EX-99.1 2 d379166dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

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Horizon Therapeutics plc Reports Fourth-Quarter and Full-Year 2022 Financial Results

Fourth-Quarter 2022 Results:

— Net Sales of $942.0 Million —

— GAAP Net Income of $120.4 Million; Adjusted EBITDA of $357.5 Million;

Includes $37.3 Million of Acquired IPR&D and Milestones Expenses —

— TEPEZZA® (teprotumumab-trbw) Net Sales of $493.5 Million —

— KRYSTEXXA® (pegloticase injection) Net Sales of $216.1 Million —

— UPLIZNA® (inebilizumab-cdon) Net Sales of $41.8 Million —

Full-Year 2022 Results:

— Record Net Sales of $3.63 Billion; Year-Over-Year Increase of 12% —

— GAAP Net Income of $521.5 Million; Record Adjusted EBITDA of $1.37 Billion;

Includes $56.3 Million of Acquired IPR&D and Milestones Expenses —

— Record TEPEZZA Net Sales of $1.97 Billion; Year-Over-Year Increase of 18% —

— Record KRYSTEXXA Net Sales of $716.2 Million; Year-Over-Year Increase of 27% —

— Record UPLIZNA Net Sales of $154.6 Million; Year-Over-Year Increase of 154% —

— Record Operating Cash Flow of $1.26 Billion —

— Cash Position of $2.35 Billion as of Dec. 31, 2022 —

Fourth-Quarter and Recent Company Highlights:

— Entered into Agreement to Be Acquired by Amgen Inc.; Transaction Expected to Close in 1H23 —

— Announced Positive Topline Data from the Second Population in Dazodalibep Sjögren’s Syndrome Phase 2 Trial;

First and Only Phase 2 Sjögren’s Syndrome Trial to Meet the Primary Endpoint in Both Patient Populations; Phase 3 Clinical Program Expected to Initiate in 2023 —

— Completed Enrollment in TEPEZZA Phase 3 Trial in Japan (OPTIC-J) in Active Thyroid Eye Disease (TED); Topline Results Expected in 3Q23 —

— Expect Topline Results from U.S. TEPEZZA Chronic/Low Clinical Activity Score (CAS) TED Trial in 2Q23 —

— Expect to Initiate TEPEZZA Phase 3 Trial in Japan in Chronic/Low CAS TED in 2023 —

— Received Approval for UPLIZNA in Brazil for the Treatment of Adult Patients with

Neuromyelitis Optica Spectrum Disorder —

— Initiated Daxdilimab Discoid Lupus Erythematosus Phase 2 Trial, HZN-457 Gout Phase 1 Trial and ADX-914 Atopic Dermatitis Phase 2 Trial in Collaboration with Q32 Bio —

DUBLIN March 1, 2023 – Horizon Therapeutics plc (Nasdaq: HZNP) today announced fourth-quarter and record full-year 2022 financial results.

“2022 marked another impressive year for Horizon, with double-digit net sales growth across our commercial portfolio and significant progress executing on our strategy to maximize the value of our growth medicines, expand our global presence and advance our pipeline, including generating positive topline results from our Phase 2 trial in Sjögren’s syndrome across both patient populations,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “I am extremely proud of what we have accomplished – not only in the last year, but over the last decade. We have built a leading, innovation-driven, profitable biotechnology company that is well-positioned going forward as we prepare to become part of Amgen.”


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Financial Highlights

 

(in millions except for per share amounts and percentages)    Q4 22      Q4 21      %
Change
    FY 22      FY 21      %
Change
 

Net sales

   $ 942.0      $ 1,014.5        (7   $ 3,629.0      $ 3,226.4        12  

Net income

     120.4        173.2        (30     521.5        534.5        (2

Non-GAAP net income

     281.5        334.0        (16     1,144.3        1,089.7        5  

Adjusted EBITDA(1)

     357.5        416.0        (14     1,370.6        1,284.3        7  

Earnings per share - diluted

     0.52        0.73        (29     2.22        2.27        (2

Non-GAAP earnings per share - diluted

     1.21        1.41        (14     4.86        4.62        5  

 

(1)

Fourth-quarter 2022 and 2021 adjusted EBITDA includes $37.3 million and $39.7 million, respectively, in acquired in-process research and development (IPR&D) and milestones expenses. Full-year 2022 and 2021 adjusted EBITDA includes $56.3 million and $86.7 million, respectively, in acquired IPR&D and milestones expenses.

Fourth-Quarter and Full-Year 2022 Net Sales Results

Beginning in the fourth quarter of 2022, the Company started operating and reporting as a single reporting segment as a result of the wind-down of the Company’s former inflammation business.

 

(in millions except for percentages)    Q4 22      Q4 21      %
Change
    FY 22      FY 21      %
Change
 

TEPEZZA®(1)

   $ 493.5      $ 589.6        (16   $ 1,965.7      $ 1,661.3        18  

KRYSTEXXA®

     216.1        170.3        27       716.2        565.5        27  

RAVICTI®

     87.5        74.4        18       325.6        291.9        12  

PROCYSBI®

     54.9        47.4        16       210.0        189.9        11  

UPLIZNA®(2)

     41.8        25.8        62       154.6        60.8        154  

ACTIMMUNE®

     30.1        30.6        (1     126.1        117.2        8  

PENNSAID 2%®(3)

     7.2        48.9        (85     73.8        191.6        (61

RAYOS®

     6.7        13.3        (50     41.9        56.9        (26

BUPHENYL®

     2.1        2.1        (0     7.3        7.9        (7

DUEXIS®(4)

     1.7        11.5        (85     4.9        74.0        (93

QUINSAIRTM

     0.2        0.3        (22     1.1        1.0        5  

VIMOVO®

     0.2        0.3        (40     1.8        8.4        (78
  

 

 

    

 

 

      

 

 

    

 

 

    

Total Net Sales

   $ 942.0      $ 1,014.5        (7   $ 3,629.0      $ 3,226.4        12  
  

 

 

    

 

 

      

 

 

    

 

 

    

 

(1)

TEPEZZA net sales in the fourth quarter of 2021 accounted for a larger share of full-year 2021 net sales due to a supply disruption caused by the U.S. government-mandated COVID-19 vaccine orders.

(2)

Fourth-quarter and full-year 2022 UPLIZNA net sales included $1.3 million and $18.3 million, respectively, in international net sales, related primarily to revenue and milestone payments from the Company’s international partners.

(3)

On May 6, 2022, Apotex Inc. initiated an at-risk launch of generic PENNSAID 2% in the United States.

(4)

On Aug. 4, 2021, Alkem Laboratories, Inc. initiated an at-risk launch of generic DUEXIS in the United States.

Conference Call

In light of the announced agreement to be acquired by Amgen Inc. and applicable securities laws, Horizon will not be hosting a conference call to discuss its financial results. The earnings press release and SEC Form 10-K are publicly available in the Investor Relations section of the Company’s website at https://ir.horizontherapeutics.com.

 

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About Horizon

Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Note Regarding Use of Non-GAAP Financial Measures

Horizon provides certain non-GAAP financial measures, including EBITDA, or earnings before interest, taxes, depreciation and amortization, adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, non-GAAP gross profit and gross profit ratio, non-GAAP operating expenses, non-GAAP operating income, non-GAAP tax benefit (expense) and tax rate, non-GAAP operating cash flow and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP measures are intended to provide additional information on Horizon’s performance, operations, expenses, profitability and cash flows. Adjustments to Horizon’s GAAP figures exclude, as applicable, acquisition and/or divestiture-related costs, costs associated with our pending transaction with Amgen Inc. as well as the process leading to the transaction, manufacturing facility start-up costs, restructuring and realignment costs, as well as non-cash items such as share-based compensation, inventory step-up expense, depreciation and amortization, non-cash interest expense, goodwill and long-lived assets impairment charges, gain (loss) on equity security investments and sales of assets and other non-cash adjustments. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Horizon maintains an established non-GAAP cost policy that guides the determination of what costs will be excluded in non-GAAP measures. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon’s financial and operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators Horizon’s management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.

 

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Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the pending transaction with Amgen Inc., development, manufacturing and commercialization plans; expected timing of clinical trials and, availability of clinical data; expected future milestones, pipeline expansions and regulatory approvals; potential market opportunities for, and benefits of, Horizon’s medicines and medicine candidates and business and other statements that are not historical facts. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, whether the pending transaction with Amgen Inc. will be completed in a timely manner or at all; the parties’ ability to satisfy (or willingness to waive) the conditions to the consummation of the pending transaction with Amgen Inc., including with respect to required regulatory approvals; the effect of the pending transaction with Amgen Inc. on Horizon’s business relationships, operating results and business generally; risks that Horizon’s actual future financial and operating results may differ from its expectations or goals; Horizon’s ability to grow net sales from existing medicines; impacts of the COVID-19 pandemic and actions taken to slow its spread, including impacts on supplies and net sales of Horizon’s medicines and potential delays in clinical trials; impacts of the on-going war between Russia and Ukraine; changes in inflation, interest rates and general economic conditions; the availability of coverage and adequate reimbursement and pricing from government and third-party payers; Horizon’s ability to successfully implement its business strategies, including the risks that its medicine growth and global expansion initiatives and strategies may not be successful and that new challenges to growth may arise in the future; risks inherent in developing novel medicine candidates and existing medicines for new indications; risks associated with regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Horizon’s filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information.

 

Contacts:   
Investors:    U.S. Media:
Tina Ventura    Geoff Curtis
Senior Vice President,    Executive Vice President,
Chief Investor Relations Officer    Corporate Affairs & Chief Communications Officer
investor-relations@horizontherapeutics.com    media@horizontherapeutics.com
Erin Linnihan    Ireland Media:
Executive Director,    Ray Gordon
Investor Relations    Gordon MRM
investor-relations@horizontherapeutics.com    ray@gordonmrm.ie

 

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Horizon Therapeutics plc

Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)

 

     Three Months Ended December 31,     Twelve Months Ended December 31,  
     2022     2021     2022     2021  
                          
     (Unaudited)        

Net sales

   $ 942,029     $ 1,014,464     $ 3,629,044     $ 3,226,410  

Cost of goods sold

     240,787       241,509       920,197       794,512  
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     701,242       772,955       2,708,847       2,431,898  
  

 

 

   

 

 

   

 

 

   

 

 

 

OPERATING EXPENSES:

        

Research and development (1)

     117,526       101,242       437,962       345,318  

Acquired in-process research and development and milestones (1)

     37,250       39,672       56,250       86,672  

Selling, general and administrative

     372,534       398,954       1,541,052       1,446,410  

Impairment of goodwill

     —         —         56,171       —    

Impairment of long-lived asset

     —         —         —         12,371  

Gain on sale of asset

     —         —         —         (2,000
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     527,310       539,868       2,091,435       1,888,771  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating income

     173,932       233,087       617,412       543,127  
  

 

 

   

 

 

   

 

 

   

 

 

 

OTHER EXPENSE, NET:

        

Interest expense, net

     (18,562     (22,045     (83,707     (81,063

Foreign exchange (loss) gain

     (882     335       (1,202     (1,028

Other (expense) income, net

     (159     (322     (5,567     1,791  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense, net

     (19,603     (22,032     (90,476     (80,300
  

 

 

   

 

 

   

 

 

   

 

 

 

Income before expense (benefit) for income taxes

     154,329       211,055       526,936       462,827  

Expense (benefit) for income taxes

     33,921       37,873       5,454       (71,664
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income

   $ 120,408     $ 173,182     $ 521,482     $ 534,491  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income per ordinary share - basic

   $ 0.53     $ 0.76     $ 2.28     $ 2.37  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average ordinary shares outstanding - basic

     226,997,506       227,028,298       229,108,881       225,551,410  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income per ordinary share - diluted

   $ 0.52     $ 0.73     $ 2.22     $ 2.27  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average ordinary shares outstanding - diluted

     233,014,974       236,806,923       235,239,651       235,680,483  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

Beginning with the third quarter of 2022, the Company is separately presenting upfront, milestone and similar payments pursuant to collaborations, licenses of third-party technologies, and asset acquisitions as “Acquired in-process research and development and milestones” expenses in the condensed consolidated statements of operations. Amounts recorded in this line item for the three and twelve months ended December 31, 2022, would have historically been recorded to research and development (“R&D”) expenses. The Company believes the new classification assists users of the financial statements in better understanding the payments incurred to acquire in-process research and development (“IPR&D”). Prior period condensed consolidated statements of operations have been reclassified to conform with the new classification.

 

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Horizon Therapeutics plc

Condensed Consolidated Balance Sheets

(in thousands, except share data)

 

     As of  
     December 31,
2022
    December 31,
2021
 
              

ASSETS

  

CURRENT ASSETS:

    

Cash and cash equivalents

   $ 2,352,833     $ 1,580,317  

Restricted cash

     4,755       3,839  

Accounts receivable, net

     676,347       632,775  

Inventories, net

     169,559       225,730  

Prepaid expenses and other current assets

     449,349       357,106  
  

 

 

   

 

 

 

Total current assets

     3,652,843       2,799,767  
  

 

 

   

 

 

 

Property, plant and equipment, net

     340,509       292,298  

Developed technology and other intangible assets, net

     2,664,777       2,960,118  

In-process research and development

     810,000       880,000  

Goodwill

     1,010,538       1,066,709  

Deferred tax assets, net

     431,814       538,098  

Other long-term assets

     204,135       140,738  
  

 

 

   

 

 

 

Total assets

   $ 9,114,616     $ 8,677,728  
  

 

 

   

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

    

CURRENT LIABILITIES:

    

Accounts payable

   $ 155,800     $ 30,125  

Accrued expenses and other current liabilities

     457,557       523,015  

Accrued trade discounts and rebates

     319,780       317,431  

Long-term debt - current portion

     16,000       16,000  
  

 

 

   

 

 

 

Total current liabilities

     949,137       886,571  
  

 

 

   

 

 

 

LONG-TERM LIABILITIES:

    

Long-term debt, net

     2,546,837       2,555,233  

Deferred tax liabilities, net

     342,017       390,455  

Other long-term liabilities

     204,451       173,076  
  

 

 

   

 

 

 

Total long-term liabilities

     3,093,305       3,118,764  
  

 

 

   

 

 

 

COMMITMENTS AND CONTINGENCIES

    

SHAREHOLDERS’ EQUITY:

    

Ordinary shares, $0.0001 nominal value; 600,000,000 shares authorized at December 31, 2022 and December 31, 2021; 227,625,913 and 227,760,936 shares issued at December 31, 2022 and December 31, 2021, respectively; and 227,241,547 and 227,376,570 shares outstanding at December 31, 2022 and December 31, 2021, respectively

     23       23  

Treasury stock, 384,366 ordinary shares at December 31, 2022 and December 31, 2021

     (4,585     (4,585

Additional paid-in capital

     4,474,199       4,373,337  

Accumulated other comprehensive income (loss)

     12,528       (14,987

Retained earnings

     590,009       318,605  
  

 

 

   

 

 

 

Total shareholders’ equity

     5,072,174       4,672,393  
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 9,114,616     $ 8,677,728  
  

 

 

   

 

 

 

 

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Horizon Therapeutics plc

Condensed Consolidated Statements of Cash Flows

(in thousands)

 

    Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
    2022     2021     2022     2021  
                         
    (Unaudited)        

CASH FLOWS FROM OPERATING ACTIVITIES:

       

Net income

  $ 120,408     $ 173,182     $ 521,482     $ 534,491  

Adjustments to reconcile net income to net cash provided by operating activities:

       

Depreciation and amortization expense

    98,774       96,535       390,393       353,751  

Equity-settled share-based compensation

    44,585       48,692       182,100       219,086  

Acquired IPR&D and milestones

    37,250       30,072       52,250       70,072  

Impairment of goodwill

    —         —         56,171       —    

Impairment of long-lived asset

    —         —         —         12,371  

Amortization of debt discount and deferred financing costs

    1,776       1,449       7,912       5,189  

Gain on sale of asset

    —         —         —         (2,000

Deferred income taxes

    41,160       46,918       49,814       (101,016

Foreign exchange and other adjustments

    2,004       61       9,700       5,067  

Changes in operating assets and liabilities:

       

Accounts receivable

    (29,776     142,572       (43,457     34,796  

Inventories

    20,713       11,761       56,122       1,267  

Prepaid expenses and other current assets

    (4,588     (27,403     (79,245     (88,193

Accounts payable

    123,087       (19,837     122,232       (12,197

Accrued trade discounts and rebates

    (35,890     13,909       2,399       (36,929

Accrued expenses and other current liabilities

    5,887       16,242       (59,101     50,622  

Other non-current assets and liabilities

    1,001       4,404       (10,930     (11,106
 

 

 

   

 

 

   

 

 

   

 

 

 

Net cash provided by operating activities

    426,391       538,557       1,257,842       1,035,271  
 

 

 

   

 

 

   

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

       

Payments for acquisitions, net of cash acquired

    —         —         (3,122     (2,843,275

Purchases of property, plant and equipment

    (24,858     (16,901     (64,026     (76,596

Payments for long-term investments

    (2,180     (14,871     (9,236     (28,256

Receipts from long-term investments

    217       —         4,633       3,588  

Proceeds from sale of asset

    —         —         —         2,000  

Payments related to license and collaboration agreements

    (22,250     (5,072     (62,250     (51,572
 

 

 

   

 

 

   

 

 

   

 

 

 

Net cash used in investing activities

    (49,071     (36,844     (134,001     (2,994,111
 

 

 

   

 

 

   

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

       

Net proceeds from term loans

    —         —         —         1,574,993  

Repayment of term loans

    (4,000     (4,000     (16,000     (12,000

Proceeds from the issuance of ordinary shares in conjunction with ESPP program

    11,167       11,046       25,051       22,528  

Proceeds from the issuance of ordinary shares in connection with stock option exercises

    7,036       10,553       30,316       50,566  

Payment of employee withholding taxes relating to share-based awards

    (13,300     (7,887     (137,247     (165,964

Repurchase of ordinary shares

    (161,869     —         (250,078     —    
 

 

 

   

 

 

   

 

 

   

 

 

 

Net cash (used in) provided by financing activities

    (160,966     9,712       (347,958     1,470,123  
 

 

 

   

 

 

   

 

 

   

 

 

 

Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash

    5,964       345       (2,451     (10,606
 

 

 

   

 

 

   

 

 

   

 

 

 

Net increase (decrease) in cash, cash equivalents and restricted cash

    222,318       511,770       773,432       (499,323

Cash, cash equivalents and restricted cash, beginning of the period(1)

    2,135,270       1,072,386       1,584,156       2,083,479  
 

 

 

   

 

 

   

 

 

   

 

 

 

Cash, cash equivalents and restricted cash, end of the period(1)

  $ 2,357,588     $ 1,584,156     $ 2,357,588     $ 1,584,156  
 

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

Amounts include restricted cash balance in accordance with ASU No. 2016-18. Cash and cash equivalents excluding restricted cash are shown on the balance sheet.

 

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Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

Net Income and Earnings Per Share (Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended December 31,     Twelve Months Ended December 31,  
     2022     2021     2022     2021  
                          

GAAP net income

   $ 120,408     $ 173,182     $ 521,482     $ 534,491  

Non-GAAP adjustments:

        

Acquisition/divestiture-related costs

     (3,676     7,763       (239     95,929  

Transaction-related costs

     11,086       —         11,086       —    

(Gain) loss on equity security investments

     (143     (1,257     6,188       (1,257

Restructuring and realignment costs

     7,456       18,606       16,977       26,309  

Manufacturing facility start-up costs

     1,139       1,910       5,552       3,622  

Amortization and step-up:

        

Intangible amortization expense

     92,916       91,017       366,462       336,277  

Inventory step-up expense

     25,367       10,658       91,709       27,572  

Amortization of debt discount and deferred financing costs

     1,776       1,449       7,912       5,189  

Impairment of long-lived asset

     —         —         —         12,371  

Impairment of goodwill

     —         —         56,171       —    

Gain on sale of asset

     —         —         —         (2,000

Share-based compensation

     44,585       48,692       182,100       219,086  

Depreciation

     5,858       5,519       23,931       17,475  

Litigation settlement

     —         —         —         5,000  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of pre-tax non-GAAP adjustments

     186,364       184,357       767,849       745,573  

Income tax effect of pre-tax non-GAAP adjustments

     (26,619     (27,889     (148,373     (169,554

Other non-GAAP income tax adjustments

     1,308       4,326       3,387       (20,800
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     161,053       160,794       622,863       555,219  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP net income

   $ 281,461     $ 333,976     $ 1,144,345     $ 1,089,710  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Earnings Per Share:

        

Weighted average ordinary shares - Basic

     226,997,506       227,028,298       229,108,881       225,551,410  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Earnings Per Share - Basic:

        

GAAP earnings per share - Basic

   $ 0.53     $ 0.76     $ 2.28     $ 2.37  

Non-GAAP adjustments

     0.71       0.71       2.71       2.46  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Basic

   $ 1.24     $ 1.47     $ 4.99     $ 4.83  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average ordinary shares - Diluted

        

Weighted average ordinary shares - Basic

     226,997,506       227,028,298       229,108,881       225,551,410  

Ordinary share equivalents

     6,017,468       9,778,625       6,130,771       10,129,073  
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average ordinary shares - Diluted

     233,014,974       236,806,923       235,239,652       235,680,483  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Earnings Per Share - Diluted

        

GAAP earnings per share - Diluted

   $ 0.52     $ 0.73     $ 2.22     $ 2.27  

Non-GAAP adjustments

     0.69       0.68       2.64       2.35  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP earnings per share - Diluted

   $ 1.21     $ 1.41     $ 4.86     $ 4.62  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

8


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Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

EBITDA and Adjusted EBITDA (Unaudited)

(in thousands)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2022     2021     2022     2021  

GAAP net income

   $  120,408     $  173,182     $  521,482     $  534,491  

Depreciation

     5,858       5,519       23,931       17,475  

Amortization and step-up:

        

Intangible amortization expense

     92,916       91,017       366,462       336,277  

Inventory step-up expense

     25,367       10,658       91,709       27,572  

Interest expense, net (including amortization of debt discount and deferred financing costs)

     18,562       22,045       83,707       81,063  

Expense (benefit) for income taxes

     33,921       37,873       5,454       (71,664
  

 

 

   

 

 

   

 

 

   

 

 

 

EBITDA

   $ 297,032     $ 340,294     $  1,092,745     $ 925,214  
  

 

 

   

 

 

   

 

 

   

 

 

 

Other non-GAAP adjustments:

        

Share-based compensation

     44,585       48,692       182,100       219,086  

(Gain) loss on equity security investments

     (143     (1,257     6,188       (1,257

Acquisition/divestiture-related costs

     (3,676     7,763       (239     95,929  

Transaction-related costs

     11,086       —         11,086       —    

Manufacturing facility start-up costs

     1,139       1,910       5,552       3,622  

Restructuring and realignment costs

     7,456       18,606       16,977       26,309  

Impairment of goodwill

     —         —         56,171       —    

Impairment of long-lived asset

     —         —         —         12,371  

Gain on sale of asset

     —         —         —         (2,000

Litigation settlement

     —         —         —         5,000  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of other non-GAAP adjustments

     60,447       75,714       277,835       359,060  
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 357,479     $ 416,008     $ 1,370,580     $  1,284,274  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

9


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Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

Operating Income (Unaudited)

(in thousands)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2022     2021     2022     2021  

GAAP operating income

   $  173,932     $  233,087     $ 617,412     $ 543,127  

Non-GAAP adjustments:

        

Acquisition/divestiture-related costs

     (3,676     7,762       (239     97,003  

Transaction-related costs

     11,086       —         11,086       —    

Restructuring and realignment costs

     7,456       18,606       16,977       26,309  

Manufacturing facility start-up costs

     1,139       1,910       5,552       3,622  

Amortization and step-up:

        

Intangible amortization expense

     92,916       91,017       366,462       336,277  

Inventory step-up expense

     25,367       10,658       91,709       27,572  

Impairment of long-lived asset

     —         —         —         12,371  

Impairment of goodwill

     —         —         56,171       —    

Gain on sale of asset

     —         —         —         (2,000

Share-based compensation

     44,585       48,692       182,100       219,086  

Depreciation

     5,858       5,520       23,931       17,475  

Litigation settlement

     —         —         —         5,000  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     184,731       184,165       753,749       742,715  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP operating income

   $ 358,663     $ 417,252     $  1,371,161     $  1,285,842  
  

 

 

   

 

 

   

 

 

   

 

 

 

Foreign exchange (loss) gain

     (882     335       (1,202     (1,028

Other (expense) income, net

     (302     (1,579     621       (540
  

 

 

   

 

 

   

 

 

   

 

 

 

Adjusted EBITDA

   $ 357,479     $ 416,008     $ 1,370,580     $ 1,284,274  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

10


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Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

Gross Profit and Operating Cash Flow (Unaudited)

(in thousands, except percentages)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2022     2021     2022     2021  

Non-GAAP Gross Profit:

        

GAAP gross profit

   $  701,242     $  772,955     $  2,708,847     $  2,431,898  

Non-GAAP gross profit adjustments:

        

Acquisition/divestiture-related costs

     (3,885     1,600       (5,035     1,525  

Intangible amortization expense

     91,868       90,466       362,900       334,848  

Inventory step-up expense

     25,367       10,658       91,709       27,572  

Share-based compensation

     2,274       1,824       8,912       8,699  

Depreciation

     58       55       225       282  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total of Non-GAAP adjustments

     115,682       104,603       458,711       372,926  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP gross profit

   $ 816,924     $ 877,558     $ 3,167,558     $ 2,804,824  
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP gross profit %

     74.4     76.2     74.6     75.4

Non-GAAP gross profit %

     86.7     86.5     87.3     86.9

GAAP cash provided by operating activities

   $ 426,391     $ 538,557     $ 1,257,842     $ 1,035,271  

Cash payments for acquisition/divestiture-related costs

     197       8,376       5,560       144,449  

Cash payments for restructuring and realignment costs

     11,205       579       13,984       2,382  

Cash payments for manufacturing facility start-up costs

     1,290       1,857       4,067       2,726  

Cash payments for transaction-related costs

     17,034       —         17,034       —    

Cash payments for litigation settlements

     —         5,000       —         5,000  
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP operating cash flow

   $ 456,117     $ 554,369     $ 1,298,487     $ 1,189,828  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

11


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Horizon Therapeutics plc

GAAP to Non-GAAP Tax Rate Reconciliation (Unaudited)

(in millions, except percentages and per share amounts)

 

     Q4 2022  
     Pre-tax Net
Income
     Income Tax
Expense
    Tax Rate      Net Income      Diluted Earnings
Per Share
 

As reported—GAAP

   $ 154.3      $ 33.9       22.0%      $ 120.4      $  0.52  

Non-GAAP adjustments

     186.4        25.3          161.1     
  

 

 

    

 

 

      

 

 

    

Non-GAAP

   $ 340.7      $ 59.2       17.4%      $ 281.5      $ 1.21  
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 
     Q4 2021  
     Pre-tax Net
Income
     Income Tax
Expense
    Tax Rate      Net Income      Diluted Earnings
Per Share
 

As reported—GAAP

   $ 211.1      $ 37.9       17.9%      $ 173.2      $ 0.73  

Non-GAAP adjustments

     184.4        23.6          160.8     
  

 

 

    

 

 

      

 

 

    

Non-GAAP

   $ 395.4      $ 61.4       15.5%      $ 334.0      $ 1.41  
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 
     FY 2022  
     Pre-tax Net
Income
     Income Tax
Expense
    Tax Rate      Net Income      Diluted Earnings
Per Share
 

As reported—GAAP

   $ 526.9      $ 5.5       1.0%      $ 521.5      $ 2.22  

Non-GAAP adjustments

     767.8        145.0          622.9     
  

 

 

    

 

 

      

 

 

    

Non-GAAP

   $  1,294.8      $  150.4       11.6%      $  1,144.3      $ 4.86  
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 
     FY 2021  
     Pre-tax Net
Income
     Income Tax
(Benefit) Expense
    Tax Rate      Net Income      Diluted Earnings
Per Share
 

As reported—GAAP

   $ 462.8      $ (71.7     (15.5)%      $ 534.5      $ 2.27  

Non-GAAP adjustments

     745.6        190.4          555.2     
  

 

 

    

 

 

      

 

 

    

Non-GAAP

   $ 1,208.4      $ 118.7       9.8%      $ 1,089.7      $ 4.62  
  

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

 

12


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Horizon Therapeutics plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Three Months Ended December 31, 2022 (Unaudited)

(in thousands)

 

     Cost of Goods
Sold
    Research &
Development (17)
    Acquired IPR&D
and milestones (17)
    Selling, General
& Administrative
    Interest
Expense, net
    Other (Expense)
Income, net
    Income Tax
Expense
(Benefit)
 

GAAP as reported

   $ (240,787   $ (117,526   $ (37,250   $ (372,534   $ (18,562   $ (159   $ (33,921

Non-GAAP Adjustments:

              

Acquisition/divestiture-related costs(1)

     (3,885     —         —         209       —         —         —    

Transaction-related costs(2)

     —         —         —         11,086       —         —         —    

Gain on equity security investments(3)

     —         —         —         —         —         (143     —    

Restructuring and realignment costs(4)

     —         39       —         7,417       —         —         —    

Manufacturing facility start-up costs(5)

     —         —         —         1,139       —         —         —    

Amortization and step-up:

              

Intangible amortization expense(6)

     91,868       —         —         1,048       —         —         —    

Inventory step-up expense(7)

     25,367       —         —         —         —         —         —    

Amortization of debt discount and deferred financing costs(8)

     —         —         —         —         1,776       —         —    

Share-based compensation(9)

     2,274       6,522       —         35,789       —         —         —    

Depreciation(10)

     58       364       —         5,436       —         —         —    

Income tax effect on pre-tax non-GAAP adjustments(11)

     —         —         —         —         —         —         (26,619

Other non-GAAP income tax adjustments(12)

     —         —         —         —         —         —         1,308  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     115,682       6,925       —         62,124       1,776       (143     (25,311
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

   $ (125,105   $ (110,601   $ (37,250   $ (310,410   $ (16,786   $ (302   $ (59,232
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Horizon Therapeutics plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Three Months Ended December 31, 2021 (Unaudited)

(in thousands)

 

     Cost of Goods
Sold
    Research &
Development (17)
    Acquired IPR&D
and milestones (17)
    Selling, General
& Administrative
    Interest
Expense, net
    Other (Expense)
Income, net
    Income Tax
Expense
(Benefit)
 

GAAP as reported

   $ (241,509   $ (101,242   $ (39,672   $ (398,954   $ (22,045   $ (322   $ (37,873

Non-GAAP Adjustments:

              

Acquisition/divestiture-related costs(1)

     1,600       2,000       —         4,163       —         —         —    

Gain on equity security investments(3)

     —         —         —         —         —         (1,257     —    

Restructuring and realignment costs(4)

     —         16,647       —         1,959       —         —         —    

Manufacturing facility start-up costs(5)

     —         —         —         1,910       —         —         —    

Amortization and step-up:

              

Intangible amortization expense(6)

     90,466       —         —         551       —         —         —    

Inventory step-up expense(7)

     10,658       —         —         —         —         —         —    

Amortization of debt discount and deferred financing costs(8)

     —         —         —         —         1,449       —         —    

Share-based compensation(9)

     1,824       6,693       —         40,175       —         —         —    

Depreciation(10)

     55       150       —         5,314       —         —         —    

Income tax effect on pre-tax non-GAAP adjustments(11)

     —         —         —         —         —         —         (27,889

Other non-GAAP income tax adjustments(12)

     —         —         —         —         —         —         4,326  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     104,603       25,490       —         54,072       1,449       (1,257     (23,563
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

   $ (136,906   $ (75,752   $ (39,672   $ (344,882   $ (20,596   $ (1,579   $ (61,436
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

13


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Horizon Therapeutics plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Twelve Months Ended December 31, 2022 (Unaudited)

(in thousands)

 

     Cost of
Goods
Sold
    Research &
Development (17)
    Acquired IPR&D
and milestones (17)
    Selling, General
& Administrative
    Impairment of
goodwill
    Interest
Expense, net
    Other (Expense)
Income, net
    Income
Tax
Expense
(Benefit)
 

GAAP as reported

   $ (920,197   $ (437,962   $ (56,250   $ (1,541,052   $ (56,171   $ (83,707   $ (5,567   $ (5,454

Non-GAAP Adjustments:

                

Acquisition/divestiture-related costs(1)

     (5,035     2,000       —         2,796       —         —         —         —    

Transaction-related costs(2)

     —         —         —         11,086       —         —         —         —    

Loss on equity security investments(3)

     —         —         —         —         —         —         6,188       —    

Restructuring and realignment costs(4)

     —         577       —         16,400       —         —         —         —    

Manufacturing facility start-up costs(5)

     —         —         —         5,552       —         —         —         —    

Amortization and step-up:

                

Intangible amortization expense(6)

     362,900       —         —         3,562       —         —         —         —    

Inventory step-up expense(7)

     91,709       —         —         —         —         —         —         —    

Amortization of debt discount and deferred financing costs(8)

     —         —         —         —         —         7,912       —         —    

Share-based compensation(9)

     8,912       27,830       —         145,358       —         —         —         —    

Depreciation(10)

     225       1,166       —         22,540       —         —         —         —    

Impairment of goodwill(13)

     —         —         —         —         56,171       —         —         —    

Income tax effect on pre-tax non-GAAP adjustments(11)

     —         —         —         —         —         —         —         (148,373

Other non-GAAP income tax adjustments(12)

     —         —         —         —         —         —         —         3,387  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     458,711       31,573       —         207,294       56,171       7,912       6,188       (144,986
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

   $ (461,486   $ (406,389   $ (56,250   $ (1,333,758   $ —       $ (75,795   $ 621     $ (150,440
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Horizon Therapeutics plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Twelve Months Ended December 31, 2021 (Unaudited)

(in thousands)

 

     Cost of Goods
Sold
    Research &
Development (17)
    Acquired IPR&D
and milestones (17)
    Selling, General
& Administrative
    Impairment of
Long-lived asset
    Gain on
Sale of Asset
    Interest
Expense, net
    Other (Expense)
Income, net
    Income Tax
Expense
(Benefit)
 

GAAP as reported

   $ (794,512   $ (345,318   $ (86,672   $ (1,446,410   $ (12,371   $ 2,000     $ (81,063     1,791     $ 71,664  

Non-GAAP Adjustments:

                  

Acquisition/divestiture-related costs(1)

     1,525       2,018       —         93,463       —         —         —         (1,077     —    

Gain on equity security investments(3)

     —         —         —         —         —         —         —         (1,257     —    

Restructuring and realignment costs(4)

     —         16,647       —         9,662       —         —         —         —         —    

Manufacturing facility start-up costs(5)

     —         —         —         3,622       —         —         —         —         —    

Amortization and step-up:

                  

Intangible amortization expense(6)

     334,848       —         —         1,429       —         —         —         —         —    

Inventory step-up expense(7)

     27,572       —         —         —         —         —         —         —         —    

Amortization of debt discount and deferred financing costs(8)

     —         —         —         —         —         —         5,189       —         —    

Impairment of long lived asset(14)

     —         —         —         —         12,371       —         —         —         —    

Gain on sale of asset(15)

     —         —         —         —         —         (2,000     —         —         —    

Share-based compensation(9)

     8,699       39,544       —         170,843       —         —         —         —         —    

Depreciation(10)

     282       442       —         16,751       —         —         —         —         —    

Litigation settlement(16)

     —         —         —         5,000       —         —         —         —         —    

Income tax effect on pre-tax non-GAAP adjustments(11)

     —         —         —         —         —         —         —         —         (169,554

Other non-GAAP income tax adjustments(12)

     —         —         —         —         —         —         —         —         (20,800
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     372,926       58,651       —         300,770       12,371       (2,000     5,189       (2,334     (190,354
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

   $ (421,586   $ (286,667   $ (86,672   $ (1,145,640   $ —       $ —       $ (75,874   $ (543   $ (118,690
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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NOTES FOR CERTAIN INCOME STATEMENT LINE ITEMS—NON-GAAP

 

1.

Primarily represents transaction and integration costs, including, advisory, legal, consulting and certain employee-related costs, incurred in connection with our acquisitions and divestitures.

 

2.

Primarily represents transaction-related costs, including, advisory, legal and consulting costs, incurred in connection with the transaction with Amgen, as well as the process leading to the transaction.

 

3.

We held investments in equity securities with readily determinable fair values of $7.0 million and $13.2 million as of December 31, 2022 and 2021, respectively, which are included in other long-term assets in the condensed consolidated balance sheet. For the year ended December 31, 2022, we recognized net unrealized losses of $6.2 million due to the change in fair value of these securities. For the year ended December 31, 2021, we recognized net unrealized gains of $1.3 million due to the change in fair value of these securities.

 

4.

Primarily represents severance and consulting costs related to the wind down of our former inflammation business during 2022 and rent and maintenance charges as a result of vacating the leased Lake Forest office in the first quarter of 2021. In addition, during the fourth quarter of 2021, we ended TEPEZZA drug substance manufacturing development activities in the Seattle facility of a contract manufacturer and recorded a charge of $16.6 million to R&D expense related to manufacturing development activities in this facility.

 

5.

During the year ended December 31, 2022, we recorded $5.6 million of manufacturing facility start-up costs related to our drug product biologics manufacturing facility in Waterford, Ireland. During the year ended December 31, 2021, we recorded $3.6 million of manufacturing facility start-up costs related to the purchase of our drug product biologics manufacturing facility in Waterford, Ireland from EirGen in July 2021.

 

6.

Intangible amortization expenses are primarily associated with our developed technology related to TEPEZZA, KRYSTEXXA, RAVICTI, PROCYSBI, UPLIZNA, ACTIMMUNE, BUPHENYL and RAYOS.

 

7.

During the years ended December 31, 2022 and 2021, we recognized in cost of goods sold $91.7 million and $27.6 million, respectively, for inventory step-up expense related to UPLIZNA inventory revalued in connection with the Viela acquisition. Because inventory step-up expense is related to an acquisition, will not continue indefinitely and has a significant effect on our gross profit, gross margin percentage and net income for all affected periods, we exclude inventory step-up expense from our non-GAAP financial measures.

 

8.

Represents amortization of debt discount and deferred financing costs associated with our debt.

 

9.

Represents share-based compensation expense associated with our restricted stock unit and performance stock unit grants to our employees and non-employee directors, and our employee share purchase plan.

 

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10.

Represents depreciation expense related to our property, plant, equipment, software and leasehold improvements.

 

11.

Income tax adjustments on pre-tax non-GAAP adjustments represent the estimated income tax impact of each pre-tax non-GAAP adjustment based on the statutory income tax rate of the applicable jurisdictions for each non-GAAP adjustment.

 

12.

During the year ended December 31, 2022, we recognized tax expense attributable to state tax legislation enacted during the period, resulting in a non-GAAP tax adjustment of $3.4 million.

During the year ended December 31, 2021, we recognized a U.S. federal and state tax liability on U.S. taxable income generated from an intercompany transfer and license of intellectual property from a U.S. subsidiary to an Irish subsidiary which was partially offset by the recognition of a deferred tax asset in the Irish subsidiary, resulting in a non-GAAP tax adjustment of $28.3 million. We also recognized a reduction in the state tax rate expected to apply to the reversal of temporary differences between the book values and tax bases of certain assets acquired through the Viela acquisition. The reduction in state tax rate resulted in a reduction in the deferred tax liability relating to these assets and a non-GAAP tax adjustment of $49.1 million.

 

13.

Our interim goodwill impairment test in the second quarter of 2022 indicated an impairment which represented the difference between the estimated fair value of our former inflammation business segment and its carrying value. As a result, we recognized an impairment charge of $56.2 million in June 2022 representing the full amount of goodwill for the former business segment.

 

14.

During the year ended December 31, 2021, we recorded a right-of-use asset impairment charge of $12.4 million as a result of vacating the leased Lake Forest office.

 

15.

We recorded $5.0 million of expense during the year ended December 31, 2021 for litigation settlements.

 

16.

Gain on sale of asset during the year ended December 31, 2021, represents a $2.0 million contingent consideration payment related to the sale of MIGERGOT in 2019.

 

17.

Beginning with the third quarter of 2022, the Company is separately presenting upfront, milestone and similar payments pursuant to collaborations, licenses of third-party technologies, and asset acquisitions as “Acquired in-process research and development and milestones” (“IPR&D”) expenses in the condensed consolidated statement of operations. Amounts recorded in this line item for the three and twelve months ended December 31, 2022, would have historically been recorded to R&D expenses. The Company believes the new classification assists users of the financial statements in better understanding the payments incurred to IPR&D. Prior period condensed consolidated statement of operations have been reclassified to conform with the new classification. There were no non-GAAP adjustments to IPR&D and milestones expenses for the three and twelve months ended December 31, 2022 and December 31, 2021.

 

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