On May 3, 2023 Horizon Therapeutics plc (Nasdaq: HZNP) reported first-quarter 2023 financial results (Press release, Horizon Pharma, MAY 3, 2023, View Source [SID1234630919]).
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"We generated strong first-quarter performance, with double-digit growth for KRYSTEXXA and UPLIZNA, and saw positive trends in TEPEZZA’s leading indicators as we exited the first quarter," said Tim Walbert, chairman, president and chief executive officer, Horizon. "Importantly, we announced positive topline results from our TEPEZZA clinical trial in low CAS and long-duration TED patients, as well as received FDA approval for an update to the TEPEZZA indication that reinforces the potential benefit of TEPEZZA, regardless of disease activity or duration. These important events will help us to ease the access burden so all eligible patients can benefit from TEPEZZA. I am extremely proud of what we have accomplished in a few short months and believe we are well positioned as we prepare to become part of Amgen."
Financial Highlights
(in millions except for per share amounts and percentages) Q1 23 Q1 22 %
Change
Net sales
$ 832.1 $ 885.2 (6 )
Net income
54.7 204.3 (73 )
Non-GAAP net income
194.3 315.8 (38 )
Adjusted EBITDA
232.9 371.2 (37 )
Earnings per share – diluted
0.23 0.87 (74 )
Non-GAAP earnings per share – diluted
0.83 1.34 (38 )
First-Quarter 2023 Net Sales Results
(in millions except for percentages) Q1 23 Q1 22 % Change
TEPEZZA
$ 405.3 $ 501.5 (19 )
KRYSTEXXA
187.0 140.7 33
RAVICTI
90.3 78.3 15
UPLIZNA(1)
53.8 30.5 77
PROCYSBI
50.5 49.6 2
ACTIMMUNE
29.1 31.3 (7 )
PENNSAID 2%(2)
9.2 35.4 (74 )
RAYOS
5.0 13.5 (63 )
BUPHENYL
1.4 2.2 (35 )
QUINSAIRTM
0.3 0.3 0
DUEXIS
0.1 1.1 (88 )
VIMOVO
0.1 0.9 (99 )
Total Net Sales
$ 832.1 $ 885.2 (6 )
(1)
First-quarter 2023 UPLIZNA net sales included $6.6 million in international net sales related primarily to revenue and milestone payments from the Company’s international partners. First-quarter 2022 UPLIZNA net sales included $5.2 million in international net sales.
(2)
On May 6, 2022, Apotex Inc. initiated an at-risk launch of generic PENNSAID 2% in the United States.
Key Growth Drivers
TEPEZZA: TEPEZZA net sales in the first quarter were $405 million, representing an 18 percent sequential decline compared to the fourth quarter of 2022. Net sales were impacted by seasonality, which the Company typically sees with its infused medicines in the first quarter each year. In addition, the TEPEZZA field-force expansion initiated late in 2022 has not yet substantially impacted net sales. More recently, the Company has seen the expansion drive positive momentum in the business, including increases in new prescribers, patient enrollment forms and patient starts. As new prescribers and patients work through the reimbursement process, the Company expects a more meaningful impact to net sales later in the year.
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. This reinforces the importance of unrestricted access for eligible patients across the full spectrum of TED and creates an opportunity to ease the access burden for patients and physicians and to decrease time to therapy for patients who may benefit from TEPEZZA. The Company plans to present data from the Phase 4 trial at a future medical congress and publish the data in a peer-reviewed medical journal to help educate key stakeholders, including physicians, patients and payors.
KRYSTEXXA: KRYSTEXXA first-quarter net sales were $187 million, representing a year-over-year increase of 33%. Sequentially, net sales declined by 13 percent compared to fourth-quarter 2022 due to seasonality. Strong performance in the first quarter was driven by the continued momentum in both the rheumatology and nephrology market segments, including the adoption of KRYSTEXXA with immunomodulation as the new standard of care following FDA approval in July 2022 for an expanded label to include KRYSTEXXA with methotrexate. 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 first-quarter 2023 net sales were $53.8 million, representing a year-over-year increase of 77%, driven by continued strong execution. Net sales in the U.S. were $47.2 million, an increase of 87%, and were driven by strong and consistent growth in new prescribers and new patient starts. The Company continues to advance its global expansion strategy with multiple planned international launches in 2023.
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 and the related Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 are publicly available in the Investor Relations section of the Company’s website at View Source