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

Fourth-Quarter 2022 Results:

— Net Sales of $942.0 Million —

— GAAP Net Income of $120.4 Million; Adjusted EBITDA of $357.5 Million; Includes $37.3 Million of Acquired IPR&D and Milestones Expenses —

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

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

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

Full-Year 2022 Results:

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

— GAAP Net Income of $521.5 Million; Record Adjusted EBITDA of $1.37 Billion; Includes $56.3 Million of Acquired IPR&D and Milestones Expenses —

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

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

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

— Record Operating Cash Flow of $1.26 Billion —

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

Fourth-Quarter and Recent Company Highlights:

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

— Announced Positive Topline Data from the Second Population in Dazodalibep Sjögren’s Syndrome Phase 2 Trial; First and Only Phase 2 Sjögren’s Syndrome Trial to Meet the Primary Endpoint in Both Patient Populations; Phase 3 Clinical Program Expected to Initiate in 2023 —

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

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

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

— Received Approval for UPLIZNA in Brazil for the Treatment of Adult Patients with Neuromyelitis Optica Spectrum Disorder —

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

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced fourth-quarter and record full-year 2022 financial results.

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

Financial Highlights

(in millions except for per share amounts and percentages)	Q4 22			Q4 21			% Change			FY 22			FY 21			% Change
Net sales	$	942.0		$	1,014.5		(7	)		$	3,629.0		$	3,226.4		12
Net income		120.4			173.2		(30	)			521.5			534.5		(2	)
Non-GAAP net income		281.5			334.0		(16	)			1,144.3			1,089.7		5
Adjusted EBITDA(1)		357.5			416.0		(14	)			1,370.6			1,284.3		7
Earnings per share – diluted		0.52			0.73		(29	)			2.22			2.27		(2	)
Non-GAAP earnings per share – diluted		1.21			1.41		(14	)			4.86			4.62		5

(1)

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

Fourth-Quarter and Full-Year 2022 Net Sales Results

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

(in millions except for percentages)	Q4 22			Q4 21			% Change			FY 22			FY 21			% Change
TEPEZZA®(1)	$	493.5		$	589.6		(16	)		$	1,965.7		$	1,661.3		18
KRYSTEXXA®		216.1			170.3		27				716.2			565.5		27
RAVICTI®		87.5			74.4		18				325.6			291.9		12
PROCYSBI®		54.9			47.4		16				210.0			189.9		11
UPLIZNA®(2)		41.8			25.8		62				154.6			60.8		154
ACTIMMUNE®		30.1			30.6		(1	)			126.1			117.2		8
PENNSAID 2%®(3)		7.2			48.9		(85	)			73.8			191.6		(61	)
RAYOS®		6.7			13.3		(50	)			41.9			56.9		(26	)
BUPHENYL®		2.1			2.1		(0	)			7.3			7.9		(7	)
DUEXIS®(4)		1.7			11.5		(85	)			4.9			74.0		(93	)
QUINSAIRTM		0.2			0.3		(22	)			1.1			1.0		5
VIMOVO®		0.2			0.3		(40	)			1.8			8.4		(78	)
Total Net Sales	$	942.0		$	1,014.5		(7	)		$	3,629.0		$	3,226.4		12

(1)		TEPEZZA net sales in the fourth quarter of 2021 accounted for a larger share of full-year 2021 net sales due to a supply disruption caused by the U.S. government-mandated COVID-19 vaccine orders.
(2)		Fourth-quarter and full-year 2022 UPLIZNA net sales included $1.3 million and $18.3 million, respectively, in international net sales, related primarily to revenue and milestone payments from the Company’s international partners.
(3)		On May 6, 2022, Apotex Inc. initiated an at-risk launch of generic PENNSAID 2% in the United States.
(4)		On Aug. 4, 2021, Alkem Laboratories, Inc. initiated an at-risk launch of generic DUEXIS in the United States.

Conference Call

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

About Horizon

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

Note Regarding Use of Non-GAAP Financial Measures

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

Forward-Looking Statements

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

Horizon Therapeutics plc
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
		Three Months Ended December 31,								Twelve Months Ended December 31,
			2022				2021				2022				2021
		(Unaudited)
Net sales		$	942,029			$	1,014,464			$	3,629,044			$	3,226,410
Cost of goods sold			240,787				241,509				920,197				794,512
Gross profit			701,242				772,955				2,708,847				2,431,898
OPERATING EXPENSES:
	Research and development (1)		117,526				101,242				437,962				345,318
	Acquired in-process research and development and milestones(1)		37,250				39,672				56,250				86,672
	Selling, general and administrative		372,534				398,954				1,541,052				1,446,410
	Impairment of goodwill		–				–				56,171				–
	Impairment of long-lived asset		–				–				–				12,371
	Gain on sale of asset		–				–				–				(2,000	)
	Total operating expenses		527,310				539,868				2,091,435				1,888,771
Operating income			173,932				233,087				617,412				543,127
OTHER EXPENSE, NET:
	Interest expense, net		(18,562	)			(22,045	)			(83,707	)			(81,063	)
	Foreign exchange (loss) gain		(882	)			335				(1,202	)			(1,028	)
	Other (expense) income, net		(159	)			(322	)			(5,567	)			1,791
	Total other expense, net		(19,603	)			(22,032	)			(90,476	)			(80,300	)
Income before expense (benefit) for income taxes			154,329				211,055				526,936				462,827
Expense (benefit) for income taxes			33,921				37,873				5,454				(71,664	)
Net income		$	120,408			$	173,182			$	521,482			$	534,491
Net income per ordinary share – basic		$	0.53			$	0.76			$	2.28			$	2.37
Weighted average ordinary shares outstanding – basic			226,997,506				227,028,298				229,108,881				225,551,410
Net income per ordinary share – diluted		$	0.52			$	0.73			$	2.22			$	2.27
Weighted average ordinary shares outstanding – diluted			233,014,974				236,806,923				235,239,651				235,680,483
(1)	Beginning with the third quarter of 2022, the Company is separately presenting upfront, milestone, and similar payments pursuant to collaborations, licenses of third-party technologies, and asset acquisitions as “Acquired in-process research and development and milestones” expenses in the condensed consolidated statements of operations. Amounts recorded in this line item for the three and twelve months ended December 31, 2022, would have historically been recorded to research and development (“R&D”) expenses. The Company believes the new classification assists users of the financial statements in better understanding the payments incurred to acquire in-process research and development (“IPR&D”). Prior period condensed consolidated statements of operations have been reclassified to conform with the new classification.

Horizon Therapeutics plc
Condensed Consolidated Balance Sheets
(in thousands, except share data)
					As of
					December 31, 2022				December 31, 2021
ASSETS
CURRENT ASSETS:
	Cash and cash equivalents				$	2,352,833			$	1,580,317
	Restricted cash					4,755				3,839
	Accounts receivable, net					676,347				632,775
	Inventories, net					169,559				225,730
	Prepaid expenses and other current assets					449,349				357,106
			Total current assets			3,652,843				2,799,767
Property, plant and equipment, net						340,509				292,298
Developed technology and other intangible assets, net						2,664,777				2,960,118
In-process research and development						810,000				880,000
Goodwill						1,010,538				1,066,709
Deferred tax assets, net						431,814				538,098
Other long-term assets						204,135				140,738
Total assets					$	9,114,616			$	8,677,728
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
	Accounts payable				$	155,800			$	30,125
	Accrued expenses and other current liabilities					457,557				523,015
	Accrued trade discounts and rebates					319,780				317,431
	Long-term debt—current portion					16,000				16,000
			Total current liabilities			949,137				886,571
LONG-TERM LIABILITIES:
	Long-term debt, net					2,546,837				2,555,233
	Deferred tax liabilities, net					342,017				390,455
	Other long-term liabilities					204,451				173,076
			Total long-term liabilities			3,093,305				3,118,764
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS’ EQUITY:
	Ordinary shares, $0.0001 nominal value; 600,000,000 shares
	authorized at December 31, 2022 and December 31, 2021;
	227,625,913 and 227,760,936 shares issued at December 31, 2022
	and December 31, 2021, respectively; and 227,241,547 and 227,376,570 shares
	outstanding at December 31, 2022 and December 31, 2021, respectively					23				23
	Treasury stock, 384,366 ordinary shares at December 31, 2022 and December 31, 2021					(4,585	)			(4,585	)
	Additional paid-in capital					4,474,199				4,373,337
	Accumulated other comprehensive income (loss)					12,528				(14,987	)
	Retained earnings					590,009				318,605
			Total shareholders’ equity			5,072,174				4,672,393
Total liabilities and shareholders’ equity					$	9,114,616			$	8,677,728

Horizon Therapeutics plc
Condensed Consolidated Statements of Cash Flows
(in thousands)
					Three Months Ended December 31,								Twelve Months Ended December 31,
						2022				2021				2022				2021
					(Unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income					$	120,408			$	173,182			$	521,482			$	534,491
Adjustments to reconcile net income to net cash provided by operating activities:
	Depreciation and amortization expense					98,774				96,535				390,393				353,751
	Equity-settled share-based compensation					44,585				48,692				182,100				219,086
	Acquired IPR&D and milestones					37,250				30,072				52,250				70,072
	Impairment of goodwill					–				–				56,171				–
	Impairment of long-lived asset					–				–				–				12,371
	Amortization of debt discount and deferred financing costs					1,776				1,449				7,912				5,189
	Gain on sale of asset					–				–				–				(2,000	)
	Deferred income taxes					41,160				46,918				49,814				(101,016	)
	Foreign exchange and other adjustments					2,004				61				9,700				5,067
	Changes in operating assets and liabilities:
		Accounts receivable				(29,776	)			142,572				(43,457	)			34,796
		Inventories				20,713				11,761				56,122				1,267
		Prepaid expenses and other current assets				(4,588	)			(27,403	)			(79,245	)			(88,193	)
		Accounts payable				123,087				(19,837	)			122,232				(12,197	)
		Accrued trade discounts and rebates				(35,890	)			13,909				2,399				(36,929	)
		Accrued expenses and other current liabilities				5,887				16,242				(59,101	)			50,622
		Other non-current assets and liabilities				1,001				4,404				(10,930	)			(11,106	)
			Net cash provided by operating activities			426,391				538,557				1,257,842				1,035,271
CASH FLOWS FROM INVESTING ACTIVITIES:
Payments for acquisitions, net of cash acquired						–				–				(3,122	)			(2,843,275	)
Purchases of property, plant and equipment						(24,858	)			(16,901	)			(64,026	)			(76,596	)
Payments for long-term investments						(2,180	)			(14,871	)			(9,236	)			(28,256	)
Receipts from long-term investments						217				–				4,633				3,588
Proceeds from sale of asset						–				–				–				2,000
Payments related to license and collaboration agreements						(22,250	)			(5,072	)			(62,250	)			(51,572	)
			Net cash used in investing activities			(49,071	)			(36,844	)			(134,001	)			(2,994,111	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from term loans						–				–				–				1,574,993
Repayment of term loans						(4,000	)			(4,000	)			(16,000	)			(12,000	)
Proceeds from the issuance of ordinary shares in conjunction with ESPP program						11,167				11,046				25,051				22,528
Proceeds from the issuance of ordinary shares in connection with stock option exercises						7,036				10,553				30,316				50,566
Payment of employee withholding taxes relating to share-based awards						(13,300	)			(7,887	)			(137,247	)			(165,964	)
Repurchase of ordinary shares						(161,869	)			–				(250,078	)			–
			Net cash (used in) provided by financing activities			(160,966	)			9,712				(347,958	)			1,470,123
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash						5,964				345				(2,451	)			(10,606	)
Net increase (decrease) in cash, cash equivalents and restricted cash						222,318				511,770				773,432				(499,323	)
Cash, cash equivalents and restricted cash, beginning of the period(1)						2,135,270				1,072,386				1,584,156				2,083,479
Cash, cash equivalents and restricted cash, end of the period(1)					$	2,357,588			$	1,584,156			$	2,357,588			$	1,584,156
(1) Amounts include restricted cash balance in accordance with ASU No. 2016-18. Cash and cash equivalents excluding restricted cash are shown on the balance sheet.

Horizon Therapeutics plc
GAAP to Non-GAAP Reconciliations
Net Income and Earnings Per Share (Unaudited)
(in thousands, except share and per share data)
			Three Months Ended December 31,								Twelve Months Ended December 31,
				2022				2021				2022				2021
GAAP net income			$	120,408			$	173,182			$	521,482			$	534,491
Non-GAAP adjustments:
	Acquisition/divestiture-related costs			(3,676	)			7,763				(239	)			95,929
	Transaction-related costs			11,086				–				11,086				–
	(Gain) loss on equity security investments			(143	)			(1,257	)			6,188				(1,257	)
	Restructuring and realignment costs			7,456				18,606				16,977				26,309
	Manufacturing facility start-up costs			1,139				1,910				5,552				3,622
	Amortization and step-up:
		Intangible amortization expense		92,916				91,017				366,462				336,277
		Inventory step-up expense		25,367				10,658				91,709				27,572
		Amortization of debt discount and deferred financing costs		1,776				1,449				7,912				5,189
	Impairment of long-lived asset			–				–				–				12,371
	Impairment of goodwill			–				–				56,171				–
	Gain on sale of asset			–				–				–				(2,000	)
	Share-based compensation			44,585				48,692				182,100				219,086
	Depreciation			5,858				5,519				23,931				17,475
	Litigation settlement			–				–				–				5,000
		Total of pre-tax non-GAAP adjustments		186,364				184,357				767,849				745,573
	Income tax effect of pre-tax non-GAAP adjustments			(26,619	)			(27,889	)			(148,373	)			(169,554	)
	Other non-GAAP income tax adjustments			1,308				4,326				3,387				(20,800	)
		Total of non-GAAP adjustments		161,053				160,794				622,863				555,219
Non-GAAP net income			$	281,461			$	333,976			$	1,144,345			$	1,089,710
Non-GAAP Earnings Per Share:
Weighted average ordinary shares – Basic				226,997,506				227,028,298				229,108,881				225,551,410
Non-GAAP Earnings Per Share – Basic:
	GAAP earnings per share – Basic		$	0.53			$	0.76			$	2.28			$	2.37
	Non-GAAP adjustments			0.71				0.71				2.71				2.46
	Non-GAAP earnings per share – Basic		$	1.24			$	1.47			$	4.99			$	4.83
Weighted average ordinary shares – Diluted
	Weighted average ordinary shares – Basic			226,997,506				227,028,298				229,108,881				225,551,410
	Ordinary share equivalents			6,017,468				9,778,625				6,130,771				10,129,073
	Weighted average ordinary shares – Diluted			233,014,974				236,806,923				235,239,652				235,680,483
Non-GAAP Earnings Per Share – Diluted
	GAAP earnings per share – Diluted		$	0.52			$	0.73			$	2.22			$	2.27
	Non-GAAP adjustments			0.69				0.68				2.64				2.35
	Non-GAAP earnings per share – Diluted		$	1.21			$	1.41			$	4.86			$	4.62

Horizon Therapeutics plc
GAAP to Non-GAAP Reconciliations
EBITDA and Adjusted EBITDA (Unaudited)
(in thousands)
		Three Months Ended December 31,								Twelve Months Ended December 31,
			2022				2021				2022				2021
GAAP net income		$	120,408			$	173,182			$	521,482			$	534,491
Depreciation			5,858				5,519				23,931				17,475
Amortization and step-up:
	Intangible amortization expense		92,916				91,017				366,462				336,277
	Inventory step-up expense		25,367				10,658				91,709				27,572
Interest expense, net (including amortization of
	debt discount and deferred financing costs)		18,562				22,045				83,707				81,063
Expense (benefit) for income taxes			33,921				37,873				5,454				(71,664	)
EBITDA		$	297,032			$	340,294			$	1,092,745			$	925,214
Other non-GAAP adjustments:
	Share-based compensation		44,585				48,692				182,100				219,086
	(Gain) loss on equity security investments		(143	)			(1,257	)			6,188				(1,257	)
	Acquisition/divestiture-related costs		(3,676	)			7,763				(239	)			95,929
	Transaction-related costs		11,086				–				11,086				–
	Manufacturing facility start-up costs		1,139				1,910				5,552				3,622
	Restructuring and realignment costs		7,456				18,606				16,977				26,309
	Impairment of goodwill		–				–				56,171				–
	Impairment of long-lived asset		–				–				–				12,371
	Gain on sale of asset		–				–				–				(2,000	)
	Litigation settlement		–				–				–				5,000
Total of other non-GAAP adjustments			60,447				75,714				277,835				359,060
Adjusted EBITDA		$	357,479			$	416,008			$	1,370,580			$	1,284,274

Contacts

Investors:
Tina Ventura

Senior Vice President,

Chief Investor Relations Officer

[email protected]

Erin Linnihan

Executive Director,

Investor Relations

[email protected]

U.S. Media:
Geoff Curtis

Executive Vice President,

Corporate Affairs & Chief Communications Officer

[email protected]

Ireland Media:
Ray Gordon

Gordon MRM

[email protected]

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