Daratumumab/Hyaluronidase-fihj

Company Granted New European Patent for ENHANZE® Drug Delivery Platform SAN DIEGO, June 6, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that the Company is raising its full year 2024 financial guidance and updating its 5-year financial outlook based on the grant of European Patent No. 4269578, covering the ENHANZE® rHuPH20 product obtained from Halozyme's ENHANZE® manufacturing methods that the Company provides to its current and future licensees. The new patent is licensed under all of Halozyme's ENHANZE® licenses. It will be validated in 37 European countries and expires on March 6, 2029. "We are pleased to be able to raise our full year 2024 financial guidance and 5-year financial outlook, which now reflect the original royalty rate for DARZALEX SC in Europe from the granting of this new European patent, which is valid through March 6, 2029," said Dr. Helen Torley, president and chief executive officer of Halozyme. Under the terms of Halozyme's ENHANZE® license with Janssen, the newly granted patent prevents the reduction in the royalty rate on sales of DARZALEX® SC in the European countries where it is validated until the patent expires. The new patent is not expected to have any impact to royalties under other ENHANZE® licenses with an issued or pending collaboration patent, as current royalty rates for these licenses already are expected to extend beyond expiration of the new patent. Based on the new European patent for ENHANZE®, the Company is raising its full year 2024 financial guidance and updating its 5-year financial outlook during its investor presentation. For the full year 2024, the Company expects: Total revenue of $935 million to $1,015 million, representing growth of 13% to 22% over 2023, primarily driven by increases in royalty revenue, collaboration revenue and growth in product sales from XYOSTED®. Revenue from royalties of $520 million to $555 million, representing growth of 16% to 24% over 2023. Adjusted EBITDA of $555 million to $615 million, representing growth of 30% to 44% over 2023. Non-GAAP diluted earnings per share of $3.65 to $4.05, representing growth of 32% to 46% over 2023. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. 2024 Financial Guidance Halozyme will provide additional details on the new European patent and its 5-year financial outlook on a conference call on Thursday, June 6 at 5:30am PT/8:30am ET. The call and presentation are available through the "Investors" section of Halozyme's corporate website. To access the webcast and presentation, please visit ir.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 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 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 discount, intangible asset amortization, transaction costs for business combinations, realized gains or losses on marketable security sales and certain adjustments to income tax expense. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding 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 contingent liabilities, 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 Halozyme's financial performance (including Halozyme's financial outlook for 2024 and five year longer term financial outlook) and expectations for total revenue, royalty and collaboration revenue, product sales, Adjusted EBITDA and non-GAAP diluted earnings-per-share. Forward-looking statements also include statements concerning the recent grant of Halozyme's European Patent No. 4269578 covering Halozyme's ENHANZE® drug delivery technology rHuPH20 product including the expected validation of the patent in thirty-seven European countries, the future expected expiration date of the patent, the expected impact the patent will have on Halozyme's current and future ENHANZE® licenses, including the expected prevention of the reduction in the royalty rate Halozyme receives under the Janssen license on sales of products co-formulated with ENHANZE® in the European countries where the patent is validated. These forward-looking statements are typically, but not always, identified through use of the words "believe," "expected," "pending," "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 validation of the recently issued European patent in European countries and termination of the European patent prior to the expected date of expiration. These and other factors that may result in differences are discussed in greater detail in Halozyme'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, Halozyme undertakes no duty or obligation to update forward-looking statements to reflect events after the date of this press release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] SOURCE Halozyme Therapeutics, Inc.