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Lantheus Reports Third Quarter 2022 Financial Results

  • Worldwide revenue of $239.3 million for the third quarter 2022, representing an increase of 134.4% from the prior year period
  • GAAP net income of $61.2 million for the third quarter 2022, compared to GAAP net loss of $13.4 million in the prior year period
  • GAAP fully diluted net income per share of $0.86 for the third quarter 2022, compared to GAAP fully diluted net loss per share of $0.20 in the prior year period; adjusted fully diluted net income per share of $0.99 for the third quarter 2022, compared to adjusted fully diluted net income per share of $0.08 in the prior year period
  • Net cash provided by operating activities was $93.6 million for the third quarter 2022. Free cash flow was $87.5 million in the third quarter 2022
  • The Company provides fourth quarter 2022 revenue and adjusted diluted earnings per share guidance; increases full year guidance

NORTH BILLERICA, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), a company committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease, today reported financial results for its third quarter ended September 30, 2022.

The Company’s worldwide revenue for the third quarter of 2022 totaled $239.3 million, compared with $102.1 million for the third quarter of 2021, representing an increase of 134.4% from the prior year period.

The Company’s third quarter 2022 GAAP net income was $61.2 million, or $0.86 per fully diluted share, as compared to GAAP net loss of $13.4 million, or $0.20 per fully diluted share for the third quarter of 2021.

The Company’s third quarter 2022 adjusted fully diluted net income per share, or earnings per share (“EPS”), were $0.99, as compared to $0.08 for the third quarter of 2021, representing an increase of approximately $0.91 from the prior year period.

Lastly, net cash provided by operating activities was $93.6 million for the third quarter 2022. Free Cash Flow was $87.5 million in the third quarter of 2022, representing an increase of approximately $85.6 million from the prior year period.

“This quarter, we executed on our strategy and delivered outstanding results,” said Mary Anne Heino, President and Chief Executive Officer. “Through the dedicated efforts of our employees, we grew our market-leading franchises while also investing in our business. As we plan for the future, we believe our leading franchises and strong balance sheet will help us to drive sustainable growth.”

The Company updates its guidance for full year 2022 and offers the following guidance for the fourth quarter:

  Q4 Guidance Issued November 3, 2022 Previous Guidance Issued August 4, 2022
Q4 FY 2022 Revenue $243 million - $247 million N/A
Q4 FY 2022 Adjusted Fully Diluted EPS $0.95 - $0.98 N/A
  FY Guidance Updated November 3, 2022 FY Guidance Issued August 4, 2022
FY 2022 Revenue $915 million - $919 million $885 million - $905 million
FY 2022 Adjusted Fully Diluted EPS $3.80 - $3.83 $3.50 - $3.60
     

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, November 3, 2022, at 8:00 a.m. ET. To access the conference call or webcast, participants should register online at https://investor.lantheus.com/news-events/calendar-of-events.

A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 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.

With more than 60 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus is headquartered in Massachusetts and has 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.

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,” “continue,” “could,” “estimate,” “expect,” “guidance,” “intend,” “introduce,” “may,” “momentum,” “plan,” “predict,” “progress,” “project,” “promising,” “target,” “will,” “would” 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) our ability to continue to grow PYLARIFY as a commercial product, including (A) our ability to obtain FDA approval for additional positron emission tomography (“PET”) manufacturing facilities (“PMFs”) to manufacture PYLARIFY, (B) the ability of PMFs to manufacture PYLARIFY to meet product demand, (C) our ability to sell PYLARIFY to customers, (D) our ability to obtain and maintain adequate coding, coverage and payment for PYLARIFY, and (E) our ability to establish PYLARIFY as a leading PSMA PET imaging agent in an increasingly competitive environment in which other PSMA PET imaging agents have been approved and additional ones are in development; (ii) 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 and challenges; (iii) the global Molybdenum-99 (“Mo-99”) supply; (iv) our ability to have third party manufacturers manufacture our products and our ability to manufacture DEFINITY in our in-house manufacturing facility; (v) our ability to successfully launch PYLARIFY AI as a commercial product; (vi) the continuing impact of the global COVID-19 pandemic on our business, supply chain, financial conditions and prospects; (vii) the efforts and timing for clinical development and regulatory approval of our product candidates and new clinical applications and territories for our products, in each case, that we may develop, including 1095 and NM-01, or that our strategic partners may develop, including piflufolastat F 18 in Europe and flurpiridaz fluorine-18 (“F 18”); (viii) our ability to identify and acquire or in-license additional diagnostic and therapeutic product opportunities in oncology and other strategic areas; (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 -

Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data – unaudited)

  Three Months Ended
September 30,
 Nine Months Ended
September 30,
   2022   2021   2022   2021 
Revenues $239,292  $102,073  $671,895  $295,646 
Cost of goods sold  91,859   59,404   257,363   165,859 
Gross profit  147,433   42,669   414,532   129,787 
Operating expenses        
Sales and marketing  25,414   17,195   73,260   48,999 
General and administrative  23,759   28,550   93,945   87,865 
Research and development  12,517   11,252   39,455   33,673 
Total operating expenses  61,690   56,997   206,660   170,537 
Gain on sale of assets           15,263 
Operating income (loss)  85,743   (14,328)  207,872   (25,487)
Interest expense  1,626   1,569   4,604   6,224 
Gain on extinguishment of debt           (889)
Other income  1,101   3,940   306   3,209 
Income (loss) before income taxes  83,016   (19,837)  202,962   (34,031)
Income tax expense (benefit)  21,784   (6,422)  55,710   (2,967)
Net income (loss) $61,232  $(13,415) $147,252  $(31,064)
Net income (loss) per common share:        
Basic $0.89  $(0.20) $2.15  $(0.46)
Diluted $0.86  $(0.20) $2.08  $(0.46)
Weighted-average common shares outstanding:        
Basic  68,756   67,623   68,482   67,409 
Diluted  71,075   67,623   70,669   67,409 


Lantheus Holdings, Inc.
Consolidated Revenues Analysis
(in thousands – unaudited)

  Three Months Ended
September 30,
 Nine Months Ended
September 30,
   2022   2021  % Change  2022   2021  % Change
DEFINITY $60,740  $57,636  5.4% $181,374  $173,448  4.6%
TechneLite  22,094   22,680  (2.6)%  64,139   69,252  (7.4)%
Other precision diagnostics  6,175   7,563  (18.4)%  16,803   21,289  (21.1)%
Total precision diagnostics  89,009   87,879  1.3%  262,316   263,989  (0.6)%
PYLARIFY  143,754   7,724  N/A  366,763   7,997  N/A
Other radiopharmaceutical oncology  928   1,166  (20.4)%  3,183   5,206  (38.9)%
Total radiopharmaceutical oncology  144,682   8,890  1,527.5%  369,946   13,203  2702.0%
Strategic Partnerships and other revenue  5,601   5,304  5.6%  39,633   18,454  114.8%
Total revenues $239,292  $102,073  134.4% $671,895  $295,646  127.3%


Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)

  Three Months Ended
September 30,
 Nine Months Ended
September 30,
   2022   2021   2022   2021 
Net income (loss) $61,232  $(13,415) $147,252  $(31,064)
Stock and incentive plan compensation  8,103   3,867   21,138   11,772 
Amortization of acquired intangible assets  8,306   8,374   24,918   19,133 
Acquired debt fair value adjustment           (307)
Contingent consideration fair value adjustments  (1,500)  2,600   25,400   28,500 
Non-recurring severance related fees     (6)     522 
Non-recurring fees        (384)   
Extinguishment of debt           (889)
Gain on sale of assets           (15,263)
Strategic collaboration and license costs        500    
Integration costs     63      93 
Acquisition-related costs  169   62   868   726 
Impairment of long-lived assets     9,540      9,540 
ARO Acceleration and other related costs  1,287      3,087    
Other  106   7   111   60 
Income tax effect of non-GAAP adjustments(a)  (7,038)  (5,411)  (21,512)  (6,059)
Adjusted net income $70,665  $5,681  $201,378  $16,764 
Adjusted net income, as a percentage of revenues  29.5%  5.6%  30.0%  5.7%


  Three Months Ended
September 30,
 Nine Months Ended
September 30,
   2022   2021   2022   2021 
Net income (loss) per share - diluted $0.86  $(0.20) $2.08  $(0.46)
Stock and incentive plan compensation  0.11   0.05   0.30   0.18 
Amortization of acquired intangible assets  0.12   0.12   0.36   0.28 
Acquired debt fair value adjustment           (0.01)
Contingent consideration fair value adjustments  (0.02)  0.04   0.36   0.42 
Non-recurring severance related fees           0.01 
Non-recurring fees        (0.01)   
Extinguishment of debt           (0.01)
Gain on sale of assets           (0.23)
Strategic collaboration and license costs        0.01    
Integration costs            
Acquisition-related costs     0.01   0.01   0.01 
Impairment of long-lived assets     0.14      0.14 
ARO Acceleration and other related costs  0.02      0.04    
Other            
Income tax effect of non-GAAP adjustments(a)  (0.10)  (0.08)  (0.30)  (0.09)
Adjusted net income per share - diluted $0.99  $0.08  $2.85  $0.24 
Weighted-average common shares outstanding - diluted  71,075   69,237   70,669   68,674 

(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.


Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)

 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2022   2021   2022   2021 
Net cash provided by operating activities$93,568  $4,340  $176,429  $40,027 
Capital expenditures (6,090)  (2,420)  (13,623)  (7,596)
Free cash flow$87,478  $1,920  $162,806  $32,431 
        
Net cash (used in) provided by investing activities$(6,090) $(2,420) $(11,823) $8,227 
Net cash used in financing activities$(1,959) $(1,726) $(6,149) $(37,232)


Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)

 September 30,
2022
 December 31,
2021
Assets   
Current assets   
Cash and cash equivalents$257,259  $98,508 
Accounts receivable, net 197,276   89,336 
Inventory 34,793   35,129 
Other current assets 12,570   12,818 
Total current assets 501,898   235,791 
Property, plant and equipment, net 120,826   116,772 
Intangibles, net 323,591   348,510 
Goodwill 61,189   61,189 
Deferred tax assets, net 46,806   62,764 
Other long-term assets 41,628   38,758 
Total assets$1,095,938  $863,784 
Liabilities and stockholders’ equity   
Current liabilities   
Current portion of long-term debt and other borrowings$15,372  $11,642 
Accounts payable 30,135   20,787 
Accrued expenses and other liabilities 190,477   58,068 
Total current liabilities 235,984   90,497 
Asset retirement obligations 23,358   20,833 
Long-term debt, net and other borrowings 152,057   163,121 
Other long-term liabilities 46,489   124,894 
Total liabilities 457,888   399,345 
Total stockholders’ equity 638,050   464,439 
Total liabilities and stockholders’ equity$1,095,938  $863,784 


Contacts:
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

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


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