13,617

Loss onextinguishment of - - - 3,196 debt

Other (income) (496 ) 7,916 (2,198 ) 6,221 loss

(Loss) incomebefore income $ (2,843 ) $ 2,396 $ (11,479 ) $ 28,627 taxes

Income tax 569 (8,054 ) 1,994 (3,040 ) expense (benefit)

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-averagecommon 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 EndedDecember 31,

Year EndedDecember 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.

Consolidated Segment Revenues Analysis

(in thousands - unaudited)

Three Months Ended Year Ended December 31, 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 12,975 10,631 22.0 % 44,614 43,348 2.9 %Revenues

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 EndedDecember 31,

Year EndedDecember 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

%

Lantheus Holdings, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(in thousands, except per share data - unaudited)

Three Months Ended Year Ended December 31, December 31,

2020 2019 2020 2019

Net (loss) income $ (3,412 ) $ 10,450 $ (13,473 ) $ 31,667

Stock and incentive 3,623 2,991 14,075 12,571 plan compensation

Amortization ofacquired intangible 4,683 451 10,770 1,804 assets

Acquired debt fair (326 ) - (711 ) - value adjustment

Contingentconsideration fair (2,800 ) - (2,000 ) - value adjustments

Non-recurringrefinancing related - - 460 - fees

Non-recurringseverance related 904 - 904 - fees

Extinguishment of - - - 3,196 debt

Arbitration award - (3,453 ) - (3,453 )

Strategiccollaboration and - - - 300 license costs

Integration costs 2,772 1,488 7,201 1,488

Acquisition-related 1,334 2,834 11,856 8,010 costs

Impairment of 2,660 - 9,935 - long-lived assets

Other 35 - (40 ) -

Income tax effectof non-GAAP (4,886 ) (1,134 ) (13,152 ) (8,583 ) adjustments^(a)

Adjusted net income $ 4,587 $ 13,627 $ 25,825 $ 47,000

Adjusted netincome, as a 4.9 % 15.3 % 7.6 % 13.5 %percentage ofrevenues

Three Months EndedDecember 31,

Year EndedDecember 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

Three Months Ended Year Ended December 31, December 31,

2020 2019 2020 2019

Net (loss) income per $ (0.05 ) $ 0.26 $ (0.25 ) $ 0.79 share - diluted

Stock and incentive plan 0.05 0.07 0.26 0.31 compensation

Amortization of acquired 0.08 0.01 0.20 0.04 intangible assets

Acquired debt fair value - - (0.01 ) - adjustment

Contingent consideration (0.04 ) - (0.05 ) - fair value adjustments

Non-recurring refinancing - - 0.01 - related fees

Non-recurring severance 0.02 - 0.02 - related fees

Extinguishment of debt - - - 0.08

Arbitration award - (0.09 ) - (0.09 )

Strategic collaboration - - - 0.01 and license costs

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 0.04 - 0.18 - assets

Income tax effect of (0.08 ) (0.02 ) (0.24 ) (0.21 ) non-GAAP adjustments^(a)

Adjusted net income per $ 0.07 $ 0.34 $ 0.47 $ 1.17 share - diluted

Weighted-average commonshares outstanding - 67,130 40,133 54,471 40,113 diluted^(b)

(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.

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(a) related tax rate that apply to each adjustment in the applicable tax jurisdiction.

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

Lantheus Holdings, Inc.

Reconciliation of Free Cash Flow

(in thousands - unaudited)

Three Months EndedDecember 31,

Year EndedDecember 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.

Reconciliation of Free Cash Flow

(in thousands - unaudited)

Three Months Ended Year Ended December 31, December 31,

2020 2019 2020 2019

Net cash provided by $ 569 $ 22,421 $ 16,396 $ 80,384 operating activities

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20210225005882/en/

CONTACT: Mark Kinarney Senior Director, Investor Relations 978-671-8842 ir@lantheus.com

CONTACT: Melissa Downs Director, Corporate Communications 646-975-2533 media@lantheus.com