EX-99.1 2 d484335dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

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Horizon Therapeutics plc Reports First-Quarter 2023 Financial Results

First-Quarter 2023 Results:

— Net Sales of $832.1 Million —

— GAAP Net Income of $54.7 Million; Adjusted EBITDA of $232.9 Million —

— TEPEZZA® (teprotumumab-trbw) Net Sales of $405.3 Million —

— KRYSTEXXA® (pegloticase injection) Net Sales of $187.0 Million —

— UPLIZNA® (inebilizumab-cdon) Net Sales of $53.8 Million —

— Cash Position of $2.31 Billion as of March 31, 2023 —

First-Quarter and Recent Company Highlights:

— Announced Positive Topline Data from TEPEZZA Phase 4 Clinical Trial in Patients with Chronic/Low Clinical Activity Score (CAS) Thyroid Eye Disease (TED) —

— Obtained U.S. FDA Approval for Updated TEPEZZA Indication to Specify Treatment of TED Patients Regardless of

Disease Activity or Duration —

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

— Announced Initiation of TEPEZZA Phase 3 Trial in Japan in Chronic/Low CAS TED and Two Daxdilimab Phase 2 Trials in Discoid Lupus Erythematosus and Lupus Nephritis —

— Continue to Expect Amgen Transaction to Close in 1H23 —

— Named One of Fortune’s 100 Best Companies to Work For® and Ranked as Top Biotechnology/Pharmaceutical Company, Both for Third Consecutive Year —

DUBLIN May 3, 2023 – Horizon Therapeutics plc (Nasdaq: HZNP) today announced first-quarter 2023 financial results.

“We generated strong first-quarter performance, with double-digit growth for KRYSTEXXA and UPLIZNA, and saw positive trends in TEPEZZA’s leading indicators as we exited the first quarter,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “Importantly, we announced positive topline results from our TEPEZZA clinical trial in low CAS and long-duration TED patients, as well as received FDA approval for an update to the TEPEZZA indication that reinforces the potential benefit of TEPEZZA, regardless of disease activity or duration. These important events will help us to ease the access burden so all eligible patients can benefit from TEPEZZA. I am extremely proud of what we have accomplished in a few short months and believe we are well positioned as we prepare to become part of Amgen.”


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Financial Highlights

 

(in millions except for per share amounts and percentages)    Q1 23      Q1 22      %
Change
 

Net sales

   $ 832.1      $ 885.2        (6

Net income

     54.7        204.3        (73

Non-GAAP net income

     194.3        315.8        (38

Adjusted EBITDA

     232.9        371.2        (37

Earnings per share - diluted

     0.23        0.87        (74

Non-GAAP earnings per share - diluted

     0.83        1.34        (38

First-Quarter 2023 Net Sales Results

 

(in millions except for percentages)    Q1 23      Q1 22      % Change  

TEPEZZA®

   $ 405.3      $ 501.5        (19

KRYSTEXXA®

     187.0        140.7        33  

RAVICTI®

     90.3        78.3        15  

UPLIZNA®(1)

     53.8        30.5        77  

PROCYSBI®

     50.5        49.6        2  

ACTIMMUNE®

     29.1        31.3        (7

PENNSAID 2%®(2)

     9.2        35.4        (74

RAYOS®

     5.0        13.5        (63

BUPHENYL®

     1.4        2.2        (35

QUINSAIRTM

     0.3        0.3        0  

DUEXIS®

     0.1        1.1        (88

VIMOVO®

     0.1        0.9        (99
  

 

 

    

 

 

    

Total Net Sales

   $ 832.1      $ 885.2        (6
  

 

 

    

 

 

    

 

(1)

First-quarter 2023 UPLIZNA net sales included $6.6 million in international net sales related primarily to revenue and milestone payments from the Company’s international partners. First-quarter 2022 UPLIZNA net sales included $5.2 million in international net sales.

(2)

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

Key Growth Drivers

TEPEZZA: TEPEZZA net sales in the first quarter were $405 million, representing an 18 percent sequential decline compared to the fourth quarter of 2022. Net sales were impacted by seasonality, which the Company typically sees with its infused medicines in the first quarter each year. In addition, the TEPEZZA field-force expansion initiated late in 2022 has not yet substantially impacted net sales. More recently, the Company has seen the expansion drive positive momentum in the business, including increases in new prescribers, patient enrollment forms and patient starts. As new prescribers and patients work through the reimbursement process, the Company expects a more meaningful impact to net sales later in the year.

 

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In April 2023, the Company announced positive topline results from its TEPEZZA Phase 4 clinical trial in patients with low CAS and long-duration TED and received FDA approval for an update to the indication for TEPEZZA that supports its potential benefit in TED, regardless of disease activity or duration. This reinforces the importance of unrestricted access for eligible patients across the full spectrum of TED and creates an opportunity to ease the access burden for patients and physicians and to decrease time to therapy for patients who may benefit from TEPEZZA. The Company plans to present data from the Phase 4 trial at a future medical congress and publish the data in a peer-reviewed medical journal to help educate key stakeholders, including physicians, patients and payors.

KRYSTEXXA: KRYSTEXXA first-quarter net sales were $187 million, representing a year-over-year increase of 33%. Sequentially, net sales declined by 13 percent compared to fourth-quarter 2022 due to seasonality. Strong performance in the first quarter was driven by the continued momentum in both the rheumatology and nephrology market segments, including the adoption of KRYSTEXXA with immunomodulation as the new standard of care following FDA approval in July 2022 for an expanded label to include KRYSTEXXA with methotrexate. The Company’s efforts to educate physicians and key stakeholders continues to lead to strong patient growth from both new and existing prescribers across both market segments.

UPLIZNA: UPLIZNA first-quarter 2023 net sales were $53.8 million, representing a year-over-year increase of 77%, driven by continued strong execution. Net sales in the U.S. were $47.2 million, an increase of 87%, and were driven by strong and consistent growth in new prescribers and new patient starts. The Company continues to advance its global expansion strategy with multiple planned international launches in 2023.

Conference Call

In light of the announced agreement to be acquired by Amgen Inc. and applicable securities laws, the Company will not be hosting a conference call to discuss its financial results. This earnings press release and the related Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 are publicly available in the Investor Relations section of the Company’s website at https://ir.horizontherapeutics.com.

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.

 

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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., including responding to a second request review of the transaction by the United States Federal Trade Commission, 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 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; expected future milestones, pipeline expansions and regulatory approvals; potential market opportunities for, and benefits of, Horizon’s medicines and medicine candidates; expected impact of commercial strategies, clinical trial results and product label updates; 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; whether additional clinical trial results or data analyses will be consistent with preliminary results, results from other trials or Horizon’s expectations; 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,    Eimear Rigby
Investor Relations    media@horizontherapeutics.com
investor-relations@horizontherapeutics.com   

 

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Horizon Therapeutics plc

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except share and per share data)

 

     Three Months Ended March 31,  
     2023     2022  

Net sales

   $ 832,059     $ 885,245  

Cost of goods sold

     208,563       215,062  
  

 

 

   

 

 

 

Gross profit

     623,496       670,183  
  

 

 

   

 

 

 

OPERATING EXPENSES:

    

Research and development (1)

     134,148       103,132  

Selling, general and administrative

     453,354       372,734  
  

 

 

   

 

 

 

Total operating expenses

     587,502       475,866  
  

 

 

   

 

 

 

Operating income

     35,994       194,317  
  

 

 

   

 

 

 

OTHER EXPENSE, NET:

    

Interest expense, net

     (15,540     (21,256

Foreign exchange gain

     91       420  

Other expense, net

     (1,343     (742
  

 

 

   

 

 

 

Total other expense, net

     (16,792     (21,578
  

 

 

   

 

 

 

Income before benefit for income taxes

     19,202       172,739  

Benefit for income taxes

     (35,482     (31,522
  

 

 

   

 

 

 

Net income

   $ 54,684     $ 204,261  
  

 

 

   

 

 

 

Net income per ordinary share - basic

   $ 0.24     $ 0.89  
  

 

 

   

 

 

 

Weighted average ordinary shares outstanding - basic

     228,397,661       229,094,311  
  

 

 

   

 

 

 

Net income per ordinary share - diluted

   $ 0.23     $ 0.87  
  

 

 

   

 

 

 

Weighted average ordinary shares outstanding - diluted

     233,788,366       235,953,318  
  

 

 

   

 

 

 

 

(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 statement of comprehensive income. Amounts recorded in this line item 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 acquired in-process research and development (“IPR&D”). Prior period consolidated statements of comprehensive income have been reclassified to conform with the new classification. No acquired IPR&D and milestones expenses were recorded during the three months ended March 31, 2023 and 2022.

 

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Horizon Therapeutics plc

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share data)

 

     As of  
     March 31,
2023
    December 31,
2022
 
    

ASSETS

  

CURRENT ASSETS:

    

Cash and cash equivalents

   $ 2,311,628     $ 2,352,833  

Restricted cash

     4,772       4,755  

Accounts receivable, net

     624,697       676,347  

Inventories, net

     164,496       169,559  

Prepaid expenses and other current assets

     497,254       449,349  
  

 

 

   

 

 

 

Total current assets

     3,602,847       3,652,843  
  

 

 

   

 

 

 

Property, plant and equipment, net

     355,872       340,509  

Developed technology and other intangible assets, net

     2,576,163       2,664,777  

In-process research and development

     810,000       810,000  

Goodwill

     1,010,538       1,010,538  

Deferred tax assets, net

     450,219       431,814  

Other long-term assets

     187,811       204,135  
  

 

 

   

 

 

 

Total assets

   $ 8,993,450     $ 9,114,616  
  

 

 

   

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

    

CURRENT LIABILITIES:

    

Accounts payable

   $ 76,619     $ 155,800  

Accrued expenses and other current liabilities

     482,334       457,557  

Accrued trade discounts and rebates

     309,935       319,780  

Long-term debt - current portion

     16,000       16,000  
  

 

 

   

 

 

 

Total current liabilities

     884,888       949,137  
  

 

 

   

 

 

 

LONG-TERM LIABILITIES:

    

Long-term debt, net

     2,544,230       2,546,837  

Deferred tax liabilities, net

     271,550       342,017  

Other long-term liabilities

     197,222       204,451  
  

 

 

   

 

 

 

Total long-term liabilities

     3,013,002       3,093,305  
  

 

 

   

 

 

 

COMMITMENTS AND CONTINGENCIES

    

SHAREHOLDERS’ EQUITY:

    

Ordinary shares, $0.0001 nominal value; 600,000,000 shares authorized at March 31, 2023 and December 31, 2022; 228,960,705 and 227,625,913 shares issued at March 31, 2023 and December 31, 2022, respectively; and 228,576,339 and 227,241,547 shares outstanding at March 31, 2023 and December 31, 2022, respectively

     23       23  

Treasury stock, 384,366 ordinary shares at March 31, 2023 and December 31, 2022

     (4,585     (4,585

Additional paid-in capital

     4,448,744       4,474,199  

Accumulated other comprehensive income

     6,685       12,528  

Retained earnings

     644,693       590,009  
  

 

 

   

 

 

 

Total shareholders’ equity

     5,095,560       5,072,174  
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

   $ 8,993,450     $ 9,114,616  
  

 

 

   

 

 

 

 

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Horizon Therapeutics plc

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

     Three Months Ended
March 31,
 
     2023     2022  

CASH FLOWS FROM OPERATING ACTIVITIES:

    

Net income

   $ 54,684     $ 204,261  

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

    

Depreciation and amortization expense

     94,860       95,112  

Equity-settled share-based compensation

     58,120       47,300  

Amortization of debt discount and deferred financing costs

     1,471       1,577  

Deferred income taxes

     (87,310     (33,896

Foreign exchange and other adjustments

     (434     3,190  

Changes in operating assets and liabilities:

    

Accounts receivable

     51,530       (51,665

Inventories

     5,067       (785

Prepaid expenses and other current assets

     (48,625     (33,205

Accounts payable

     (78,040     36,067  

Accrued trade discounts and rebates

     (9,938     47,279  

Accrued expenses and other current liabilities

     42,858       (113,775

Other non-current assets and liabilities

     2,080       14,331  
  

 

 

   

 

 

 

Net cash provided by operating activities

     86,323       215,791  
  

 

 

   

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

    

Payments for acquisitions, net of cash acquired

     —         (3,122

Purchases of property, plant and equipment

     (24,128     (14,198

Payments for long-term investments

     (2,623     (1,464

Receipts from long-term investments

     —         3,060  

Payments related to license and collaboration agreements

     (15,000     (25,000
  

 

 

   

 

 

 

Net cash used in investing activities

     (41,751     (40,724
  

 

 

   

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

    

Repayment of term loans

     (4,000     (4,000

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

     3,421       9,071  

Payment of employee withholding taxes relating to share-based awards

     (87,549     (115,108
  

 

 

   

 

 

 

Net cash used in financing activities

     (88,128     (110,037
  

 

 

   

 

 

 

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

     2,368       (1,921
  

 

 

   

 

 

 

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

     (41,188     63,109  

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

     2,357,588       1,584,156  
  

 

 

   

 

 

 

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

   $ 2,316,400     $ 1,647,265  
  

 

 

   

 

 

 

 

(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 March 31,  
     2023     2022  

GAAP net income

   $ 54,684     $ 204,261  

Non-GAAP adjustments:

    

Acquisition/divestiture-related costs

     681       1,589  

Transaction-related costs

     9,784       —    

(Gain) loss on equity security investments

     (352     4,646  

Restructuring and realignment costs

     1,822       537  

Manufacturing facility start-up costs

     3,476       807  

Amortization and step-up:

    

Intangible amortization expense

     88,614       89,260  

Inventory step-up expense

     29,743       27,201  

Amortization of debt discount and deferred financing costs

     1,471       1,577  

Share-based compensation

     58,120       47,300  

Depreciation

     6,246       5,852  
  

 

 

   

 

 

 

Total of pre-tax non-GAAP adjustments

     199,605       178,769  

Income tax effect of pre-tax non-GAAP adjustments

     (59,943     (67,212
  

 

 

   

 

 

 

Total of non-GAAP adjustments

     139,662       111,557  
  

 

 

   

 

 

 

Non-GAAP net income

   $ 194,346     $ 315,818  
  

 

 

   

 

 

 

Non-GAAP Earnings Per Share:

    

Weighted average ordinary shares - Basic

     228,397,661       229,094,311  
  

 

 

   

 

 

 

Non-GAAP Earnings Per Share - Basic:

    

GAAP earnings per share - Basic

   $ 0.24     $ 0.89  

Non-GAAP adjustments

     0.61       0.49  
  

 

 

   

 

 

 

Non-GAAP earnings per share - Basic

   $ 0.85     $ 1.38  
  

 

 

   

 

 

 

Weighted average ordinary shares - Diluted

    

Weighted average ordinary shares - Basic

     228,397,661       229,094,311  

Ordinary share equivalents

     5,390,705       6,859,006  
  

 

 

   

 

 

 

Weighted average ordinary shares - Diluted

     233,788,366       235,953,318  
  

 

 

   

 

 

 

Non-GAAP Earnings Per Share - Diluted

    

GAAP earnings per share - Diluted

   $ 0.23     $ 0.87  

Non-GAAP adjustments

     0.60       0.47  
  

 

 

   

 

 

 

Non-GAAP earnings per share - Diluted

   $ 0.83     $ 1.34  
  

 

 

   

 

 

 

 

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Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

EBITDA and Adjusted EBITDA (Unaudited)

(in thousands)

 

     Three Months Ended
March 31,
 
     2023     2022  

GAAP net income

   $ 54,684     $ 204,261  

Depreciation

     6,246       5,852  

Amortization and step-up:

    

Intangible amortization expense

     88,614       89,260  

Inventory step-up expense

     29,743       27,201  

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

     15,540       21,256  

Benefit for income taxes

     (35,482     (31,522
  

 

 

   

 

 

 

EBITDA

   $ 159,345     $ 316,308  
  

 

 

   

 

 

 

Other non-GAAP adjustments:

    

Share-based compensation

     58,120       47,300  

(Gain) loss on equity security investments

     (352     4,646  

Acquisition/divestiture-related costs

     681       1,589  

Transaction-related costs

     9,784       —    

Manufacturing facility start-up costs

     3,476       807  

Restructuring and realignment costs

     1,822       537  
  

 

 

   

 

 

 

Total of other non-GAAP adjustments

     73,531       54,879  
  

 

 

   

 

 

 

Adjusted EBITDA

   $ 232,876     $ 371,187  
  

 

 

   

 

 

 

 

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Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

Operating Income (Unaudited)

(in thousands)

 

     Three Months Ended
March 31,
 
     2023     2022  

GAAP operating income

   $ 35,994     $ 194,317  

Non-GAAP adjustments:

    

Acquisition/divestiture-related costs

     681       1,589  

Transaction-related costs

     9,784       —    

Restructuring and realignment costs

     1,822       537  

Manufacturing facility start-up costs

     3,476       807  

Amortization and step-up:

    

Intangible amortization expense

     88,614       89,260  

Inventory step-up expense

     29,743       27,201  

Share-based compensation

     58,120       47,300  

Depreciation

     6,246       5,852  
  

 

 

   

 

 

 

Total of non-GAAP adjustments

     198,486       172,546  
  

 

 

   

 

 

 

Non-GAAP operating income

   $ 234,480     $ 366,863  
  

 

 

   

 

 

 

Foreign exchange gain

     91       420  

Other (expense) income, net

     (1,695     3,904  
  

 

 

   

 

 

 

Adjusted EBITDA

   $ 232,876     $ 371,187  
  

 

 

   

 

 

 

 

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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
March 31,
 
     2023     2022  

Non-GAAP Gross Profit:

    

GAAP gross profit

   $ 623,496     $ 670,183  

Non-GAAP gross profit adjustments:

    

Acquisition/divestiture-related costs

     (32     (1,304

Intangible amortization expense

     88,278       88,725  

Inventory step-up expense

     29,743       27,201  

Share-based compensation

     2,662       2,177  

Depreciation

     48       56  
  

 

 

   

 

 

 

Total of Non-GAAP adjustments

     120,699       116,855  
  

 

 

   

 

 

 

Non-GAAP gross profit

   $ 744,195     $ 787,038  
  

 

 

   

 

 

 

GAAP gross profit %

     74.9     75.7

Non-GAAP gross profit %

     89.4     88.9

GAAP cash provided by operating activities

   $ 86,323     $ 215,791  

Cash payments for acquisition/divestiture-related costs

     40       4,448  

Cash payments for restructuring and realignment costs

     4,641       574  

Cash payments for manufacturing facility start-up costs

     3,794       1,768  

Cash payments for transaction-related costs

     6,594       —    
  

 

 

   

 

 

 

Non-GAAP operating cash flow

   $ 101,392     $ 222,581  
  

 

 

   

 

 

 

 

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Horizon Therapeutics plc

GAAP to Non-GAAP Tax Rate Reconciliation (Unaudited)

(in millions, except percentages and per share amounts)

 

     Q1 2023  
     Pre-tax Net
Income
     Income Tax
(Benefit) Expense
    Tax Rate     Net Income      Diluted Earnings Per
Share
 

As reported - GAAP

   $ 19.2      $ (35.5     (184.8 )%    $ 54.7      $ 0.23  

Non-GAAP adjustments

     199.6        59.9         139.7     
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

Non-GAAP

   $ 218.8      $ 24.5       11.2   $ 194.3      $ 0.83  
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 
     Q1 2022  
     Pre-tax Net
Income
     Income Tax
(Benefit) Expense
    Tax Rate     Net Income      Diluted Earnings Per
Share
 

As reported - GAAP

   $ 172.7      $ (31.5     (18.2 )%    $ 204.3      $ 0.87  

Non-GAAP adjustments

     178.8        67.2         111.6     
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

Non-GAAP

   $ 351.5      $ 35.7       10.2   $ 315.8      $ 1.34  
  

 

 

    

 

 

   

 

 

   

 

 

    

 

 

 

 

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Horizon Therapeutics plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Three Months Ended March 31, 2023 (Unaudited)

(in thousands)

 

     Cost of Goods
Sold
    Research &
Development
    Selling, General
& Administrative
    Interest
Expense, net
    Other (Expense)
Income, net
    Income Tax
(Benefit)
Expense
 

GAAP as reported

   $ (208,563   $ (134,148   $ (453,354   $ (15,540   $ (1,343   $ 35,482  

Non-GAAP Adjustments:

            

Acquisition/divestiture-related costs(1)

     (32     —         713       —         —         —    

Transaction-related costs(2)

     —         —         9,784       —         —         —    

Gain on equity security investments(3)

     —         —         —         —         (352     —    

Restructuring and realignment costs(4)

     —         (203     2,025       —         —         —    

Manufacturing facility start-up costs(5)

     —         —         3,476       —         —         —    

Amortization and step-up:

            

Intangible amortization expense(6)

     88,278       —         336       —         —         —    

Inventory step-up expense(7)

     29,743       —         —         —         —         —    

Amortization of debt discount and deferred financing costs(8)

     —         —         —         1,471       —         —    

Share-based compensation(9)

     2,662       9,165       46,293       —         —         —    

Depreciation(10)

     48       383       5,815       —         —         —    

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

     —         —         —         —         —         (59,943
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     120,699       9,345       68,442       1,471       (352     (59,943
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

   $ (87,864   $ (124,803   $ (384,912   $ (14,069   $ (1,695   $ (24,461
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
Horizon Therapeutics plc  
Certain Income Statement Line Items - Non-GAAP Adjusted  
For the Three Months Ended March 31, 2022 (Unaudited)  
(in thousands)  
     Cost of Goods
Sold
    Research &
Development
    Selling, General
& Administrative
    Interest
Expense, net
    Other (Expense)
Income, net
    Income Tax
(Benefit)
Expense
 

GAAP as reported

   $ (215,062   $ (103,132   $ (372,734   $ (21,256   $ (742   $ 31,522  

Non-GAAP Adjustments:

            

Acquisition/divestiture-related costs(1)

     (1,304     2,001       892       —         —         —    

Loss on equity security investments(3)

     —         —         —         —         4,646       —    

Restructuring and realignment costs(4)

     —         —         537       —         —         —    

Manufacturing facility start-up costs(5)

     —         —         807       —         —         —    

Amortization and step-up:

            

Intangible amortization expense(6)

     88,725       —         535       —         —         —    

Inventory step-up expense(7)

     27,201       —         —         —         —         —    

Amortization of debt discount and deferred financing costs(8)

     —         —         —         1,577       —         —    

Share-based compensation(9)

     2,177       8,976       36,147       —         —         —    

Depreciation(10)

     56       225       5,571       —         —         —    

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

     —         —            —         —         —         (67,212
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total of non-GAAP adjustments

     116,855       11,202       44,489       1,577       4,646       (67,212
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP

   $ (98,207   $ (91,930   $ (328,245   $ (19,679   $ 3,904     $ (35,690
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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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, including responding to the FTC’s second request.

 

3.

We held investments in equity securities with readily determinable fair values of $7.4 million and $8.5 million as of March 31, 2023 and 2022, respectively, which are included in other long-term assets in the condensed consolidated balance sheet. For the three months ended March 31, 2023 and 2022, we recognized a net unrealized gain of $0.4 million and a net unrealized loss of $4.6 million, respectively, 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.

 

5.

During the three months ended March 31, 2023 and 2022, we recorded $3.5 million and $0.8 million, respectively, of manufacturing facility start-up costs related to our drug product biologics manufacturing facility in Waterford, Ireland.

 

6.

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

 

7.

During the three months ended March 31, 2023 and 2022, we recognized $29.7 million and $27.2 million in cost of goods sold, respectively, for inventory step-up expense related to UPLIZNA inventory revalued in connection with the Viela Bio, Inc. 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 restricted stock unit and performance stock unit grants to our employees and non-employee directors, and our employee share purchase plan.

 

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.

 

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