On August 8, 2023 Horizon Therapeutics plc (Nasdaq: HZNP) reported second-quarter 2023 financial results (Press release, Horizon Pharma, AUG 8, 2023, View Source [SID1234633973]).

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"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

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).