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Horizon Therapeutics plc Reports Second-Quarter 2022 Financial Results and Revises Full-Year 2022 Net Sales and Adjusted EBITDA Guidance

Second-Quarter 2022 Results:

— Net Sales of $876.4 Million; Orphan Segment Net Sales Increased 13% to $841.3 Million —

— GAAP Net Income of $61.0 Million; Adjusted EBITDA of $306.6 Million —

— TEPEZZA® (teprotumumab-trbw) Net Sales of $479.8 Million —

— KRYSTEXXA® (pegloticase injection) Net Sales of $167.8 Million —

— Cash Position of $1.89 Billion as of June 30, 2022 —

Revises Full-Year 2022 Guidance:

— Full-Year 2022 Net Sales Guidance of $3.53 Billion to $3.60 Billion, Reflecting Revised Net Sales Expectations for TEPEZZA and Inflammation Segment

— Full-Year 2022 Adjusted EBITDA Guidance of $1.30 Billion to $1.35 Billion

— Full-Year 2022 TEPEZZA Net Sales Percentage Growth in the High-Teens —

Recent Company Highlights:

— Obtained U.S. FDA Approval for Expanded KRYSTEXXA Label to Include Co-Administration with Methotrexate Based on Positive MIRROR Results That Demonstrated Improved and Sustained Patient Response —

— UPLIZNA® (inebilizumab) Approved by European Commission for the Treatment of Adult Patients with NMOSD; Commercial Launch Underway in Germany —

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced second-quarter 2022 financial results and revised its full-year 2022 net sales and adjusted EBITDA guidance.

“Double-digit net sales growth in our orphan segment drove our second-quarter performance, with very strong growth of KRYSTEXXA and an increasing contribution from UPLIZNA,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “We were also pleased to receive FDA approval of our expanded KRYSTEXXA label in July, to include co-administration of KRYSTEXXA with methotrexate, which will enable many more patients to benefit from this important medicine.”

“We are revising our full-year guidance to reflect our expectation for TEPEZZA full-year net sales percentage growth in the high-teens and reflect recent generic competition in our inflammation segment. Importantly, our long-term outlook for TEPEZZA has not changed and we continue to estimate that our three key growth drivers TEPEZZA, KRYSTEXXA and UPLIZNA can generate aggregate global peak annual net sales of greater than $5.5 billion. We understand the dynamics impacting the pace of growth of TEPEZZA, and we are executing on our strategy to address them, including a more significant expansion of our TEPEZZA field force and implementing initiatives to drive further penetration. We are excited about the future prospects for Horizon, with our growth drivers, our expanding pipeline and our global expansion initiatives.”

Financial Highlights

(in millions except for per share amounts and percentages) Q2 22 Q2 21 %
Change
YTD 22 YTD 21 %
Change
 
Net sales

$

876.4

$

832.5

5

 

$

1,761.7

$

1,175.0

50

Net income

 

61.0

 

158.1

(61

)

 

265.2

 

34.8

NM

Non-GAAP net income

 

253.8

 

340.7

(26

)

 

569.6

 

345.5

65

Adjusted EBITDA

 

306.6

 

320.4

(4

)

 

677.8

 

363.2

87

 
Earnings per share – diluted

 

0.26

 

0.67

(61

)

 

1.12

 

0.15

NM

Non-GAAP earnings per share – diluted

 

1.07

 

1.45

(26

)

 

2.41

 

1.47

64

 

Second Quarter and Recent Company Highlights

Key Clinical Development Programs

Second-Quarter Financial Results

Note: For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release.

Second-Quarter Segment Results

Management uses net sales and segment operating income to evaluate the performance of the Company’s two segments, the orphan segment and the inflammation segment. While segment operating income contains certain adjustments to the directly comparable GAAP figures in the Company’s consolidated financial results, such as the exclusion of upfront and milestone payments related to license and collaboration agreements, it is considered to be prepared in accordance with GAAP for purposes of presenting the Company’s segment operating results.

Orphan Segment
(in millions except for percentages) Q2 22 Q2 21 %
Change
YTD 22 YTD 21 %
Change
 
 
TEPEZZA®

$

479.8

$

453.3

6

 

$

981.3

$

455.3

116

 

KRYSTEXXA®

 

167.8

 

130.3

29

 

 

308.5

 

237.1

30

 

RAVICTI®

 

75.7

 

68.4

11

 

 

154.1

 

141.3

9

 

PROCYSBI®

 

47.7

 

49.8

(4

)

 

97.3

 

93.1

4

 

UPLIZNA®(1)

 

38.6

 

14.5

167

 

 

69.1

 

16.3

323

 

ACTIMMUNE®

 

30.0

 

27.8

8

 

 

61.3

 

56.5

9

 

BUPHENYL®

 

1.4

 

2.2

(39

)

 

3.5

 

3.9

(10

)

QUINSAIRTM

 

0.3

 

0.2

51

 

 

0.6

 

0.5

46

 

Orphan Net Sales

$

841.3

$

746.5

13

 

$

1,675.7

$

1,004.0

67

 

 
Orphan Segment Operating Income

$

315.1

$

321.2

(2

)

$

666.6

$

322.3

107

 

(1)

Second-quarter and year-to-date 2022 UPLIZNA net sales included $8.6 million and $13.8 million, respectively, in revenue and milestone payments from the Company’s international partners.

Inflammation Segment

(in millions except for percentages) Q2 22 Q2 21 %
Change
YTD 22 YTD 21 %
Change
 
PENNSAID 2%®(1)

$

23.6

 

$

48.9

(52

)

$

59.0

$

94.8

(38

)

RAYOS®

 

11.1

 

 

13.4

(17

)

 

24.6

 

28.7

(14

)

VIMOVO®

 

0.3

 

 

1.6

(81

)

 

1.2

 

5.9

(80

)

DUEXIS®(2)

 

0.1

 

 

22.1

(100

)

 

1.2

 

41.6

(97

)

Inflammation Net Sales

$

35.1

 

$

86.0

(59

)

$

86.0

$

171.0

(50

)

 
Inflammation Segment Operating (Loss) Income

$

(6.6

)

$

46.8

NM

$

8.8

$

89.4

(90

)

(1)

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

(2)

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

Cash Flow Statement and Balance Sheet Highlights

Revised 2022 Guidance

The Company now expects full-year 2022 net sales to range between $3.53 billion and $3.60 billion, updated from the previous guidance range of $3.9 billion to $4.0 billion. The Company now expects TEPEZZA full-year 2022 net sales percentage growth in the high-teens, compared to the previous guidance of mid-30s percentage growth. The Company continues to expect KRYSTEXXA full-year 2022 net sales growth of more than 20%. The Company expects inflammation segment second-half 2022 net sales of less than $30 million due to an at-risk launch of a generic PENNSAID 2% initiated on May 6, 2022. Full-year 2022 adjusted EBITDA is now expected to range between $1.30 billion and $1.35 billion, updated from the previous guidance range of $1.63 billion to $1.70 billion.

Webcast

At 8 a.m. EDT / 1 p.m. IST today, the Company will host a live webcast to review its financial and operating results and provide a general business update. The live webcast and a replay may be accessed at http://ir.horizontherapeutics.com. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

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, manufacturing plant 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.

Contacts

Investors:
Tina Ventura

Senior Vice President,

Chief Investor Relations Officer

investor-relations@horizontherapeutics.com
Erin Linnihan

Executive Director,

Investor Relations

investor-relations@horizontherapeutics.com
Ruth Venning

Executive Director,

Investor Relations and ESG

investor-relations@horizontherapeutics.com

U.S. Media:
Geoff Curtis

Executive Vice President,

Corporate Affairs & Chief Communications Officer

media@horizontherapeutics.com
Ireland Media:
Ray Gordon

Gordon MRM

ray@gordonmrm.ie

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