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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 --

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.”

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.

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.

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.

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.

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, we separately present 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 R&D expenses. We believe the new classification assists users of the financial statements in better understanding the payments incurred to acquire in-process research and development, or IPR&D. Prior period consolidated statements of comprehensive income have been reclassified to conform with the new classification. There were no acquired IPR&D and milestones expenses during the three months ended March 31, 2023 and 2022.
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

 

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.
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

 

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

 

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

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

 

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

 
Horizon Therapeutics plc
Certain Income Statement Line Items - Non-GAAP Adjusted
For the Three Months Ended March 31, 2023 (Unaudited)
(in thousands)
 
 
Income Tax
Cost of Goods Research & Selling, General Interest Other (Expense) (Benefit)
Sold Development & Administrative Expense, net Income, net 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)
 
 
Income Tax
Cost of Goods Research & Selling, General Interest Other (Expense) (Benefit)
Sold Development & Administrative Expense, net Income, net 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

)

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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