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PRNewswire 18-Feb-2025 4:01 PM
Fourth Quarter Total Revenue Increased 30% YOY to $298 million and Royalty Revenue Increased 40% YOY to $170 million
Fourth Quarter Net Income Increased 60% YOY to $137 million; Adjusted EBITDA Increased 61% YOY to $196 million; GAAP EPS Increased 63% YOY to $1.06; non-GAAP EPS Increased 54% YOY to $1.261
Record Full Year 2024 Total Revenue Increased 22% YOY to $1,015 million and Record Royalty Revenue Exceeded Guidance Increasing 27% YOY to $571 million
Full Year 2024 Net Income Increased 58% YOY to $444 million; GAAP EPS Increased 63% YOY to $3.43; Adjusted EBITDA Increased 48% YOY to $632 million and non-GAAP EPS Increased 53% YOY to $4.231, Both Exceeding Guidance
Reiterating 2025 Financial Guidance Ranges for Total Revenue of $1,150 - 1,225 million, Representing YOY Growth of 13% - 21%, Adjusted EBITDA of $755 - $805 million, Representing YOY Growth of 19% - 27% and non-GAAP Diluted EPS of $4.95 - $5.35, Representing YOY Growth of 17% - 26%1
SAN DIEGO, Feb. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the fourth quarter and full year ended December 31, 2024, provided an update on its recent corporate activities and reiterated its 2025 financial guidance.
"I am excited to announce that the significant growth we achieved throughout the year culminated in two important milestones for the Company: achievement of more than $1 billion in total revenue and reaching a cumulative one million patients with our ENHANZE drug delivery technology. Our 2024 royalty revenue exceeded guidance driven by continued strong growth of DARZALEX SC and Phesgo, with modest initial contribution from VYVGART Hytrulo resulting from growing adoption and use primarily from its first indication for generalized myasthenia gravis. These three products will continue to drive our 2025 royalty revenues, with VYVGART Hytrulo becoming the largest dollar growth contributor in 2025," said Dr. Helen Torley, president and chief executive officer of Halozyme.
"I am also pleased that we achieved four additional, significant ENHANZE regulatory product and indication approvals in the U.S. and EU in 2024 for VYVGART Hytrulo for CIDP, Tecentriq Hybreza, Ocrevus Zunovo and Opdivo Qvantiq, positioning Halozyme for strong continued growth, post 2025, once coverage reimbursement and access are fully established," said Dr. Torley.
"Our leadership position in rapid subcutaneous drug delivery and long-term growth was further fortified with five new ENHANZE nominations from argenx and ViiV and an extension of our ENHANZE patent in Europe out to 2029, with a similar patent submitted in the U.S. Our 2025 guidance reflects our confidence in continuing robust total revenue, royalty revenue, adjusted EBITDA and non-GAAP EPS growth," Dr. Torley concluded.
Fourth Quarter and Recent Corporate Highlights:
Fourth Quarter and Recent Partner Highlights:
Fourth Quarter and Full Year 2024 Financial Highlights:
Financial Outlook for 2025
The Company is reiterating its financial guidance for 2025, which was initially provided on January 8, 2025. For the full year 2025, the Company expects:
Table 1. 2025 Financial Guidance
Guidance Range | ||
Total Revenue | $1,150 to $1,225 million | |
Royalty Revenue | $725 to $750 million | |
Adjusted EBITDA | $755 to $805 million | |
Non-GAAP Diluted EPS | $4.95 to $5.35 |
1 Adjusted EBITDA and non-GAAP Diluted EPS are non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures. |
Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the fourth quarter and full year ended December 31, 2024 today, Tuesday, February 18, 2025 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/Q4I7813760. 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 one million patient lives in post-marketing use in nine 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, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, 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, if any, such as 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, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges and transaction costs for business combinations. 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. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides non-GAAP financial measures that it believes will be achieved, however it cannot accurately predict all of the components of the adjusted calculations and the U.S. GAAP measures may be materially different than the non-GAAP measures.
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 expected financial outlook for 2025) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share and potential share repurchases under its share repurchase program. 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 and the expected expiration date of our ENHANZE® patent in Europe. 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 delays in the execution of the Company's share repurchase program, 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 termination of the European ENHANZE® patent prior to the date of expiration, 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 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
609-333-7668
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. Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts) | ||||||||
Three Months Ended | Twelve Months Ended | |||||||
2024 | 2023 | 2024 | 2023 | |||||
Revenues | ||||||||
Royalties | $ 170,419 | $ 122,052 | $ 570,991 | $ 447,865 | ||||
Product sales, net | 79,364 | 79,602 | 303,492 | 300,854 | ||||
Revenues under collaborative agreements | 48,225 | 28,385 | 140,841 | 80,534 | ||||
Total revenues | 298,008 | 230,039 | 1,015,324 | 829,253 | ||||
Operating expenses | ||||||||
Cost of sales | 42,055 | 52,298 | 159,417 | 192,361 | ||||
Amortization of intangibles | 17,762 | 17,762 | 71,049 | 73,773 | ||||
Research and development | 20,441 | 21,336 | 79,048 | 76,363 | ||||
Selling, general and administrative | 42,249 | 37,608 | 154,335 | 149,182 | ||||
Total operating expenses | 122,507 | 129,004 | 463,849 | 491,679 | ||||
Operating income | 175,501 | 101,035 | 551,475 | 337,574 | ||||
Other income (expense) | ||||||||
Investment and other income, net | 7,253 | 5,360 | 23,752 | 16,317 | ||||
Contingent liability fair value measurement gain | — | — | — | 13,200 | ||||
Interest expense | (4,540) | (5,220) | (18,095) | (18,762) | ||||
Income before income tax expense | 178,214 | 101,175 | 557,132 | 348,329 | ||||
Income tax expense | 41,202 | 15,787 | 113,041 | 66,735 | ||||
Net income | $ 137,012 | $ 85,388 | $ 444,091 | $ 281,594 | ||||
Earnings per share | ||||||||
Basic | $ 1.08 | $ 0.66 | $ 3.50 | $ 2.13 | ||||
Diluted | $ 1.06 | $ 0.65 | $ 3.43 | $ 2.10 | ||||
Weighted average common shares outstanding | ||||||||
Basic | 126,406 | 129,054 | 126,827 | 131,927 | ||||
Diluted | 128,980 | 131,035 | 129,424 | 134,197 |
Halozyme Therapeutics, Inc. Consolidated Balance Sheets (Unaudited) (In thousands) | ||||
December 31, | December 31, | |||
ASSETS | ||||
Current assets | ||||
Cash and cash equivalents | $ 115,850 | $ 118,370 | ||
Marketable securities, available-for-sale | 480,224 | 217,630 | ||
Accounts receivable, net and contract assets | 308,455 | 234,210 | ||
Inventories | 141,860 | 127,601 | ||
Prepaid expenses and other current assets | 38,951 | 48,613 | ||
Total current assets | 1,085,340 | 746,424 | ||
Property and equipment, net | 75,035 | 74,944 | ||
Prepaid expenses and other assets | 80,596 | 17,816 | ||
Goodwill | 416,821 | 416,821 | ||
Intangible assets, net | 401,830 | 472,879 | ||
Deferred tax assets, net | 3,855 | 4,386 | ||
Total assets | $ 2,063,477 | $ 1,733,270 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities | ||||
Accounts payable | $ 10,249 | $ 11,816 | ||
Accrued expenses | 128,851 | 100,678 | ||
Total current liabilities | 139,100 | 112,494 | ||
Long-term debt, net | 1,505,798 | 1,499,248 | ||
Other long-term liabilities | 54,758 | 37,720 | ||
Total liabilities | 1,699,656 | 1,649,462 | ||
Stockholders' equity | ||||
Common stock | 123 | 127 | ||
Additional paid-in capital | — | 2,409 | ||
Accumulated other comprehensive income (loss) | 3,829 | (9,278) | ||
Retained earnings | 359,869 | 90,550 | ||
Total stockholders' equity | 363,821 | 83,808 | ||
Total liabilities and stockholders' equity | $ 2,063,477 | $ 1,733,270 |
Halozyme Therapeutics, Inc. GAAP to Non-GAAP Reconciliations EBITDA (Unaudited) (In thousands) | ||||||||
Three Months Ended | Twelve Months Ended | |||||||
2024 | 2023 | 2024 | 2023 | |||||
GAAP Net Income | $ 137,012 | $ 85,388 | $ 444,091 | $ 281,594 | ||||
Adjustments | ||||||||
Investment and other income, net | (7,320) | (5,360) | (24,356) | (16,317) | ||||
Interest expense | 4,540 | 5,220 | 18,095 | 18,762 | ||||
Income tax expense | 41,202 | 15,787 | 113,041 | 66,735 | ||||
Depreciation and amortization | 20,415 | 20,693 | 81,312 | 84,856 | ||||
EBITDA | 195,849 | 121,728 | 632,183 | 435,630 | ||||
Adjustments | ||||||||
Gain on changes in fair value of contingent liability(1) | — | — | — | (13,200) | ||||
Inventory write-off(2) | — | — | — | 3,509 | ||||
Transaction costs for business combinations(3) | — | — | — | 278 | ||||
Adjusted EBITDA | $ 195,849 | $ 121,728 | $ 632,183 | $ 426,217 |
(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. ("Antares"). |
(3) | Amounts represent incremental costs including legal fees, accounting fees and advisory fees incurred for the Antares acquisition. |
Halozyme Therapeutics, Inc. GAAP to Non-GAAP Reconciliations Diluted EPS (Unaudited) (In thousands, except per share amounts) | ||||||||
Three Months Ended | Twelve Months Ended December 31, | |||||||
2024 | 2023 | 2024 | 2023 | |||||
GAAP Diluted EPS | $ 1.06 | $ 0.65 | $ 3.43 | $ 2.10 | ||||
Adjustments | ||||||||
Share-based compensation | 0.09 | 0.07 | 0.34 | 0.27 | ||||
Amortization of debt discount | 0.01 | 0.01 | 0.06 | 0.05 | ||||
Amortization of intangible assets | 0.14 | 0.14 | 0.55 | 0.53 | ||||
Amortization of inventory step-up at fair value(1) | — | — | — | 0.02 | ||||
Prior income tax benefit adjustments | — | (0.04) | — | (0.04) | ||||
TLANDO Related Adjustments | ||||||||
Gain on changes in fair value of contingent liability(2) | — | — | — | (0.10) | ||||
Inventory write-off(2) | — | — | — | 0.03 | ||||
Impairment charge of TLANDO product rights intangible assets(2) | — | — | — | 0.02 | ||||
Income tax effect of above adjustments(3) | (0.04) | (0.01) | (0.14) | (0.12) | ||||
Non-GAAP Diluted EPS | $ 1.26 | $ 0.82 | $ 4.23 | $ 2.77 | ||||
GAAP Diluted Shares | 128,980 | 131,035 | 129,424 | 134,197 | ||||
Adjustments | ||||||||
Adjustment for dilutive impact of senior 2028 Convertible Notes(4) | — | — | (74) | — | ||||
Non-GAAP Diluted Shares | 128,980 | 131,035 | 129,350 | 134,197 |
Dollar amounts, as presented, are rounded. Consequently, totals may not add up. | |
(1) | Amounts relate to amortization of the inventory step-up associated with purchase accounting for the Antares acquisition. |
(2) | 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. |
(3) | 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. |
(4) | 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.