lnth-20211231
FALSE000152103600015210362021-05-042021-05-04

 
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): December 31, 2021
LANTHEUS HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Delaware001-3656935-2318913
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
331 Treble Cove Road, North Billerica, MA
01862
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code: (978671-8001
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 classTrading Symbol(s)Name of each exchange on which registered
Common stock, par value $0.01 per shareLNTHThe 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 24, 2022, Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and twelve months ended December 31, 2021. 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*
104Cover Page Interactive Data File (embedded within the Inline XBRL document)
*    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/ Daniel M. Niedzwiecki
Name:
Daniel M. Niedzwiecki
Title:
Senior Vice President and General Counsel
Date: February 24, 2022
 


Document

Exhibit 99.1
https://cdn.kscope.io/ba7f68a596f51974b151482954073853-lantheusa11a.jpg
331 Treble Cove Road
North Billerica, MA 01862
800.362.2668
www.lantheus.com
Lantheus Holdings, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results
Worldwide revenue of $129.6 million and $425.2 million for the fourth quarter and full year 2021, representing an increase of 37.6% and an increase of 25.3% over the prior year period, respectively
GAAP net loss of $40.2 million and $71.3 million for the fourth quarter and full year 2021, compared to GAAP net loss of $3.4 million and $13.5 million in the prior year period; adjusted net income of $17.2 million and $34.0 million for the fourth quarter and full year 2021, compared to adjusted net income of $4.6 million and $25.8 million in the prior year period
GAAP fully diluted net loss of $0.59 and $1.06 for the fourth quarter and full year 2021, compared to GAAP fully diluted net loss of $0.05 and $0.25 in the prior year period; adjusted fully diluted EPS of $0.25 and $0.49 for the fourth quarter and full year 2021, compared to adjusted fully diluted EPS of $0.07 and $0.47 in the prior year period
Net cash provided by operating activities was $13.9 million and $53.9 million for the fourth quarter and full year 2021. Free cash flow of $9.3 million and $41.8 million for the fourth quarter and full year 2021, compared to free cash flow of $(3.2) million and $3.9 million for the fourth quarter and full year 2020
The Company provides first quarter and full year 2022 revenue and adjusted diluted earnings per share guidance
NORTH BILLERICA, MA., February 24, 2022 - Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider committed to 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, 2021.
The Company’s worldwide revenue for the fourth quarter of 2021 totaled $129.6 million, compared with $94.2 million for the fourth quarter of 2020, representing an increase of 37.6% over the prior year period. Full year 2021 worldwide revenues were $425.2 million, compared with $339.4 million for the full year 2020, representing an increase of 25.3% over the prior year period.
The Company’s fourth quarter 2021 net loss was $40.2 million, or $0.59 per fully diluted share, as compared to net loss of $3.4 million, or $0.05 per fully diluted share for the fourth quarter of 2020. Full year 2021 net loss was $71.3 million, or $1.06 per fully diluted share, as compared to net loss of $13.5 million, or $0.25 per fully diluted share for the full year 2020.
The Company’s fourth quarter 2021 adjusted fully diluted earnings per share were $0.25, as compared to $0.07 for the fourth quarter of 2020, representing an increase of 263.5% over the prior year period. The Company’s full year 2021 adjusted fully diluted earnings per share were $0.49, as compared to $0.47 for the full year 2020, representing an increase of 4.0% over the prior year period.
Lastly, net cash provided by operating activities was $13.9 million and $53.9 million for the fourth quarter and full year 2021. Free Cash Flow was $9.3 million for the fourth quarter of 2021, as compared to $(3.2) million for the fourth quarter of 2020, representing an increase of approximately $12.5 million from the prior year period. Full year 2021 free cash flow was $41.8 million, as compared to $3.9 million for the full year 2020, representing an increase of approximately $37.9 million from the prior year period.
“Lantheus delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively,” said Mary Anne Heino, President and CEO. “We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and market leadership for DEFINITY, and delivered top quartile returns for our shareholders, even amidst a backdrop of macro external challenges. This year is off to a similarly productive start as we received FDA approval for our on-site manufacturing facility for DEFINITY. In 2022, we will continue to advance our purpose to Find, Fight and Follow serious medical conditions to improve patient outcomes, and continue to drive revenue growth and shareholder value.”
Outlook
The Company updates its guidance for the first quarter and full year 2022 is as follows:
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Guidance Issued February 24, 2022
Q1 FY 2022 Revenue
$160 million - $170 million
Q1 FY 2022 Adjusted Fully Diluted EPS
$0.45 - $0.50
Guidance Issued February 24, 2022
FY 2022 Revenue
$685 million - $710 million
FY 2022 Adjusted Fully Diluted EPS
$1.95 - $2.05

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 (including liability accruals relating to the contingent value rights issued as part of the Progenics Pharmaceuticals, Inc. acquisition), 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 24, 2022 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 4894137. 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 committed to 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; PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that assists in the evaluation of PSMA PET images; 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 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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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 “believe,” “could,” “estimate,” “expect,” “look forward to,” “may,” “plan,” “predict,” “target,” “will,” “commit,” “advance,” “continue” 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) continued market expansion and penetration for our established commercial products, particularly DEFINITY, in the face of segment competition and potential generic competition, including as a result of patent and regulatory exclusivity expirations; (ii) our ability to successfully launch PYLARIFY as a commercial product, including (A) our ability to obtain United States Food and Drug Administration (“FDA”) approval for additional positron emission tomography (“PET”) manufacturing facilities (“PMFs”) to manufacture PYLARIFY, (B) the ability of those PMFs to manufacture PYLARIFY, (C) our ability to sell PYLARIFY to customers, and (D) our ability to obtain and maintain adequate coding, coverage and payment for PYLARIFY; (iii) the global Molybdenum-99 supply; (iv) our ability to use in-house manufacturing capacity; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) our ability to have products manufactured at Jubilant HollisterStier and our modified formulation of DEFINITY at Samsung Biologics, including our ability to renew, modify or replace the agreements related to such manufacturing services on commercially reasonable terms, as may be necessary; (vii) the continuing impact of the global COVID-19 pandemic on our business, financial conditions and prospects; (viii) the efforts and timing for clinical development of our product candidates and new clinical applications for our products, in each case, that we may develop, including 1095 and LMI 1195 or that our strategic partners may develop, including flurpiridaz fluorine-18; (ix) the potential reclassification by the FDA of certain of our products and product candidates from drugs to devices with the expense, complexity and potentially more limited competitive protection such reclassification could cause and (x) 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
December 31,
Year Ended
December 31,
2021202020212020
Revenues$129,562 $94,152 $425,208 $339,410 
Cost of goods sold71,654 55,501 237,513 200,649 
Gross profit57,908 38,651 187,695 138,761 
Operating expenses
Sales and marketing19,423 12,857 68,422 40,901 
General and administrative62,530 13,684 150,395 69,270 
Research and development11,293 12,638 44,966 32,788 
Total operating expenses93,246 39,179 263,783 142,959 
Gain on sale of assets— — 15,263 — 
Operating loss(35,338)(528)(60,825)(4,198)
Interest expense1,528 2,811 7,752 9,479 
Gain on extinguishment of debt— — (889)— 
Other loss (income)4,141 (496)7,350 (2,198)
 Loss before income taxes(41,007)(2,843)(75,038)(11,479)
Income tax (benefit) expense(792)569 (3,759)1,994 
Net loss$(40,215)$(3,412)$(71,279)$(13,473)
Net loss per common share:
Basic$(0.59)$(0.05)$(1.06)$(0.25)
Diluted$(0.59)$(0.05)$(1.06)$(0.25)
Weighted-average common shares outstanding:
Basic67,713 66,870 67,486 54,134 
Diluted67,713 66,870 67,486 54,134 
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Lantheus Holdings, Inc.
Consolidated Revenues Analysis
(in thousands – unaudited)
Three Months Ended
December 31,
Year Ended
December 31,
2021
2020 (1)
% Change2021
2020 (1)
% Change
DEFINITY$59,311 $55,876 6.1 %$232,759 $195,865 18.8 %
TechneLite22,041 22,385 (1.5)%91,293 84,945 7.5 %
Other precision diagnostics5,684 8,042 (29.3)%26,973 36,824 (26.8)%
Total precision diagnostics87,036 86,303 0.8 %351,025 317,634 10.5 %
PYLARIFY35,417 — N/A43,414 — N/A
Other radiopharmaceutical oncology267 2,548 (89.5)%5,473 10,022 (45.4)%
Total radiopharmaceutical oncology35,684 2,548 1300.5 %48,887 10,022 387.8 %
Strategic Partnerships and other revenue6,842 5,301 29.1 %25,296 11,754 115.2 %
Total revenues$129,562 $94,152 37.6 %$425,208 $339,410 25.3 %
________________________________
1.The Company reclassified aggregate rebates and allowances of $5.3 million and $19.1 million for the three months and year ended December 31, 2020, respectively, which included $4.9 million and $17.5 million for DEFINITY, $0.4 million and $1.3 million for TechneLite and $0.1 million and $0.3 million for other precision diagnostics.
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Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)
Three Months Ended
December 31,
Year Ended
December 31,
2021202020212020
Net loss$(40,215)$(3,412)$(71,279)$(13,473)
Stock and incentive plan compensation4,162 3,623 15,934 14,075 
Amortization of acquired intangible assets8,373 4,683 27,506 10,770 
Acquired debt fair value adjustment— (326)(307)(711)
Contingent consideration fair value adjustments43,900 (2,800)72,400 (2,000)
Non-recurring refinancing related fees— — — 460 
Non-recurring severance related fees— 904 522 904 
Non-recurring fees818 — 818 — 
Extinguishment of debt— — (889)— 
Gain on sale of assets— — (15,263)— 
Integration costs2,772 102 7,201 
Acquisition-related costs823 1,334 1,549 11,856 
Impairment of long-lived assets189 2,660 9,729 9,935 
ARO Acceleration5,259 — 5,259 — 
Other35 62 (40)
Income tax effect of non-GAAP adjustments(a)
(6,079)(4,886)(12,138)(13,152)
Adjusted net income$17,241 $4,587 $34,005 $25,825 
Adjusted net income, as a percentage of revenues13.3 %4.9 %8.0 %7.6 %
Three Months Ended
December 31,
Year Ended
December 31,
2021202020212020
Net loss per share - diluted$(0.59)$(0.05)$(1.06)$(0.25)
Stock and incentive plan compensation0.06 0.05 0.24 0.26 
Amortization of acquired intangible assets0.13 0.08 0.41 0.20 
Acquired debt fair value adjustment— — (0.01)(0.01)
Contingent consideration fair value adjustments0.63 (0.04)1.05 (0.05)
Non-recurring refinancing related fees— — — 0.01 
Non-recurring severance related fees— 0.02 0.01 0.02 
Non-recurring fees0.01 — 0.01 — 
Extinguishment of debt— — (0.01)— 
Gain on sale of assets— — (0.23)— 
Integration costs— 0.04 — 0.13 
Acquisition-related costs0.01 0.01 0.02 0.22 
Impairment of long-lived assets— 0.04 0.14 0.18 
ARO Acceleration0.08 — 0.08 — 
Income tax effect of non-GAAP adjustments(a)
(0.08)(0.08)(0.16)(0.24)
Adjusted net income per share - diluted$0.25 $0.07 $0.49 $0.47 
Weighted-average common shares outstanding - diluted69,446 67,130 68,963 54,471 
(a)The income tax effect of the adjustments between GAAP net loss 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.
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Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)
Three Months Ended
December 31,
Year Ended
December 31,
2021202020212020
Net cash provided by operating activities$13,889 $569 $53,916 $16,396 
Capital expenditures(4,544)(3,785)(12,140)(12,474)
Free cash flow$9,345 $(3,216)$41,776 $3,922 
Net cash (used in) provided by investing activities$(4,544)$(3,785)$3,683 $(4,912)
Net cash used in financing activities$(2,100)$(4,373)$(39,332)$(21,861)
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Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
December 31,
2021
December 31,
2020
Assets
Current assets
Cash and cash equivalents$98,508 $79,612 
Accounts receivable, net89,336 54,002 
Inventory35,129 35,744 
Other current assets12,818 9,625 
Assets held for sale— 5,242 
Total current assets235,791 184,225 
Property, plant and equipment, net116,772 120,171 
Intangibles, net348,510 376,012 
Goodwill61,189 58,632 
Deferred tax assets, net62,764 70,147 
Other long-term assets38,758 60,634 
Total assets$863,784 $869,821 
Liabilities and stockholders’ equity
Current liabilities
Current portion of long-term debt and other borrowings$11,642 $20,701 
Accounts payable20,787 16,284 
Accrued expenses and other liabilities58,068 41,726 
Liabilities held for sale— 1,793 
Total current liabilities90,497 80,504 
Asset retirement obligations20,833 14,020 
Long-term debt, net and other borrowings163,121 197,699 
Other long-term liabilities124,894 63,393 
Total liabilities399,345 355,616 
Total stockholders’ equity464,439 514,205 
Total liabilities and stockholders’ equity$863,784 $869,821 
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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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