別紙99.1
ハロジムは2024年第3四半期の財務および運営結果を報告しました
売上高は前年比34%増の29000万ドル、ロイヤルティ収入は前年比36%増の15500万ドルとなりました。
当期純利益は前年比67%増の13700万ドルに増加し、調整後のEBITDAは前年比60%増の18400万ドルに増加しました
GAAPの希薄化後epsが前年比72％増の1.05ドル、非GAAPの希薄化後epsが前年比69％増の1.27ドルに増加しました1
2024年の売上高の調整後の予測範囲を$9.7億〜$102000万に引き上げ、前年比成長率は17%〜23%を示しています。調整後のEBITDAは$5.95億〜$62500万で、前年比成長率は40%〜47%を示し、非GAAP希薄化後epsは$4.00〜$4.20で、前年比成長率は44%〜52%を示しています。
2024年10月31日、サンディエゴ -- ハロザイム・セラピューティクス社（ナスダック: HALO）（以下「ハロザイム」という）は、2024年9月30日に終了した第3四半期の財務および運営結果を発表し、最近の企業活動および展望についての最新情報を提供しました。
弊社の力強い第3四半期の財務成績は、ビジネス全体における強力な実行力と加速する勢いを強調し、売上高が34%、調整後EBITDAが60%の成長で期待を上回りました。これまでの強力なパフォーマンスを受けて、私たちは2024年のガイダンス範囲を引き上げ、ENHANZEパイプラインの進展と2つのグローバルライセンス契約からの新規指名を受けて、将来の成長トラジェクトリを支援することを期待しています。”Halozymeの社長兼最高経営責任者であるDr. Helen Torleyは、「今四半期、RocheのTECENTRIQ HYBREZAとOCREVUS ZUNOVOの米国での２つの高い期待を受けたパートナー承認の発表は、ENHANZEが100%の第3相試験およびその後の規制成功を実現し、さらなる成果を出しています。. argenxからのENHANZEへの新規指名（合計6つのターゲット）とViiV Healthcareからの追加の非公表のターゲットのさらなる指名は、迅速で大容量の皮下投与のための当社の先進テクノロジーの価値をさらに示しています。」と述べています。
最近のパートナーのハイライト：
•2024年10月、argenxは、VYVGARTを評価する2つの研究を開始しました® ENHANZEと組み合わせたHytrulo®成人患者に対する第3相研究「眼筋無力症（oMG）」および抗体媒介性拒絶反応（AMR）をもつ腎移植患者に対する第2相研究
•2024年10月、Janssen社はヨーロッパ委員会がDARZALEXの承認を発表しました® SC投与による自家造血幹細胞移植が適応とされる多発性骨髄腫（NDMM）の新規診断を受けた患者の治療において、ボルテゾミブ、レナリドミド、デキサメタゾン（“D-VRd”）との併用が承認されました
•2024年9月、argenxはグローバルな提携およびライセンス契約を拡大し、追加の4つのターゲットを指名し、彼らにENHANZEの独占的アクセス権を提供しました。® 総計6つのターゲットに対する医薬品送達テクノロジーの前払い金として、各指名ターゲットに対して750万ドルを受け取り、合計3000万ドルを受け取りました。拡大された独占的契約の条件の下、argenxは新たに指名された各ターゲットに対して、特定の開発、規制、および売り上げに基づくマイルストーンを達成することで、最大8500万ドルまでの未来のマイルストーン支払いを行う責任があります。® また、ENHANZEテクノロジーを用いて商業化された製品の純売上高に対するロイヤルティを受け取る権利があります。
•2024年9月、ViiVはグローバル協力およびライセンス契約を拡大し、ViiVにENHANZE技術への独占的アクセス権を追加提供しました。® 別の未公表のターゲット用に1つの追加の薬剤送達技術を提供しました。
•2024年9月、ロシュは米国食品医薬品局（FDA）がOCREVUS ZUNOVO™ with ENHANZEを承認したことを発表した® 再発性多発性硬化症および原発性進行性多発性硬化症の治療のための半年に2回の10分間の皮下注射（SC）として
•2024年9月、ロシュはFDAがTECENTRIQ HYBREZA™ with ENHANZEを承認したことを発表しました® 全ての承認された成人静注（“IV”）TECENTRIQ向けの適応に対して® 患者に提供され、1200万ドルのマイルストーン支払いが発生しました
•2024年9月、Janssen社は、DARZALEX FASPROの新しい適応のFDAへの補足生物製剤ライセンス申請を発表しました。® ASCtが延期されるかASCtが適格でないNDMm成人患者の治療のため、D-VRdとの併用に関して。
•2024年8月、FDAはJanssenの生物製剤ライセンス申請（"BLA"）について、amivantamab SCをLAZCLUZE™と組み合わせた非小型細胞肺癌の特定患者における静脈内投与の現在承認されたまたは提出された適応の優先審査の地位を指定しました。
•2024年8月、武田はENHANZEを用いたTAk-771の承認を求め、日本に新薬承認申請を提出しました® 慢性炎症性脱髄性多発性神経病/多発性脱髄ニューロパチーの治療に
•2024年7月、ヤンセンは、FDAがDARZALEX FASPROの追加適応を承認したことを発表しました。® ASCtとD-VRdとの併用が可能なNDMm患者向けに
•2024年7月、argenxは、中国において一般化ミアステニア重症筋無力症用のefgartigimod SCのBLAが国家医療製品管理局に承認されたと発表しました。
•2024年7月、アキュメンは、アルツハイマー病の早期治療のためにサビルネタグ（"ACU193"）をENHANZEと共に配合した第1相研究を開始しました。® 早期アルツハイマー病の治療のために。
2024年第3四半期の財務ハイライト：
•売上高は29010万ドルで、2023年第3四半期の21600万ドルと比較しています。34%の前年同期比増収は、特にロイヤルティ収入の成長とマイルストーン収入の増加によるものです。四半期の売上高には、15510万ドルのロイヤリティが含まれており、2023年第3四半期の11440万ドルと比較して36%増加しています。これは主にDARZALEX、SCおよびPhesgoの売上高が増加したことによるものであり、前年にVYVGARTとHytruloを導入したものです。® SCとPhesgo®、そしてVYVGART® Hytrulo。
•売上原価は2023年第3四半期の$5480万に対して$4940万でした。この減少は主にデバイスとバルクrHuPH20の販売が低かったためです。
•無形資産の償却費は1億7800万ドルであり、2023年第3四半期の2億30万ドルと比較して減少しました。この減少は、TLANDOの全額減価償却を行うために前年に認識された2億50万ドルの減損費用に主に起因しています。® 製品権利無形資産。
•研究開発費は2023年第3四半期の$1730万に対して$1850万でした。増加の主な理由は賃金費の増加によるものでした。
•営業、一般管理費は4,120万ドルで、2023年第3四半期の3,530万ドルと比較して増加しました。増加の主な要因は、報酬費用とコンサルティング費用、専門サービス料の増加です。
•2023年第3四半期の営業利益は8,830万ドルに対して、16,320万ドルとなりました。
•当期純利益は1億3700万ドルで、2023年第3四半期の8180万ドルと比較しています。
•EBITDAは2023年第3四半期の12460万ドルに比べて、18360万ドルでした。調整後のEBITDAは2023年第3四半期の11490万ドルに対して、18360万ドルでした。1
•GAAP希薄化後1株当たり利益は2023年第3四半期が1.05ドルで、2023年第3四半期の0.61ドルと比較しています。非GAAP希薄化後1株当たり利益は2023年第3四半期が1.27ドルで、2023年第3四半期の0.75ドルと比較しています。1
•2024年9月30日時点での現金、現金同等物および有価証券は66630万ドルで、2023年12月31日時点の33600万ドルと比較して増加しました。この増加は主に営業活動から生じた現金によるものです。
Financial Outlook for 2024
The Company is raising its financial guidance for 2024. For the full year 2024, the Company expects:
•Total revenue of $970 million to $1,020 million, representing growth of 17% to 23% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $550 million to $565 million, representing growth of 23% to 26% over 2023.
•Adjusted EBITDA of $595 million to $625 million, representing growth of 40% to 47% over 2023.
•Non-GAAP diluted earnings per share of $4.00 to $4.20, representing growth of 44% to 52% over 2023. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.
Table 1. 2024 Financial Guidance
Previous Guidance Range | New Guidance Range | ||||||||||
| Total Revenue | $935 to $1,015 million | $970 to $1,020 million | |||||||||
| Royalty Revenue | $520 to $555 million | $550 to $565 million | |||||||||
| Adjusted EBITDA | $555 to $615 million | $595 to $625 million | |||||||||
| Non-GAAP Diluted EPS | $3.65 to $4.05 | $4.00 to $4.20 | |||||||||
Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the third quarter ended September 30, 2024 today, Thursday, October 31, 2024 at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: https://registrations.events/direct/Q4I7813747. The call will also be webcast live through the “Investors” section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme’s commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in eight commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Note Regarding Use of Non-GAAP Financial Measures
In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization (“EBITDA”), adjusted EBITDA and Non-GAAP diluted earnings per share, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items such as changes in contingent liabilities and inventory adjustments. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company’s ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company’s normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important
because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company’s core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs.
Safe Harbor Statement
In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company’s financial performance (including the Company’s financial outlook for 2024) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share. Forward-looking statements regarding the Company’s ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company’s business may include potential growth and receipt of royalty and milestone payments driven by our partners’ development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners’ drug franchises, potential new or expanded collaborations and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words “expect,” “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company’s business, or in the development, regulatory review or commercialization of the Company’s partnered or proprietary products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
Footnotes:
1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end.
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||
Revenues | ||||||||||||||||||||||||||
| Royalties | $ | 155,061 | $ | 114,433 | $ | 400,572 | $ | 325,813 | ||||||||||||||||||
| Product sales, net | 86,659 | 86,569 | 224,128 | 221,252 | ||||||||||||||||||||||
| Revenues under collaborative agreements | 48,364 | 15,031 | 92,616 | 52,149 | ||||||||||||||||||||||
| Total revenues | 290,084 | 216,033 | 717,316 | 599,214 | ||||||||||||||||||||||
Operating expenses | ||||||||||||||||||||||||||
| Cost of sales | 49,426 | 54,823 | 117,362 | 140,063 | ||||||||||||||||||||||
| Amortization of intangibles | 17,762 | 20,341 | 53,287 | 56,011 | ||||||||||||||||||||||
| Research and development | 18,458 | 17,321 | 58,607 | 55,027 | ||||||||||||||||||||||
| Selling, general and administrative | 41,241 | 35,269 | 112,086 | 111,574 | ||||||||||||||||||||||
| Total operating expenses | 126,887 | 127,754 | 341,342 | 362,675 | ||||||||||||||||||||||
| Operating income | 163,197 | 88,279 | 375,974 | 236,539 | ||||||||||||||||||||||
Other income (expense) | ||||||||||||||||||||||||||
Investment and other income, net | 6,474 | 4,786 | 16,499 | 10,957 | ||||||||||||||||||||||
| Contingent liability fair value measurement gain | — | 13,200 | — | 13,200 | ||||||||||||||||||||||
| Interest expense | (4,524) | (4,505) | (13,555) | (13,542) | ||||||||||||||||||||||
Income before income tax expense | 165,147 | 101,760 | 378,918 | 247,154 | ||||||||||||||||||||||
| Income tax expense | 28,136 | 19,923 | 71,839 | 50,948 | ||||||||||||||||||||||
| Net income | $ | 137,011 | $ | 81,837 | $ | 307,079 | $ | 196,206 | ||||||||||||||||||
Earnings per share | ||||||||||||||||||||||||||
| Basic | $ | 1.08 | $ | 0.62 | $ | 2.42 | $ | 1.48 | ||||||||||||||||||
| Diluted | $ | 1.05 | $ | 0.61 | $ | 2.37 | $ | 1.45 | ||||||||||||||||||
Weighted average common shares outstanding | ||||||||||||||||||||||||||
| Basic | 126,850 | 131,965 | 126,969 | 132,896 | ||||||||||||||||||||||
| Diluted | 130,134 | 134,083 | 129,526 | 135,233 | ||||||||||||||||||||||
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
| September 30, 2024 | December 31, 2023 | |||||||||||||
| ASSETS | ||||||||||||||
Current assets | ||||||||||||||
| Cash and cash equivalents | $ | 154,318 | $ | 118,370 | ||||||||||
| Marketable securities, available-for-sale | 511,988 | 217,630 | ||||||||||||
| Accounts receivable, net and contract assets | 285,743 | 234,210 | ||||||||||||
Inventories | 131,412 | 127,601 | ||||||||||||
| Prepaid expenses and other current assets | 43,515 | 48,613 | ||||||||||||
| Total current assets | 1,126,976 | 746,424 | ||||||||||||
| Property and equipment, net | 74,490 | 74,944 | ||||||||||||
| Prepaid expenses and other assets | 80,151 | 17,816 | ||||||||||||
| Goodwill | 416,821 | 416,821 | ||||||||||||
| Intangible assets, net | 419,592 | 472,879 | ||||||||||||
| Deferred tax assets, net | — | 4,386 | ||||||||||||
| Total assets | $ | 2,118,030 | $ | 1,733,270 | ||||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||||
Current liabilities | ||||||||||||||
| Accounts payable | $ | 12,398 | $ | 11,816 | ||||||||||
| Accrued expenses | 96,417 | 100,678 | ||||||||||||
| Total current liabilities | 108,815 | 112,494 | ||||||||||||
| Long-term debt, net | 1,504,154 | 1,499,248 | ||||||||||||
| Other long-term liabilities | 40,406 | 37,720 | ||||||||||||
| Deferred tax liabilities, net | 11,952 | — | ||||||||||||
| Total liabilities | 1,665,327 | 1,649,462 | ||||||||||||
Stockholders’ equity | ||||||||||||||
| Common stock | 127 | 127 | ||||||||||||
| Additional paid-in capital | 61,886 | 2,409 | ||||||||||||
| Accumulated other comprehensive loss | (6,939) | (9,278) | ||||||||||||
Retained earnings | 397,629 | 90,550 | ||||||||||||
| Total stockholders’ equity | 452,703 | 83,808 | ||||||||||||
| Total liabilities and stockholders’ equity | $ | 2,118,030 | $ | 1,733,270 | ||||||||||
Halozyme Therapeutics, Inc.
GAAP to Non-GAAP Reconciliations
EBITDA
(Unaudited)
(In thousands)
| Three Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | |||||||||||||
| GAAP Net Income | $ | 137,011 | $ | 81,837 | ||||||||||
Adjustments | ||||||||||||||
Investment and other income, net | (6,475) | (4,786) | ||||||||||||
| Interest expense | 4,524 | 4,505 | ||||||||||||
| Income tax expense | 28,136 | 19,923 | ||||||||||||
| Depreciation and amortization | 20,360 | 23,078 | ||||||||||||
| EBITDA | 183,556 | 124,557 | ||||||||||||
Adjustments | ||||||||||||||
Gain on changes in fair value of contingent liability(1) | — | (13,200) | ||||||||||||
Inventory write-off(2) | — | 3,509 | ||||||||||||
| Adjusted EBITDA | $ | 183,556 | $ | 114,866 | ||||||||||
(1)Amount relates to fair value gain on contingent liability due to the termination of the TLANDO license agreement in September 2023 (“TLANDO Termination”).
(2)Amount relates to inventory write-off due to TLANDO Termination and amortization of the inventory step-up associated with purchase accounting for the prior year acquisition of Antares Pharma, Inc.
Halozyme Therapeutics, Inc.
GAAP to Non-GAAP Reconciliations
Diluted EPS
(Unaudited)
(In thousands, except per share amounts)
| Three Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | |||||||||||||
| GAAP Diluted EPS | $ | 1.05 | $ | 0.61 | ||||||||||
Adjustments | ||||||||||||||
| Share-based compensation | 0.10 | 0.07 | ||||||||||||
| Amortization of debt discount | 0.01 | 0.01 | ||||||||||||
| Amortization of intangible assets | 0.14 | 0.13 | ||||||||||||
TLANDO Related Adjustments | ||||||||||||||
Gain on changes in fair value of contingent liability(1) | — | (0.10) | ||||||||||||
Inventory write-off(1) | — | 0.03 | ||||||||||||
Impairment charge of TLANDO product rights intangible assets(1) | — | 0.02 | ||||||||||||
Income tax effect of above adjustments(2) | (0.03) | (0.03) | ||||||||||||
| Non-GAAP Diluted EPS | $ | 1.27 | $ | 0.75 | ||||||||||
GAAP Diluted Shares | 130,134 | 134,083 | ||||||||||||
Adjustments | 130,134 | 134,083 | ||||||||||||
Adjustment for dilutive impact of senior 2028 Convertible Notes(3) | (293) | — | ||||||||||||
Non-GAAP Diluted Shares | 129,841 | 134,083 | ||||||||||||
Dollar amounts, as presented, are rounded. Consequently, totals may not add up.
(1)Amounts relate to fair value gain on contingent liability, inventory write-off and impairment of TLANDO product rights intangible assets due to the TLANDO Termination.
(2)Adjustments relate to taxes for the reconciling items, as well as excess benefits or tax deficiencies from stock-based compensation, and the quarterly impact of other discrete items.
(3)Adjustment made for the dilutive effect of our Convertible Senior Notes due 2028 when the effect is not the same on a GAAP and non-GAAP basis for the reporting period.