展示99.1
即時リリース
ユナイテッドセラピューティクス社は2024年第3四半期の財務結果を報告
シルバースプリング（ メリーランド州 ）とRESEARCH TRIANGLE PARK （ノースカロライナ州）、2024年10月30日：ユナイテッドセラピューティクス 株式会社（ナスダック： ユナイテッドセラピューティクス）、公益法人は、本日2024年9月30日の四半期決算を発表しました。2024年第三四半期の総収入は、前年同期比23％増の74890万ドルで、2023年第三四半期の60940万ドルに比べて成長しました。
「過去最高の収益四半期に貢献し、第3四半期には年間収益が30億ドルに達した1,300人近くのユニテリアン社員を誇りに思います」と言いました。 マルティーヌ・ロスブラット博士、ユナイテッド・セラピューティクスの会長兼最高経営責任者。「当社の素晴らしい収益実績に加えて、2025年には、複数年にわたる臨床データの読み取りと規制上の出来事が次々と始まります。これらのイベントは、10年の残りの期間、そしてそれ以降も当社の成長を牽引し続けるはずです。データは テトン 特発性肺線維症に関する研究と 事前の成果 肺動脈高血圧症で、ミロレバーからのデータ飛躍します 急性肝不全の第1相試験が現在進行中です。そして重要なのは、UKidneyのヒト臨床プログラムの開始です。間もなく治験薬申請を提出する予定です。」
マイケル・ベンコウィッツさん、United Therapeuticsの社長兼最高執行責任者は、次のように付け加えました。「私たちのチームの努力は再び素晴らしい業績につながり、6四半期連続で記録的な収益を達成しました。これは、肺高血圧症と高リスク神経芽腫患者に役立つ革新的な製品に対する需要の高まりを浮き彫りにしています。タイバソは依然として当社の最大の短期的成長ドライバーであり、肺動脈高血圧症と間質性肺疾患に関連する肺高血圧症への継続的な普及を後押ししている根底にあるダイナミクスに勇気づけられています。」
2024年第3四半期の財務結果
主要な財務ハイライトには、以下のものが含まれます（百万ドル、1株あたりのデータを除く）:
| 年度第3四半期が終了した時点での 9月30日 | ドル変化 | パーセンテージの変化 | |||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| 収益合計 | $ | 748.9 | $ | 609.4 | $ | 139.5 | 23 | % | |||||||||||||||
| 当期純利益 | $ | 309.1 | $ | 267.6 | $ | 41.5 | 16 | % | |||||||||||||||
| 当期純利益、1株当たり | $ | 6.93 | $ | 5.71 | $ | 1.22 | 21 | % | |||||||||||||||
| 当期純利益、希薄化後1株当たり | $ | 6.39 | $ | 5.38 | $ | 1.01 | 19 | % | |||||||||||||||
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収益
以下の表は、総収入の部品（百万ドル単位）を示しています：
| 年度第3四半期が終了した時点での 9月30日 | ドル変化 | パーセンテージ 変化 | |||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| 純製品売上: | |||||||||||||||||||||||
タイバソ DPI®(1) | $ | 274.6 | $ | 205.1 | $ | 69.5 | 34 | % | |||||||||||||||
ネブライズドタイバソ®(1) | 159.2 | 120.7 | 38.5 | 32 | % | ||||||||||||||||||
| 合計タイバソ | 433.8 | 325.8 | 108.0 | 33 | % | ||||||||||||||||||
レモデュリン®(2) | 128.3 | 131.1 | (2.8) | (2) | % | ||||||||||||||||||
オレニトラム® | 113.2 | 92.0 | 21.2 | 23 | % | ||||||||||||||||||
ユニトゥキシン® | 61.1 | 51.3 | 9.8 | 19 | % | ||||||||||||||||||
Adcirca® | 7.0 | 7.3 | (0.3) | (4) | % | ||||||||||||||||||
| 他 | 5.5 | 1.9 | 3.6 | 189 | % | ||||||||||||||||||
総収益 | $ | 748.9 | $ | 609.4 | $ | 139.5 | 23 | % | |||||||||||||||
(1)ネット製品販売には、医薬品製品とそれに対応する吸入デバイスの両方が含まれます。
(2)ネット製品販売には、Remunityを含む点滴装置の販売が含まれます® ポンプ。
2024年第3四半期、Total Tyvasoの収益は32580万ドルから43380万ドルに増加し、2023年第3四半期の3258億ドルと比較して33％増加しました。この成長は、2022年6月にTyvaso DPIの商業ローンチに伴う販売数量の増加や、間質性肺疾患に伴う肺高血圧を持つ患者による商業利用の継続的な成長、または価格上昇によるものです。
Tyvaso DPIの収益の成長は、主に販売数量の増加、そしてそれに付随する程度で価格の上昇によるものでした。Tyvaso DPIの販売数量の増加は、製品の導入後の患者数の持続的な成長、そしてそれに付随する程度で、インフレ抑制法の下でのPart Dのリデザインの実施に伴う商業利用の増加に起因していました。IRA).
ネビュライズされたTyvaso収益の増加は、販売数量の増加と、それに比べて小さな程度での価格上昇に主に起因しています。
Remodulin収入の減少は、国際的なRemodulin収入の減少によるものであり、部分的には、数量売り上げの増加によるU.S. Remodulin収入の増加によるものです。
オレニトラムの収益増加は、主に販売数量の増加および、それに伴う価格上昇によるものです。販売数量の増加は、少なくとも部分的に、IRAの下でのパートDのリデザインの実施後に商業利用が増加し、平均投与量の増加によるものです。
Unituxinの売り上げ増加は価格の引き上げと販売数量の増加によるものです。
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以下の表は、合計収益の米国と世界（ROW含む）との内訳を示しています。ROW（百万ドル単位）
| 9月30日までの3か月間 | |||||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| 米国 | 列 | 総計 | 米国 | 列 | 総計 | ||||||||||||||||||
| 売上高: | |||||||||||||||||||||||
Tyvaso DPI(1) | $ | 274.6 | $ | — | $ | 274.6 | $ | 205.1 | $ | — | $ | 205.1 | |||||||||||
Nebulized Tyvaso(1) | 145.2 | 14.0 | 159.2 | 118.1 | 2.6 | 120.7 | |||||||||||||||||
| Total Tyvaso | 419.8 | 14.0 | 433.8 | 323.2 | 2.6 | 325.8 | |||||||||||||||||
Remodulin(2) | 115.4 | 12.9 | 128.3 | 111.6 | 19.5 | 131.1 | |||||||||||||||||
| Orenitram | 113.2 | — | 113.2 | 92.0 | — | 92.0 | |||||||||||||||||
| Unituxin | 57.6 | 3.5 | 61.1 | 48.8 | 2.5 | 51.3 | |||||||||||||||||
| Adcirca | 7.0 | — | 7.0 | 7.3 | — | 7.3 | |||||||||||||||||
| 他 | 4.3 | 1.2 | 5.5 | 1.7 | 0.2 | 1.9 | |||||||||||||||||
| 収益合計 | $ | 717.3 | $ | 31.6 | $ | 748.9 | $ | 584.6 | $ | 24.8 | $ | 609.4 | |||||||||||
(1)ネット製品販売には、医薬品とそれに対応する吸入デバイスの両方が含まれます。
(2) ネット製品販売には、Remunity Pumpを含む点滴装置の販売が含まれます。
費用
販売費用 以下の表は、主要カテゴリ別の売上原価を要約したものです（単位：百万ドル）。
| 年度第3四半期が終了した時点での 9月30日 | ドル変化 | パーセンテージの変化 | |||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| カテゴリー: | |||||||||||||||||||||||
| 売上原価 | $ | 81.8 | $ | 69.1 | $ | 12.7 | 18 | % | |||||||||||||||
シェアベースの報酬費用(1) | 1.3 | 1.0 | 0.3 | 30 | % | ||||||||||||||||||
| 販売費及び一般管理費の総額 | $ | 83.1 | $ | 70.1 | $ | 13.0 | 19 | % | |||||||||||||||
(1)参照：株式報酬費用以下を参照してください。
シェアベースの報酬を除く売上原価。 2024年9月30日までの3ヵ月間の売上原価は、主にTyvaso DPIの収益増によるTyvaso DPIの利益率の増加に伴い、2023年の同じ期間と比較して増加しました。
研究開発。 下記の表は、主要な費目別の研究開発費の性質を要約しています（百万ドル単位）：
| 3 か月が終了 9月30日 | ドル変更 | パーセンテージ変更 | |||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| カテゴリ: | |||||||||||||||||||||||
外部の研究開発(1) | $ | 51.7 | $ | 47.2 | $ | 4.5 | 10 | % | |||||||||||||||
社内研究開発(2) | 43.9 | 34.3 | 9.6 | 28 | % | ||||||||||||||||||
株式ベースの報酬費用(3) | 7.4 | 3.6 | 3.8 | 106 | % | ||||||||||||||||||
その他(4) | 0.5 | (0.4) | 0.9 | 225 | % | ||||||||||||||||||
| 研究開発費総額 | $ | 103.5 | $ | 84.7 | $ | 18.8 | 22 | % | |||||||||||||||
(1)外部研究開発 前臨床および臨床において、主に第三者（臨床試験施設、医薬品開発業務受託機関、契約研究所など）へ支払われる料金を含んでいます
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関連製品のFDA承認前に第三者代理工メーカーへの研究と支払い。
(2)内部の研究開発 主に研究開発機能に関連する給与関連経費、FDAの承認前に医薬品候補の製造にかかる内部コスト、および研究開発活動に関連する内部の施設関連経費（研究開発活動に関連する減価償却を含む）を含んでいます。
(3)See Share-based compensation below.
(4)Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products and adjustments to the fair value of our contingent consideration obligations.
Research and development, excluding share-based compensation. Research and development expense for the three months ended September 30, 2024 increased as compared to the same period in 2023, primarily due to increased expenditures related to manufactured organ and organ alternative projects.
Selling, general, and administrative. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):
| Three Months Ended September 30, | Dollar Change | Percentage Change | |||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| Category: | |||||||||||||||||||||||
General and administrative(1) | $ | 100.4 | $ | 90.4 | $ | 10.0 | 11 | % | |||||||||||||||
Litigation accrual | 65.1 | — | 65.1 | NM(2) | |||||||||||||||||||
| Sales and marketing | 20.7 | 20.7 | — | — | % | ||||||||||||||||||
Share-based compensation expense(3) | 33.0 | 16.5 | 16.5 | 100 | % | ||||||||||||||||||
| Total selling, general, and administrative expense | $ | 219.2 | $ | 127.6 | $ | 91.6 | 72 | % | |||||||||||||||
(1) Excluding litigation accrual. See Litigation accrual section below.
(2) Calculation is not meaningful.
(3) See Share-based compensation below.
General and administrative, excluding litigation accrual and share-based compensation. General and administrative expense for the three months ended September 30, 2024 increased as compared to the same period in 2023, primarily due to an increase in personnel expense due to growth in headcount.
Litigation accrual. In the third quarter of 2024, we accrued a liability of $65.1 million related to ongoing litigation with Sandoz Inc., reflecting the amount of damages we calculated based on factual findings made by the court and included in our submission to the court regarding damages. We currently do not expect that the amount of any loss in excess of the accrual would be material to our financial statements; however, the amount ultimately payable, if any, could be higher or lower than this amount depending on the final judgment entered by the court, the amount of post judgment interest, and the outcome of any appeals. The litigation accrual is included within selling, general, and administrative in our consolidated statements of operations.
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Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions):
| Three Months Ended September 30, | Dollar Change | Percentage Change | |||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||
| Category: | |||||||||||||||||||||||
| Stock options | $ | 8.0 | $ | 6.0 | $ | 2.0 | 33 | % | |||||||||||||||
| Restricted stock units | 27.2 | 12.5 | 14.7 | 118 | % | ||||||||||||||||||
Share tracking awards plan | 5.9 | 2.1 | 3.8 | 181 | % | ||||||||||||||||||
| Employee stock purchase plan | 0.6 | 0.5 | 0.1 | 20 | % | ||||||||||||||||||
Total share-based compensation expense | $ | 41.7 | $ | 21.1 | $ | 20.6 | 98 | % | |||||||||||||||
The increase in share-based compensation expense for the three months ended September 30, 2024, as compared to the same period in 2023, was primarily due to an increase in restricted stock unit expense due to a greater number of awards remaining outstanding for the three months ended September 30, 2024, as compared to the same period in 2023.
Other income (expense), net. The change in other income (expense), net for the three months ended September 30, 2024, as compared to the same period in 2023, was primarily due to net unrealized gains on equity securities.
Income tax expense. Income tax expense for the three months ended September 30, 2024 and 2023 was $79.5 million and $84.2 million, respectively. Our effective income tax rate (ETR) for the three months ended September 30, 2024 and 2023 was 20 percent and 24 percent, respectively. Our ETR for the three months ended September 30, 2024 decreased compared to our ETR for the three months ended September 30, 2023, primarily due to increased excess tax benefits from share-based compensation.
Share repurchase. In March 2024, we entered into an accelerated share repurchase agreement (the ASR agreement) with Citibank, N.A. (Citi). Under the ASR agreement, we made an aggregate upfront payment of $1.0 billion to Citi and received an aggregate initial delivery of 3,275,199 shares of our common stock on March 27, 2024, representing approximately 80 percent of the total shares that would be repurchased under the ASR agreement measured based on the closing price of our common stock on March 25, 2024.
The share repurchase under the ASR agreement was divided into two tranches, resulting in upfront payments of $300 million and $700 million, respectively. The final settlement of the $300 million tranche occurred in June 2024, and we received an additional 181,772 shares of our common stock upon settlement. The final settlement of the $700 million tranche occurred in September 2024, and we received an additional 90,403 shares of our common stock upon settlement. In total, we repurchased 3,547,374 shares of our common stock under the ASR agreement that we currently hold as treasury stock on our consolidated balance sheet.
Webcast
We will host a webcast to discuss our third quarter 2024 financial results on Wednesday, October 30, 2024, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. A replay of the webcast will also be available at the same location on our website.
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United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun; we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
You can learn more about what it means to be a PBC here: unither.com/pbc.
Forward-Looking Statements
Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to our anticipated clinical data reads and regulatory events, and their potential to propel our growth, including expectations concerning the timing and success of the TETON, ADVANCE OUTCOMES, and miroliverELAP studies, and the potential launch of our UKidney human clinical program and the timing of our anticipated investigational new drug application filing for UKidney; the increasing demand for our products serving pulmonary hypertension and high-risk neuroblastoma patients; the expectation that Tyvaso DPI will be a near-term growth driver; and our goals of innovating for the unmet medical needs of our patients and to benefit our other stakeholders, furthering our public benefit purpose of developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of October 30, 2024, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason.
ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries.
MIROLIVERELAP and UKIDNEY are trademarks of United Therapeutics Corporation and/or its subsidiaries.
ADCIRCA is a registered trademark of Eli Lilly and Company.
For Further Information Contact:
Dewey Steadman at (202) 919-4097 (media/investors)
Harry Silvers at (301) 578-1401 (investors)
https://ir.unither.com/contact-ir
Harry Silvers at (301) 578-1401 (investors)
https://ir.unither.com/contact-ir
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UNITED THERAPEUTICS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(In millions, except per share data)
| Three Months Ended September 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| (Unaudited) | |||||||||||
| Total revenues | $ | 748.9 | $ | 609.4 | |||||||
| Operating expenses: | |||||||||||
| Cost of sales | 83.1 | 70.1 | |||||||||
| Research and development | 103.5 | 84.7 | |||||||||
| Selling, general, and administrative | 219.2 | 127.6 | |||||||||
| Total operating expenses | 405.8 | 282.4 | |||||||||
| Operating income | 343.1 | 327.0 | |||||||||
| Interest income | 49.8 | 45.3 | |||||||||
| Interest expense | (10.1) | (15.6) | |||||||||
Other income (expense), net | 5.8 | (4.9) | |||||||||
Total other income, net | 45.5 | 24.8 | |||||||||
| Income before income taxes | 388.6 | 351.8 | |||||||||
| Income tax expense | (79.5) | (84.2) | |||||||||
| Net income | $ | 309.1 | $ | 267.6 | |||||||
| Net income per common share: | |||||||||||
| Basic | $ | 6.93 | $ | 5.71 | |||||||
| Diluted | $ | 6.39 | $ | 5.38 | |||||||
| Weighted average number of common shares outstanding: | |||||||||||
| Basic | 44.6 | 46.9 | |||||||||
| Diluted | 48.4 | 49.7 | |||||||||
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Unaudited, in millions)
| September 30, 2024 | |||||
| Cash, cash equivalents, and marketable investments | $ | 4,605.9 | |||
| Total assets | 7,123.1 | ||||
| Total liabilities | 1,022.2 | ||||
| Total stockholders’ equity | 6,100.9 | ||||
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