Lantheus Holdings, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results

February 24, 2022 at 7:01 AM EST
  • 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, Mass., Feb. 24, 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 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:

  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.

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 -


Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data – unaudited)
 
  Three Months Ended
December 31,
 Year Ended
December 31,
  2021 2020 2021 2020
Revenues $129,562  $94,152  $425,208  $339,410 
Cost of goods sold  71,654   55,501   237,513   200,649 
Gross profit  57,908   38,651   187,695   138,761 
Operating expenses        
Sales and marketing  19,423   12,857   68,422   40,901 
General and administrative  62,530   13,684   150,395   69,270 
Research and development  11,293   12,638   44,966   32,788 
Total operating expenses  93,246   39,179   263,783   142,959 
Gain on sale of assets        15,263    
Operating loss  (35,338)  (528)  (60,825)  (4,198)
Interest expense  1,528   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:        
Basic  67,713   66,870   67,486   54,134 
Diluted  67,713   66,870   67,486   54,134 


Lantheus Holdings, Inc.
Consolidated Revenues Analysis
(in thousands – unaudited)
 
  Three Months Ended
December 31,
 Year Ended
December 31,
  2021 2020 (1)
 % Change 2021 2020 (1)
 % Change
DEFINITY $59,311 $55,876 6.1% $232,759 $195,865 18.8%
TechneLite  22,041  22,385 (1.5)%  91,293  84,945 7.5%
Other precision diagnostics  5,684  8,042 (29.3)%  26,973  36,824 (26.8)%
Total precision diagnostics  87,036  86,303 0.8%  351,025  317,634 10.5%
PYLARIFY  35,417   N/A  43,414   N/A
Other radiopharmaceutical oncology  267  2,548 (89.5)%  5,473  10,022 (45.4)%
Total radiopharmaceutical oncology  35,684  2,548 1300.5%  48,887  10,022 387.8%
Strategic Partnerships and other revenue  6,842  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.


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,
  2021 2020 2021 2020
Net loss $(40,215) $(3,412) $(71,279) $(13,473)
Stock and incentive plan compensation  4,162   3,623   15,934   14,075 
Amortization of acquired intangible assets  8,373   4,683   27,506   10,770 
Acquired debt fair value adjustment     (326)  (307)  (711)
Contingent consideration fair value adjustments  43,900   (2,800)  72,400   (2,000)
Non-recurring refinancing related fees           460 
Non-recurring severance related fees     904   522   904 
Non-recurring fees  818      818    
Extinguishment of debt        (889)   
Gain on sale of assets        (15,263)   
Integration costs  9   2,772   102   7,201 
Acquisition-related costs  823   1,334   1,549   11,856 
Impairment of long-lived assets  189   2,660   9,729   9,935 
ARO Acceleration  5,259      5,259    
Other  2   35   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 revenues  13.3%  4.9%  8.0%  7.6%


  Three Months Ended
December 31,
 Year Ended
December 31,
  2021 2020 2021 2020
Net loss per share - diluted $(0.59) $(0.05) $(1.06) $(0.25)
Stock and incentive plan compensation  0.06   0.05   0.24   0.26 
Amortization of acquired intangible assets  0.13   0.08   0.41   0.20 
Acquired debt fair value adjustment        (0.01)  (0.01)
Contingent consideration fair value adjustments  0.63   (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 fees  0.01      0.01    
Extinguishment of debt        (0.01)   
Gain on sale of assets        (0.23)   
Integration costs     0.04      0.13 
Acquisition-related costs  0.01   0.01   0.02   0.22 
Impairment of long-lived assets     0.04   0.14   0.18 
ARO Acceleration  0.08      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 - diluted  69,446   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.


Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)
 
 Three Months Ended
December 31,
 Year Ended
December 31,
 2021 2020 2021 2020
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)


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, net 89,336  54,002
Inventory 35,129  35,744
Other current assets 12,818  9,625
Assets held for sale   5,242
Total current assets 235,791  184,225
Property, plant and equipment, net 116,772  120,171
Intangibles, net 348,510  376,012
Goodwill 61,189  58,632
Deferred tax assets, net 62,764  70,147
Other long-term assets 38,758  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 payable 20,787  16,284
Accrued expenses and other liabilities 58,068  41,726
Liabilities held for sale   1,793
Total current liabilities 90,497  80,504
Asset retirement obligations 20,833  14,020
Long-term debt, net and other borrowings 163,121  197,699
Other long-term liabilities 124,894  63,393
Total liabilities 399,345  355,616
Total stockholders’ equity 464,439  514,205
Total liabilities and stockholders’ equity$863,784 $869,821

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

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