Lantheus Holdings, Inc. Reports First Quarter 2022 Financial Results

April 29, 2022 at 7:07 AM EDT
  • Worldwide revenue of $208.9 million for the first quarter 2022, representing an increase of 125.8% from the prior year period
  • GAAP net income of $43.0 million for the first quarter 2022, compared to GAAP net income of $9.0 million in the prior year period
  • GAAP fully diluted net income of $0.61 for the first quarter 2022, compared to GAAP fully diluted net income of $0.13 in the prior year period; adjusted fully diluted EPS of $0.97 for the first quarter 2022, compared to adjusted fully diluted EPS of $0.05 in the prior year period
  • Net cash provided by operating activities was $10.3 million for the first quarter 2022. Free cash flow was $7.1 million in the first quarter 2022
  • The Company provides second quarter 2022 revenue and adjusted diluted earnings per share guidance; increases full year guidance

NORTH BILLERICA, Mass., April 29, 2022 (GLOBE NEWSWIRE) -- 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 first quarter ended March 31, 2022.

The Company’s worldwide revenue for the first quarter of 2022 totaled $208.9 million, compared with $92.5 million for the first quarter of 2021, representing an increase of 125.8% from the prior year period.

The Company’s first quarter 2022 GAAP net income was $43.0 million, or $0.61 per fully diluted share, as compared to GAAP net income of $9.0 million, or $0.13 per fully diluted share for the first quarter of 2021.

The Company’s first quarter 2022 adjusted fully diluted earnings per share were $0.97, as compared to $0.05 for the first quarter of 2021, representing an increase of approximately $0.92 from the prior year period.

Lastly, net cash provided by operating activities was $10.3 million for the first quarter 2022. Free Cash Flow was $7.1 million in the first quarter of 2022, representing a decrease of approximately $0.2 million from the prior year period.

“We continued to deliver strong performance with record revenue and earnings in the first quarter of 2022, led primarily by rapidly increasing PYLARIFY sales,” said Mary Anne Heino, President and CEO. “We are executing on our strategy to accelerate growth, diversify our portfolio, and position Lantheus as the category leader in markets in which we compete. We are excited by our recent strategic collaborations for PYLARIFY and PYLARIFY AI and continue to assess longer-term revenue opportunities through strategic transactions and internal development to drive shareholder value.”

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

    Q2 Guidance Issued April 29, 2022   Previous Guidance Issued February 24, 2022
Q2 FY 2022 Revenue   $200 million - $215 million   N/A
Q2 FY 2022 Adjusted Fully Diluted EPS   $0.67 - $0.73   N/A
    FY Guidance Updated April 29, 2022   FY Guidance Issued February 24, 2022
FY 2022 Revenue   $800 million - $835 million   $685 million - $710 million
FY 2022 Adjusted Fully Diluted EPS   $2.90 - $3.15   $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, August 4, 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.
 

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 additional 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 “believe,” “could,” “estimate,” “expect,” “look forward to,” “may,” “plan,” “predict,” “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) 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; (ii) 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 a competitive environment in which other PSMA PET imaging agents have been approved and additional ones are in development; (iii) the global Molybdenum-99 (“Mo-99”) supply; (iv) our ability to have third party manufacturers manufacture our products and our ability to use our in-house manufacturing capacity; (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, financial condition and prospects; (vii) 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 (“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
March 31,
      2022       2021  
Revenues   $ 208,880     $ 92,509  
Cost of goods sold     79,810       51,479  
Gross profit     129,070       41,030  
Operating expenses        
Sales and marketing     20,354       14,173  
General and administrative     37,588       16,138  
Research and development     12,203       10,360  
Total operating expenses     70,145       40,671  
Gain on sale of assets           15,263  
Operating income     58,925       15,622  
Interest expense     1,509       2,718  
Gain on extinguishment of debt           (889 )
Other income     (485 )     (549 )
Income before income taxes     57,901       14,342  
Income tax expense     14,939       5,334  
Net income   $ 42,962     $ 9,008  
Net income per common share:        
Basic   $ 0.63     $ 0.13  
Diluted   $ 0.61     $ 0.13  
Weighted-average common shares outstanding:        
Basic     68,008       67,094  
Diluted     70,051       67,714  
                 

Lantheus Holdings, Inc.

Consolidated Revenues Analysis

(in thousands – unaudited)

    Three Months Ended
March 31,
      2022       2021     % Change
DEFINITY   $ 58,328     $ 55,971     4.2 %
TechneLite     22,605       22,800     (0.9 )%
Other precision diagnostics     5,265       6,984     (24.6 )%
Total precision diagnostics     86,198       85,755     0.5 %
PYLARIFY     92,777           N/A  
Other radiopharmaceutical oncology     1,327       1,500     (11.5 )%
Total radiopharmaceutical oncology     94,104       1,500     6,173.6 %
Strategic Partnerships and other revenue     28,578       5,254     443.9 %
Total revenues   $ 208,880     $ 92,509     125.8 %
                       

Lantheus Holdings, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(in thousands, except per share data – unaudited)

    Three Months Ended
March 31,
      2022       2021  
Net income   $ 42,962     $ 9,008  
Stock and incentive plan compensation     5,623       3,317  
Amortization of acquired intangible assets     8,306       4,685  
Acquired debt fair value adjustment           (307 )
Contingent consideration fair value adjustments     18,400       300  
Non-recurring severance related fees           436  
Non-recurring fees     (732 )      
Extinguishment of debt           (889 )
Gain on sale of assets           (15,263 )
Integration costs           19  
Acquisition-related costs     447       (103 )
ARO Acceleration and other related costs     1,591        
Other     129       10  
Income tax effect of non-GAAP adjustments(a)     (8,896 )     2,083  
Adjusted net income   $ 67,830     $ 3,296  
Adjusted net income, as a percentage of revenues     32.5 %     3.6 %
                 

 

    Three Months Ended
March 31,
      2022       2021  
Net income per share - diluted   $ 0.61     $ 0.13  
Stock and incentive plan compensation     0.08       0.05  
Amortization of acquired intangible assets     0.12       0.08  
Acquired debt fair value adjustment           (0.01 )
Contingent consideration fair value adjustments     0.26       0.01  
Non-recurring severance related fees           0.01  
Non-recurring fees     (0.01 )      
Extinguishment of debt           (0.01 )
Gain on sale of assets           (0.23 )
Integration costs            
Acquisition-related costs     0.01       (0.01 )
ARO Acceleration and other related costs     0.02        
Income tax effect of non-GAAP adjustments(a)     (0.12 )     0.03  
Adjusted net income per share - diluted   $ 0.97     $ 0.05  
Weighted-average common shares outstanding - diluted     70,051       67,714  
                 

(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
March 31,
    2022       2021  
Net cash provided by operating activities $ 10,264     $ 9,818  
Capital expenditures   (3,190 )     (2,520 )
Free cash flow $ 7,074     $ 7,298  
       
Net cash (used in) provided by investing activities $ (1,390 )   $ 13,303  
Net cash used in financing activities $ (2,179 )   $ (34,791 )
               

Lantheus Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands – unaudited)

  March 31,
2021
  December 31,
2021
Assets      
Current assets      
Cash and cash equivalents $ 105,355     $ 98,508  
Accounts receivable, net   172,283       89,336  
Inventory   34,249       35,129  
Other current assets   12,860       12,818  
Total current assets   324,747       235,791  
Property, plant and equipment, net   116,959       116,772  
Intangibles, net   340,204       348,510  
Goodwill   61,189       61,189  
Deferred tax assets, net   47,868       62,764  
Other long-term assets   42,199       38,758  
Total assets $ 933,166     $ 863,784  
Liabilities and stockholders’ equity      
Current liabilities      
Current portion of long-term debt and other borrowings $ 12,878     $ 11,642  
Accounts payable   22,383       20,787  
Accrued expenses and other liabilities   142,396       58,068  
Total current liabilities   177,657       90,497  
Asset retirement obligations   21,514       20,833  
Long-term debt, net and other borrowings   159,369       163,121  
Other long-term liabilities   58,776       124,894  
Total liabilities   417,316       399,345  
Total stockholders’ equity   515,850       464,439  
Total liabilities and stockholders’ equity $ 933,166     $ 863,784  
               

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

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