Full Press Release Details
Reiterating 2024 Financial Guidance: Total Revenue of $915 -985 Million, Representing YOY Growth of 10-19%, Adjusted EBITDA of $535 -585 Million, Representing YOY Growth of 26- 37% and Non-GAAP Diluted EPS of $3.55 -3.90, Representing YOY Growth of 28-41%
Fourth Quarter Revenue Increased 27% YOY to $230 million ; GAAP Diluted EPS of $0.65 and Non-GAAP Diluted EPS of $0.82 1
Full Year 2023 Revenue Increased 26% YOY to $829 million ; GAAP Diluted EPS of $2.10 and Non-GAAP Diluted EPS of $2.77 1
Announcing New $750 million Share Repurchase Program
SAN DIEGO , Feb. 20, 2024 /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, 2023 and provided an update on its recent corporate activities and outlook.
"We are pleased to reiterate our 2024 financial guidance, which represents continued robust growth of total revenue, royalty revenue, adjusted EBITDA and non-GAAP diluted EPS, and builds upon our strong 2023 performance and results. Multiple, positive, value-creating events including the first approvals of VYVGART Hytrulo and Tecentriq SC and positive phase 3 data readouts with ENHANZE for VYVGART Hytrulo in CIDP, ocrelizumab SC and nivolumab SC all achieved in 2023, add new opportunities for continued revenue growth," said Dr. Helen Torley , president and chief executive officer of Halozyme. "Today's announcement of a new $750 million share repurchase program demonstrates our confidence in sustained and durable growth."
Fourth Quarter and Recent Corporate Highlights:
Fourth Quarter and Recent Partner Highlights:
Fourth Quarter 2023 Financial Highlights:
Financial Outlook for 2024
The Company is reiterating its financial guidance for 2024, which was initially provided on January 17, 2024 . For the full year 2024, the Company expects:
Table 1. 2024 Financial Guidance
| Guidance Range | |||
| Total Revenue | $915 to $985 million | ||
| Royalty Revenue | $500 to $525 million | ||
| Adjusted EBITDA | $535 to $585 million | ||
| Non-GAAP Diluted EPS | $3.55 to $3.90 |
Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the fourth quarter and full year December 31, 2023 today, Tuesday, February 20, 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/Q4I871904 . 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.
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 reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven 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 several pharmaceutical companies including 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 convertible notes inducement expense, share-based compensation expense, amortization of debt discount, intangible asset amortization, transaction costs for business combinations, realized gains or losses on marketable security sales, one-time changes in contingent liabilities, inventory adjustments and impairment charges, and certain adjustments to income tax expense. 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 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. 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 longer term projections) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, non-GAAP diluted earnings-per-share and potential share repurchase 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. 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 Company's development and partnership potential of a high volume auto-injector. 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 (including its high volume auto-injector), 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 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 [email protected]
Samantha Gaspar Teneo 617-877-9710 [email protected]
Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information and adjusted guidance measures are provided at the end.
| Halozyme Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts) | ||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| Revenues | ||||||||
| Royalties | $ 122,052 | $ 105,979 | $ 447,865 | $ 360,475 | ||||
| Product sales, net | 79,602 | 61,163 | 300,854 | 191,030 | ||||
| Revenues under collaborative agreements | 28,385 | 14,354 | 80,534 | 108,611 | ||||
| Total revenues | 230,039 | 181,496 | 829,253 | 660,116 | ||||
| Operating expenses | ||||||||
| Cost of sales | 52,298 | 42,120 | 192,361 | 139,304 | ||||
| Amortization of intangibles | 17,762 | 4,552 | 73,773 | 43,148 | ||||
| Research and development | 21,336 | 22,566 | 76,363 | 66,607 | ||||
| Selling, general and administrative | 37,608 | 37,749 | 149,182 | 143,526 | ||||
| Total operating expenses | 129,004 | 106,987 | 491,679 | 392,585 | ||||
| Operating income | 101,035 | 74,509 | 337,574 | 267,531 | ||||
| Other income (expense) | ||||||||
| Investment and other (expense) income, net | 5,360 | 852 | 16,317 | 1,046 | ||||
| Inducement expense related to convertible note | — | — | — | (2,712) | ||||
| Contingent liability fair value measurement gain | — | — | 13,200 | — | ||||
| Interest expense | (5,220) | (4,570) | (18,762) | (16,947) | ||||
| Net income before income taxes | 101,175 | 70,791 | 348,329 | 248,918 | ||||
| Income tax expense | 15,787 | 13,089 | 66,735 | 46,789 | ||||
| Net income | $ 85,388 | $ 57,702 | $ 281,594 | $ 202,129 | ||||
| Earnings per share | ||||||||
| Basic | $ 0.66 | $ 0.43 | $ 2.13 | $ 1.48 | ||||
| Diluted | $ 0.65 | $ 0.42 | $ 2.10 | $ 1.44 | ||||
| Weighted average common shares outstanding | ||||||||
| Basic | 129,054 | 135,284 | 131,927 | 136,844 | ||||
| Diluted | 131,035 | 138,601 | 134,197 | 140,608 |
| Halozyme Therapeutics, Inc. Consolidated Balance Sheets (Unaudited) (In thousands) | ||||
| December 31, 2023 | December 31, 2022 | |||
| ASSETS | ||||
| Current assets | ||||
| Cash and cash equivalents | $ 118,370 | $ 234,195 | ||
| Marketable securities, available-for-sale | 217,630 | 128,599 | ||
| Accounts receivable, net and contract assets | 234,210 | 231,072 | ||
| Inventories, net | 127,601 | 100,123 | ||
| Prepaid expenses and other current assets | 48,613 | 45,024 | ||
| Total current assets | 746,424 | 739,013 | ||
| Property and equipment, net | 74,944 | 75,570 | ||
| Prepaid expenses and other assets | 17,816 | 26,301 | ||
| Goodwill | 416,821 | 409,049 | ||
| Intangible assets, net | 472,879 | 546,652 | ||
| Deferred tax assets, net | 4,386 | 44,426 | ||
| Restricted cash | — | 500 | ||
| Total assets | $ 1,733,270 | $ 1,841,511 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
| Current liabilities | ||||
| Accounts payable | $ 11,816 | $ 17,693 | ||
| Accrued expenses | 100,678 | 99,762 | ||
| Current portion of long-term debt, net | — | 13,334 | ||
| Total current liabilities | 112,494 | 130,789 | ||
| Long-term debt, net | 1,499,248 | 1,492,766 | ||
| Other long-term liabilities | 37,720 | 32,686 | ||
| Contingent liability | — | 15,472 | ||
| Total liabilities | 1,649,462 | 1,671,713 | ||
| Stockholders' equity | ||||
| Common stock | 127 | 135 | ||
| Additional paid-in capital | 2,409 | 27,368 | ||
| Accumulated other comprehensive loss | (9,278) | (922) | ||
| Retained earnings | 90,550 | 143,217 | ||
| Total stockholders' equity | 83,808 | 169,798 | ||
| Total liabilities and stockholders' equity | $ 1,733,270 | $ 1,841,511 |
| Halozyme Therapeutics, Inc. GAAP to Non-GAAP Reconciliations EBITDA (Unaudited) (In thousands) | ||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| GAAP Net Income | $ 85,388 | $ 57,702 | $ 281,594 | $ 202,129 | ||||
| Adjustments | ||||||||
| Investment and other income | (5,360) | (852) | (16,317) | (1,046) | ||||
| Interest expense | 5,220 | 4,570 | 18,762 | 16,947 | ||||
| Income tax expense | 15,787 | 13,089 | 66,735 | 46,789 | ||||
| Depreciation and amortization | 20,693 | 7,114 | 84,856 | 49,641 | ||||
| EBITDA | 121,728 | 81,623 | 435,630 | 314,460 | ||||
| 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) | — | 1,391 | 278 | 21,934 | ||||
| Severance and share-based compensation acceleration expense (4) | — | — | — | 22,552 | ||||
| Adjusted EBITDA | $ 121,728 | $ 83,014 | $ 426,217 | $ 358,946 |
| Dollar amounts, as presented, are rounded. Consequently, totals may not add up. | |
| (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 prior year Antares acquisition. |
| (4) | Amount represents severance cost and acceleration of unvested equity awards as part of the Antares merger agreement. |
| Halozyme Therapeutics, Inc. GAAP to Non-GAAP Reconciliations Net Income and Diluted EPS (Unaudited) (In thousands, except per share amounts) | ||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2023 | 2022 | 2023 | 2022 | |||||
| GAAP Diluted EPS | $ 0.65 | $ 0.42 | $ 2.10 | $ 1.44 | ||||
| Adjustments | ||||||||
| Inducement expense related to convertible notes | — | — | — | 0.02 | ||||
| Share-based compensation | 0.07 | 0.05 | 0.27 | 0.17 | ||||
| Amortization of debt discount | 0.01 | 0.01 | 0.05 | 0.06 | ||||
| Amortization of intangible assets | 0.14 | 0.03 | 0.53 | 0.31 | ||||
| Transaction costs for business combinations (1) | — | — | — | 0.16 | ||||
| Severance and share-based compensation acceleration expense (2) | — | — | — | 0.16 | ||||
| Amortization of inventory step-up at fair value (3) | — | (0.01) | 0.02 | 0.06 | ||||
| Realized loss from marketable securities (4) | — | — | — | 0.01 | ||||
| Prior income tax benefit adjustments | (0.04) | — | (0.04) | — | ||||
| TLANDO Related Adjustments | ||||||||
| Gain on changes in fair value of contingent liability (5) | — | — | (0.10) | — | ||||
| Inventory write-off (5) | — | — | 0.03 | — | ||||
| Impairment charge of TLANDO product rights intangible assets (5) | — | — | 0.02 | — | ||||
| Income tax effect of above adjustments (6) | (0.01) | (0.03) | (0.12) | (0.17) | ||||
| Non-GAAP Diluted EPS | $ 0.82 | $ 0.48 | $ 2.77 | $ 2.21 | ||||
| GAAP & Non-GAAP Diluted Shares | 131,035 | 138,601 | 134,197 | 140,608 |
| Dollar amounts, as presented, are rounded. Consequently, totals may not add up. | |
| (1) | Amount represents incremental costs including legal fees, accounting fees and advisory fees incurred for the prior year Antares acquisition. |
| (2) | Amount represents severance cost and acceleration of unvested equity awards as part of the Antares merger agreement. |
| (3) | Amounts relate to amortization of the inventory step-up associated with purchase accounting for the Antares acquisition. |
| (4) | Amount represents a realized loss from the sale of our marketable securities to finance the prior year acquisition of Antares. |
| (5) | Amounts relate to a fair value gain on contingent liability, inventory write-off and impairment of TLANDO product rights intangible assets due to the TLANDO Termination. |
| (6) | 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. |
SOURCE Halozyme Therapeutics, Inc.