04.05.2021 13:00:00

Lantheus Holdings, Inc. Reports First Quarter 2021 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 first quarter ended March 31, 2021.

The Company’s worldwide revenue for the first quarter of 2021 totaled $92.5 million, compared with $90.7 million for the first quarter of 2020, representing an increase of 2.0% from the prior year period.

The Company’s first quarter 2021 net income was $9.0 million, or $0.13 per fully diluted share, as compared to net income of $3.3 million, or $0.08 per fully diluted share for the first quarter of 2020.

The Company’s first quarter 2021 adjusted fully diluted earnings per share were $0.05, as compared to $0.36 for the first quarter of 2020, representing a decrease of 86.3% from the prior year period.

Lastly, net cash provided by operating activities was $9.8 million for the first quarter 2021. Free Cash Flow was $7.3 million in the first quarter of 2021, representing an increase of approximately $0.6 million from the prior year period.

"We had a strong start to 2021 with solid first quarter revenue and earnings overperformance driven mainly by DEFINITY volume. While COVID-19 did impact the early part of the quarter, we are encouraged by the continued trend toward in-person delivery of healthcare,” said Mary Anne Heino, President and CEO. "Currently, we are focused on preparation for the potential FDA approval and commercial launch of PyL, a best-in-class PSMA prostate cancer imaging agent, to help drive long-term value for patients, healthcare professionals, and shareholders.”

Outlook

The Company updates its guidance for full year 2021 and offers the following guidance for the second quarter.

 

 

Q2 Guidance Issued May 4, 2021

 

Previous Guidance Issued February 25, 2021

Q2 FY 2021 Revenue

 

$93 million - $97 million

 

N/A

Q2 FY 2021 Adjusted Diluted EPS

 

$0.03 - $0.06

 

N/A

 

 

FY Guidance Updated May 4, 2021

 

FY Guidance Issued February 25, 2021

FY 2021 Revenue

 

$390 million - $400 million

 

$385 million - $400 million

FY 2021 Adjusted Diluted EPS

 

$0.36 - $0.41

 

$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 Tuesday, May 4, 2021 at 8:00 a.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 9275247. 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.

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, including statements regarding potential U.S. Food and Drug Administration ("FDA") approval of PyL, 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 and prospects, and 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 FDA 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).

 

Lantheus Holdings, Inc.

Consolidated Statements of Operations

(in thousands, except per share data – unaudited)

 

 

 

Three Months Ended

March 31,

 

 

2021

 

2020

Revenues

 

$

92,509

 

 

$

90,704

 

Cost of goods sold

 

51,479

 

 

52,702

 

Gross profit

 

41,030

 

 

38,002

 

Operating expenses

 

 

 

 

Sales and marketing

 

14,173

 

 

10,130

 

General and administrative

 

16,138

 

 

16,699

 

Research and development

 

10,360

 

 

4,048

 

Total operating expenses

 

40,671

 

 

30,877

 

Gain on sale of assets

 

15,263

 

 

 

Operating income

 

15,622

 

 

7,125

 

Interest expense

 

2,718

 

 

1,946

 

Gain on extinguishment of debt

 

(889

)

 

 

Other income

 

(549

)

 

(350

)

Income before income taxes

 

$

14,342

 

 

$

5,529

 

Income tax expense

 

5,334

 

 

2,192

 

Net income

 

$

9,008

 

 

$

3,337

 

Net income per common share:

 

 

 

 

Basic

 

$

0.13

 

 

$

0.08

 

Diluted

 

$

0.13

 

 

$

0.08

 

Weighted-average common shares outstanding:

 

 

 

 

Basic

 

67,094

 

 

39,433

 

Diluted

 

67,714

 

 

40,102

 

 

Lantheus Holdings, Inc.

Consolidated Revenues Analysis

(in thousands – unaudited)

 

 

 

Three Months Ended

March 31,

 

 

2021

2020 (1)

% Change

DEFINITY

 

$

55,971

 

$

52,505

 

6.6

%

TechneLite

 

22,800

 

22,779

 

0.1

%

Other precision diagnostics

 

6,984

 

13,057

 

(46.5)

%

Total precision diagnostics

 

85,755

 

88,341

 

(2.9)

%

Radiopharmaceutical oncology

 

1,500

 

1,968

 

(23.8)

%

Strategic partnerships and other

 

5,254

 

395

 

1,230.1

%

Total revenues

 

$

92,509

 

$

90,704

 

2.0

%

________________________________

  1. The Company reclassified rebates and allowances of $4.7 million for the three months ended March 31, 2020 within each product category, which included $4.3 million for DEFINITY, $0.3 million for TechneLite and $0.1 million for other precision diagnostics.

     

 

Lantheus Holdings, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(in thousands, except per share data – unaudited)

 

 

 

Three Months Ended

March 31,

 

 

2021

 

2020

Net income

 

$

9,008

 

 

$

3,337

 

Stock and incentive plan compensation

 

3,317

 

 

3,075

 

Amortization of acquired intangible assets

 

4,685

 

 

392

 

Acquired debt fair value adjustment

 

(307

)

 

 

Contingent consideration fair value adjustments

 

300

 

 

 

Non-recurring severance related fees

 

436

 

 

 

Extinguishment of debt

 

(889

)

 

 

Gain on sale of assets

 

(15,263

)

 

 

Integration costs

 

19

 

 

2,372

 

Acquisition-related costs

 

(103

)

 

1,412

 

Impairment of long-lived assets

 

 

 

7,275

 

Other

 

10

 

 

(75

)

Income tax effect of non-GAAP adjustments(a)

 

2,083

 

 

(3,506

)

Adjusted net income

 

$

3,296

 

 

$

14,282

 

Adjusted net income, as a percentage of revenues

 

3.6

%

 

15.7

%

 

 

Three Months Ended

March 31,

 

 

2021

 

 

2020

 

Net income per share - diluted

 

$

0.13

 

 

$

0.08

 

Stock and incentive plan compensation

 

0.05

 

 

0.08

 

Amortization of acquired intangible assets

 

0.08

 

 

0.01

 

Acquired debt fair value adjustment

 

(0.01

)

 

 

Contingent consideration fair value adjustments

 

0.01

 

 

 

Non-recurring severance related fees

 

0.01

 

 

 

Extinguishment of debt

 

(0.01

)

 

 

Gain on sale of assets

 

(0.23

)

 

 

Integration costs

 

 

 

0.06

 

Acquisition-related costs

 

(0.01

)

 

0.04

 

Impairment of long-lived assets

 

 

 

0.18

 

Other

 

 

 

 

Income tax effect of non-GAAP adjustments(a)

 

0.03

 

 

(0.09

)

Adjusted net income per share - diluted

 

$

0.05

 

 

$

0.36

 

Weighted-average common shares outstanding - diluted

 

67,714

 

 

40,102

 

(a)

The income tax effect of the adjustments between GAAP net 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.

 

Lantheus Holdings, Inc.

Reconciliation of Free Cash Flow

(in thousands – unaudited)

 

 

Three Months Ended

March 31,

 

2021

 

 

2020

 

Net cash provided by operating activities

$

9,818

 

 

$

9,408

 

Capital expenditures

(2,520

)

 

(2,698

)

Free cash flow

$

7,298

 

 

$

6,710

 

 

Lantheus Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands – unaudited)

 

 

March 31,
2021

 

December 31,
2020

Assets

 

 

 

Current assets

 

 

 

Cash and cash equivalents

$

68,861

 

$

79,612

Accounts receivable, net

58,991

 

54,002

Inventory

30,357

 

35,744

Other current assets

10,145

 

9,625

Assets held for sale

 

5,242

Total current assets

168,354

 

184,225

Property, plant and equipment, net

118,381

 

120,171

Intangibles, net

371,331

 

376,012

Goodwill

61,189

 

58,632

Deferred tax assets, net

62,832

 

70,147

Other long-term assets

61,361

 

60,634

Total assets

$

843,448

 

$

869,821

Liabilities and stockholders’ equity

 

 

 

Current liabilities

 

 

 

Current portion of long-term debt and other borrowings

$

10,251

 

$

20,701

Accounts payable

19,099

 

16,284

Accrued expenses and other liabilities

35,240

 

41,726

Liabilities held for sale

 

1,793

Total current liabilities

64,590

 

80,504

Asset retirement obligations

14,408

 

14,020

Long-term debt, net and other borrowings

171,474

 

197,699

Other long-term liabilities

64,857

 

63,393

Total liabilities

315,329

 

355,616

Total stockholders’ equity

528,119

 

514,205

Total liabilities and stockholders’ equity

$

843,448

 

$

869,821

 

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