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8-K - FORM 8-K - Lantheus Holdings, Inc.d144586d8k.htm

Exhibit 99.1

 

LOGO   

 

331 Treble Cove Road

 

North Billerica, MA 01862

  

 

800.362.2668

 

www.lantheus.com

FOR RELEASE 4:02 PM EASTERN

MONDAY, FEBRUARY 22, 2016

CONTACTS:

Meara Murphy

978-671-8508

Lantheus Holdings, Inc. Reports 2015 Fourth Quarter and Full Year

Financial Results; Provides 2016 Guidance

Lantheus posts fourth quarter net income of $3.9 million and Adjusted EBITDA of $18.3 million;

Full year adjusted net income of $14.2 million and Adjusted EBITDA of $76.3 million

Fourth quarter worldwide DEFINITY® revenue increased 13% as-reported

NORTH BILLERICA, Mass., February 22, 2016Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today reported financial results for its fourth quarter and full year ended December 31, 2015.

The Company’s worldwide revenue for the fourth quarter of 2015 totaled $71.2 million, representing a decrease of 7% as-reported compared to $77.0 million reported for the fourth quarter of 2014. Constant currency revenue decreased by 5% versus the prior year period. Fourth quarter worldwide revenue reflects decreased revenues as a result of lower sales volumes for TechneLite® from a major customer offset by revenue gains with DEFINITY® and Xenon.

Net income for the fourth quarter of 2015 totaled $3.9 million or $0.13 per diluted share, an improvement of $3.7 million compared to a net income of $200,000 or $0.01 per diluted share in the fourth quarter of 2014. Fourth quarter net income results reflect gross margin expansion driven by the continued strong performance of DEFINITY along with growth of Xenon driven by non-contracted status with certain key customers and favorability on expenses.

The Company’s fourth quarter 2015 Adjusted EBITDA, as defined in the GAAP to non-GAAP reconciliation provided later in this release, was $18.3 million, or 25.7% of reported revenue, compared to $19.4 million, or 25.2% of reported revenue, in the fourth quarter of 2014. Lower Adjusted EBITDA was driven by lower sales of TechneLite. EBITDA margin improvement was driven by gross margin expansion, product mix and good expense management.

For full year 2015, worldwide revenue totaled $293.5 million, a 2.7% decrease on an as-reported basis from $301.6 million in 2014. On a constant currency basis, revenue was consistent with prior year. Full year 2015 net income, as adjusted, totaled $14.2 million, an improvement of $16.6 million, compared to a net loss, as adjusted, of $2.4 million for 2014. Full year 2015 Adjusted EBITDA totaling $76.3 million, represented 26.0% of reported revenue for the year, and grew 7.9% compared to $70.8 million reported for 2014. The attached financial tables include a reconciliation of U.S. GAAP to as-adjusted results.


Mary Anne Heino, President and CEO commented, “We are pleased with our 2015 financial results. We met our revenue guidance and exceeded Adjusted EBITDA guidance. The Adjusted EBITDA results are attributable primarily to product mix together with good expense management. We made positive progress on executing our business strategy, including growing our key product, DEFINITY. DEFINITY posted 17% top line growth in a market where we continue to see increased use of contrast agents in suboptimal echocardiogram studies. Additionally, in the fourth quarter we significantly expanded our Operating and Adjusted EBITDA margins over last year, driving those margins to 17% and 26%, respectively.

Ms. Heino continued, “Looking to 2016 and beyond, we now have supply agreements with the four largest radiopharmacy providers in the U.S. These supply agreements specify product volumes for key nuclear medicine products. In particular, we entered into multiple year agreements with these key Xenon customers to ensure committed volumes at lower Xenon prices, which will negatively affect revenue, net income and Adjusted EBITDA in 2016 versus 2015 but will provide for additional revenue and unit volumes in 2017. In 2016, we will continue to focus on optimizing revenue and unit volumes in our commercial portfolio while creating further efficiencies in our business footprint. In addition, we will actively advance our development pipeline and continue to pursue business development opportunities to strengthen our product offering and manufacturing capabilities. In summary, we believe our leading position in the echo market and the steps we are taking in the balance of our business create a strong foundation in 2016 and a platform for increased revenue and unit volumes in 2017 and beyond.”

Outlook

The Company anticipates worldwide revenue for full year 2016 of approximately $285 million to $290 million, compared to $293.5 million in 2015. This lower revenue level is driven primarily by its new Xenon contracts with key customers that specify committed volumes at lower prices. This is largely offset by positive growth in DEFINITY and, to a lesser extent, by improved revenue from its nuclear products. For the first quarter of 2016, the Company expects worldwide revenue in the range of $72 million to $74 million.

The Company anticipates full year 2016 Adjusted EBITDA, as described in the GAAP to non-GAAP reconciliation provided later in this release, of $60 million to $64 million, measuring 21% to 22% of reported worldwide revenue. This lower level from full year 2015 is driven primarily by its new Xenon contracts with key customers that specify committed volumes at lower prices. With anticipated increased volumes in 2017 for Xenon and other key nuclear products, the Company believes 2017 revenue and Adjusted EBITDA levels will improve in comparison to 2016. For the first quarter of 2016, the Company expects Adjusted EBITDA in the range of $14 million to $16 million.

The Company’s guidance does not give effect to the impact or timing of Xenon competition other than the committed volumes and new pricing levels previously described.

The Company’s guidance for worldwide revenue and Adjusted EBITDA are forward-looking statements. They are subject to various risks and uncertainties that could cause the Company’s actual results to differ materially from the anticipated targets. The anticipated targets are not predictions of the Company’s actual performance. See the cautionary information about forward-looking statements in the “Safe-Harbor Statement” section of this press release.


Internet Posting of Information

The Company routinely posts information that may be important to investors in the “Investor Relations” 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 starting at 4:30 p.m. (Eastern Time) today. 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 42121023. A live audio webcast of the call also will be available on the homepage of the Company’s website at www.lantheus.com.

A replay of the telephone conference call and audio webcast will be available from approximately 8:30 p.m. ET on February 22, 2016 through midnight on March 7, 2016. To access a replay of the conference call, dial 1-855-859-2056 (U.S. callers) or 1-404-537-3406 (international callers), and provide passcode 42121023. A replay of this conference call will also be available in the Investor Relations section of our website located at www.lantheus.com.

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. and Lantheus Medical Imaging, Inc.

Lantheus Holdings, Inc. is the parent company of LMI, which is a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, which are primarily used for the diagnosis of cardiovascular diseases. LMI’s key products include the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; and Xenon (Xenon Xe 133 Gas), an inhaled radiopharmaceutical imaging agent used to evaluate pulmonary function and for imaging the lungs. The Company is headquartered in North Billerica, Massachusetts with offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.

Non-GAAP Financial Measures

The Company uses non-GAAP financial measures, such as net sales excluding the impact of foreign currency; operating income, as adjusted; net income, as adjusted; Adjusted EBITDA; net income, as adjusted, per diluted share; Adjusted EBITDA per diluted share; 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. The measures may exclude such items which may be highly variable, difficult to predict and of a size that could have substantial impact on the Company’s reported results of operations for a 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” as defined under U.S. federal securities laws, including statements about our 2016 outlook. These statements reflect management’s current knowledge, assumptions, beliefs, estimates and expectations and express management’s current view of future performance, results and trends. 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 subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. 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 are discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section of our prospectus dated June 24, 2015 and filed with the SEC on June 26, 2015, and as may be further set forth or supplemented in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).

– Tables Follow –


Lantheus Holdings, Inc. and subsidiaries

Condensed Consolidated Statements of Operations

(dollars in thousands, except share data – unaudited)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2015     2014     2015     2014  

Revenues

   $ 71,201      $ 76,969      $ 293,461      $ 301,600   

Cost of goods sold

     37,820        44,208        157,939        176,081   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     33,381        32,761        135,522        125,519   

Operating expenses

        

Sales and marketing expenses

     7,806        7,889        34,740        35,116   

General and administrative expenses

     10,121        8,430        43,894        37,313   

Research and development expenses

     3,066        4,715        14,358        13,673   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     20,993        21,034        92,992        86,102   

Operating income

     12,388        11,727        42,530        39,417   

Interest expense

     (7,098     (10,564     (38,715     (42,288

Interest income

     6        7        24        27   

Loss on extinguishment of debt

     —          —          (15,528     —     

Other income (expense), net

     (323     626        (89     478   
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income taxes

     4,973        1,796        (11,778     (2,366

Provision for income taxes

     1,057        1,569        2,968        1,195   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss)

   $ 3,916      $ 227      $ (14,746   $ (3,561
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per common share

        

Basic

   $ 0.13      $ 0.01      $ (0.60   $ (0.20

Diluted

   $ 0.13      $ 0.01      $ (0.60   $ (0.20

Common shares

        

Basic

     30,364,501        18,080,968        24,439,845        18,080,615   

Diluted

     30,364,914        19,308,598        24,439,845        18,080,615   


Lantheus Holdings, Inc. and subsidiaries

Consolidated Revenue Analysis

(dollars in thousands – unaudited)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2015      2014      % change     2015      2014      % change  
                

U.S.

                

DEFINITY

     28,324         25,080         12.9     109,656         93,848         16.8

TechneLite

     14,667         20,719         (29.2 )%      62,034         82,321         (24.6 )% 

Xenon

     10,931         9,023         21.1     48,868         36,542         33.7

Other

     3,645         6,890         (47.1 )%      15,266         23,809         (35.9 )% 
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total U.S.

   $ 57,567       $ 61,712         (6.7 )%    $ 235,824       $ 236,520         (0.3 )% 
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

International

                

DEFINITY

     558         545         2.4     2,203         1,912         15.2

TechneLite

     2,450         2,691         (9.0 )%      10,528         11,267         (6.6 )% 

Xenon

     2         1         100.0     30         7         328.6

Other

     10,624         12,020         (11.6 )%      44,876         51,894         (13.5 )% 
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total International

   $ 13,634       $ 15,257         (10.6 )%    $ 57,637       $ 65,080         (11.4 )% 
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Worldwide

                

DEFINITY

     28,882         25,625         12.7     111,859         95,760         16.8

TechneLite

     17,117         23,410         (26.9 )%      72,562         93,588         (22.5 )% 

Xenon

     10,933         9,024         21.2     48,898         36,549         33.8

Other

     14,269         18,910         (24.5 )%      60,142         75,703         (20.6 )% 
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total Revenues

   $ 71,201       $ 76,969         (7.5 )%    $ 293,461       $ 301,600         (2.7 )% 
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 


Lantheus Holdings, Inc. and subsidiaries

Supplemental Revenue Information

(unaudited)

 

     December 31, 2015 Quarter to Date Sales Growth/(Decline)  
     Domestic As
Reported
    Int’l
Constant
Currency
    Int’l As
Reported
    Total
Constant
Currency
    Total As
Reported
 

Products

          

DEFINITY

     13     21     2     13     13

TechneLite

     (29 )%      4     (9 )%      (25 )%      (27 )% 

Xenon

     21     100     100     21     21

Other

     (47 )%      (1 )%      (12 )%      (18 )%      (25 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Revenues

     (7 )%      0     (11 )%      (5 )%      (7 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
     December 31, 2015 Year to Date Sales Growth/(Decline)  
     Domestic As
Reported
    Int’l
Constant
Currency
    Int’l As
Reported
    Total
Constant
Currency
    Total As
Reported
 

Products

          

DEFINITY

     17     34     15     17     17

TechneLite

     (25 )%      5     (7 )%      (21 )%      (22 )% 

Xenon

     34     386     329     34     34

Other

     (36 )%      (4 )%      (14 )%      (14 )%      (21 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total Revenues

     0     (1 )%      (11 )%      0     (3 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 


Lantheus Holdings, Inc. and subsidiaries

Reconciliation of Revenues to Revenues Excluding the Impact of Foreign Currency

(dollars in thousands – unaudited)

 

     Three Months Ended December 31, 2015      Twelve Months Ended December 31, 2015  
     International Net Sales      Total Net Sales      International Net Sales      Total Net Sales  

Net sales, as reported

   $ 13,634       $ 71,201       $ 57,637       $ 293,461   

Currency impact as compared to prior period

     1,687         1,687         6,833         6,833   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net sales, excluding the impact of foreign currency

   $ 15,321       $ 72,888       $ 64,470       $ 300,294   
  

 

 

    

 

 

    

 

 

    

 

 

 


Lantheus Holdings, Inc. and subsidiaries

Reconciliations of As Reported Results to Non-GAAP Financial Measures

(dollars in thousands – unaudited)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2015     2014     2015     2014  

Operating Income

        

Operating Income, as reported

   $ 12,388      $ 11,727      $ 42,530      $ 39,417   

Reconciling items impacting

        

Operating Income:

        

Campus Consolidation Costs

     —          —          3,630        —     

Sponsor Termination Costs

     —          —          6,527        —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating income, as adjusted

   $ 12,388      $ 11,727      $ 52,687      $ 39,417   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Income, as adjusted, as a percentage of net sales

     17.4     15.2     18.0     13.1
  

 

 

   

 

 

   

 

 

   

 

 

 
     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2015     2014     2015     2014  

Net income (loss)

        

Net income (loss), as reported

   $ 3,916      $ 227      $ (14,746   $ (3,561

Reconciling items impacting

        

Gross Profit:

        

Campus Consolidation Costs

     —          —          77        —     

Reconciling items impacting

        

Operating Expenses:

        

Campus Consolidation Costs

     —          1,210        3,553        1,210   

Sponsor Termination Costs

     —          —          6,527        —     

Reconciling items impacting

        

Non-operating Expenses:

        

Loss on Debt Extinguishment

     —          —          15,528        —     

Interest Upon Redemption of Senior Notes

     —          —          3,250        —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss), as adjusted

   $ 3,916      $ 1,437      $ 14,189      $ (2,351
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss), as adjusted, as a percentage of net sales

     5.5     1.9     4.8     (0.8 )% 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss), as adjusted, per common share

        

Basic

   $ 0.13      $ 0.08      $ 0.58      $ (0.13

Diluted

   $ 0.13      $ 0.07      $ 0.57      $ (0.13

Common shares

        

Basic

     30,364,501        18,080,968        24,439,845        18,080,615   

Diluted

     30,364,914        19,308,598        24,733,592        18,080,615   


Lantheus Holdings, Inc. and subsidiaries

Reconciliation of As Reported Results to Non-GAAP Financial Measures

(dollars in thousands – unaudited)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2015     2014     2015     2014  

EBITDA

        

Net income (loss), as reported

   $ 3,916      $ 227      $ (14,746   $ (3,561

Interest expense, net

     7,092        10,557        38,691        42,261   

Provision for income taxes

     619        977        1,314        441   

Depreciation

     2,164        3,387        11,813        9,901   

Amortization of intangible assets

     2,160        2,275        7,838        9,123   
  

 

 

   

 

 

   

 

 

   

 

 

 

EBITDA

     15,951        17,423        44,910        58,165   

Reconciling items impacting

        

EBITDA:

        

Non-cash stock-based compensation

     478        249        2,002        1,031   

Legal fees relating to business interruption claim

     5        186        72        1,113   

Asset write-off

     286        107        1,468        1,257   

Severance and recruiting costs

     507        306        1,360        818   

Sponsor fee and other

     —          321        7,340        3,412   

Extinguishment of debt

     —          —          15,528        —     

New manufacturer costs

     1,081        771        3,649        4,959   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 18,308      $ 19,363      $ 76,329      $ 70,755   
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA as a percentage of net sales

     25.7     25.2     26.0     23.5
  

 

 

   

 

 

   

 

 

   

 

 

 


Lantheus Holdings, Inc. and subsidiaries

Reconciliation of Free Cash Flow

(dollars in thousands – unaudited)

 

     Three Months Ended     Twelve Months Ended  
     December 31, 2015     December 31, 2014     December 31, 2015     December 31, 2014  

Net cash provided by (used in) operating activities

   $ 12,626      $ (3,875   $ 21,762      $ 11,590   

Capital expenditures

     (4,732     (2,834     (13,151 )     (8,137
  

 

 

   

 

 

   

 

 

   

 

 

 

Free cash flow

   $ 7,894      $ (6,709   $ 8,611      $ 3,453   
  

 

 

   

 

 

   

 

 

   

 

 

 


Lantheus Holdings, Inc. and subsidiaries

Condensed Consolidated Balance Sheets

(dollars in thousands – unaudited)

 

     December 31, 2015     December 31, 2014  

Assets

    

Current assets

    

Cash and cash equivalents

   $ 28,596      $ 19,739   

Accounts receivable, net

     37,293        41,540   

Inventory

     15,622        15,582   

Other current assets

     3,946        4,374   

Assets held for sale

     4,644        —     
  

 

 

   

 

 

 

Total current assets

     90,101        81,235   

Property, plant and equipment, net

     86,517        96,014   

Capitalized software development costs, net

     9,137        2,421   

Intangibles, net

     20,496        27,191   

Goodwill

     15,714        15,714   

Other long-term assets

     20,414        20,578   
  

 

 

   

 

 

 

Total assets

   $ 242,379      $ 243,153   
  

 

 

   

 

 

 

Liabilities and stockholders’ deficit

    

Current liabilities

    

Current portion of long-term debt

   $ 3,650      $ —     

Line of credit

     —          8,000   

Accounts payable

     11,657        15,665   

Accrued expenses and other liabilities

     18,696        24,863   

Liabilities held for sale

     1,715        —     
  

 

 

   

 

 

 

Total current liabilities

     35,718        48,528   

Asset retirement obligation

     8,145        7,435   

Long-term debt, net

     349,858        392,863   

Other long-term liabilities

     33,947        33,597   
  

 

 

   

 

 

 

Total liabilities

     427,668        482,423   
  

 

 

   

 

 

 

Stockholders’ deficit

     (185,289     (239,270
  

 

 

   

 

 

 

Total liabilities and stockholders’ deficit

   $ 242,379      $ 243,153   
  

 

 

   

 

 

 

###