HALOZYME REPORTS THIRD QUARTER 2024 FINANCIAL AND OPERATING RESULTS
Halozyme (HALO) reported strong Q3 2024 financial results with total revenue increasing 34% YOY to $290.1 million, driven by 36% growth in royalty revenue to $155.1 million. Net income rose 67% to $137 million, while adjusted EBITDA grew 60% to $184 million. The company raised its 2024 guidance, now expecting total revenue of $970-$1,020 million (17-23% YOY growth) and adjusted EBITDA of $595-$625 million (40-47% YOY growth). Key highlights include FDA approvals for Roche's TECENTRIQ HYBREZA and OCREVUS ZUNOVO with ENHANZE technology, plus expanded partnerships with argenx and ViiV Healthcare.
Halozyme (HALO) ha riportato risultati finanziari forti per il terzo trimestre del 2024, con un aumento del fatturato totale del 34% rispetto all'anno precedente, raggiungendo 290,1 milioni di dollari, sostenuto da una crescita del 36% nel fatturato da royalties a 155,1 milioni di dollari. Il reddito netto è aumentato del 67% a 137 milioni di dollari, mentre l'EBITDA rettificato è cresciuto del 60% a 184 milioni di dollari. L'azienda ha innalzato le previsioni per il 2024, ora aspettandosi un fatturato totale di 970-1.020 milioni di dollari (crescita del 17-23% anno su anno) e un EBITDA rettificato di 595-625 milioni di dollari (crescita del 40-47% anno su anno). I punti salienti includono le approvazioni della FDA per il TECENTRIQ HYBREZA e l'OCREVUS ZUNOVO di Roche con la tecnologia ENHANZE, oltre a partnership espanse con argenx e ViiV Healthcare.
Halozyme (HALO) reportó fuertes resultados financieros en el tercer trimestre de 2024, con un aumento del 34% en ingresos totales en comparación con el año anterior, alcanzando los 290,1 millones de dólares, impulsado por un crecimiento del 36% en los ingresos por regalías, totalizando 155,1 millones de dólares. El ingreso neto aumentó un 67% a 137 millones de dólares, mientras que el EBITDA ajustado creció un 60% alcanzando los 184 millones de dólares. La compañía elevó su guía para 2024, ahora espera ingresos totales de 970 a 1,020 millones de dólares (crecimiento del 17-23% interanual) y un EBITDA ajustado de 595 a 625 millones de dólares (crecimiento del 40-47% interanual). Los aspectos destacados incluyen las aprobaciones de la FDA para TECENTRIQ HYBREZA y OCREVUS ZUNOVO de Roche con la tecnología ENHANZE, además de asociaciones ampliadas con argenx y ViiV Healthcare.
Halozyme (HALO)는 2024년 3분기 강력한 재무 결과를 보고했습니다. 총 수익은 작년 대비 34% 증가하여 2억 9010만 달러에 달했으며, 로열티 수익은 36% 성장하여 1억 5510만 달러에 이르렀습니다. 순이익은 67% 증가하여 1억 3700만 달러에 달했고, 조정된 EBITDA는 60% 증가하여 1억 8400만 달러에 달했습니다. 회사는 2024년 가이드를 상향 조정하여 총 수익이 9억 7000만 달러에서 10억 2000만 달러(전년 대비 17-23% 성장), 조정된 EBITDA가 5억 9500만에서 6억 2500만 달러(전년 대비 40-47% 성장)로 예상하고 있습니다. 주요 하이라이트로는 Roche의 TECENTRIQ HYBREZA와 OCREVUS ZUNOVO가 ENHANZE 기술로 FDA 승인을 받았으며, argenx와 ViiV Healthcare와의 파트너십 확장이 포함됩니다.
Halozyme (HALO) a annoncé de solides résultats financiers pour le troisième trimestre de 2024, avec un chiffre d'affaires total en hausse de 34 % par rapport à l'année précédente, atteignant 290,1 millions de dollars, soutenu par une croissance de 36 % des revenus de redevances pour atteindre 155,1 millions de dollars. Le revenu net a augmenté de 67 % pour atteindre 137 millions de dollars, tandis que l'EBITDA ajusté a crû de 60 % pour atteindre 184 millions de dollars. La société a relevé ses prévisions pour 2024, s'attendant désormais à un chiffre d'affaires total de 970 à 1 020 millions de dollars (croissance de 17 à 23 % en variation annuelle) et à un EBITDA ajusté de 595 à 625 millions de dollars (croissance de 40 à 47 % en variation annuelle). Les points saillants comprennent les approbations de la FDA pour le TECENTRIQ HYBREZA et l'OCREVUS ZUNOVO de Roche avec la technologie ENHANZE, ainsi que l'expansion des partenariats avec argenx et ViiV Healthcare.
Halozyme (HALO) hat starke Finanzresultate für das dritte Quartal 2024 gemeldet, mit einem Anstieg des Gesamtumsatzes um 34 % im Vergleich zum Vorjahr auf 290,1 Millionen USD, getrieben durch ein Wachstum der Lizenzgebühren um 36 % auf 155,1 Millionen USD. Der Nettogewinn stieg um 67 % auf 137 Millionen USD, während das bereinigte EBITDA um 60 % auf 184 Millionen USD wuchs. Das Unternehmen hat die Prognose für 2024 angehoben und erwartet nun einen Gesamtumsatz von 970 bis 1.020 Millionen USD (17-23 % Wachstum im Jahresvergleich) und ein bereinigtes EBITDA von 595 bis 625 Millionen USD (40-47 % Wachstum im Jahresvergleich). Zu den wichtigsten Punkten gehören die FDA-Zulassungen für Roches TECENTRIQ HYBREZA und OCREVUS ZUNOVO mit ENHANZE-Technologie sowie erweiterte Partnerschaften mit argenx und ViiV Healthcare.
- Revenue increased 34% YOY to $290.1 million
- Royalty revenue grew 36% YOY to $155.1 million
- Net income rose 67% YOY to $137 million
- Adjusted EBITDA increased 60% YOY to $183.6 million
- GAAP EPS grew 72% YOY to $1.05
- Cash position strengthened to $666.3 million from $336.0 million in December 2023
- Raised 2024 guidance for revenue and earnings
- Increased operating expenses with higher SG&A costs
- Rising R&D expenses due to increased compensation costs
Insights
Halozyme delivered exceptional Q3 2024 results with significant growth across key metrics. Revenue surged
The company's raised guidance reflects strong business momentum, projecting total revenue of
The quarter showcased significant clinical and regulatory achievements, particularly with ENHANZE technology. Key approvals include Roche's TECENTRIQ HYBREZA and OCREVUS ZUNOVO, maintaining ENHANZE's perfect Phase 3 and regulatory success rate. The expansion of partnerships with argenx (four additional targets) and ViiV Healthcare demonstrates growing industry confidence in the subcutaneous delivery platform.
The robust pipeline progress, including Janssen's priority review for amivantamab SC and multiple new studies initiated by partners, indicates strong future growth potential and validates ENHANZE as a leading drug delivery technology.
Total Revenue Increased
Net Income Increased
GAAP Diluted EPS Increased
Raised 2024 Financial Guidance Ranges for Total Revenue of
"Our robust third quarter financial results highlight the strong execution and accelerating momentum we have across our business and exceeded expectations with total revenue growth of
Recent Partner Highlights:
- In October 2024, argenx initiated two studies evaluating VYVGART® Hytrulo with ENHANZE®, a Phase 3 study for adult patients with ocular myasthenia gravis ("oMG") and a Phase 2 study for kidney transplant recipients with antibody mediated rejection ("AMR").
- In October 2024, Janssen announced the European Commission approved DARZALEX® SC for the treatment of patients newly diagnosed with multiple myeloma ("NDMM") who are eligible for autologous stem cell transplant ("ASCT") in combination with bortezomib, lenalidomide, and dexamethasone ("D-VRd").
- In September 2024, argenx expanded its global collaboration and license agreement nominating four additional targets that provides them exclusive access to our ENHANZE® drug delivery technology for a total of six targets. Under the terms of the expanded exclusive agreement, we received upfront payments of
per target nomination for a total of$7.5 million . argenx is obligated to make future milestone payments of up to$30.0 million per new nominated target, subject to achievements of specified development, regulatory and sales-based milestones. We are also entitled to receive royalties on net sales of commercialized products with our ENHANZE® technology.$85.0 million - In September 2024, ViiV expanded its global collaboration and license agreement providing ViiV the ability to exclusively access our ENHANZE® drug delivery technology for one additional undisclosed target.
- In September 2024, Roche announced the
U.S. Food and Drug Administration ("FDA") approved OCREVUS ZUNOVO™ with ENHANZE® as a twice a year ten-minute subcutaneous ("SC") injection for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis. - In September 2024, Roche announced the FDA approved TECENTRIQ HYBREZA™ with ENHANZE® for all approved adult indications of intravenous ("IV") TECENTRIQ® and was made available to patients, resulting in a
milestone payment.$12.0 million - In September 2024, Janssen announced the submission of a supplemental Biologic License Application to the FDA for approval of a new indication of DARZALEX FASPRO® in combination with D-VRd for the treatment of adult patients with NDMM for whom ASCT is deferred or who are ineligible for ASCT.
- In August 2024, the FDA designated Janssen's Biologics License Application ("BLA") priority review status for amivantamab SC in combination with LAZCLUZE™ for currently approved or submitted indication of IV in certain patients with non-small cell lung cancer.
- In August 2024, Takeda submitted a New Drug Application in
Japan seeking approval for TAK-771 with ENHANZE® for treatment of chronic inflammatory demyelinating polyneuropathy/Multifocal Motor Neuropathy. - In July 2024, Janssen announced the FDA approved DARZALEX FASPRO® for an additional indication in NDMM patients who are eligible for ASCT in combination with D-VRd.
- In July 2024, argenx announced the National Medical Products Administration approved the BLA of efgartigimod SC for generalized myasthenia gravis in
China . - In July 2024, Acumen initiated a Phase 1 study of sabirnetug ("ACU193") co-formulated with ENHANZE® for the treatment of early Alzheimer's disease.
Third Quarter 2024 Financial Highlights:
- Revenue was
, compared to$290.1 million in the third quarter of 2023. The$216.0 million 34% year-over-year increase was primarily driven by royalty revenue growth and an increase in milestone revenue. Revenue for the quarter included in royalties, an increase of$155.1 million 36% compared to in the third quarter of 2023, primarily attributable to increases in revenue of DARZALEX® SC and Phesgo®, and the prior year launch of VYVGART® Hytrulo.$114.4 million - Cost of sales was
, compared to$49.4 million in the third quarter of 2023. The decrease was primarily due to lower device and bulk rHuPH20 sales.$54.8 million - Amortization of intangibles expense was
, compared to$17.8 million in the third quarter of 2023. The decrease was primarily due to an impairment charge of$20.3 million recognized in the prior year to fully impair the TLANDO® product rights intangible asset.$2.5 million - Research and development expense was
, compared to$18.5 million in the third quarter of 2023. The increase was primarily due to increased compensation expense.$17.3 million - Selling, general and administrative expense was
, compared to$41.2 million in the third quarter of 2023. The increase was primarily due to increased compensation expense and consulting and professional service fees.$35.3 million - Operating income was
, compared to$163.2 million in the third quarter of 2023.$88.3 million - Net Income was
, compared to$137.0 million in the third quarter of 2023.$81.8 million - EBITDA was
, compared to$183.6 million in the third quarter of 2023. Adjusted EBITDA was$124.6 million , compared to$183.6 million in the third quarter of 2023.1$114.9 million - GAAP diluted earnings per share was
, compared to$1.05 in the third quarter of 2023. Non-GAAP diluted earnings per share was$0.61 , compared to$1.27 in the third quarter of 2023.1$0.75 - Cash, cash equivalents and marketable securities were
on September 30, 2024, compared to$666.3 million on December 31, 2023. The increase was primarily a result of cash generated from operations.$336.0 million
Financial Outlook for 2024
The Company is raising its financial guidance for 2024. For the full year 2024, the Company expects:
- Total revenue of
to$970 million , representing growth of$1,020 million 17% to23% over 2023 total revenue primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of to$550 million , representing growth of$565 million 23% to26% over 2023. - Adjusted EBITDA of
to$595 million , representing growth of$625 million 40% to47% over 2023. - Non-GAAP diluted earnings per share of
to$4.00 , representing growth of$4.20 44% to52% 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 | |||
Royalty Revenue | |||
Adjusted EBITDA | |||
Non-GAAP Diluted EPS |
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
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
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. | ||||||||
Three Months Ended | Nine Months Ended | |||||||
2024 | 2023 | 2024 | 2023 | |||||
Revenues | ||||||||
Royalties | ||||||||
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 | $ 81,837 | |||||||
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. | ||||
September 30, | December 31, | |||
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. | ||||
Three Months Ended | ||||
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. | ||||
Three Months Ended | ||||
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. |
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SOURCE Halozyme Therapeutics, Inc.
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