8-K

Lantheus Holdings, Inc. (LNTH)

8-K 2021-02-25 For: 2021-02-25
View Original
Added on April 11, 2026

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 25, 2021

LANTHEUS HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware 001-36569 35-2318913
(State or other jurisdiction<br>of incorporation) (Commission<br>File Number) (IRS Employer<br>Identification No.) 331 Treble Cove Road, North Billerica, MA 01862
--- ---
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (978) 671-8001

Not Applicable
(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common stock, par value $0.01 per share LNTH The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02.     Results of Operations and Financial Condition.

On February 25, 2021, Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and twelve months ended December 31, 2020. A copy of that press release is being furnished as Exhibit 99.1 and is hereby incorporated by reference.

The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.

Item 9.01.    Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description
99.1* Press release of Lantheus Holdings, Inc. dated February 25, 2021, entitled "Lantheus Reports Fourth Quarter and Full Year 2020 Financial Results"

*    Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

LANTHEUS HOLDINGS, INC.
By: /s/ Michael P. Duffy
Name: Michael P. Duffy
Title: Senior Vice President and General Counsel

Date: February 25, 2021

Document

Exhibit 99.1

331 Treble Cove Road<br>North Billerica, MA 01862 800.362.2668<br>www.lantheus.com

Lantheus Reports Fourth Quarter and Full Year 2020 Financial Results

•Worldwide revenue of $94.2 million and $339.4 million for the fourth quarter and full year 2020, representing an increase of 5.4% and a decline of 2.3% over the prior year period, respectively

•Net loss of $3.4 million and $13.5 million for the fourth quarter and full year 2020, compared to net income of $10.5 million and $31.7 million for the fourth quarter and full year 2019

•GAAP fully diluted net loss of $0.05 and $0.25 for the fourth quarter and full year 2020, compared to GAAP fully diluted net income of $0.26 and $0.79 for the fourth quarter and full year 2019; adjusted fully diluted EPS of $0.07 and $0.47 for the fourth quarter and full year 2020, compared to adjusted fully diluted EPS of $0.34 and $1.17 for the fourth quarter and full year 2019

•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 of $(3.2) million and $3.9 million for the fourth quarter and full year 2020, compared to free cash flow of $17.7 million and $58.3 million for the fourth quarter and full year 2019

•The Company provides first quarter and full year 2021 revenue and adjusted fully diluted earnings per share guidance

NORTH BILLERICA, MA., February 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:

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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.

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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 -

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Lantheus Holdings, Inc.

Consolidated Statements of Operations

(in thousands, except per share data – unaudited)

Three Months Ended <br>December 31, Year Ended <br>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

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Lantheus Holdings, Inc.

Consolidated Segment Revenues Analysis

(in thousands – unaudited)

Three Months Ended <br>December 31, Year Ended <br>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) %

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Lantheus Holdings, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(in thousands, except per share data – unaudited)

Three Months Ended <br>December 31, Year Ended <br>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 <br>December 31, Year Ended <br>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.

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Lantheus Holdings, Inc.

Reconciliation of Free Cash Flow

(in thousands – unaudited)

Three Months Ended <br>December 31, Year Ended <br>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

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Lantheus Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands – unaudited)

December 31,<br>2020 December 31,<br>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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Contacts:

Mark Kinarney

Senior Director, Investor Relations

978-671-8842

ir@lantheus.com

Melissa Downs

Director, Corporate Communications

646-975-2533

media@lantheus.com

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