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Horizon Therapeutics plc Reports Second-Quarter 2023 Financial Results

Second-Quarter 2023 Results:

-- Net Sales of $945.0 Million, Representing Year-Over-Year Growth of 11% Excluding Inflammation Medicines --

-- GAAP Net Income of $127.1 Million; Adjusted EBITDA of $320.4 Million --

-- TEPEZZA® (teprotumumab-trbw) Net Sales of $445.5 Million --

-- KRYSTEXXA® (pegloticase injection) Net Sales of $244.3 Million --

-- UPLIZNA® (inebilizumab-cdon) Net Sales of $68.1 Million --

-- Cash Position of $2.5 Billion as of June 30, 2023 --

Second-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 TEPEZZA Phase 3 Clinical Trial (OPTIC-J) in Japanese Patients --

-- Received Approval for TEPEZZA in Brazil for the Treatment of TED; First Country Outside the U.S. to Approve TEPEZZA --

-- Announced Initiation of TEPEZZA Phase 3 Clinical Trial in Chronic/Low CAS TED in Japan and Daxdilimab Phase 2 Clinical Trial in Lupus Nephritis --

-- Presented New Data from Dazodalibep Phase 2 Clinical Trial in Sjögren’s Syndrome and KRYSTEXXA MIRROR Randomized Controlled Trial at EULAR European Congress of Rheumatology --

-- Continue to Expect Amgen Transaction to Close by Mid-December, Assuming the Federal Trade Commission’s Request for a Preliminary Injunction Is Denied --

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

-- Ranked First in Overall Corporate Reputation by U.S. Patient Advocacy Groups --

Horizon Therapeutics plc (Nasdaq: HZNP) today announced second-quarter 2023 financial results.

“We delivered strong growth in the second quarter, with double-digit year-over-year growth in our core business and mid-teens growth sequentially,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “This performance was driven by exceptional 46% year-over-year KRYSTEXXA sales growth as a result of strong commercial execution and the success of our immunomodulation strategy, in addition to positive and consistent trends we are generating for TEPEZZA, which reflects the success of our expansion efforts to further penetrate the TED market and reach new prescribers. We delivered impressive 76% year-over-year UPLIZNA sales growth and see a long runway ahead as we progress our two Phase 3 programs in IgG4-RD and MG. We also announced several important clinical milestones for TEPEZZA, including strong data in low CAS and long-duration TED and data from our Phase 3 clinical trial in Japan, both of which we expect to contribute to the future growth of this medicine.”

Financial Highlights

 
(in millions except for per share amounts and percentages)

Q2 23

 

Q2 22

 

%

Change

 

YTD 23

 

YTD 22

 

%

Change

 
Net sales

$

945.0

$

876.4

8

$

1,777.0

$

1,761.7

1

 

Net income

 

127.1

 

61.0

108

 

181.8

 

265.2

(31

)

Non-GAAP net income

 

280.1

 

253.8

10

 

474.4

 

569.6

(17

)

Adjusted EBITDA

 

320.4

 

306.6

4

 

553.3

 

677.8

(18

)

 
Earnings per share - diluted

 

0.54

 

0.26

108

 

0.78

 

1.12

(30

)

Non-GAAP earnings per share - diluted

 

1.20

 

1.07

12

 

2.03

 

2.41

(16

)

Second-Quarter and Year-to-Date 2023 Net Sales Results

 
(in millions except for percentages) Q2 23 Q2 22 %

Change
YTD 23 YTD 22 %

Change
 
 
TEPEZZA®

$

445.5

$

479.8

(7

)

$

850.8

$

981.3

(13

)

KRYSTEXXA®

 

244.3

 

167.8

46

 

 

431.3

 

308.5

40

 

RAVICTI®

 

88.4

 

75.7

17

 

 

178.7

 

154.1

16

 

UPLIZNA®(1)

 

68.1

 

38.6

76

 

 

121.9

 

69.1

76

 

PROCYSBI®

 

53.1

 

47.7

11

 

 

103.6

 

97.3

7

 

ACTIMMUNE®

 

29.0

 

30.0

(3

)

 

58.2

 

61.3

(5

)

PENNSAID 2%®(2)

 

7.0

 

23.6

(70

)

 

16.1

 

59.0

(72

)

RAYOS®

 

8.0

 

11.1

(28

)

 

13.0

 

24.6

(47

)

BUPHENYL®

 

1.3

 

1.4

(10

)

 

2.6

 

3.5

(25

)

QUINSAIRTM

 

0.3

 

0.3

3

 

 

0.6

 

0.6

1

 

DUEXIS®

 

-

 

0.1

(100

)

 

0.1

 

1.2

(91

)

VIMOVO®

 

-

 

0.3

(100

)

 

0.1

 

1.2

(91

)

Total Net Sales(3)

$

945.0

$

876.4

8

 

$

1,777.0

$

1,761.7

1

 

(1)

Second-quarter and year-to-date 2023 UPLIZNA net sales included $15.4 million and $22.0 million, respectively, in international net sales. Second-quarter and year-to-date 2022 UPLIZNA net sales included $8.6 million and $13.8 million, respectively, in international net sales.

(2)

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

(3)

Excluding the Company’s inflammation business unit (RAYOS, PENNSAID 2%, DUEXIS and VIMOVO), which was wound down at the end of 2022 due to generic competition, second-quarter year-over-year net sales growth was 11%.

Key Growth Drivers

TEPEZZA: TEPEZZA net sales in the second quarter were $446 million, representing a 10% sequential increase compared to the first quarter of 2023 and a 7% year-over-year decline compared to the second quarter of 2022. The TEPEZZA field-force expansion initiated late in 2022 continues to drive consistent and positive momentum in the business, including increases in new prescribers, patient enrollment forms and patient starts. Through the first half of 2023, as a result of the field-force expansion, the Company expanded its reach to new physician targets, which led to a 50% year-over-year increase in the number of ophthalmologists and endocrinologists prescribing TEPEZZA. In line with the Company’s expansion strategy, prescriber growth has largely come from ophthalmologists, with continued strong referral volume from endocrinologists.

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. The Company is executing on its payer strategy to educate key stakeholders and ease the access burden so all eligible patients can benefit from TEPEZZA. As a result of this process, large national and regional payers are beginning the process of updating their access requirements. To date, the Company has obtained favorable policy changes for greater than 20% of U.S. covered lives, which are expected to take effect in the second half of 2023. The Company expects these strategies and initiatives to further develop the TED market and impact net sales in 2024.

In addition, the Company made significant advancements in its global expansion strategy by announcing the positive topline results from its TEPEZZA Phase 3 clinical trial in Japanese patients, as well as the approval of TEPEZZA in Brazil for patients with TED. There are no medicines approved for the treatment of TED in Brazil or Japan, representing a significant unmet need in both markets. These accomplishments, which are expected to impact net sales beginning in 2025, are important milestones in the Company’s global expansion strategy to bring TEPEZZA to more patients worldwide.

KRYSTEXXA: KRYSTEXXA net sales in the second quarter were a record $244 million, representing a 31% sequential increase compared to the first quarter of 2023 and a 46% year-over-year increase compared to the second quarter of 2022. KRYSTEXXA net sales are now annualizing at a nearly one-billion-dollar run rate. The second-quarter results were driven by execution across all phases of the patient journey – demand generation, stakeholder education and adherence to treatment. The Company continued to see significant uptake from both its rheumatology and nephrology market segments in the quarter, with KRYSTEXXA with immunomodulation usage now at more than 70% of new patient starts. 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 net sales in the second quarter were a record $68 million, representing a 27% sequential increase compared to the first quarter of 2023 and a 76% year-over-year increase compared to the second quarter of 2022. Net sales in the U.S. were $53 million, an increase of 76% year-over-year, driven by strong commercial execution. The second-quarter results were driven by robust demand generation and new patient starts, increased depth among the Company’s existing prescribers and strong adherence to maintenance treatment. The Company continues to drive uptake among both patients naïve to biologics as well as patients switching from competitive biologic therapies, establishing UPLIZNA as the fastest-growing biologic in neuromyelitis optica spectrum disorder (NMOSD) year-to-date by market share. The Company expects to advance its global expansion strategy, with multiple planned international launches in 2023. The Company also continues to make progress on its two Phase 3 programs in IgG4-related disease (IgG4-RD) and myasthenia gravis (MG).

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, investor deck and the related Quarterly Report on Form 10-Q for the quarter ended June 30, 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 (the “FTC”) and subsequent lawsuit seeking to enjoin the transaction, manufacturing facility start-up costs, restructuring and realignment costs and gain on sale of asset, 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 and commercial launches; 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, including whether the district court grants or denies the FTC’s request for a preliminary injunction; 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 the absence of orders preventing the consummation of the transaction; 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 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 June 30,

 

Six Months Ended June 30,

2023

 

2022

 

2023

 

2022

 
Net sales

$

944,959

 

$

876,411

 

$

1,777,018

 

$

1,761,656

 

Cost of goods sold

 

219,958

 

 

230,216

 

 

428,521

 

 

445,278

 

Gross profit

 

725,001

 

 

646,195

 

 

1,348,497

 

 

1,316,378

 

 
OPERATING EXPENSES:
Research and development (1)

 

150,035

 

 

103,246

 

 

284,183

 

 

206,378

 

Selling, general and administrative

 

434,125

 

 

398,221

 

 

887,479

 

 

770,955

 

Impairment of goodwill

 

-

 

 

56,171

 

 

-

 

 

56,171

 

Gain on sale of asset

 

(2,000

)

 

-

 

 

(2,000

)

 

-

 

Total operating expenses

 

582,160

 

 

557,638

 

 

1,169,662

 

 

1,033,504

 

Operating income

 

142,841

 

 

88,557

 

 

178,835

 

 

282,874

 

 
OTHER EXPENSE, NET:
Interest expense, net

 

(12,098

)

 

(21,409

)

 

(27,638

)

 

(42,665

)

Foreign exchange gain

 

326

 

 

28

 

 

417

 

 

448

 

Other income (expense), net

 

4,183

 

 

(2,389

)

 

2,840

 

 

(3,131

)

Total other expense, net

 

(7,589

)

 

(23,770

)

 

(24,381

)

 

(45,348

)

 
Income before expense (benefit) for income taxes

 

135,252

 

 

64,787

 

 

154,454

 

 

237,526

 

Expense (benefit) for income taxes

 

8,181

 

 

3,813

 

 

(27,301

)

 

(27,709

)

Net income

$

127,071

 

$

60,974

 

$

181,755

 

$

265,235

 

 
Net income per ordinary share - basic

$

0.56

 

$

0.27

 

$

0.80

 

$

1.16

 

 
Weighted average ordinary shares outstanding - basic

 

228,743,143

 

 

230,020,004

 

 

228,571,356

 

 

229,559,715

 

 
Net income per ordinary share - diluted

$

0.54

 

$

0.26

 

$

0.78

 

$

1.12

 

 
Weighted average ordinary shares outstanding - diluted

 

233,935,591

 

 

236,166,384

 

 

233,938,149

 

 

236,077,147

 

(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, 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 and six months ended June 30, 2023 and 2022.

Horizon Therapeutics plc

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share data)
 
As of
June 30,

2023
December 31,

2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents

$

2,464,623

 

$

2,352,833

 

Restricted cash

 

4,791

 

 

4,755

 

Accounts receivable, net

 

717,417

 

 

676,347

 

Inventories, net

 

170,325

 

 

169,559

 

Prepaid expenses and other current assets

 

564,808

 

 

449,349

 

Total current assets

 

3,921,964

 

 

3,652,843

 

Property, plant and equipment, net

 

362,326

 

 

340,509

 

Developed technology and other intangible assets, net

 

2,486,565

 

 

2,664,777

 

In-process research and development

 

810,000

 

 

810,000

 

Goodwill

 

1,010,538

 

 

1,010,538

 

Deferred tax assets, net

 

444,306

 

 

431,814

 

Other long-term assets

 

263,042

 

 

204,135

 

Total assets

$

9,298,741

 

$

9,114,616

 

 
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable

$

85,543

 

$

155,800

 

Accrued expenses and other current liabilities

 

496,669

 

 

457,557

 

Accrued trade discounts and rebates

 

319,469

 

 

319,780

 

Long-term debt—current portion

 

16,000

 

 

16,000

 

Total current liabilities

 

917,681

 

 

949,137

 

 
LONG-TERM LIABILITIES:
Long-term debt, net

 

2,541,458

 

 

2,546,837

 

Deferred tax liabilities, net

 

264,815

 

 

342,017

 

Other long-term liabilities

 

263,828

 

 

204,451

 

Total long-term liabilities

 

3,070,101

 

 

3,093,305

 

 
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Ordinary shares, $0.0001 nominal value; 600,000,000 shares
authorized at June 30, 2023 and December 31, 2022;
229,323,393 and 227,625,913 shares issued at June 30, 2023
and December 31, 2022, respectively; and 228,939,027 and 227,241,547 shares
outstanding at June 30, 2023 and December 31, 2022, respectively

 

23

 

 

23

 

Treasury stock, 384,366 ordinary shares at June 30, 2023 and December 31, 2022

 

(4,585

)

 

(4,585

)

Additional paid-in capital

 

4,522,145

 

 

4,474,199

 

Accumulated other comprehensive income

 

21,612

 

 

12,528

 

Retained earnings

 

771,764

 

 

590,009

 

Total shareholders' equity

 

5,310,959

 

 

5,072,174

 

Total liabilities and shareholders' equity

$

9,298,741

 

$

9,114,616

 

Horizon Therapeutics plc

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)
 
 

Three Months Ended June 30,

 

Six Months Ended June 30,

2023

 

2022

 

2023

 

2022

 
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income

$

127,071

 

$

60,974

 

$

181,755

 

$

265,235

 

Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization expense

 

96,285

 

 

97,426

 

 

191,145

 

 

192,538

 

Equity-settled share-based compensation

 

60,271

 

 

45,149

 

 

118,391

 

 

92,449

 

Impairment of goodwill

 

-

 

 

56,171

 

 

-

 

 

56,171

 

Amortization of debt discount and deferred financing costs

 

1,308

 

 

2,327

 

 

2,779

 

 

3,904

 

Gain on sale of asset

 

(2,000

)

 

-

 

 

(2,000

)

 

-

 

Deferred income taxes

 

(4,642

)

 

30,864

 

 

(91,952

)

 

(3,032

)

Foreign exchange and other adjustments

 

(5,708

)

 

7,376

 

 

(6,143

)

 

10,566

 

Changes in operating assets and liabilities:
Accounts receivable

 

(92,670

)

 

11,152

 

 

(41,140

)

 

(40,513

)

Inventories

 

(5,833

)

 

22,818

 

 

(766

)

 

22,033

 

Prepaid expenses and other current assets

 

(60,191

)

 

(38,373

)

 

(108,816

)

 

(71,578

)

Accounts payable

 

7,807

 

 

(48,047

)

 

(70,233

)

 

(11,980

)

Accrued trade discounts and rebates

 

9,386

 

 

(27,047

)

 

(552

)

 

20,232

 

Accrued expenses and other current liabilities

 

20,532

 

 

36,874

 

 

63,390

 

 

(76,901

)

Other non-current assets and liabilities

 

9,851

 

 

(8,468

)

 

11,931

 

 

5,863

 

Net cash provided by operating activities

 

161,467

 

 

249,196

 

 

247,789

 

 

464,987

 

CASH FLOWS FROM INVESTING ACTIVITIES:
Payments for acquisitions, net of cash acquired

 

-

 

 

-

 

 

-

 

 

(3,122

)

Purchases of property, plant and equipment

 

(18,466

)

 

(10,154

)

 

(42,594

)

 

(24,352

)

Payments for long-term investments

 

(1,560

)

 

(6,443

)

 

(4,183

)

 

(4,847

)

Receipts from long-term investments

 

-

 

 

4,416

 

 

-

 

 

4,416

 

Payments related to license and collaboration agreements

 

-

 

 

-

 

 

(15,000

)

 

(25,000

)

Net cash used in investing activities

 

(20,026

)

 

(12,181

)

 

(61,777

)

 

(52,905

)

CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of term loans

 

(4,000

)

 

(4,000

)

 

(8,000

)

 

(8,000

)

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

 

14,912

 

 

13,884

 

 

14,912

 

 

13,884

 

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

 

2,628

 

 

12,951

 

 

6,049

 

 

22,022

 

Payment of employee withholding taxes relating to share-based awards

 

(4,506

)

 

(5,419

)

 

(92,055

)

 

(120,527

)

Net cash provided by (used in) financing activities

 

9,034

 

 

17,416

 

 

(79,094

)

 

(92,621

)

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

 

2,539

 

 

(4,396

)

 

4,908

 

 

(6,317

)

 
Net increase in cash, cash equivalents and restricted cash

 

153,014

 

 

250,035

 

 

111,826

 

 

313,144

 

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

 

2,316,400

 

 

1,647,265

 

 

2,357,588

 

 

1,584,156

 

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

$

2,469,414

 

$

1,897,300

 

$

2,469,414

 

$

1,897,300

 

(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 June 30,

 

Six Months Ended June 30,

2023

 

2022

 

2023

 

2022

 
GAAP net income

$

127,071

 

$

60,974

 

$

181,755

 

$

265,235

 

Non-GAAP adjustments:
Acquisition/divestiture-related costs

 

52

 

 

1,023

 

 

733

 

 

2,612

 

Transaction-related costs

 

16,539

 

 

-

 

 

26,323

 

 

-

 

(Gain) loss on equity security investments

 

(2,437

)

 

438

 

 

(2,789

)

 

5,084

 

Restructuring and realignment costs

 

854

 

 

1,253

 

 

2,676

 

 

1,790

 

Manufacturing facility start-up costs

 

1,896

 

 

1,582

 

 

5,372

 

 

2,389

 

Amortization and step-up:
Intangible amortization expense

 

89,598

 

 

91,335

 

 

178,212

 

 

180,595

 

Inventory step-up expense

 

1,572

 

 

17,362

 

 

31,315

 

 

44,563

 

Amortization of debt discount and deferred financing costs

 

1,308

 

 

2,327

 

 

2,779

 

 

3,904

 

Impairment of goodwill

 

-

 

 

56,171

 

 

-

 

 

56,171

 

Gain on sale of asset

 

(2,000

)

 

-

 

 

(2,000

)

 

-

 

Share-based compensation

 

60,271

 

 

45,149

 

 

118,391

 

 

92,449

 

Depreciation

 

6,687

 

 

6,091

 

 

12,933

 

 

11,943

 

Total of pre-tax non-GAAP adjustments

 

174,340

 

 

222,731

 

 

373,945

 

 

401,500

 

Income tax effect of pre-tax non-GAAP adjustments

 

(21,354

)

 

(29,919

)

 

(81,297

)

 

(97,131

)

Total of non-GAAP adjustments

 

152,986

 

 

192,812

 

 

292,648

 

 

304,369

 

Non-GAAP net income

$

280,057

 

$

253,786

 

$

474,403

 

$

569,604

 

 
Non-GAAP Earnings Per Share:
 
Weighted average ordinary shares - Basic

 

228,743,143

 

 

230,020,004

 

 

228,571,356

 

 

229,559,715

 

 
Non-GAAP Earnings Per Share - Basic:
GAAP earnings per share - Basic

$

0.56

 

$

0.27

 

$

0.80

 

$

1.16

 

Non-GAAP adjustments

 

0.66

 

 

0.83

 

 

1.28

 

 

1.32

 

Non-GAAP earnings per share - Basic

$

1.22

 

$

1.10

 

$

2.08

 

$

2.48

 

 
Weighted average ordinary shares - Diluted
Weighted average ordinary shares - Basic

 

228,743,143

 

 

230,020,004

 

 

228,571,356

 

 

229,559,715

 

Ordinary share equivalents

 

5,192,448

 

 

6,146,380

 

 

5,366,793

 

 

6,517,432

 

Weighted average ordinary shares - Diluted

 

233,935,591

 

 

236,166,384

 

 

233,938,149

 

 

236,077,147

 

 
Non-GAAP Earnings Per Share - Diluted
GAAP earnings per share - Diluted

$

0.54

 

$

0.26

 

$

0.78

 

$

1.12

 

Non-GAAP adjustments

 

0.66

 

 

0.81

 

 

1.25

 

 

1.29

 

Non-GAAP earnings per share - Diluted

$

1.20

 

$

1.07

 

$

2.03

 

$

2.41

 

Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

EBITDA and Adjusted EBITDA (Unaudited)

(in thousands)
 

Three Months Ended June 30,

 

Six Months Ended June 30,

2023

 

2022

 

2023

 

2022

 
GAAP net income

$

127,071

 

$

60,974

$

181,755

 

$

265,235

 

Depreciation

 

6,687

 

 

6,091

 

12,933

 

 

11,943

 

Amortization and step-up:
Intangible amortization expense

 

89,598

 

 

91,335

 

178,212

 

 

180,595

 

Inventory step-up expense

 

1,572

 

 

17,362

 

31,315

 

 

44,563

 

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

 

12,098

 

 

21,409

 

27,638

 

 

42,665

 

Expense (benefit) for income taxes

 

8,181

 

 

3,813

 

(27,301

)

 

(27,709

)

EBITDA

$

245,207

 

$

200,984

$

404,552

 

$

517,292

 

Other non-GAAP adjustments:
Share-based compensation

 

60,271

 

 

45,149

 

118,391

 

 

92,449

 

(Gain) loss on equity security investments

 

(2,437

)

 

438

 

(2,789

)

 

5,084

 

Impairment of goodwill

 

-

 

 

56,171

 

-

 

 

56,171

 

Gain on sale of asset

 

(2,000

)

 

-

 

(2,000

)

 

-

 

Acquisition/divestiture-related costs

 

52

 

 

1,023

 

733

 

 

2,612

 

Transaction-related costs

 

16,539

 

 

-

 

26,323

 

 

-

 

Manufacturing facility start-up costs

 

1,896

 

 

1,582

 

5,372

 

 

2,389

 

Restructuring and realignment costs

 

854

 

 

1,253

 

2,676

 

 

1,790

 

Total of other non-GAAP adjustments

 

75,175

 

 

105,616

 

148,706

 

 

160,495

 

Adjusted EBITDA

$

320,382

 

$

306,600

$

553,258

 

$

677,787

 

Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

Operating Income (Unaudited)

(in thousands)
 

Three Months Ended June 30,

 

Six Months Ended June 30,

2023

 

2022

 

2023

 

2022

 
GAAP operating income

$

142,841

 

$

88,557

 

$

178,835

 

$

282,874

Non-GAAP adjustments:
Acquisition/divestiture-related costs

 

52

 

 

1,023

 

 

733

 

 

2,612

Transaction-related costs

 

16,539

 

 

-

 

 

26,323

 

 

-

Restructuring and realignment costs

 

854

 

 

1,253

 

 

2,676

 

 

1,790

Manufacturing facility start-up costs

 

1,896

 

 

1,582

 

 

5,372

 

 

2,389

Amortization and step-up:
Intangible amortization expense

 

89,598

 

 

91,335

 

 

178,212

 

 

180,595

Inventory step-up expense

 

1,572

 

 

17,362

 

 

31,315

 

 

44,563

Impairment of goodwill

 

-

 

 

56,171

 

 

-

 

 

56,171

Gain on sale of asset

 

(2,000

)

 

-

 

 

(2,000

)

 

-

Share-based compensation

 

60,271

 

 

45,149

 

 

118,391

 

 

92,449

Depreciation

 

6,687

 

 

6,091

 

 

12,933

 

 

11,943

Total of non-GAAP adjustments

 

175,469

 

 

219,966

 

 

373,955

 

 

392,512

Non-GAAP operating income

$

318,310

 

$

308,523

 

$

552,790

 

$

675,386

 
Foreign exchange gain

 

326

 

 

28

 

 

417

 

 

448

Other income (expense), net

 

1,746

 

 

(1,951

)

 

51

 

 

1,953

Adjusted EBITDA

$

320,382

 

$

306,600

 

$

553,258

 

$

677,787

Horizon Therapeutics plc

GAAP to Non-GAAP Reconciliations

Gross Profit and Operating Cash Flow (Unaudited)

(in thousands, except percentages)
 
 

Three Months Ended June 30,

 

Six Months Ended June 30,

2023

 

2022

 

2023

 

2022

 
Non-GAAP Gross Profit:
 
GAAP gross profit

$

725,001

 

$

646,195

 

$

1,348,497

 

$

1,316,378

 

Non-GAAP gross profit adjustments:
Acquisition/divestiture-related costs

 

52

 

 

(119

)

 

20

 

 

(1,423

)

Intangible amortization expense

 

89,259

 

 

90,439

 

 

177,537

 

 

179,164

 

Inventory step-up expense

 

1,572

 

 

17,362

 

 

31,315

 

 

44,563

 

Share-based compensation

 

3,141

 

 

2,294

 

 

5,803

 

 

4,471

 

Depreciation

 

130

 

 

55

 

 

178

 

 

111

 

Total of Non-GAAP adjustments

 

94,154

 

 

110,031

 

 

214,853

 

 

226,886

 

Non-GAAP gross profit

$

819,155

 

$

756,226

 

$

1,563,350

 

$

1,543,264

 

 
GAAP gross profit %

 

76.7

%

 

73.7

%

 

75.9

%

 

74.7

%

Non-GAAP gross profit %

 

86.7

%

 

86.3

%

 

88.0

%

 

87.6

%

 
 
 
GAAP cash provided by operating activities

$

161,467

 

$

249,196

 

$

247,789

 

$

464,987

 

Cash payments for acquisition/divestiture-related costs

 

11

 

 

748

 

 

51

 

 

5,196

 

Cash payments for restructuring and realignment costs

 

931

 

 

570

 

 

5,572

 

 

1,144

 

Cash payments for manufacturing facility start-up costs

 

2,116

 

 

895

 

 

5,910

 

 

2,663

 

Cash payments for transaction-related costs

 

14,074

 

 

-

 

 

20,668

 

 

-

 

Non-GAAP operating cash flow

$

178,599

 

$

251,409

 

$

279,990

 

$

473,990

 

Horizon Therapeutics plc

GAAP to Non-GAAP Tax Rate Reconciliation (Unaudited)

(in millions, except percentages and per share amounts)

 
Q2 2023
Pre-tax Net Income Income Tax Expense Tax Rate Net Income Diluted Earnings Per Share
As reported - GAAP

$

135.3

$

8.2

 

6.0

%

$

127.1

$

0.54

Non-GAAP adjustments

 

174.3

 

21.4

 

 

153.0

Non-GAAP

$

309.6

$

29.5

 

9.5

%

$

280.1

$

1.20

 
 
Q2 2022
Pre-tax Net Income Income Tax Expense Tax Rate Net Income Diluted Earnings Per Share
As reported - GAAP

$

64.8

$

3.8

 

5.9

%

$

61.0

$

0.26

Non-GAAP adjustments

 

222.7

 

29.9

 

 

192.8

Non-GAAP

$

287.5

$

33.7

 

11.7

%

$

253.8

$

1.07

 
 

YTD 2023

Pre-tax Net Income

Income Tax (Benefit) Expense

Tax Rate

Net Income

Diluted Earnings Per Share

As reported - GAAP

$

154.5

$

(27.3

)

(17.7

)%

$

181.8

$

0.78

Non-GAAP adjustments

 

373.9

 

81.3

 

 

292.6

Non-GAAP

$

528.4

$

54.0

 

10.2

%

$

474.4

$

2.03

 
 

YTD 2022

Pre-tax Net Income

Income Tax (Benefit) Expense

Tax Rate

Net Income

Diluted Earnings Per Share

As reported - GAAP

$

237.5

$

(27.7

)

(11.7

)%

$

265.2

$

1.12

Non-GAAP adjustments

 

401.5

 

97.1

 

 

304.4

Non-GAAP

$

639.0

$

69.4

 

10.9

%

$

569.6

$

2.41

Horizon Therapeutics plc

Certain Income Statement Line Items - Non-GAAP Adjusted

For the Three Months Ended June 30, 2023 (Unaudited)

(in thousands)

 
 
Cost of Goods Research & Selling, General Gain on sale Interest Other Income Income Tax
Sold Development & Administrative of asset Expense, net (Expense), net Expense
 
GAAP as reported

$

(219,958

)

$

(150,035

)

$

(434,125

)

$

2,000

 

$

(12,098

)

$

4,183

 

$

(8,181

)

 
Non-GAAP Adjustments:
 
Acquisition/divestiture-related costs(1)

 

52

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Transaction-related costs(2)

 

-

 

 

-

 

 

16,539

 

 

-

 

 

-

 

 

-

 

 

-

 

Gain on equity security investments(3)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(2,437

)

 

-

 

Restructuring and realignment costs(4)

 

-

 

 

253

 

 

601

 

 

-

 

 

-

 

 

-

 

 

-

 

Manufacturing facility start-up costs(5)

 

-

 

 

-

 

 

1,896

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization and step-up:
Intangible amortization expense(6)

 

89,259

 

 

-

 

 

339

 

 

-

 

 

-

 

 

-

 

 

-

 

Inventory step-up expense(7)

 

1,572

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization of debt discount and deferred financing costs(8)

 

-

 

 

-

 

 

-

 

 

-

 

 

1,308

 

 

-

 

 

-

 

Gain on sale of asset(9)

 

-

 

 

-

 

 

-

 

 

(2,000

)

 

-

 

 

-

 

 

-

 

Share-based compensation(10)

 

3,141

 

 

9,395

 

 

47,735

 

 

-

 

 

-

 

 

-

 

 

-

 

Depreciation(11)

 

130

 

 

588

 

 

5,969

 

 

-

 

 

-

 

 

-

 

 

-

 

Income tax effect on pre-tax non-GAAP adjustments(12)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(21,354

)

Total of non-GAAP adjustments

 

94,154

 

 

10,236

 

 

73,079

 

 

(2,000

)

 

1,308

 

 

(2,437

)

 

(21,354

)

 
Non-GAAP

$

(125,804

)

$

(139,799

)

$

(361,046

)

$

-

 

$

(10,790

)

$

1,746

 

$

(29,535

)

Horizon Therapeutics plc

 

Certain Income Statement Line Items - Non-GAAP Adjusted

 

For the Three Months Ended June 30, 2022 (Unaudited)

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of Goods

Research &

Selling, General

Impairment of

Interest

Other (Expense)

Income Tax

Sold

Development

& Administrative

goodwill

Expense, net

Income, net

Expense

 
GAAP as reported

$

(230,216

)

$

(103,246

)

$

(398,221

)

$

(56,171

)

$

(21,409

)

$

(2,389

)

$

(3,813

)

 
Non-GAAP Adjustments:
 
Acquisition/divestiture-related costs(1)

 

(119

)

 

-

 

 

1,142

 

 

-

 

 

-

 

 

-

 

 

-

 

Loss on equity security investments(3)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

438

 

 

-

 

Restructuring and realignment costs(4)

 

-

 

 

804

 

 

449

 

 

-

 

 

-

 

 

-

 

 

-

 

Manufacturing facility start-up costs(5)

 

-

 

 

-

 

 

1,582

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization and step-up:
Intangible amortization expense(6)

 

90,439

 

 

-

 

 

896

 

 

-

 

 

-

 

 

-

 

 

-

 

Inventory step-up expense(7)

 

17,362

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization of debt discount and deferred financing costs(8)

 

-

 

 

-

 

 

-

 

 

-

 

 

2,327

 

 

-

 

 

-

 

Share-based compensation(10)

 

2,294

 

 

6,742

 

 

36,113

 

 

-

 

 

-

 

 

-

 

 

-

 

Depreciation(11)

 

55

 

 

267

 

 

5,769

 

 

-

 

 

-

 

 

-

 

 

-

 

Impairment of goodwill(13)

 

-

 

 

-

 

 

-

 

 

56,171

 

 

-

 

 

-

 

 

-

 

Income tax effect on pre-tax non-GAAP adjustments(12)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(29,919

)

Total of non-GAAP adjustments

 

110,031

 

 

7,813

 

 

45,951

 

 

56,171

 

 

2,327

 

 

438

 

 

(29,919

)

 
Non-GAAP

$

(120,185

)

$

(95,433

)

$

(352,270

)

$

-

 

$

(19,082

)

$

(1,951

)

$

(33,732

)

 
Horizon Therapeutics plc
Certain Income Statement Line Items - Non-GAAP Adjusted
For the Six Months Ended June 30, 2023 (Unaudited)
(in thousands)
 
 
Income Tax
Cost of Goods Research & Selling, General Gain on sale Interest Other Income Benefit
Sold Development & Administrative of asset Expense, net (Expense), net (Expense)
 
GAAP as reported

$

(428,521

)

$

(284,183

)

$

(887,479

)

$

2,000

 

$

(27,638

)

$

2,840

 

$

27,301

 

 
Non-GAAP Adjustments:
 
Acquisition/divestiture-related costs(1)

 

20

 

 

-

 

 

713

 

 

-

 

 

-

 

 

-

 

 

-

 

Transaction-related costs(2)

 

-

 

 

-

 

 

26,323

 

 

-

 

 

-

 

 

-

 

 

-

 

Gain on equity security investments(3)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(2,789

)

 

-

 

Restructuring and realignment costs(4)

 

-

 

 

50

 

 

2,626

 

 

-

 

 

-

 

 

-

 

 

-

 

Manufacturing facility start-up costs(5)

 

-

 

 

-

 

 

5,372

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization and step-up:
Intangible amortization expense(6)

 

177,537

 

 

-

 

 

675

 

 

-

 

 

-

 

 

-

 

 

-

 

Inventory step-up expense(7)

 

31,315

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization of debt discount and deferred financing costs(8)

 

-

 

 

-

 

 

-

 

 

-

 

 

2,779

 

 

-

 

 

-

 

Gain on sale of asset(9)

 

-

 

 

-

 

 

-

 

 

(2,000

)

 

-

 

 

-

 

 

-

 

Share-based compensation(10)

 

5,803

 

 

18,561

 

 

94,027

 

 

-

 

 

-

 

 

-

 

 

-

 

Depreciation(11)

 

178

 

 

971

 

 

11,784

 

 

-

 

 

-

 

 

-

 

 

-

 

Income tax effect on pre-tax non-GAAP adjustments(12)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(81,297

)

Total of non-GAAP adjustments

 

214,853

 

 

19,582

 

 

141,520

 

 

(2,000

)

 

2,779

 

 

(2,789

)

 

(81,297

)

 
Non-GAAP

$

(213,668

)

$

(264,601

)

$

(745,959

)

$

-

 

$

(24,859

)

$

51

 

$

(53,996

)

 
Horizon Therapeutics plc
Certain Income Statement Line Items - Non-GAAP Adjusted
For the Six Months Ended June 30, 2022 (Unaudited)
(in thousands)
 
 
Income Tax
Cost of Goods Research & Selling, General Impairment of Interest Other (Expense) Benefit
Sold Development & Administrative goodwill Expense, net Income, net (Expense)
 
GAAP as reported

$

(445,278

)

$

(206,378

)

$

(770,955

)

$

(56,171

)

$

(42,665

)

 

(3,131

)

$

27,709

 

 
Non-GAAP Adjustments:
 
Acquisition/divestiture-related costs(1)

 

(1,423

)

 

2,000

 

 

2,035

 

 

-

 

 

-

 

 

-

 

 

-

 

Loss on equity security investments(3)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

5,084

 

 

-

 

Restructuring and realignment costs(4)

 

-

 

 

804

 

 

986

 

 

-

 

 

-

 

 

-

 

 

-

 

Manufacturing facility start-up costs(5)

 

-

 

 

-

 

 

2,389

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization and step-up:
Intangible amortization expense(6)

 

179,164

 

 

-

 

 

1,431

 

 

-

 

 

-

 

 

-

 

 

-

 

Inventory step-up expense(7)

 

44,563

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

Amortization of debt discount and deferred financing costs(8)

 

-

 

 

-

 

 

-

 

 

-

 

 

3,904

 

 

-

 

 

-

 

Impairment of goodwill(13)

 

-

 

 

-

 

 

-

 

 

56,171

 

 

-

 

 

-

 

 

-

 

Share-based compensation(10)

 

4,471

 

 

15,720

 

 

72,258

 

 

-

 

 

-

 

 

-

 

 

-

 

Depreciation(11)

 

111

 

 

493

 

 

11,339

 

 

-

 

 

-

 

 

-

 

 

-

 

Income tax effect on pre-tax non-GAAP adjustments(12)

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

-

 

 

(97,131

)

Total of non-GAAP adjustments

 

226,886

 

 

19,017

 

 

90,438

 

 

56,171

 

 

3,904

 

 

5,084

 

 

(97,131

)

 
Non-GAAP

$

(218,392

)

$

(187,361

)

$

(680,517

)

$

-

 

$

(38,761

)

$

1,953

 

$

(69,422

)

 

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, consulting and field-based employee retention costs, incurred in connection with the transaction with Amgen. The legal costs include costs incurred in responding to the FTC’s second request and subsequent lawsuit seeking to enjoin the transaction.

  3. We held investments in equity securities with readily determinable fair values of $9.8 million and $8.1 million as of June 30, 2023 and 2022, respectively, which are included in other long-term assets in the condensed consolidated balance sheet. For the three and six months ended June 30, 2023, we recognized net unrealized gains of $2.4 million and $2.8 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 June 30, 2023 and 2022, we recorded $1.9 million and $1.6 million, respectively, and $5.4 million and $2.4 million for the six months ended June 30, 2023 and 2022, 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 and six months ended June 30, 2023, we recognized in cost of goods sold $1.6 million and $31.3 million, respectively, for inventory step-up expense related to UPLIZNA inventory revalued in connection with the Viela Bio, Inc. acquisition. We recorded $17.4 million and $44.6 million of UPLIZNA inventory step-up expense in cost of goods sold during the three and six months ended June 30, 2022, respectively. 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. During the six months ended June 30, 2023, gain on sale of asset represents a $2.0 million contingent consideration payment related to the sale of MIGERGOT in 2019. The contingent consideration payment was triggered during the second quarter of 2023 and it was received in July 2023.

  10. 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.

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

  12. 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.

  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 the former inflammation reporting unit 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 inflammation reporting unit.

 

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