Horizon Therapeutics plc Reports Record Third-Quarter 2021 Financial Results; Increasing

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— Record Third-Quarter 2021 Net Sales of $1.037 Billion Increased 63 Percent; Third-Quarter 2021 GAAP Net Income of $326.5 Million; Record Adjusted EBITDA of $509.0 Million —

— Record TEPEZZA® (teprotumumab-trbw) Third-Quarter 2021 Net Sales of $616.4 Million; Increasing Full-Year 2021 Net Sales Guidance to Greater Than $1.625 Billion, Representing Year-Over-Year Growth of More Than 98 Percent —

— Record KRYSTEXXA® (pegloticase injection) Third-Quarter 2021 Net Sales of $158.1 Million; KRYSTEXXA Plus Immunomodulation Now at More Than 45 Percent; Increasing Full-Year 2021 Net Sales Guidance to Greater Than $550 Million, Representing Year-Over-Year Growth of More Than 35 Percent —

— Increasing Full-Year 2021 Net Sales Guidance to $3.16 Billion to $3.21 Billion, Representing 45 Percent Growth at the Midpoint; Increasing Full-Year 2021 Adjusted EBITDA Guidance to $1.315 Billion to $1.345 Billion, Representing 33 Percent Growth at the Midpoint —

— Announced Five New Programs for Development-Stage Candidates Daxdilimab (HZN-7734) and Dazodalibep (HZN-4920) —

— Announced Positive Topline Data from MIRROR Trial Evaluating the Use of KRYSTEXXA Plus Methotrexate; 71 Percent of Patients Achieved a Complete Response Rate at Month 6; Expect to Submit a Supplemental Biologics License Application (sBLA) to the U.S. FDA in the First Quarter of 2022 —

— Initiated Enrollment in TEPEZZA Chronic Thyroid Eye Disease (TED) Trial; Results Expected in Second Half of 2022 —

— Cash Position of $1.07 Billion; Achieved Gross Leverage Target of 2.0 Times at Sept. 30, 2021, Ahead of Year-End 2021 Goal —

DUBLIN, November 03, 2021–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) today announced record third-quarter 2021 financial results and increased both its full-year 2021 net sales and adjusted EBITDA guidance.

“We generated record results in the third quarter and made significant progress executing our R&D strategy, further expanding our pipeline with five new programs,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “In addition to our strong commercial execution with TEPEZZA and KRYSTEXXA, our expanded pipeline positions us to drive future growth and diversification, as well as address the unmet medical needs of many people living with rare, autoimmune and severe inflammatory diseases around the world.”

Financial Highlights

(in millions except for per share amounts and percentages)

Q3 21

Q3 20

%
Change

YTD 21

YTD 20

%
Change

Net sales

$

1,037.0

$

636.4

63

$

2,211.9

$

1,455.1

52

Net income

326.5

292.8

12

361.3

199.2

81

Non-GAAP net income

413.8

392.2

6

802.5

559.2

44

Adjusted EBITDA

509.0

329.8

54

921.8

627.7

47

Earnings per share – diluted

1.38

1.31

5

1.54

0.95

62

Non-GAAP earnings per share – diluted

1.75

1.74

1

3.41

2.58

32

Third Quarter and Recent Company Highlights

  • Announced Five New R&D Programs and Highlighted Expanded Pipeline at Inaugural R&D Day: In September, the Company announced four new programs for its development-stage candidate daxdilimab (HZN-7734) in alopecia areata, discoid lupus erythematosus, dermatomyositis and lupus nephritis and one new program for its development-stage candidate dazodalibep (HZN-4920) in focal segmental glomerulosclerosis. The Company expects to initiate Phase 2 trials in each of these indications in 2022. The new programs, in addition to the Company’s R&D strategy and other key programs, were highlighted at the Company’s inaugural R&D Day in September.

  • Announced Positive Topline Data from KRYSTEXXA MIRROR Trial: In October, the Company announced positive topline results from the MIRROR Phase 4 randomized, placebo-controlled trial evaluating the use of KRYSTEXXA plus methotrexate. The MIRROR trial results demonstrated that 71 percent of patients who were randomized to receive KRYSTEXXA plus methotrexate achieved a complete response rate at Month 6 (p<0.001), a significant improvement from the 40 percent response rate in patients who were randomized to receive KRYSTEXXA plus placebo. In the Phase 3 clinical program, which evaluated KRYSTEXXA alone compared to placebo, 42 percent of patients receiving KRYSTEXXA achieved a complete response. The Company plans to submit a sBLA to the U.S. FDA in the first quarter of 2022. Full data from the trial is expected to be presented at future medical meetings. KRYSTEXXA plus immunomodulation is a core element of the Company’s strategy to maximize the value of KRYSTEXXA and enable more patients with uncontrolled gout to benefit from the medicine.

  • Initiated Enrollment in TEPEZZA Chronic TED Trial: In September, the first patient was enrolled in a Phase 4 randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of TEPEZZA for the treatment of chronic TED. TED is a serious, progressive and potentially vision-threatening rare autoimmune disease. It begins with an acute phase where inflammatory signs and symptoms, such as eye pain, swelling, proptosis (eye bulging) and diplopia (double vision), progress over time. The acute stage is followed by a chronic phase in which inflammation is no longer present or has markedly diminished; however, significant signs and symptoms may remain and continue to impact the quality of life. The objective of the trial is to generate clinical data to better inform physicians and payers about the safety and efficacy of TEPEZZA in patients with chronic TED. Results are expected in the second half of 2022.

  • Presented New UPLIZNA® (inebilizumab-cdon) Data at Key Medical Meetings: New UPLIZNA data were presented at the 15th World Congress on Controversies in Neurology (CONy Virtual), including end-of-study data from the open-label extension period of the Phase 3 trial in patients with neuromyelitis optica spectrum disorder (NMOSD). The data indicated that UPLIZNA may provide durable efficacy and a favorable safety profile for African Americans with NMOSD. Multiple new data were also presented at the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October. Additionally, a new analysis of data from the Phase 3 trial was published in the Multiple Sclerosis Journal that highlighted a sustained effect on attack risk in people with NMOSD who were treated with UPLIZNA for four or more years.

  • Acquired Biologics Manufacturing Facility in Waterford, Ireland: In July, the Company completed the acquisition of a biologics drug product manufacturing facility in Waterford, Ireland. The Company intends to use the manufacturing facility to support the growth of the Company’s on-market medicines, including TEPEZZA, KRYSTEXXA and UPLIZNA, as well as development-stage biologics.

  • Continued to Demonstrate Gender and Ethnicity Pay Equity: A second study conducted by Aon, a leading compensation consulting firm, showed that Horizon continues to demonstrate both gender and ethnicity pay equity. This study was a follow-on study to the gender and pay ethnicity study Aon conducted in 2019. The Company maintained its gender and ethnicity pay equity despite having grown significantly in the two years since the first study, as well as having completed the acquisition of Viela Bio, which included the addition of a significant number of employees.

  • Multiple Additional Recognitions as a Best Workplace: In September, the Company was named one of the “2021 Best Workplaces for Women™” by Fortune and Great Place to Work® for the first time. In addition, the Company was also recognized as one of PEOPLE’s “100 Companies That Care® for the third year. In July, Fortune and Great Place to Work named the Company to the “Best Workplaces for Millennials™” list for the second consecutive year and the Company was the highest ranked biotechnology company on the list. In addition, in October the Company was named one of the Top 100 Adoption-Friendly Workplaces by the Dave Thomas Foundation for Adoption for the third consecutive year. Most recently, Horizon was named to Newsweek’s inaugural “Most Loved Workplaces” list, ranking among the top 100 companies recognized for employee happiness and satisfaction at work and was the highest-ranked company in the biotechnology and pharmaceutical category. To date in 2021, the Company has received 11 workplace-related recognitions, reflecting the high level of engagement of its employees.

Key Clinical Development Programs

  • Daxdilimab (HZN-7734), an anti-ILT7 human monoclonal antibody that depletes certain dendritic cells. Depleting these cells may interrupt the cycle of inflammation that causes tissue damage in diseases such as lupus, and a variety of other autoimmune conditions.

    • Systemic Lupus Erythematosus (SLE) Trial: Phase 2 randomized, placebo-controlled trial underway to evaluate daxdilimab in patients with SLE, a disease in which the body’s immune system attacks its own tissues and organs.

    • Alopecia Areata Trial: Phase 2 trial to evaluate daxdilimab in patients with alopecia areata, an autoimmune disorder characterized by nonscarring hair loss, expected to initiate in the first half of 2022.

    • Discoid Lupus Erythematosus (DLE) Trial:Phase 2 trial to evaluate daxdilimab in patients with DLE, a rare, chronic,…

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