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lnth-20210728
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): July 28, 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: (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 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 July 28, 2021, Lantheus Holdings, Inc. (the “Company”) announced via press release its financial results as of and for the three and six months ended June 30, 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: July 28, 2021
 
Document

Exhibit 99.1
https://cdn.kscope.io/196064d726a43e9f9249d791107d7c1f-lantheusa11.jpg
331 Treble Cove Road
North Billerica, MA 01862		800.362.2668
www.lantheus.com
Lantheus Holdings, Inc. Reports Second Quarter 2021 Financial Results
•Worldwide revenue of $101.1 million for the second quarter 2021, representing an increase of 53.1% from the prior year period
•    GAAP net loss of $26.7 million for the second quarter 2021, compared to GAAP net loss of $7.0 million in the prior year period
• GAAP fully diluted net loss of $0.39 for the second quarter 2021, compared to GAAP fully diluted net loss of $0.16 in the prior year period; adjusted fully diluted EPS of $0.11 for the second quarter 2021, compared to adjusted fully diluted EPS of $0.10 in the prior year period
• Net cash provided by operating activities was $25.9 million for the second quarter 2021. Free cash flow was $23.2 million in the second quarter 2021
•The Company provides third quarter 2021 revenue and adjusted diluted earnings per share guidance; increases full year guidance
NORTH BILLERICA, MA., July 28, 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 second quarter ended June 30, 2021.
The Company’s worldwide revenue for the second quarter of 2021 totaled $101.1 million, compared with $66.0 million for the second quarter of 2020, representing an increase of 53.1% from the prior year period.
The Company’s second quarter 2021 GAAP net loss was $26.7 million, or $0.39 per fully diluted share, as compared to GAAP net loss of $7.0 million, or $0.16 per fully diluted share for the second quarter of 2020.
The Company’s second quarter 2021 adjusted fully diluted earnings per share were $0.11, as compared to $0.10 for the second quarter of 2020, representing an increase of 8.1% from the prior year period.
Lastly, net cash provided by operating activities was $25.9 million for the second quarter 2021. Free Cash Flow was $23.2 million in the second quarter of 2021, representing an increase of approximately $27.6 million from the prior year period.
“Our second quarter was highlighted by the FDA approval of PYLARIFY, the first and only commercially available PSMA PET imaging agent for prostate cancer, and the strong performance of DEFINITY which exceeded pre COVID-19 levels,” said Mary Anne Heino, President and Chief Executive Officer. “With the investments Lantheus has made and continues to make in the business, we’ve laid the foundation to take full advantage of our diversified portfolio of products. We remain committed to delivering on our financial commitments while positively impacting the lives of the patients we serve and delivering shareholder value.”
Outlook
The Company updates its guidance for full year 2021 and offers the following guidance for the third quarter.
Q3 Guidance Issued July 28, 2021
Previous Guidance Issued May 4, 2021
Q3 FY 2021 Revenue
$95 million - $100 million
N/A
Q3 FY 2021 Adjusted Diluted EPS
$0.05 - $0.07
N/A
FY Guidance Updated July 28, 2021
FY Guidance Issued May 4, 2021
FY 2021 Revenue
$395 million - $402 million
$390 million - $400 million
FY 2021 Adjusted Diluted EPS
$0.38 - $0.42
$0.36 - $0.41

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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 Wednesday, July 28, 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 6149638. 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; 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, 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,
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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, including as a result of patent and regulatory exclusivity expirations; (iii) our ability to successfully launch PYLARIFY as a commercial product, including (A) our ability to obtain U.S. Food and Drug Administration approval for additional PET manufacturing facilities (“PMFs”) that could manufacture PYLARIFY, (B) the ability of those PMFs to supply PYLARIFY to customers, and (C) our ability to sell PYLARIFY to customers; (iv) the global Molybdenum-99 supply; (v) our products manufactured at Jubilant HollisterStier and our recently-approved modified formulation of DEFINITY (“DEFINITY RT”) to be commercially manufactured at Samsung Biologics; (vi) the continued integration of the Progenics products and product candidate portfolio into our business following the Progenics Acquisition; (vii) our ability to use in-house manufacturing capacity; (viii) the efforts and timing for commercialization of products or new clinical applications for our products that we or our strategic partners may develop, including flurpiridaz F 18; (ix) our ability to develop highly contextualized assessments of disease burden using artificial intelligence (“AI”); 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
June 30,		Six Months Ended
June 30,
2021202020212020
Revenues$101,064 $66,010 $193,573 $156,714 
Cost of goods sold54,976 40,162 106,455 92,864 
Gross profit46,088 25,848 87,118 63,850 
Operating expenses
Sales and marketing17,631 6,305 31,804 16,435 
General and administrative43,177 20,670 59,315 37,369 
Research and development12,061 4,418 22,421 8,466 
Total operating expenses72,869 31,393 113,540 62,270 
Gain on sale of assets— — 15,263 — 
Operating (loss) income(26,781)(5,545)(11,159)1,580 
Interest expense1,937 1,914 4,655 3,860 
Gain on extinguishment of debt— — (889)— 
Other income(182)(756)(731)(1,106)
 Loss before income taxes(28,536)(6,703)(14,194)(1,174)
Income tax (benefit) expense(1,879)309 3,455 2,501 
Net loss$(26,657)$(7,012)$(17,649)$(3,675)
Net loss per common share:
Basic$(0.39)$(0.16)$(0.26)$(0.09)
Diluted$(0.39)$(0.16)$(0.26)$(0.09)
Weighted-average common shares outstanding:
Basic67,505 43,135 67,300 41,284 
Diluted67,505 43,135 67,300 41,284 
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Lantheus Holdings, Inc.
Consolidated Revenues Analysis
(in thousands – unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2021
2020 (1)
% Change2021
2020 (1)
% Change
   DEFINITY$59,842 $37,125 61.2 %$115,813 $89,630 29.2 %
   TechneLite23,772 18,668 27.3 %46,572 41,447 12.4 %
   Other precision diagnostics6,742 7,140 (5.6)%13,726 20,197 (32.0)%
Total precision diagnostics90,356 62,933 43.6 %176,111 151,274 16.4 %
Radiopharmaceutical oncology2,812 2,183 28.8 %4,312 4,151 3.9 %
Strategic partnerships and other7,896 894 783.2 %13,150 1,289 920.2 %
   Total revenues$101,064 $66,010 53.1 %$193,573 $156,714 23.5 %
________________________________
1.The Company reclassified rebates and allowances of $3.5 million and $8.2 million within each product category, which included $3.2 million and $7.5 million for DEFINITY, $0.3 million and $0.6 million for TechneLite and zero and $0.1 million for other precision diagnostics, for the three and six months ended June 30, 2020, respectively.
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Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)
Three Months Ended
June 30,		Six Months Ended
June 30,
2021202020212020
Net loss$(26,657)$(7,012)$(17,649)$(3,675)
Stock and incentive plan compensation4,588 3,385 7,905 6,460 
Amortization of acquired intangible assets6,074 927 10,759 1,319 
Acquired debt fair value adjustment— — (307)— 
Contingent consideration fair value adjustments25,600 — 25,900 — 
Non-recurring refinancing related fees— 460 — 460 
Non-recurring severance related fees92 — 528 — 
Extinguishment of debt— — (889)— 
Gain on sale of assets— — (15,263)— 
Integration costs11 1,201 30 3,573 
Acquisition-related costs767 7,517 664 8,929 
Impairment of long-lived assets— — — 7,275 
Other43 — 53 (75)
Income tax effect of non-GAAP adjustments(a)
(2,731)(1,940)(648)(5,446)
Adjusted net income$7,787 $4,538 $11,083 $18,820 
Adjusted net income, as a percentage of revenues7.7 %6.9 %5.7 %12.0 %
Three Months Ended
June 30,		Six Months Ended
June 30,
2021202020212020
Net loss per share - diluted$(0.39)$(0.16)$(0.26)$(0.09)
Stock and incentive plan compensation0.07 0.08 0.12 0.14 
Amortization of acquired intangible assets0.08 0.02 0.16 0.03 
Acquired debt fair value adjustment— — (0.01)— 
Contingent consideration fair value adjustments0.37 — 0.38 — 
Non-recurring refinancing related fees— 0.01 — 0.01 
Non-recurring severance related fees— — 0.01 — 
Extinguishment of debt— — (0.01)— 
Gain on sale of assets— — (0.23)— 
Integration costs— 0.03 — 0.09 
Acquisition-related costs0.02 0.18 0.01 0.22 
Impairment of long-lived assets— — — 0.18 
Other— — — — 
Income tax effect of non-GAAP adjustments(a)
(0.04)(0.06)(0.01)(0.13)
Adjusted net income per share - diluted$0.11 $0.10 $0.16 $0.45 
Weighted-average common shares outstanding - diluted68,705 43,303 68,281 41,702 
(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
June 30,		Six Months Ended
June 30,
2021202020212020
Net cash provided by (used in) operating activities$25,869 $(2,156)$35,687 $7,252 
Capital expenditures(2,656)(2,255)(5,176)(4,953)
Free cash flow$23,213 $(4,411)$30,511 $2,299 
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Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
June 30,
2021		December 31,
2020
Assets
Current assets
Cash and cash equivalents$91,500 $79,612 
Accounts receivable, net54,892 54,002 
Inventory31,719 35,744 
Other current assets8,102 9,625 
Assets held for sale— 5,242 
Total current assets186,213 184,225 
Property, plant and equipment, net118,493 120,171 
Intangibles, net365,259 376,012 
Goodwill61,189 58,632 
Deferred tax assets, net64,777 70,147 
Other long-term assets61,871 60,634 
Total assets$857,802 $869,821 
Liabilities and stockholders’ equity
Current liabilities
Current portion of long-term debt and other borrowings$10,372 $20,701 
Accounts payable21,471 16,284 
Accrued expenses and other liabilities41,983 41,726 
Liabilities held for sale— 1,793 
Total current liabilities73,826 80,504 
Asset retirement obligations14,797 14,020 
Long-term debt, net and other borrowings169,249 197,699 
Other long-term liabilities91,790 63,393 
Total liabilities349,662 355,616 
Total stockholders’ equity508,140 514,205 
Total liabilities and stockholders’ equity$857,802 $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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